Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack)
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Romiplostim may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Nplate's active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune primary thrombocytopenia (called ITP). ITP is a disease in which your body's immune system destroys its own platelets. Platelets are the cells in your blood that help seal cuts and form blood clots. Very low platelet counts can cause bruising and serious bleeding. Nplate is used to treat adult patients (aged 18 years and over) with ITP who may or may not have had their spleen removed and who have been previously treated with corticosteroids or immunoglobulins, where these treatments don't work. Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets. This should help to prevent bruising and bleeding associated with ITP. 2.
What you need to know before you take it
e Nplate
Do not use Nplate: • •
if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6). if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
Warnings and precautions •
If you stop taking Nplate a low blood platelet count (thrombocytopenia) is likely to reoccur. If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
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•
If you are at risk of blood clots or if blood clots are common in your family. The risk of blood clotting may also be increased if you: have liver problems; are elderly (≥ 65 years); are bedridden; have cancer; are taking the contraceptive pill or hormone replacement therapy; have recently had surgery or suffered an injury; are obese (overweight); are a smoker. Talk to your doctor, pharmacist or nurse before using Nplate. If you have very high blood platelet counts this may increase the risk of blood clotting. Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high. Bone marrow changes (increased reticulin and possible bone marrow fibrosis) Long-term use of Nplate may cause changes in your bone marrow. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called "increased reticulin" and has been observed in Nplate clinical trials. It is not known if this may progress to a more severe form called "fibrosis." Signs of bone marrow changes may show up as abnormalities in your blood tests. Your doctor will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate. Worsening of blood cancers Your doctor may decide to take a bone marrow biopsy if they decide it is necessary to ensure that you have ITP, and not another condition such as Myelodysplastic Syndrome (MDS). If you have MDS and receive Nplate you may have an increase in your blast cell counts and your MDS condition may worsen to become an acute myeloid leukaemia, which is a type of cancer of the blood. Loss of response to romiplostim If you experience a loss of response or failure to maintain a platelet response with romiplostim treatment, your doctor will investigate the reasons why including whether you are experiencing increased bone marrow fibres (reticulin) or have developed antibodies which neutralise romiplostim's activity. Children and adolescents Nplate is not recommended for use in children below age 18. Other medicines and Nplate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are also taking medicines which prevent blood clots (anticoagulants or anti-platelet therapy) there is a greater risk of bleeding. Your doctor will discuss this with you. If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your ITP, these may be reduced or stopped when given together with Nplate.
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Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Nplate is not recommended for use if you are pregnant unless indicated by your doctor. It is not known whether romiplostim is present in human milk. Nplate is not recommended for use if you are breast-feeding. A decision on whether to discontinue breast-feeding or discontinue therapy with romiplostim should be made taking into account the benefit of breast-feeding to your child and the benefit of romiplostim therapy to you. Driving and using machines You should speak with your doctor before driving or using machines, as some side effects (e.g. temporary bouts of dizziness) may impair your ability to do so safely. 3.
How to take it
Nplate
Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you. Nplate is administered once a week as an injection under the skin (subcutaneous). Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week. Your doctor will tell you how much you must take. Nplate should be injected once per week in order to keep your platelet counts up. Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary. Once your platelet count is under control, your doctor will continue to regularly check your blood. Your dose may be adjusted further in order to maintain long-term control of your platelet count. Always use Nplate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure of how to use Nplate. Instructions for preparing and giving an injection of Nplate After suitable training, your doctor may also allow you to inject Nplate yourself. Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor. If your doctor has allowed you to self-inject, you should follow up with your doctor every month to have the doctor determine if Nplate is working for you or if another treatment needs to be considered. After the first month of self-injecting Nplate, you will need to show that you can still prepare and inject Nplate correctly. If you use more Nplate than you should Your doctor will ensure that you receive the right amount of Nplate. If you have been given more Nplate than you should, you may not experience any physical symptoms but your blood platelet counts may rise to very high levels and this may increase the risk of blood clotting. Therefore if your doctor suspects that you have been given more Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately. If your doctor has allowed you to self-inject and you use more Nplate than you should, then inform your doctor immediately.
