10 mg, 15 mg, 20 mg, 25 mg, or 30 mg powder and liquid for injection, solution
pegvisomant
What SOMAVERT is and what it is used for
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder that involves increased secretion of growth hormone ( GH ) and IGF -I ( Insulin-like growth factors), which can lead to increased bone growth, swelling in soft tissues, heart disease, and other problems.
The active substance in SOMAVERT, pegvisomant, is a so-called antagonist against the receptor for growth hormone. Such substances reduce the effect of growth hormone ( GH ) and lower the level of IGF -I ( Insulin-like growth factors) circulating in the blood.
What you need to know before you use 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 visual disturbances or headaches, contact your doctor immediately.
- Your doctor or nurse will measure the levels of IGF ‑1 ( Insulin-growth factors) circulating in the blood and adjust the SOMAVERT dose if necessary.
- Your doctor will also check your adenoma (benign tumor ).
- Your doctor will take blood tests to measure your liver function before and during treatment with SOMAVERT. If the values are abnormal, your doctor will discuss with you what treatment options are available. Once treatment is started, your doctor or nurse will measure the level of liver enzymes every 4-6 weeks for the first 6 months of treatment with SOMAVERT. Treatment with SOMAVERT should be discontinued if there are persistent signs of liver disease.
- If you have diabetes, your doctor may need to adjust the amount of insulin or other medicine you take.
- Fertility in female patients may increase as the disease improves. Use of this medicine during pregnancy is not recommended and women of childbearing potential should be advised to use contraception. See also the sections on Pregnancy below.
Other medicines and SOMAVERT
You must tell your doctor if you have previously used any other medicine for the treatment of acromegaly or the treatment of diabetes.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may receive other medicines as part of your treatment. You must take all the medicines you have been prescribed as well as SOMAVERT, unless your doctor, pharmacist, or nurse tells you otherwise.
Pregnancy, breastfeeding, and fertility
Use of SOMAVERT during pregnancy is not recommended. If you are a fertile woman, you must use contraception during treatment.
It is not known whether pegvisomant passes into breast milk. You should not breastfeed while taking SOMAVERT unless your doctor has discussed this with you.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
No studies have been performed on the ability to drive or use machines.
SOMAVERT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to use SOMAVERT
Always inject this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will give you an initial subcutaneous (under the skin) injection of 80 mg pegvisomant. After that, the daily dose is one of pegvisomant 10 mg, taken as a subcutaneous (under the skin) injection.
Your doctor will change the dose every 4-6 weeks, in increments of 5 mg pegvisomant/day, depending on your so-called serum IGF -I values, to maintain an optimal treatment result.
Mode of administration and route of administration:
SOMAVERT is injected under the skin. Injection 1 can be taken on your own or given by someone else, such as your doctor or nurse. The detailed instructions on injection technique at the end of this leaflet should be followed. Continue to inject this medicine for as long as your doctor prescribes.
This medicine must be dissolved before use. The injection fluid must not be mixed in the same syringe or bottle as any other medicine.
Adipose tissue may form at the injection site. To avoid this, you should inject in different places each time, see the description in Step 2 of “Instructions for preparing and giving an injection of SOMAVERT “ in this leaflet. It gives the skin and tissue under the skin an opportunity to recover after an injection before the next one is given in the same place.
If you feel that the effect of this medicine is too strong or too weak, contact your doctor, pharmacist, or nurse.
If you use too much SOMAVERT
If you accidentally inject more SOMAVERT than your doctor prescribed, nothing serious is likely to happen, 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. Then continue injecting SOMAVERT as directed by your doctor. Do not inject a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Mild to severe 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 difficulty breathing (spasm of the larynx), generalized skin rash, hives ( 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 users:
- Headache.
- Diarrhea.
- Joint pain.
Common: may affect up to 1 in 10 users:
- Shortness of breath.
- Increased levels of substances that measure liver function, can be seen in blood test results.
- Blood in the urine.
- Increased blood pressure.
- Constipation, feeling sick, vomiting, feeling bloated, indigestion, flatulence.
- Dizziness, sleepiness, involuntary tremors, decreased sensitivity to touch.
- Bruising, bleeding, tenderness, or swelling at the injection site. Fat formation under the skin at the injection site, swollen arms and legs, feeling weak, fever.
- Sweating, itching, rash, increased tendency to bruise.
- Muscle pain, arthritis.
- Increase in cholesterol in the blood, weight gain, increase in blood glucose, and decreased blood glucose.
- Flu-like symptoms, feeling tired.
- Abnormal dreams.
- Pain in the eyes.
Uncommon: may affect up to 1 in 100 users:
- Allergic reaction after drug administration (fever, skin rash, itching, and, in severe cases, breathing difficulties, rapid swelling of the skin, which requires immediate medical attention). May occur immediately or several days after drug administration.
- Protein in the urine, increased urine volume, kidney problems
- Indifference, confusion, increased sex drive, panic attacks, memory loss, and sleep problems.
- Decreased amount of platelets, increased or decreased amount of white blood cells, tendency to bleed
- Feeling of being abnormal, impaired healing.
