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.
SOMAVERT 10mg 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 Pegvisomant 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
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders. The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist. These substances decrease the action of GH and levels of IGF-I circulating in the blood.
2.
What you need to know before you take it
e SOMAVERT
Do not use SOMAVERT • If you are allergic to pegvisomant or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using SOMAVERT. –
If you experience disturbed vision or headaches you must contact your doctor immediately.
–
Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in the blood and adjust the dose of SOMAVERT if necessary.
–
Your doctor should also monitor your adenoma (benign tumour).
- Your doctor will conduct tests of your liver function before starting and during treatment with SOMAVERT. If these test results are not normal, your doctor will discuss treatment options with you. Once treatment begins, your doctor or nurse will monitor the level of liver enzymes in Page 1 of 16
the blood every 4-6 weeks for the first 6 months of treatment with SOMAVERT. Administration of SOMAVERT should be discontinued if signs of liver disease persist. –
If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you are using.
–
Fertility in women patients may be increased as the disease improves. The use of this medicine in pregnant women is not recommended and women of childbearing age should be advised to use a contraception. See also the section about Pregnancy below.
Other medicines and SOMAVERT You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes. Tell your doctor or pharmacist if you are using or have recently used any other medicines. As part of your treatment you may be given other medicines. It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor, pharmacist or nurse. Pregnancy, breast-feeding and fertility The use of SOMAVERT in pregnant women is not recommended. If you are a woman of childbearing age, a contraception should be used during treatment. It is not known if pegvisomant passes into breast milk. You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you. 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. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. SOMAVERT contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per dose i.e. essentially 'sodium-free'.
3.
How to take it
SOMAVERT
Always inject this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. A starting dose of 80 mg of pegvisomant will be given subcutaneously (just under the skin) by your doctor. Following this, the usual daily dose of pegvisomant is 10 mg, which is given by subcutaneous injection (just under the skin). Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 5 mg pegvisomant/day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic response. Method and route of administration SOMAVERT is injected under the skin. The injection can be self-administered or given by another person, for example your doctor or his/her assistant. The detailed instructions on injection procedure provided at the end of this leaflet must be followed. You should continue to inject this medicine for as long as instructed by your doctor. This medicine must be dissolved before use. The injection must not be mixed in the same syringe or vial as any other medicine. Page 2 of 16
Fatty tissue of the skin can build-up at the site of injection. To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the 'instructions for preparing and giving an injection of SOMAVERT' section of this leaflet. This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place. If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor, pharmacist or nurse. If you inject more SOMAVERT than you should If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor, pharmacist or nurse immediately. If you forget to use SOMAVERT If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor. Do not inject a double dose to make up for forgotten individual doses. 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. Mild to serious allergic (anaphylactic) reactions have been reported in some patients taking SOMAVERT. Symptoms of a serious allergic reaction may include one or more of the following: swelling of the face, tongue, lips, or throat; wheezing or trouble breathing (spasm of the larynx); generalized skin rash, nettle rash (urticaria) or itching; or dizziness. Contact your doctor immediately if you develop any of these symptoms. Very common: may affect more than 1 in 10 people • • •
Headache Diarrhoea Joint pain
Common: may affect up to 1 in 10 people • • • • • • • • • • • • •
Shortness of breath. Increased levels of substances that measure the function of the liver. These can be seen in the results of blood tests. Blood in the urine. Increased blood pressure. Constipation, feeling sick, being sick, feeling bloated, indigestion, gas. Dizziness, sleepiness, uncontrolled trembling, decreased sense of touch. Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site, swelling of the extremities, weakness, fever. Sweating, itching, rash, tendency to bruise. Muscle pain, arthritis. Increased blood cholesterol, weight gain, increased blood glucose, decreased blood glucose. Flu-like illness, fatigue. Abnormal dreams. Eye pain.