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If you use less Nplate than you should Your doctor will ensure that you receive the right amount of Nplate. If you have been given less Nplate than you should, you may not experience any physical symptoms but your blood platelet counts may become low and this may increase the risk of bleeding. Therefore if your doctor suspects that you have been given less Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately. If your doctor has allowed you to self-inject and you use less Nplate than you should, then inform your doctor immediately. If you forget to use Nplate If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose. If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inform your doctor immediately. If you stop using Nplate If you stop using Nplate, your low blood platelet count (thrombocytopenia) is likely to reoccur. Your doctor will decide if you should stop using Nplate. Injecting Nplate yourself Your doctor may decide that it is best for you to inject Nplate. Your doctor, nurse or pharmacist will show you how to inject yourself with Nplate. Do not try to inject yourself if you have not been trained. It is very important that you prepare Nplate properly and take the correct dose (see section 7. Instructions for preparing and giving an injection of Nplate, at the end of this leaflet). 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common: may affect more than 1 in 10 people • headache; • allergic reaction; • upper respiratory tract infection. Common: may affect up to 1 in 10 people • bone marrow disorder, including increased bone marrow fibres (reticulin); • trouble sleeping (insomnia); • dizziness; • tingling or numbness of the hands or feet (paraesthesia); • migraine; • redness of the skin (flushing); • blood clot in a lung artery (pulmonary embolism); • nausea; • diarrhoea; • abdominal pain; • indigestion (dyspepsia); • constipation; • itching of the skin (pruritis); • bleeding under the skin (ecchymosis); 4
• • • • • • • • • • • • • • • • • • • • • • •
bruising (contusion); rash; joint pain (arthralgia); muscles pain or weakness (myalgia); pain in your hands and feet; muscle spasm; back pain; bone pain; tiredness (fatigue); injection site reactions; swelling in the hands and feet (oedema peripheral); flu like symptoms (influenza like illness); pain; weakness (asthenia); fever (pyrexia); chills; contusion; swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema); gastroenteritis; palpitations; inflammation of the sinuses (sinusitis); inflammation of the passages that carry air to the lungs (bronchitis). blood clot in the veins (deep vein thrombosis).
Common: may affect up to 1 in 10 people (may show up in blood or urine tests) • low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia) after stopping Nplate; • higher than normal platelet counts (thrombocytosis); • anaemia. Uncommon: may affect up to 1 in 100 people • bone marrow failure; disorder of the bone marrow that causes scarring (myelofibrosis); enlarged spleen (splenomegaly); bleeding of the vagina (vaginal haemorrhage), bleeding in the rectum (rectal haemorrhage); bleeding mouth (mouth haemorrhage); injection site bleeding (injection site haemorrhage); • heart attack (myocardial infarction); increased heart rate; • dizziness or a spinning sensation (vertigo); • problems with the eyes including: bleeding in the eye (conjunctival haemorrhage); difficulty focussing or blurred vision (accommodation disorder, papilloedema or eye disorder); blindness; itchy eye (eye pruritus); increased tears (lacrimation increased); or visual disturbances; • problems with the digestive system including: vomiting; bad breath (breath odour); difficulty swallowing (dysphagia); indigestion or heartburn (gastro-oesophageal reflux disease); blood in the stools (haematochezia); stomach discomfort; mouth ulcers or mouth blistering (stomatitis); discoloured teeth (tooth discolouration); • weight decreased; weight increased; intolerance of alcohol; loss of appetite (anorexia or decreased appetite); dehydration; • generally feeling unwell (malaise); chest pain; irritability; swelling of the face (face oedema); feeling hot; increased body temperature; feeling jittery; • influenza; localised infection; inflammation of the passages in the nose and throat (nasopharyngitis); • problems with the nose and throat including: cough; runny nose (rhinorrhoea); dry throat; shortness of breath or difficulty breathing (dyspnoea); nasal congestion; painful breathing (painful respiration) • painful swollen joints caused by uric acid (food breakdown product) (gout); 5
• •
• •
•
•
muscle tightness; muscular weakness; shoulder pain; muscle twitching; problems with your nervous system including involuntary muscle contractions (clonus); distorted sense of taste (dysgeusia); decrease in sense of taste (hypogeusia); decreased feeling of sensitivity, especially in the skin (hypoaesthesia); alteration in the nerve functions in the arms and legs (neuropathy peripheral); blood clot in the transverse sinus (transverse sinus thrombosis); depression; abnormal dreams; hair loss (alopecia); sensitivity to light (photosensitivity reaction); acne; allergic reaction in the skin upon contact with allergen (dermatitis contact); skin manifestation with rash and blisters (eczema); dry skin; redness of the skin (erythema); severe flaking or peeling rash (exfoliative rash); abnormal hair growth; thickening and itching of the skin due to repeated scratching (prurigo); bleeding beneath the surface of the skin or bruising under the skin (purpura); bumpy skin rash (rash papular); itchy skin rash (rash pruritic); generalised itchy rash (urticaria); bump on the skin (skin nodule); abnormal smell to the skin (skin odour abnormal); problems with the circulation including blood clot in the vein in the liver (portal vein thrombosis); low blood pressure (hypotension); increased blood pressure; blocking of a blood vessel or (peripheral embolism); reduced blood flow in the hands, ankles or feet (peripheral ischaemia); swelling and clotting in a vein, which may be extremely tender when touched (phlebitis or thrombophlebitis superficial); blood clot (thrombosis). a rare disorder characterised by periods of burning pain, redness and warmth in the feet and hands (erythromelalgia).