- Strained eyes, problems with the inner ear.
- Facial swelling, dry skin, night sweats, skin redness ( erythema ), raised itchy nodules on the skin ( hives ).
- Elevated blood fats, increased appetite.
- Dry mouth, increased salivation, dental problems, hemorrhoids.
- Altered sense of taste, migraine.
Has been reported: occurring in an unknown number of users:
- Anger.
- Severe shortness of breath ( laryngospasm ).
- Rapid swelling of the skin and underlying tissue and mucous membranes in the organs ( angioedema ).
Approximately 17% of patients will develop antibodies to growth hormone during treatment. Antibodies do not seem to counteract the effect of this medicine.
How SOMAVERT should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the vial and packaging after EXP. The expiration date is the last day of the specified month.
Store the vials of powder in the carton in a refrigerator (2 °C – 8 °C). Light sensitive. Do not freeze.
Carton containing SOMAVERT vials of powder can be stored at room temperature at a maximum of 25 °C for a period of a maximum of 30 days. Use by date must be indicated on the carton with day/month/year (no more than 30 days from the date it was taken out of the refrigerator). The vials must be protected from light. This medicine must not be put back in the refrigerator.
Discard this medicine if it has not been used by the new use-by date or expiry date printed on the carton, whichever comes first.
Store pre-filled syringe(s) at a maximum of 30 °C or in a refrigerator (2 °C – 8 °C). Do not freeze.
After preparation of the SOMAVERT solution, it must be used immediately.
Do not use this medicine if the solution is cloudy or contains particles.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is pegvisomant.
- SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant. After reconstitution with 1 ml diluent, 1 ml solution for injection contains 10 mg pegvisomant.
- SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant. After reconstitution with 1 ml diluent, 1 ml solution for injection contains 15 mg pegvisomant.
- SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant. After reconstitution with 1 ml diluent, 1 ml solution for injection contains 20 mg pegvisomant.
- SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant. After reconstitution with 1 ml diluent, 1 ml solution for injection contains 25 mg pegvisomant.
- SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant. After reconstitution with 1 ml diluent, 1 ml solution for injection contains 30 mg pegvisomant.
- Other ingredients are glycine, mannitol (E421), anhydrous disodium phosphate, and sodium dihydrogen phosphate monohydrate (see section 2 “SOMAVERT contains sodium”)
- The diluent is water for injections.
Appearance and package sizes of the medicine
SOMAVERT consists of powder and liquid for injection (10 mg, 15 mg, 20 mg, 25 mg, or 30 mg pegvisomant in a vial and 1 ml of liquid in a pre-filled syringe ). Packaging sizes 1 and/or 30 pcs. Not all pack sizes will be marketed.
The powder is white and the diluent is clear and colorless.
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
Contact the representative of the marketing authorization holder if you want to know more about this medicine.
| België/Belgique/BelgienLuxembourg/LuxembourgPfizer NV/SATel/Tel: +32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000 |
| BulgariaPfizer Luxembourg САРЛ, Клон БулгарияTel.: +359 2 970 4333 | MagyarországPfizer Kft.Tel.: + 36 1 488 37 00 |
| Czech RepublicPfizer, coil. s iPhone: +420 283 004 111 | MaltaVivian Corporation Ltd.Phone: +356 21344610 |
| DenmarkPfizer ApSPhone: +45 44 20 11 00 | The NetherlandsPfizer by phone: +31 (0)10 406 43 01 |
| DeutschlandPfizer Pharma GmbHPhone: +49 (0)30 550055 51000 | NorwayPfizer iPhone: +47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti branch phone: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0 |
| GreecePFIZER ΕΛΛΑΣ Α.Ε.Tel.: +30 210 6785800 | PolishPfizer Polska Sp. z o. oTel.: +48 22 3356100 |
| SpainPfizer SLPhone: +34 91 490 99 00 | PortugalLaboratórios Pfizer, Lda.Phone: +351 21 423 5500 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | RomaniaPfizer România SRLPhone: +40 (0)21 207 28 00 |
| HrvatskaPfizer Croatia dooPhone: + 385 1 3908 777 | SlovenijaPfizer branch of marketing s połoška farmacevtske activities, LjubljanaPhone: + 386 (0)1 52 11 400 |
| IrelandPfizer Healthcare IrelandPhone: 1800 633 363 (toll free)+44 (0)1304 616161 | Slovenian RepublicPfizer Luxembourg SARL, organizačná zložkaPhone: +421 2 5941 8500 |
| IcelandIcepharma hf.Phone: + 354 540 8000 | Finland/FinlandPfizer OyTel: +358 (0) 9 43 00 40 |
| ItalyPfizer SrlPhone: +39 06 33 18 21 | SwedenPfizer phone: +46 (0)8 550 520 00 |
| CyprusPFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)Phone: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedPhone: +44 (0)1304 616161 |
| LatviaPfizer Luxembourg SARL branch in LatviaPhone: +371 670 35 775 | |
| LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000 |