Uncommon: may affect up to 1 in 100 people Page 3 of 16
• • • • • • • • • •
Allergic reaction after administration (fever, rash, pruritus and, in severe cases, difficulty to breathe, rapid swelling of skin, requiring urgent medical attention). May occur immediately, or several days after administration. Protein in the urine, increased urine, kidney problems. Lack of interest, feeling confused, increased sex drive, panic attack, loss of memory, problems sleeping. Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed. Feeling abnormal, impaired healing. Eyestrain, inner ear problems. Facial swelling, dry skin, night sweats, redness of the skin (erythema), raised itchy bumps on the skin (urticaria). Increased fatty substances in the blood, increased appetite. Dry mouth, increased saliva, tooth problems, haemorrhoids. Abnormal sense of taste, migraine.
Not known: frequency cannot be estimated from the available data • • •
Anger Severe breathlessness (laryngospasm) Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs (angioedema)
About 17% of patients will develop antibodies to growth hormone during treatment. The antibodies do not seem to stop this medicine from working. 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 via the Yellow Card Scheme at: 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
SOMAVERT
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 and the carton after EXP. The expiry date refers to the last day of that month. Store the powder vial(s) in a refrigerator (2C – 8C) in their carton(s) in order to protect from light. Do not freeze. The carton(s) containing the SOMAVERT powder vial(s) may be stored at room temperature up to a maximum of 25°C for a single period of up to 30 days. Write the Use by date on the carton including day/month/year (up to 30 days from the date removed from the refrigerator). The vial(s) must be protected from light. Do not return this medicine to refrigerator. Discard this medicine if not used by the new Use by date or the expiry date printed on the carton, whichever is earlier. Store the pre-filled syringe(s) below 30C or store in a refrigerator (2C – 8C). Do not freeze. After preparing the SOMAVERT solution it must be used immediately. Do not use this medicine if you notice that the solution is cloudy or contains particulate matter. Page 4 of 16
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 SOMAVERT contains
- The active substance is pegvisomant.
- SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant. After reconstitution with 1 ml of solvent, 1 ml of the solution contains 10 mg pegvisomant.
- SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant. After reconstitution with 1 ml of solvent, 1 ml of the solution contains 15 mg pegvisomant.
- SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant. After reconstitution with 1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant.
- SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant. After reconstitution with 1 ml of solvent, 1 ml of the solution contains 25 mg pegvisomant.
- SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant. After reconstitution with 1 ml of solvent, 1 ml of the solution contains 30 mg pegvisomant.
- The other ingredients are glycine, mannitol (E421), disodium phosphate anhydrous and sodium dihydrogen phosphate monohydrate (see section 2 "SOMAVERT contains sodium").
- The solvent is water for injections. What SOMAVERT looks like and contents of the pack SOMAVERT is presented as a powder and a solvent for injection (either 10 mg, 15 mg, 20 mg, 25 mg or 30 mg pegvisomant in a vial and 1 ml of solvent in a pre-filled syringe). Pack sizes of 1 and/or 30. Not all pack sizes are marketed. The powder is white and the solvent is clear and colourless. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Manufacturer: Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs-Sint-Amands Belgium For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone 01304 616161.
This leaflet was last revised in 11/2023
<—————————————————————————————————————————–Ref: SV 21_0 Page 5 of 16
INSTRUCTIONS FOR USE SOMAVERT powder in vial with solvent in a pre-filled syringe pegvisomant for injection For Subcutaneous Injection Only single dose vial SOMAVERT comes in a vial as a white block of powder. You must mix SOMAVERT with a liquid (diluent) before you can use it. The liquid comes in a pre-filled syringe labeled 'Solvent for SOMAVERT'. Do not use any other liquid to mix with SOMAVERT. It is important that you do not try to give yourself or someone else an injection unless you have received training from your healthcare provider. Store the carton(s) of powder vials in the refrigerator at 2°C to 8°C and away from direct sunlight. The carton(s) containing the SOMAVERT powder vial(s) may be stored at room temperature up to a maximum of 25°C for a single period of up to 30 days. Write the Use by date on the carton including day/month/year (up to 30 days from the date removed from the refrigerator). The vial(s) must be protected from light. Do not return this medicine to refrigerator. Discard this medicine if not used by the new Use by date or the expiry date printed on the carton, whichever is earlier. The pre-filled solvent syringe may be stored at room temperature. Keep out of reach of children. 1.