Uncommon: may affect up to 1 in 100 people (may show up in blood or urine tests) • a rare type of anaemia in which the red blood cells, white blood cells and platelets are all reduced in number (aplastic anaemia); • raised white blood cell count (leucocytosis); • excess platelet production (thrombocythaemia); increased platelet counts; abnormal count in the cells in the blood that prevents bleeding (platelet count abnormal); • changes in some blood tests (increase in transaminase; blood lactate dehydrogenase increased); • or cancer of white blood cells (multiple myeloma); • protein in the urine. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5.
How to store it
Nplate
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the vial label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original carton in order to protect from light.
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This medicine may be removed from the refrigerator for a period of 30 days at room temperature (up to 25°C) when stored in the original carton. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Nplate contains –
The active substance is romiplostim. Each vial of Nplate 250 micrograms powder for solution for injection contains a total of 375 micrograms of romiplostim. An additional overfill is included in each vial to ensure that 250 micrograms of romiplostim can be delivered. After dissolving, a deliverable amount of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
–
The other ingredients are: Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20. Solvent: water for injections.
What Nplate looks like and contents of the pack Nplate is a white powder for solution for injection supplied in a 5 mL single-dose glass vial. Nplate is supplied as a 1 pack or multipack comprising 4 packs. Each pack contains: 1 vial of 250 micrograms of romiplostim. 1 pre-filled syringe containing 0.72 mL of water for injections. 1 plunger rod for pre-filled syringe. 1 sterile vial adapter. 1 sterile 1 mL Luer lock syringe. 1 sterile safety needle. 4 alcohol swabs. Not all pack sizes may be marketed. Marketing Authorisation Holder Amgen Limited 216 Cambridge Science Park Milton Road Cambridge CB4 0WA United Kingdom Manufacturer Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands
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Manufacturer Amgen Technology (Ireland) Unlimited Company Pottery Road Dun Laoghaire Co Dublin Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Amgen Limited Tel: +44 (0)1223 420305 This leaflet was last revised in July 2025. ————————————————————————————————————————–7.
Instructions for preparing and giving an injection of Nplate
This section contains information on how to give yourself an injection of Nplate. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance. It is very important the product is prepared correctly and the correct dose is taken. This section is divided into the following subsections: Before you begin Step 1. Set up materials for an injection Step 2. Prepare vial for use, attach vial adapter Step 3. Prepare sterile water syringe Step 4. Dissolving Nplate by injecting water into vial Step 5. Prepare new syringe for injection Step 6. Prepare injection needle Step 7. Choose and prepare an injection site Step 8. Injecting the Nplate liquid Step 9. Disposing of supplies Before you begin Read all instructions for use thoroughly. These instructions are for patients who are already trained by their healthcare professional, such as your doctor, nurse, or pharmacist, in self injection. If you have not been trained, please contact your healthcare professional. The Nplate self injection kit must be kept in the original package until use in order to protect the Nplate vial from light. Keep the Nplate self injection kit refrigerated at 2°C to 8°C. Once Nplate has been dissolved, inject immediately. You may have excess Nplate left over after administering your prescribed dose. Do not re-use Nplate! Any excess dissolved Nplate must be thrown away immediately after completing the injection process. Left over Nplate in vial must NEVER be re-used for another injection.
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Step 1. Set up materials for an injection Do the following: •
Select a well lit, flat work surface, such as a table.
•
Take the Nplate self injection kit out of the refrigerator. Do not use if frozen. If you have any questions about storage, contact your healthcare professional for further instructions. Check the expiry date on the self injection kit. If the expiry date has passed, do not use. Stop and contact your healthcare professional.
•
Note: If your healthcare professional has instructed you that your Nplate dose requires more than one injection of Nplate, you will need to use more than one self injection kit. Follow the steps as described in this leaflet and use as many self injection kits as necessary to complete your prescribed dose of Nplate.
•
Make sure you have the following items: Alcohol swab package x4
A vial of powder, either 250 micrograms x1
13 mm vial adapter x1
Plunger rod for pre-filled sterile water syringe x1
Pre-filled sterile water syringe x1
1 mL Luer-lock tip syringe x1
Injection safety needle x1
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•
Do not open items until directed in instructions.
•
Do not use components that have evidence of tampering or damage.
•
Do not re-use items.
Step 2. Prepare vial for use, attach vial adapter Using: 2 alcohol swab packages, 1 vial, and 1 vial adapter package. Do the following: •
Wash your hands with soap and warm water.
•
Clean the flat work surface with a new alcohol swab.
•
Remove red (250 micrograms) plastic cap from vial.
•
Using a new alcohol swab clean vial stopper.
•
Do not touch vial stopper after cleaning it.
•
Peel off paper backing slowly from vial adapter while keeping vial adapter in the plastic package.
•
Do not touch vial stopper or spike of vial adapter.
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•
Keeping the vial on a table, and keeping the vial adapter in the plastic packaging, line up spike on the vial adapter to the centre of the stopper on the vial.
•
Push the vial adapter down onto the vial until it is firmly in place and you can't push down any more.
•
Lift off plastic vial adapter packaging, leaving vial adapter on vial.
•
Do not touch the top of vial adapter.
