Pegvisomant

Pegvisomant is a synthetic protein that is similar to human growth hormone. Pegvisomant attaches to the same receptor in the body as growth hormone and prevents growth hormone from working.

Pegvisomant is used to treat acromegaly (a growth disorder caused by excess growth hormone).

Pegvisomant is typically given after other treatments, such as medications, surgery, or radiation, have been attempted without successfully relieving symptoms.

Pegvisomant may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to ensure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pegvisomant is injected under the skin. You may be taught how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Pegvisomant is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you the best places on your body to inject pegvisomant. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use pegvisomant regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Each single-use vial (bottle) of this medicine is for one use only. Throw it away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

You will need frequent blood tests to check your liver function.

Store the powder medicine in a refrigerator. Do not freeze.

After mixing pegvisomant powder with a diluent, store it at room temperature and use it within 6 hours after mixing.

Follow all the instructions on your medicine label and package. Inform all your healthcare providers about your medical conditions, allergies, and all medicines you are taking.

You should not use pegvisomant if you are allergic to it.

To make sure pegvisomant is safe for you, tell your doctor if you have:

• diabetes (pegvisomant can lower your blood sugar);
• liver disease;
• a latex allergy; or
• a tumor that secretes growth hormone.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether pegvisomant passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Pegvisomant is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; feeling faint; swelling of your face, lips, tongue, or throat.

Pegvisomant may cause serious side effects. Stop using pegvisomant and call your doctor immediately if you have:

• thickening of the skin or a hard lump where you injected the medicine;
• easy bruising; or
• liver problems—nausea, upper stomach pain, itching, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of pegvisomant may include:

• pain;
• fever, chills, body aches, flu symptoms;
• nausea, diarrhea;
• abnormal liver function tests; or
• pain or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Acromegaly:

Loading dose: 40 mg subcutaneously once under medical supervisionInitial dose: 10 mg subcutaneously once a dayMaintenance dose: 10 to 30 mg subcutaneously once a day Maximum dose: 30 mg per dayComments:-Assess baseline liver tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP) prior to therapy initiation.

Use the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling very tired.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all the medicines you are currently taking and any that you begin or stop using, especially:

• insulin or oral diabetes medicine; or
• narcotic medicines like fentanyl (Abstral, Actiq, Fentora, Duragesic, Lazanda, Onsolis), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid), methadone, morphine, oxycodone (OxyContin, Percocet), and many others.

This list is not complete. Other drugs may interact with pegvisomant, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.