Things you need
A single SOMAVERT pack containing: • A vial of SOMAVERT powder. • A pre-filled syringe with solvent. • A safety needle. You will also need: • A cotton ball. • An alcohol swab. • A suitable sharps container.
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2.
Getting ready
Before you start: • Only mix SOMAVERT and the solvent when you are ready to inject your dose. • Remove a single SOMAVERT pack from the refrigerator and allow it to come to room temperature naturally in a safe place. • Wash your hands with soap and water, and dry thoroughly. • Peel open the packaging of the syringe and safety needle to make it easier to pick up each item as you prepare for your injection. • Do not use the syringe or vial if: o they are damaged or faulty; o the expiration date has passed; o it has been frozen, even if it has now thawed (syringe only).
3.
Choose injection area
• • • •
Choose a different location within an area for each injection. Avoid bony areas or areas that are bruised, red, sore or hard, or areas that have scars or skin conditions. Clean the injection area with the alcohol swab as instructed by your healthcare provider. Allow the injection area to dry.
Page 7 of 16
4.
Remove vial cap
• •
5.
Remove the cap from the vial. Throw the cap away; it is not needed again. Caution: Do not let anything touch the vial stopper.
Remove syringe cap
• • •
Snap off the syringe cap. It may take more effort to snap off than you might expect. Throw the syringe cap away; it is not needed again. Keep the syringe upright to avoid leakage. Caution: Do not let the end of the syringe touch anything when the syringe cap is off.
Page 8 of 16
6.
Attach safety needle
•
7.
Twist the safety needle firmly onto the syringe as far as it will go.
Remove needle cover
• • •
Fold the needle guard out of the way of the needle cover. Carefully pull the needle cover straight off. Throw the needle cover away; it is not needed again. Caution: Do not let the needle touch anything.
Page 9 of 16
8.
Insert needle
• •
9.
Push the needle through the centre of vial stopper, as shown. Support the syringe while the needle is in the vial stopper to prevent bending the needle.
Add liquid
• • • •
Tilt both the vial and syringe at an angle, as shown. Push the plunger rod down slowly until all the liquid has emptied into the vial. Caution: Do not squirt the liquid directly onto the powder, as this creates foam. Foam makes the medicine unusable. Do not withdraw the needle yet.
Page 10 of 16
10.
Swirl vial
• • •
11.
Support both the syringe and vial in one hand, as shown. Gently swirl the liquid, sliding the vial in a circular motion on a flat surface. Continue swirling the liquid until all the powder has fully dissolved. Note: This may take up to 5 minutes.
Check medicine
• •
Keeping the needle in the vial, look carefully at the medicine. It must be clear and free of particles. Do not use if: o the medicine is cloudy or hazy; o the medicine has any colour at all; o there are any particles or there is a layer of foam in the vial.
Page 11 of 16
12.
Reposition needle
• • •
13.
Turn the vial so that you can see the stopper gap, as shown. Pull the needle down so that the needle tip is at the lowest point in the liquid. This will help you to draw off as much liquid as possible. Check that the plunger rod has not moved-if it has, then push it back all the way into the syringe. This ensures that all air is removed from the syringe before you draw off the dose.
Draw off dose
• •
Slowly pull back the plunger rod to withdraw as much medicine as possible from the vial. Note: If you see air in the syringe, tap the barrel to float the bubbles to the top,and then gently push the bubbles out into the vial. Pull the needle out of the vial.
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14.
Insert needle
• •
15.
Gently pinch the skin at the site of injection. Insert the needle to its full depth into the pinched skin.
Inject medicine
• •
Push the plunger rod down slowly until the barrel is empty. Note: Make sure you keep the needle in at full depth. Release the pinched skin and pull the needle straight out.