Step 3. Prepare sterile water syringe Using: Pre-filled sterile water syringe and plunger rod. Before you begin Step 3 please note the following: •
The clear plastic plunger rod MUST always be attached first before breaking the white tip off of the pre-filled water syringe. Perform step 3a before step 3b.
Do the following: •
Step 3a: Attach clear plastic plunger rod to pre-filled sterile water syringe by placing the threaded end of the plunger rod into the syringe and carefully twisting the rod clockwise onto the grey syringe plunger, until you feel a slight resistance. Do not over tighten. 11
•
Step 3b: Holding the syringe with one hand, bend the tip of the white plastic cover downward with your other hand. This will break the seal of the white plastic cover.
•
Once the seal is broken, pull the white plastic cover off. You will see grey rubber in the cap.
Step 4. Dissolving Nplate by injecting water into vial Using: Pre-filled sterile water syringe and vial with vial adapter attached. Before you begin Step 4 please note the following: •
Do dissolve slowly and carefully. This is a protein product and proteins can be easily damaged by improper mixing and excessive shaking.
Do the following: •
Keeping the vial on the table, attach water-filled syringe to vial adapter by holding the side of the vial adapter with one hand and twisting the syringe tip clockwise onto the adapter with the other hand until you feel a slight resistance.
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•
Very slowly and gently push down on plunger rod to inject all water in the syringe into the vial. Water must flow slowly onto powder.
•
Do not force the water into the vial.
•
Note: After injecting the water into the vial it is common for the plunger to move back up. You do not have to maintain pressure on the plunger for the rest of Step 4. Push slowly and gently
Before continuing: •
Do ensure that all water is injected from the syringe into the vial before dissolving. •
Holding the area where the vial and vial adapter connect between your fingers, gently swirl the vial by rotating your wrist until all of the powder has dissolved and the liquid in the vial is clear and colourless.
•
Do gently swirl the vial.
•
Do not shake the vial.
•
Do not roll vial between palms.
•
Note: It may take up to 2 minutes for the powder to completely dissolve.
Correct
Incorrect Before continuing: •
Do visually inspect the dissolved liquid for particles and/or discolouration. It must be clear and colourless and fully dissolved.
•
Note: If there is any colour or particles in the liquid, contact your healthcare professional.
•
Do make sure liquid is fully dissolved before removing syringe.
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•
When Nplate is completely dissolved, remove the empty syringe by twisting it anti-clockwise off of the vial adapter.
•
Discard the empty syringe into sharps or hazard container. Keep the dissolved Nplate Vial. Immediately prepare new syringe for injection.
•
Do not delay injecting Nplate.
Step 5. Prepare new syringe for injection Using: A new 1 mL syringe package and the vial of dissolved, clear Nplate. Before continuing: •
Do check your dose before starting this step.
•
Note: The Nplate liquid is highly potent which is why accuracy and dose measurement are important.
•
Do make sure that all air bubbles are removed before injection.
Do the following: •
Remove 1 mL syringe from package.
•
Draw air into syringe to 1 mL marking.
•
Do not pull plunger back to more than 1 mL.
Draw air into syringe to the 1 mL mark
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•
Attach 1 mL syringe to vial adapter of the dissolved Nplate by twisting the syringe tip clockwise onto the vial adapter until you feel a slight resistance.
A.
Push air into vial.
B.
Maintain pressure on plunger.
C.
Turn vial assembly and syringe upside down, so the vial is directly above the syringe.
A.
B.
C. Flip
•
Withdraw the full amount of liquid into the syringe. –
•
The maximum deliverable volume for the 250 microgram vial is 0.5 mL.
Do not pull the plunger out of the back of the syringe.
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•
Do ensure that the plunger remains in the syringe.
Correct •
Check and remove all air bubbles in the syringe. Gently tap the syringe with your fingers to separate the bubbles from the liquid. –
Slowly push the plunger up to force the air bubbles out of the syringe. Air bubbles: Incorrect
•
Slowly push back on the plunger to leave only the amount prescribed by your healthcare professional.
•
Make sure the top of the plunger head lines up with the syringe marking that matches your prescribed dose. If necessary push liquid back into the vial to achieve the desired dose.
Correct
Adjust the amount to your prescribed dose •
Do a final check to ensure the correct amount of liquid for your dose is in the syringe and all air bubbles have been removed.
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Before continuing: •
Do make sure the correct amount of liquid for your dose remains in the syringe.
•
Do make sure all air bubbles are removed from the syringe. •
Once all air bubbles are removed and syringe is filled with your correct dose, twist off syringe from vial adapter.
•
Keep filled syringe in your hand and do not touch syringe tip.
•
Do not set filled syringe down after removing from vial.
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Step 6. Prepare injection needle Using: Filled syringe with measured Nplate dose and safety needle. Do the following: •
Holding the syringe in the palm of your hand with the tip facing up, remove the safety needle from the package.
•
Attach safety needle to filled syringe. Apply strong force while twisting to attach the safety needle onto syringe. Turn clockwise to lock into Luer lock tip.
