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.
Optivate 100 IU/ml powder and solvent for solution for injection
⚠ 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 Human coagulation factor viii, Von willebrand factor 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
Optivate contains a high purity factor VIII and von Willebrand factor concentrate, proteins that are needed for blood to clot. The factor VIII and von Willebrand factor concentrate in Optivate is extracted from human blood plasma (the liquid part of blood). Optivate is used to prevent and treat bleeding in patients of all age groups with haemophilia A (a congenital factor VIII deficiency in the blood). 2.
What you need to know before you take it
e Optivate
Do not use Optivate: if you are allergic (hypersensitive) to human coagulation factor VIII or von Willebrand factor concentrate or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Take special care with Optivate and talk to your doctor or haemophilia nurse if:
- you have heart or vascular disease
- you experience an allergic reaction to this medicine (see section 4)
- your or your child's bleeding is not being controlled with your usual dose of this medicine. The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. Your doctor or nurse will check the level of factor VIII and antibodies in your blood before and after treatment, especially for your first injection.
- you require a central venous access device (CVAD) for the administration of Optivate. You may be at risk of complications including local infections, bacteria in the blood (bacteraemia) and the blood clot at the catheter site. Virus safety
2
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include: careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded the testing of each donation and pools of plasma for signs of virus/infections the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). It is strongly recommended that every time you receive a dose of Optivate, the name and batch number of the product are recorded to maintain a record of the batches used. Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human plasma-derived factor VIII products. Children and adolescents The listed warnings and precautions apply to both adults and children. Other medicines and Optivate Tell your doctor if you are using, have recently used or might use any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines Optivate does not affect your ability to drive or operate machines. Optivate contains sodium and polysorbate Sodium This medicine contains approximately 7.4 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.4% of the recommended maximum daily dietary intake of sodium for an adult. Polysorbate Optivate 250 IU contains 5 mg of polysorbate 20 in each 2.5 ml which is equivalent to 2 mg/ml. Optivate 500 IU contains 10 mg of polysorbate 20 in each 5 ml which is equivalent to 2 mg/ml. Optivate 1000 IU contains 20 mg of polysorbate 20 in each 10 ml which is equivalent to 2 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.
3
3.
How to take it
Optivate
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Optivate should be injected directly in a vein. Before injecting this medicine, you should have received training by your healthcare professional on how to do this. Use only the recommended injection equipment provided with your medicine. Your doctor will explain how much you should use and when you should use it. Your doctor will tell you your dose in terms of the number of full vials nearest to the dose most suited to you. If further treatment is needed, doses may be repeated. Your doctor will advise you if this is necessary. The amount of Optivate you or your child need and the duration of treatment will depend on several factors, such as your body weight, the severity and nature of your condition, the site and intensity of the bleeding or the need to prevent bleeding during an operation or medical procedure. When to inject Optivate Optivate can be used to stop bleeding, when it occurs, or to prevent bleeding from happening. When to inject Optivate to stop bleeding: The medicine should be injected when the first sign of bleeding occurs. The injection should be repeated as necessary to stop the bleeding. Each individual bleed should be judged on its own severity. If you are using this product for the first time, your doctor will supervise you. If you are using Optivate to prevent bleeding from happening, your doctor will tell you when to inject your medicine. Dissolving your medicine before use Your medicine must only be dissolved in the sterile water provided with the product. Quantity of Optivate 250 IU 500 IU 1000 IU
Volume of Water Supplied 2.5 ml or 5 ml 5 ml 10 ml
1. Before you remove the cap, make sure that the vials of Optivate and water for injections supplied are both at room temperature (between 20°C and 30°C). There are two ways of continuing to make up Optivate for injection by the use of a filter needle or Mix2VialTM transfer device – only one of these options will be provided in your pack. Ensure the correct method below is utilised for the transfer device supplied: Using the Filter Needle (where supplied): 1. If the Water for Injections is in a plastic ampoule, break open the top and draw up the volume of water needed with a sterile needle and syringe (not the filter needle). 2. If the Water for Injections is in a glass vial remove the "flip-off" top and clean the top of the stopper with an alcohol swab. 4
3. If using a double spiked needle (only for use with the correct volume of water for injection in glass vials), remove the cover guard from one end of the double-ended transfer needle (which your doctor can provide) and insert the needle through the stopper into the vial of water. 4. Remove the other end of the needle guard, turn it upside down over the vial of Optivate and push the needle through the Optivate stopper. 5. On piercing the stopper of the Optivate vial, the water will be drawn in as the vial is sealed under vacuum. A small amount of water will remain in the water vial, which can be discarded. Continue from point 8 below. 6. If using a transfer needle, transfer the water to the vial of Optivate by pushing the needle through the stopper of the vial. The water in the syringe will be drawn into the vial, which is under vacuum, so there is no need to push the plunger of the syringe. Note: The filter needle provided must not be used to draw up the Water for Injections. 7. Gently swirl the Optivate vial (do not shake) and then remove the syringe from the needle to release the vacuum in the vial. 8. Continue to swirl the Optivate vial gently until the powder is dissolved (usually in about 2 to 21/2 minutes). 9. When dissolved, draw up the solution using the filter needle attached to a syringe. Use a new filter needle for each vial of Optivate if your dose is more than one vial. 10. Disconnect the filter needle from the syringe. 11. The product is now ready for administration. Follow the normal safety practices for administration. Use the product immediately after reconstitution, the product must not be stored.