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16.
Make needle safe
• •
17.
Dispose
•
18.
Fold the needle guard over the needle. Gently apply pressure using a hard surface to lock the needle guard in place. Note: You will hear a click when the needle guard has been locked.
The syringe and needle should NEVER be reused. Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist and in accordance with local health and safety laws.
After injection
Page 14 of 16
• •
If necessary, use a clean cotton ball and press lightly on the injection area. Do not rub the area.
QUESTIONS & ANSWERS What should I do if anything has accidentally touched the vial stopper? • Clean the vial stopper with a fresh alcohol wipe, and leave it to dry completely. If you are unable to clean the stopper, do not use the vial. What should I do with the syringe if it has been dropped? • Do not use it-even if it looks undamaged. Dispose of the syringe in the same way as a used syringe. You will need a replacement syringe. How many times can I safely insert the needle into the vial stopper? • Once only. Withdrawing and reinserting greatly increases the risk of needle damage, and will blunt the needle. This can cause discomfort and increases risk of skin damage and infection. There is also a risk you may lose some of the medicine. Is it OK to shake the vial if the powder is not dissolving? • No-never shake the vial. Shaking can destroy the medicine and create foam. The powder may take a few minutes to dissolve fully, so continue swirling the vial gently until the liquid is completely clear. How can I tell if there is any foam in the vial? • Foam looks like a mass of small bubbles that float as a layer to the top of the liquid. Do not inject SOMAVERT if it has foamed.
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How can I prevent the medicine from foaming? • Press the plunger very slowly so that the liquid gently runs down the inside of the vial. Do not spray the liquid directly onto the powder, as this creates foam. This technique will also reduce the swirling time and allow more of the medicine to be drawn off. I can see some air in the syringe. Is this OK? • Tiny air bubbles in the liquid are normal and are safe to inject. However, it is possible to accidently draw air into the syringe, which should be removed before injecting. Bubbles or air gaps that float to the top of the liquid should be pushed back out into the vial. Why can't I get all of the medicine out of the vial? • The shape of the vial means that a very small amount of the medicine will be left behind in the vial. This is normal. To ensure that only a trace of medicine remains, make sure the needle tip is as low as it can be in the vial when drawing off your dose. What should I do if I have any doubts about my medicine? • All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.
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Frequently asked questions about SOMAVERT 10mg powder and solvent for solution for injection
How do I take SOMAVERT 10mg powder and solvent for solution for injection?
SOMAVERT 10mg powder and solvent for solution for injection comes as injection containing 10mg. 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 SOMAVERT 10mg powder and solvent for solution for injection?
The active substance in SOMAVERT 10mg powder and solvent for solution for injection is pegvisomant.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for SOMAVERT 10mg 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 SOMAVERT 10mg 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: pegvisomant
- 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 of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-I concentrations or was not tolerated.
4.2. Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly.
Posology
A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision. Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.
Dose adjustments should be based on serum IGF-I levels. Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.
Assessment of baseline levels of liver enzymes prior to initiation of SOMAVERT
Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests (LTs) [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)]. For recommendations regarding initiation of SOMAVERT based on baseline LTs and recommendations for monitoring of LTs while on SOMAVERT, refer to Table A in Special warnings and precautions for use (4.4).
The maximum dose should not exceed 30 mg/day.
For the different dose regimens, the following strengths are available: SOMAVERT 10 mg, SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg and SOMAVERT 30 mg.
Paediatric population
The safety and efficacy of SOMAVERT in children aged 0 to 17 years have not been established. No data are available.
Elderly
No dose adjustment is required.
Hepatic or renal impairment
The safety and efficacy of SOMAVERT in patients with renal or hepatic insufficiency has not been established.
Method of administration
Pegvisomant should be administered by subcutaneous injection.
The site of injection should be rotated daily to help prevent lipohypertrophy.
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 the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Growth hormone-secreting tumours
As growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable.