•
The product is now ready for injection. IMMEDIATELY continue to step 7.
Step 7. Choose and prepare an injection site Using: New alcohol swab. Do the following: Injection Site •
Select your injection site. Three recommended injection sites for Nplate include: Front of the middle thighs –
Abdomen, except for the 5 centimetre area right around the navel
–
If someone else is giving you the injection, they can also use the outer area of the upper arms
–
Do rotate the site for each injection. Front 18
Back
•
Do not inject into areas where the skin is tender, bruised and hard.
•
Do not inject into areas with scars or stretch marks.
•
Wipe the site where Nplate is to be injected with an alcohol swab, using a circular motion.
•
Do not touch this area again before giving the injection.
Step 8. Injecting the Nplate liquid Using: Filled syringe and needle assembly. Do the following: •
Pull back on the pink safety cover (toward the syringe and away from the needle).
•
Remove clear needle shield by holding syringe in one hand and carefully pulling shield straight off with the other hand.
•
Do remove the clear needle shield before injecting.
•
With one hand, gently pinch the cleaned area of skin and hold it firmly. With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin.
•
With a short, sharp motion, push the needle into the skin.
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•
Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.
•
When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
•
There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds.
•
Do not rub the injection site. If needed, you may cover the injection site with a plaster.
•
After injecting, use your thumb (or tip of your finger) to activate the pink safety cover by pushing the cover forward using the same hand until you hear and/or feel it click and lock into place over the needle.
•
Visually confirm that the needle tip is covered. Always cover the needle with the pink safety cover before disposal.
Step 9. Disposing of supplies Do the following: • • •
Immediately discard syringe with covered needle into a sharps container. Immediately discard used Nplate vial into an appropriate waste container. Make sure all other materials are discarded into proper containers.
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The injection device and Nplate vial must NEVER be reused. • Do dispose of the used needle and syringe in a puncture-resistant container. • Do dispose of any left-over Nplate in proper waste container. Left over Nplate in the vial must NEVER be re-used for another injection.
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Frequently asked questions about Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack)
How do I take Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack)?
Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack) comes as injection containing 250mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack)?
The active substance in Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack) is romiplostim.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Nplate 250 micrograms powder and solvent for solution for injection (Reconstitution Pack) without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: romiplostim
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
4.2. Posology and method of administration
Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Posology
Nplate should be administered once weekly as a subcutaneous injection.
Initial dose
The initial dose of romiplostim is 1 mcg/kg based on actual body weight.
Dose calculation
Initial or subsequent once weekly dose:
Weight* in kg x Dose in mcg/kg = Individual patient dose in mcg
Volume to administer:
Example:
75 kg patient is initiated at 1 mcg/kg of romiplostim.
The individual patient dose =
75 kg x 1 mcg/kg = 75 mcg
The corresponding amount of Nplate solution to inject =
75mcg x 1 mL/500 mcg = 0.15 mL
*Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim. Future dose adjustments are based on changes in platelet counts only and made in 1 mcg/kg increments (see table below).
Dose adjustments
A subject's actual body weight at initiation of therapy should be used to calculate dose. The once weekly dose of romiplostim should be increased by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 x 109/L. Platelet counts should be assessed weekly until a stable platelet count (≥ 50 x 109/L for at least 4 weeks without dose adjustment) has been achieved. Platelet counts should be assessed monthly thereafter. A maximum once weekly dose of 10 mcg/kg should not be exceeded.
Adjust the dose as follows:
Platelet count (x 109/L)
Action
< 50
Increase once weekly dose by 1 mcg/kg
> 150 for two consecutive weeks
Decrease once weekly dose by 1 mcg/kg
> 250
Do not administer, continue to assess the platelet count weekly
After the platelet count has fallen to < 150 x 109/L, resume dosing with once weekly dose reduced by 1 mcg/kg
Due to the interindividual variable platelet response, in some patients platelet count may abruptly fall below 50 x 109/L after dose reduction or treatment discontinuation. In these cases, if clinically appropriate, higher cut‑off levels of platelet count for dose reduction (200 x 109/L) and treatment interruption (400 x 109/L) may be considered according to medical judgement.
A loss of response or failure to maintain a platelet response with romiplostim within the recommended dosing range should prompt a search for causative factors (see section 4.4, loss of response to romiplostim).
Treatment discontinuation
Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non‑splenectomised patients this should include evaluation relative to splenectomy. The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
Elderly patients (≥ 65 years)
No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1). Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Paediatric population
The safety and efficacy of romiplostim 250mcg powder and solvent for solution for injection, also used for self‑administration in eligible adult patients, have not been established in patients aged under 18 years. Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Self‑administration of romiplostim is not allowed for paediatric patients. No data are available.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Patients with hepatic impairment
Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child‑Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with thrombopoietin (TPO) agonists (see section 4.4).
If the use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Patients with renal impairment
No formal clinical trials have been conducted in these patient populations. Nplate should be used with caution in these populations.