5
Using the Mix2VialTM (where supplied): Step 1
- Remove the cap from the product vial and clean the top of the stopper with an alcohol swab.
- Repeat this step with the water vial.
- Peel back the top of the Mix2VialTM transfer device package but leave the device in the package.
Step 2
- Place the blue end of the Mix2VialTM transfer device on the water vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
- Remove the plastic outer packaging from the Mix2VialTM transfer device and discard it, taking care not to touch the exposed end of the device.
Step 3
- Turn the water vial upside down with the device still attached.
- Place the clear end of the Mix2VialTM transfer device on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Step 4
- The water will be pulled into the product vial by the vacuum contained within it.
- Gently swirl the vial to make sure the product is thoroughly mixed. Do not shake the vial.
- A clear or slightly pearl-like solution should be obtained, usually in about 2 to 2 1⁄2 minutes (5 minutes maximum).
Step 5
- Separate the empty water vial and blue part from the clear part by unscrewing anti-clockwise.
- Draw air into the syringe by pulling the plunger to the required volume of water added.
- Connect the syringe to the white filter.
- Push the air in the syringe into the vial. Step 6
- Immediately invert the vial of solution which will be drawn into the syringe.
- Disconnect the filled syringe from the Mix2VialTM transfer device.
- The product is now ready for administration. Follow the normal safety practices for administration. Use the product immediately after reconstitution, the product must not be stored.
6
Note: If you have to use more than one vial to make up your required dose, repeat Steps 1 to 6 withdrawing the solution in the vial into the same syringe. The Mix2VialTM transfer device supplied with your product is sterile and cannot be used more than once. Do not use this medicine if: the water is not pulled into the product vial (this indicates a loss of vacuum in the vial, so the product must not be used) the dissolved product and water form a gel or a clot or if the solution is cloudy there are any particles in the syringe. If any of these happens, tell your doctor or pharmacist, reporting the batch number printed on the vials. If you use more Optivate than you should If you think you may be using too much, stop the injection and tell your doctor. If you know you have used too much, tell your doctor as soon as possible. If you forget to use Optivate Do not use a double dose to make up for a forgotten dose. Inject your normal dose as soon as you remember and then continue to use as told by your doctor or haemophilia nurse. If you stop using Optivate Always talk to your doctor before deciding to stop your treatment. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop the infusion and tell your doctor immediately or go to the emergency department of your nearest hospital, if you get any of the following symptoms: • Swelling around the throat • Flushing • Hives (nettle rash) • Feeling lightheaded or dizzy (low blood pressure) • Rapid heart beat • Feeling sick or being sick • Restlessness • Tightness in the chest or wheezing • Tingling sensation These symptoms may worsen into severe shock. The above allergic-type reactions are very rare (may affect up to 1 in 10,000 people). Other known side effects include: Common (may affect more than 1 in 100 people): • Headache • Sleepiness, lethargy or feeling unwell • Feeling that everything is moving, spinning round or tilting (vertigo) • Itching, skin rash • Local site reaction where the medicine was injected (redness, rash, pain) • Sudden shivering and feeling cold, fever • Swelling in the extremities of the body • Stiffness in muscles and joints
7
Not known (frequency cannot be estimated from the available data): • Cough, sneezing, throat irritation • Abdominal pain For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however, for patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens, your or your child's medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Optivate
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 containers after "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light. Do not use this medicine if you notice small bits in the dissolved product. Once reconstituted, Optivate must be used immediately or within 1 hour of reconstitution. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or doctor 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 Optivate contains The active substance is human coagulation factor VIII with associated von Willebrand factor. The excipients are: sodium chloride, sodium citrate, calcium chloride, polysorbate 20 and trehalose. Solvent: water for injections What Optivate looks like and contents of the pack Optivate is a white or pale yellow powder in quantities of 250 IU (International Units), 500 IU or 1000 IU in glass vials. These vials are closed with a rubber stopper under vacuum, held with a tamperevident cap. Optivate should only be reconstituted with the water for injections which is supplied with Optivate in vials. Optivate is provided with either one Filter Needle device or one Mix2VialTM transfer device. Marketing Authorisation Holder Bio Products Laboratory Limited Dagger Lane 8
Elstree Hertfordshire WD6 3BX United Kingdom tel: +44 (0) 20 8957 2255 e-mail: [email protected] Manufacturer Bio Products Laboratory Limited Dagger Lane Elstree Borehamwood WD6 3BX United Kingdom This leaflet was last revised in October 2024.
9
Frequently asked questions about Optivate 100 IU/ml powder and solvent for solution for injection
How do I take Optivate 100 IU/ml powder and solvent for solution for injection?
Optivate 100 IU/ml powder and solvent for solution for injection comes as injection containing 100iu/ml. 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 Optivate 100 IU/ml powder and solvent for solution for injection?