Serum IGF-1 monitoring
Pegvisomant is a potent antagonist of growth hormone action. A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels. Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of the pegvisomant dose.
ALT or AST elevations
Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and AST or in patients with a prior history of treatment with any somatostatin analogue. Administration of pegvisomant should be discontinued if signs of liver disease persist.
For recommendations regarding initiation of SOMAVERT, based on baseline liver tests (LTs) and recommendations for monitoring of liver tests while on SOMAVERT, refer to Table A.
Table A: Recommendations for initiation of SOMAVERT treatment based on baseline LTs and for periodic monitoring of LTs during SOMAVERT treatment
Baseline LT Levels
Recommendations
Normal
• May treat with SOMAVERT.
• Serum concentrations of ALT and AST should be monitored at 4- to 6-week intervals for the first 6 months of treatment with SOMAVERT, or at any time in patients exhibiting symptoms suggestive of hepatitis.
Elevated, but less than or equal to 3 times ULN
• May treat with SOMAVERT; however, monitor LTs monthly for at least 1 year after initiation of therapy and then bi-annually for the next year.
Greater than 3 times ULN
• Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient's liver dysfunction.
• Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs.
• Based on the workup, consider initiation of therapy with SOMAVERT.
• If the decision is to treat, LTs and clinical symptoms should be monitored very closely.
Abbreviations: ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; ULN = upper limit of normal.
If a patient develops LT elevations, or any other signs or symptoms of liver dysfunction while receiving SOMAVERT, the following patient management is recommended (Table B).
Table B. Clinical recommendations based on abnormal liver test results while on SOMAVERT
LT Levels and Clinical Signs/Symptoms
Recommendations
Elevated, but less than or equal to 3 times ULN
• May continue therapy with SOMAVERT. However, monitor LTs monthly to determine if further increases occur.
Greater than 3 but less than 5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL)
• May continue therapy with SOMAVERT. However, monitor LTs weekly to determine if further increases occur (see below).
• Perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present.
At least 5 times ULN, or transaminase elevations at least 3 times ULN associated with any increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury)
• Discontinue SOMAVERT immediately.
• Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal.
• If LTs normalise (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
Signs or symptoms suggestive of hepatitis or other liver injury (e.g., jaundice, bilirubinuria, fatigue, nausea, vomiting, right upper quadrant pain, ascites, unexplained oedema, easy bruisability)
• Immediately perform a comprehensive hepatic workup.
• If liver injury is confirmed, the drug should be discontinued.
Hypoglycaemia
The study conducted with pegvisomant in diabetic patients treated either by insulin or by oral hypoglycaemic medicinal products revealed the risk of hypoglycaemia in this population. Therefore, in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products may need to be decreased (see section 4.5).
Improved fertility
The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient's clinical condition could potentially also improve fertility in female patients (see section 4.6).
Pregnancy
Acromegaly control may improve during pregnancy. Pegvisomant is not recommended during pregnancy (see section 4.6). If pegvisomant is used during pregnancy, IGF-I levels should be closely monitored and pegvisomant doses may need to be adjusted (see section 4.2) based on IGF-I values.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. It should be considered whether to continue treatment with somatostatin analogues. The use of this medicine in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.
Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).
Pegvisomant has significant structural similarity to growth hormone which causes it to cross-react in commercially available growth hormone assays. Since serum concentrations of therapeutically-effective doses of this medicine are generally 100 to 1000 times higher than the actual serum growth hormone concentrations seen in acromegalics, measurements of serum growth hormone concentrations will be spuriously reported in commercially available growth hormone assays. Pegvisomant treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of pegvisomant in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
SOMAVERT is not recommended during pregnancy and in women of childbearing potential not using contraception.
If pegvisomant is used during pregnancy, IGF-I levels should be closely monitored, especially during the first trimester. It may be necessary to adjust the dose of pegvisomant during pregnancy (see section 4.4).