Method of administration
For subcutaneous use.
After reconstitution of the powder, Nplate solution for injection is administered subcutaneously. The injection volume may be very small. Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection. Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration – a syringe with graduations of 0.01 mL should be used.
Patients who have a stable platelet count ≥ 50 x 109/L for at least 4 weeks without dose adjustment may, at the discretion of the supervising physician, self‑administer Nplate solution for injection. Patients eligible for self‑administration of Nplate should be trained in these procedures.
After the first 4 weeks of self‑administration, the patient should again be supervised while reconstituting and administering Nplate. Only patients who demonstrate the ability to reconstitute and self‑administer Nplate are allowed to continue doing so.
For instructions on reconstitution and administration of the medicinal product, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Reoccurrence of thrombocytopenia and bleeding after cessation of treatment
Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim. There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti‑platelet agents. Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim. It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines. Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Increased bone marrow reticulin
Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines. Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy. Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended. See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered. If available, comparison to a prior bone marrow biopsy should be made. If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk‑benefit of romiplostim and alternative ITP treatment options should be re‑assessed.
Thrombotic/thromboembolic complications
Thrombotic/thromboembolic events including deep vein thrombosis, pulmonary embolism, and myocardial infarction have been observed with the use of romiplostim in the ITP population. These events have occurred regardless of platelet count (see section 4.8).The incidence of thrombotic/thromboembolic events observed in clinical trials was 6.0% with romiplostim and 3.6% with placebo. Caution should be used when administering romiplostim to patients with known risk factors for thromboembolism including but not limited to inherited (e.g. Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking. It is recommended to monitor patients for signs and symptoms of thrombotic/thromboembolic events and treat promptly as per institutional guidance and standard medical practice.
Cases of thromboembolic events (TEEs), including portal vein thrombosis, have been reported in patients with chronic liver disease receiving romiplostim. Romiplostim should be used with caution in these populations. Dose adjustment guidelines should be followed (see section 4.2).
Medication errors
Medication errors including overdose and underdose have been reported in patients receiving Nplate, dose calculation and dose adjustment guidelines should be followed (see section 4.2).
Overdose may result in an excessive increase in platelet counts associated with thrombotic/thromboembolic complications. If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations. Underdose may result in lower than expected platelet counts and potential for bleeding. Platelet counts should be monitored in patients receiving Nplate (see sections 4.2, 4.4 and 4.9).
Progression of existing Myelodysplastic Syndromes (MDS)
A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with ITP (see section 4.1) and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
The diagnosis of ITP in adults and elderly patients should have been confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded. A bone marrow aspirate and biopsy should normally have been done over the course of the disease and treatment for those with systemic symptoms or abnormal signs such as increased peripheral blast cells.
In clinical studies of treatment with romiplostim in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to AML were reported. In a randomised placebo‑controlled trial in MDS subjects, treatment with romiplostim was prematurely stopped due to a numerical excess of disease progression to AML and an increase in circulating blasts greater than 10% in patients receiving romiplostim. Of the cases of MDS disease progression to AML that were observed, patients with RAEB‑1 classification of MDS at baseline were more likely to have disease progression to AML compared to lower risk MDS.
Romiplostim must not be used for the treatment of thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP outside of clinical trials.
Loss of response to romiplostim
A loss of response or failure to maintain a platelet response with romiplostim treatment within the recommended dosing range should prompt a search for causative factors, including immunogenicity (see section 4.8) and increased bone marrow reticulin (see above).
Effects of romiplostim on red and white blood cells
Alterations in red (decrease) and white (increase) blood cell parametres have been observed in non‑clinical toxicology studies (rat and monkey) as well as in ITP patients. Concurrent anaemia and leucocytosis (within a 4‑week window) may occur in patients regardless of splenectomy status, but have been seen more often in patients who have had a prior splenectomy. Monitoring of these parametres should be considered in patients treated with romiplostim.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The potential interactions of romiplostim with co‑administered medicinal products due to binding to plasma proteins remain unknown.
Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti‑D immunoglobulin. Platelet counts should be monitored when combining romiplostim with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2).
Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1). Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of romiplostim in pregnant women.
Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts. Post implantation loss and a slight increase in peri‑natal pup mortality also occurred in animal studies (see section 5.3).
Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast‑feeding
It is unknown whether romiplostim/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast‑feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There is no data available on fertility.
4.7. Effects on ability to drive and use machines
Nplate has moderate influence on the ability to drive and use machines. In clinical trials, mild to moderate, transient bouts of dizziness were experienced by some patients.
4.8. Undesirable effects
Summary of the safety profile
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim‑treated subjects was 91.5% (248/271). The mean duration of exposure to romiplostim in this study population was 50 weeks.
The most serious adverse reactions that may occur during Nplate treatment include: thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML. The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.
Tabulated list of adverse reactions
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data). Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence.