The active substance in Optivate 100 IU/ml powder and solvent for solution for injection is human coagulation factor viii, von willebrand factor.
Are there equivalent medicines to Optivate 100 IU/ml powder and solvent for solution for injection?
Medicines with the same active substance, strength and form include: Octanate LV 100 IU/ml powder and solvent for solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Optivate 100 IU/ml powder and solvent for solution for injection, 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 Optivate 100 IU/ml powder and solvent for solution for injection 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: human coagulation factor viii, von willebrand factor
- 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
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Optivate can be used for all age groups.
4.2. Posology and method of administration
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Treatment monitoring
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half‑lives and recoveries. Dose based on body weight may require adjustment in underweight or overweight patients.
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Posology
The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in IU (relative to an International Standard for factor VIII in plasma).
One IU of factor VIII activity is equivalent to that quantity of factor VIII in 1 ml of normal human plasma.
On demand treatment
The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2.2% - 2.7% of normal activity (2.2 - 2.7 IU/dl). The required dosage is determined using the following formula:
Required units = body weight (kg) x desired factor VIII rise (%) or (IU/dl) x 0.4
The amount to be administered and the frequency of administration should always be orientated to the clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:
Degree of haemorrhage/Type of surgical procedure
Factor VIII level required
(%) or (IU/dl)
Frequency of doses (hours)/ Duration of therapy (days)
Haemorrhage
Early haemarthrosis, muscle bleeding or oral bleeding.
20-40
Repeat every 12 to 24 hours.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleeding or haematoma
30-60
Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages
60-100
Repeat infusion every 8 to 24 hours until threat is resolved.
Surgery
Minor surgery including tooth extraction.
30-60
Every 24 hours, at least 1 day, until healing is achieved.
Major surgery
80-100
(pre- and post-operative)
Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Prophylaxis
For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Continuous infusion
Prior to surgery, a pharmacokinetic analysis should be performed to obtain an estimate of clearance.
The initial infusion rate can be calculated as follows:
Clearance x desired steady state level = infusion rate (IU/kg/hr).
After the initial 24 hours of continuous infusion, the clearance should be calculated again every day using steady state equation with the measured level and the known rate of infusion.
Paediatric population
Children under 6 years of age
The recommended dose is 17 to 30 IU/kg. This can be given up to 3 times a week to prevent bleeding.
Children over 6 years of age
There are very limited data on the use of Optivate in children aged 6 to 11 years. The recommended dose and frequency for children and adolescents aged 6-17 years are as recommended for adults. Monitoring of trough levels is recommended for patients on prophylaxis.
Method of administration
Intravenous use.
Optivate should be administered at a rate not exceeding 3 ml per minute.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity
Allergic type hypersensitivity reactions are possible with Optivate. The product contains traces of human proteins other than factor VIII and VWF.
If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
In case of shock, standard medical treatment for shock should be implemented.
Inhibitors
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII pro-coagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
In general, all patients treated with human coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Cardiovascular events
In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Catheter-related complications
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Transmissible agents
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma derived factor VIII products.
It is strongly recommended that every time Optivate is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Important information about excipients of Optivate
Sodium
This medicinal product contains 7.4 mg sodium per ml, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Polysorbate
Optivate 250 IU contains 5 mg of polysorbate 20 in each 2.5 ml which is equivalent to 2 mg/ml.
Optivate 500 IU contains 10 mg of polysorbate 20 in each 5 ml which is equivalent to 2 mg/ml.
Optivate 1000 IU contains 20 mg of polysorbate 20 in each 10 ml which is equivalent to 2 mg/ml.
Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.
Paediatric population
The listed warnings and precautions apply both to adults and children.
4.5. Interaction with other medicinal products and other forms of interaction
No interactions of human coagulation factor VIII products with other medicinal products have been reported.
4.6. Fertility, pregnancy and lactation
Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
4.7. Effects on ability to drive and use machines
Optivate has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including Optivate. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.
For safety information with respect to transmissible agents, see section 4.4.
Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequencies have been evaluated according to the following convention: 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), not known (cannot be estimated from the available data). The table lists adverse reactions reported from 96 patients in clinical studies. Approximately 10% of patients can be expected to experience adverse reactions on long-term treatment.
MedDRA Standard System Organ Class
Adverse reactions
Frequency
Blood and lymphatic system disorders
Factor VIII inhibition
Uncommon (PTPs)*
Very common (PUPs)*
Nervous system disorders
Headache
Common
Somnolence
Common
Ear and labyrinth disorders
Vertigo
Common
Skin and subcutaneous tissue disorders
Rash
Common
Pruritus
Common
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness and joint stiffness
Common
General disorders and administration site disorders
Infusion site erythema, rash or pain
Common
Oedema peripheral
Common
Chills
Common
Pyrexia
Common
* Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
In post-marketing experience, the following additional undesirable effects have been reported: sneezing, cough, throat irritation, abdominal pain and malaise.
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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 the 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 cases of overdose with human coagulation factor VIII and VWF have been reported.
💬 Ask about this leaflet
Ask anything about Optivate 100 IU/ml powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.