Pegvisomant (peg-VI-soe-mant)

Treats acromegaly (a growth hormone disorder) in patients who cannot be treated with surgery or radiation.

Brand Name(s):

Somavert

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.

If a dose is missed:

• If you miss a dose or forget to use your medicine, skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• Store the medicine that has been mixed at room temperature and use it within 6 hours. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. Throw away old medicine after the expiration date has passed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using diabetes medicine (insulin or oral medicine such as glyburide, metformin, Actos®, Glucotrol®) or narcotic pain relievers (such as morphine, codeine, fentanyl, Sublimaze®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, diabetes, tumors, or growth hormone deficiency.
• Tell your doctor if you are allergic to rubber. The rubber stopper on the vials of this medicine contains latex, which may cause an allergic reaction if you have a latex allergy.
• This medicine may raise or lower your blood sugar level.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, dizziness, headache, or slow or fast heartbeat.
• Chest pain.
• Dark-colored urine or pale stools.
• Fever, chills, cough, sore throat, and body aches.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Pain, itching, burning, swelling, or a lump under your skin where the shot is given.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Thickening of the skin.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Mild nausea or diarrhea.
• Numbness, tingling, burning, or painful feelings.
• Stuffy or runny nose.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088