MedDRA system organ class
Very common
Common
Uncommon
Infections and infestations
Upper respiratory tract infection
Rhinitis***
Gastroenteritis
Pharyngitis***
Conjunctivitis***
Ear infection***
Sinusitis***/****
Bronchitis****
Influenza
Localised infection
Nasopharyngitis
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Multiple myeloma
Myelofibrosis
Blood and lymphatic system disorders
Bone marrow disorder*
Thrombocytopenia*
Anaemia
Aplastic anaemia
Bone marrow failure
Leucocytosis
Splenomegaly
Thrombocythaemia
Platelet count increased
Platelet count abnormal
Immune system disorders
Hypersensitivity**
Angioedema
Metabolism and nutrition disorders
Alcohol intolerance
Anorexia
Decreased appetite
Dehydration
Gout
Psychiatric disorders
Insomnia
Depression
Abnormal dreams
Nervous system disorders
Headache
Dizziness
Migraine
Paraesthesia
Clonus
Dysgeusia
Hypoaesthesia
Hypogeusia
Neuropathy peripheral
Transverse sinus thrombosis
Eye disorders
Conjunctival haemorrhage
Accommodation disorder
Blindness
Eye disorder
Eye pruritus
Lacrimation increased
Papilloedema
Visual disturbances
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Palpitations
Myocardial infarction
Heart rate increased
Vascular disorders
Flushing
Deep vein thrombosis
Hypotension
Peripheral embolism
Peripheral ischaemia
Phlebitis
Thrombophlebitis superficial
Thrombosis
Erythromelalgia
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain***
Pulmonary embolism*
Cough
Rhinorrhoea
Dry throat
Dyspnoea
Nasal congestion
Painful respiration
Gastrointestinal disorders
Upper abdominal pain***
Nausea
Diarrhoea
Abdominal pain
Constipation
Dyspepsia
Vomiting
Rectal haemorrhage
Breath odour
Dysphagia
Gastro‑oesophageal reflux disease
Haematochezia
Mouth haemorrhage
Stomach discomfort
Stomatitis
Tooth discolouration
Hepatobiliary disorders
Portal vein thrombosis
Increase in transaminase
Skin and subcutaneous tissue disorders
Pruritus
Ecchymosis
Rash
Alopecia
Photosensitivity reaction
Acne
Dermatitis contact
Dry skin
Eczema
Erythema
Exfoliative rash
Hair growth abnormal
Prurigo
Purpura
Rash papular
Rash pruritic
Skin nodule
Skin odour abnormal
Urticaria
Musculoskeletal and connective tissue disorders
Arthralgia
Myalgia
Muscle spasms
Pain in extremity
Back pain
Bone pain
Muscle tightness
Muscular weakness
Shoulder pain
Muscle twitching
Renal and urinary disorders
Protein urine present
Reproductive system and breast disorders
Vaginal haemorrhage
General disorders and administration site conditions
Fatigue
Oedema peripheral
Influenza like illness
Pain
Asthenia
Pyrexia
Chills
Injection site reaction
Peripheral swelling***
Injection site haemorrhage
Chest pain
Irritability
Malaise
Face oedema
Feeling hot
Feeling jittery
Investigations
Blood pressure increased
Blood lactate dehydrogenase increased
Body temperature increased
Weight decreased
Weight increased
Injury, poisoning and procedural complications
Contusion
* see section 4.4
** Hypersensitivity reactions including cases of rash, urticaria, and angioedema
*** Additional adverse reactions observed in paediatric studies
**** Additional adverse reactions observed in adult patients with ITP duration up to 12 months
Adult population with ITP duration up to 12 months
The safety profile of romiplostim was similar across adult patients, regardless of ITP duration. Specifically in the integrated analysis of ITP ≤ 12 months duration (n = 311), 277 adult patients with ITP ≤ 12 months duration and who received at least one dose of romiplostim from among those patients in 9 ITP studies were included (see also section 5.1). In this integrated analysis, the following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in romiplostim patients with ITP duration up to 12 months, but were not observed in those adult patients with ITP duration > 12 months: bronchitis, sinusitis (reported commonly (≥ 1/100 to < 1/10)).
Paediatric population
In the paediatric studies, 282 paediatric ITP subjects were treated with romiplostim in 2 controlled and 3 uncontrolled clinical trials. The median duration of exposure was 65.4 weeks. The overall safety profile was similar to that seen in adults.
The paediatric adverse reactions are derived from each of the paediatric ITP randomised safety set (2 controlled clinical trials) and paediatric ITP safety set (2 controlled and 3 uncontrolled clinical trials) where the subject incidence was at least 5% higher in the romiplostim arm compared to placebo and at least a 5% subject incidence in romiplostim‑treated subjects.
The most common adverse reactions in paediatric ITP patients 1 year and older were upper respiratory tract infection, rhinitis, cough, oropharyngeal pain, upper abdominal pain, diarrhoea, rash, pyrexia, contusion (reported very commonly (≥ 1/10)), and pharyngitis, conjunctivitis, ear infection, gastroenteritis, sinusitis, purpura, urticaria and peripheral swelling (reported commonly (≥ 1/100 to < 1/10)).