Breast-feeding
The excretion of pegvisomant in breast milk has not been studied in animals. Clinical data are too limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast milk. Therefore, pegvisomant should not be used in breast-feeding women. However, breast-feeding may be continued if this medicine is discontinued: this decision should take into account the benefit of pegvisomant therapy to the mother and the benefit of breast-feeding to the child.
Fertility
For pegvisomant no data on fertility are available.
The therapeutic benefits of a reduction in IGF I concentration which results in improvement of the patient's clinical condition could potentially also improve fertility in female patients.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Summary of the safety profile
The list below contains adverse reactions seen in clinical trials with SOMAVERT.
In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
The most commonly reported adverse reactions occurring in ≥ 10% of patients with acromegaly treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea 13%.
Tabulated list of adverse reactions
The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
Adverse reactions are listed according to the following categories:
Very common:
≥1/10
Common:
≥1/100 to <1/10
Uncommon:
≥1/1,000 to <1/100
Not known (cannot be estimated from the available data)
System Organ Class
Very Common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to < 1/100)
Frequency Not Known
(Cannot Be Estimated From Available Data)
Blood and lymphatic system disorders
thrombocytopenia, leukopenia, leukocytosis, haemorrhagic diathesis
Immune system disorders
hypersensitivity reactionsb
anaphylactic reactionb, anaphylactoid reactionb
Metabolism and nutrition disorders
hypercholesterolaemia, hyperglycaemia, hypoglycaemia, weight increased
hypertriglyceridemia
Psychiatric disorders
abnormal dreams
panic attack, short term memory loss, apathy, confusion, sleep disorder, libido increased
anger
Nervous system disorders
headache
somnolence, tremor, dizziness, hypoaesthesia
narcolepsy, migraine, dysgeusia
Eye disorders
eye pain
asthenopia
Ear and labyrinth disorders
Meniere's disease
Cardiac disorders
oedema peripheral
Vascular disorders
hypertension
Respiratory, thoracic and mediastinal disorders
dyspnoea
laryngospasmb
Gastrointestinal disorders
diarrhoea
vomiting, constipation, nausea, abdominal distension, dyspepsia, flatulence
haemorrhoids, salivary hypersecretion, dry mouth, tooth disorder
Hepatobiliary disorders
abnormal liver function tests (e.g. transaminase elevation) (see section 4.4)
Skin and subcutaneous tissue disorders
hyperhidrosis, contusion, pruritusb, rashb
face oedema, dry skin, increased tendency to bruise, night sweats, erythemab, urticariab
angioedemab
Musculoskeletal and connective tissue disorders
arthralgia
myalgia, arthritis
Renal and urinary disorders
haematuria
proteinuria, polyuria, renal impairment
General disorders and administration site conditions
injection site reaction (including injection site hypersensitivity), injection site bruising or bleeding, injection site hypertrophy (e.g. lipohypertrophy)a, influenza-like illness, fatigue, asthenia, pyrexia
feeling abnormal, impaired healing, hunger
a see Description of selected adverse reactions below
b ADR related to hypersensitivity reaction
Description of selected adverse reactions
Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued. Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.
The development of isolated low-titre anti-growth hormone antibodies was observed in 16.9% of patients treated with pegvisomant. The clinical significance of these antibodies is unknown.
Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria) have been reported in post marketing use. Some patients required hospitalization. Upon re-administration, symptoms did not re-occur in all patients.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is limited experience of overdose with pegvisomant. In the one reported incident of acute overdose, where 80 mg/day was administered for 7 days, the patient experienced a slight increase in fatigue and dry mouth. In the week following discontinuation of treatment the adverse reactions noted were: insomnia, increased fatigue, oedema peripheral, tremor, and weight gain. Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to pegvisomant.
In cases of overdose, administration of this medicine should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- SOMAVERT 10 mg prescriptionPEGVISOMANTUM · injection / infusion
- SOMAVERT 20 mg prescriptionPEGVISOMANTUM · 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
- SomavertPegvisomantum · 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 →
💬 Ask about this leaflet
Ask anything about SOMAVERT 10mg 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.