Indications:
SOMAVERT is used to treat acromegaly, a hormonal disorder that occurs as a result of increased secretion of growth hormone (GH) and IGF-I (insulin-like growth factors) and is characterized by excessive bone growth, soft tissue swelling, heart disease and other associated disorders.
The active substance in SOMAVERT, pegvisomant, is a growth hormone receptor antagonist. It reduces the action of growth hormone (GH) and lowers the blood levels of IGF-I (insulin-like growth factor).

Contraindications:
Do not use SOMAVERT:
- If you are allergic to pegvisomant or any of the other ingredients of this medicine (listed in section 6).

Precautions:
Talk to your doctor or pharmacist before using SOMAVERT.

Pregnancy, lactation and fertility:
SOMAVERT is not recommended for pregnant women. If you are a woman of childbearing potential, you must use a method of contraception during treatment.

It is not known whether 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 become pregnant, 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.

Method of administration:
Always inject this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

Your doctor will give you an initial dose of 80 mg pegvisomant subcutaneously (just under the skin). After this, the usual daily dose is 10 mg pegvisomant, which is given by injection.
subcutaneous injection (just under the skin).

Every 4-6 weeks, your doctor will make appropriate dose adjustments, increasing it by 5 mg pegvisomant/day, based on the so-called IGF-I blood concentration values ​​to maintain an optimal therapeutic response.

Method and route of administration:
SOMAVERT is injected under the skin. The injection can be given by yourself or by someone else, for example a doctor or nurse. The detailed instructions for the injection procedure given at the end of this leaflet should be followed. You should continue to take this medicine by injection for as long as your doctor tells you to.

This medicine must be dissolved before administration. As with other similar medicines, the solution for injection should not be mixed in the same syringe or vial with other medicines.

Fatty tissue from the skin may build up at the injection site. To avoid this, give your injection in a different place each time as described in Step 2 of the “Instructions for preparing and giving a SOMAVERT injection” section of this leaflet. This allows your skin and the area under your skin to recover from one injection before you give another injection 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 have any further questions on this medicine, ask your doctor or pharmacist.

Composition:
- The active substance is pegvisomant.
- SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant. After reconstitution with 1 ml solvent, 1 ml of solution contains 10 mg pegvisomant.
- SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant. After reconstitution with 1 ml solvent, 1 ml of solution contains 15 mg pegvisomant.
- SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant. After reconstitution with 1 ml solvent, 1 ml of solution contains 20 mg pegvisomant.
- SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant. After reconstitution with 1 ml solvent, 1 ml of solution contains 25 mg pegvisomant.
- SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant. After reconstitution with 1 ml solvent, 1 ml of solution contains 30 mg pegvisomant.
- The other ingredients are: glycine, mannitol (E421), disodium phosphate anhydrous and sodium dihydrogen phosphate monohydrate.
- The solvent is water for injections.

Presentation:
30 pre-filled syringes

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.