Oropharyngeal pain, upper abdominal pain, rhinitis, pharyngitis, conjunctivitis, ear infection, sinusitis and peripheral swelling were additional adverse reactions observed in paediatric studies compared to those seen in adult studies.
Some of the adverse reactions seen in adults were reported more frequently in paediatric subjects such as cough, diarrhoea, rash, pyrexia and contusion reported very commonly (≥ 1/10) in paediatric subjects and purpura and urticaria were reported commonly (≥ 1/100 to < 1/10) in paediatric subjects.
Description of selected adverse reactions
In addition, the reactions listed below have been deemed to be related to romiplostim treatment.
Bleeding events
Across the entire adult ITP clinical programme an inverse relationship between bleeding events and platelet counts was observed. All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 109/L. All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 109/L. No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients.
In the two adult placebo‑controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)). Bleeding events that were grade 2 or higher were reported by 15% of patients treated with romiplostim and 34% of patients treated with placebo (Odds Ratio; [romiplostim/placebo] = 0.35; 95% CI = (0.14, 0.85)).
In the Phase 3 paediatric study, the mean (SD) number of composite bleeding episodes (see section 5.1) was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm.
Thrombocytosis
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 3 events of thrombocytosis were reported, n = 271. No clinical sequelae were reported in association with the elevated platelet counts in any of the 3 subjects.
Thrombocytosis in paediatric subjects occurred uncommonly (≥ 1/1 000 to < 1/100), with a subject incidence of 1 (0.4%). Subject incidence was 1 (0.4%) for either grade ≥ 3 or serious thrombocytosis.
Thrombocytopenia after cessation of treatment
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 4 events of thrombocytopenia after cessation of treatment were reported, n = 271 (see section 4.4).
Progression of existing Myelodysplastic Syndromes (MDS)
In a randomised placebo‑controlled trial in MDS subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo. Of the cases of MDS disease progression to AML that were observed, patients with RAEB‑1 classification of MDS at baseline were more likely to have disease progression to AML (see section 4.4). Overall survival was similar to placebo.
Increased bone marrow reticulin
In clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition. In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
In a paediatric clinical trial (see section 5.1), of the subjects with an evaluable on‑study bone marrow biopsy, 5 out of 27 subjects (18.5%) developed increased reticulin at year 1 after exposure to romiplostim (cohort 1) and 17 out of 36 subjects (47.2%) developed increased reticulin at year 2 after exposure to romiplostim (cohort 2). However, no subject showed any bone marrow abnormalities that were inconsistent with an underlying diagnosis of ITP at baseline or on‑treatment.
Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. Clinical trials in adult ITP patients examined antibodies to romiplostim and TPO. While 5.7% (60/1,046) and 3.2% (33/1 046) of the subjects were positive for developing binding antibodies to romiplostim and TPO respectively, only 4 subjects were positive for neutralising antibodies to romiplostim but these antibodies did not cross react with endogenous TPO. Of the 4 subjects, 2 subjects tested negative for neutralising antibodies to romiplostim at the subject's last timepoint (transient positive) and 2 subjects remained positive at the subject's last timepoint (persistent antibodies). The incidence of pre‑existing antibodies to romiplostim and TPO was 3.3% (35/1 046) and 3.0% (31/1 046), respectively.
In paediatric studies, the incidence of binding antibodies to romiplostim at any time was 9.6% (27/282). Of the 27 subjects, 2 subjects had pre‑existing binding non‑neutralising romiplostim antibodies at baseline. Additionally, 2.8% (8/282) developed neutralising antibodies to romiplostim. A total of 3.9% (11/282) subjects had binding antibodies to TPO at any time during romiplostim treatment. Of these 11 subjects, 2 subjects had pre‑existing binding non‑neutralising antibodies to TPO. One subject (0.35%) had a weakly positive postbaseline result for neutralising antibodies against TPO while on study (consistently negative for anti-romiplostim antibodies) with a negative result at baseline. The subject showed a transient antibody response for neutralising antibodies against TPO, with a negative result at the subject's last timepoint tested within the study period.
In the post‑marketing registry study, 19 confirmed paediatric patients were included. The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralising antibodies to romiplostim. There were no antibodies detected to TPO. A total of 184 confirmed adult patients were included in this study; for these patients, the incidence of binding antibody post treatment was 3.8% (7/184) to romiplostim, of which 0.5% (1/184) was positive for neutralising antibodies to romiplostim. A total of 2.2% (4/184) adult patients developed binding, non‑neutralising antibody against TPO.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No adverse effects were seen in rats given a single dose of 1 000 mcg/kg or in monkeys after repeated administration of romiplostim at 500 mcg/kg (100 or 50 times the maximum clinical dose of 10 mcg/kg, respectively).
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations (see sections 4.2 and 4.4).
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- NPLATE 250µg prescriptionROMIPLOSTIMUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- NplateRomiplostimum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
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