Generic Name: pegvisomant (peg VIH so mant)Brand Names: Somavert
Pegvisomant is a manufactured protein similar to human growth hormone (GH). Pegvisomant binds to the same receptor in the body as growth hormone, and blocks the effects of growth hormone.
Pegvisomant is used for the treatment of acromegaly (a growth disorder caused by too much growth hormone).
Pegvisomant may also be used for purposes other than those listed here.
Your doctor will want you to have blood tests and/or other medical evaluations during treatment with pegvisomant to monitor progress and side effects. It is especially important to monitor liver function and insulin-like growth factor (IGF-I) with regularly scheduled blood tests.
Before taking pegvisomant, tell your doctor if you
have an allergy to pegvisomant, another growth hormone product, or latex (the stopper on the vial of Somavert contains latex);
have a tumor that secretes growth hormone;
are taking a narcotic pain or cough medication such as codeine (Tylenol #3, others), hydrocodone (Vicodin, Lorcet, others), oxycodone (Percocet, others), morphine (MS Contin, MSIR, OxyContin, others), fentanyl (Duragesic, others), and others.
You may not be able to take pegvisomant or you may require a dosage adjustment or special monitoring during treatment.Pegvisomant is in the FDA pregnancy category B. This means that pegvisomant is not expected to be harmful to an unborn baby. Do not take pegvisomant without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether pegvisomant passes into breast milk. Do not take pegvisomant without first talking to your doctor if you are breast-feeding a baby.
Take pegvisomant exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.
Pegvisomant is administered as a subcutaneous (under the skin) injection. Your healthcare provider will give you detailed instructions regarding how to administer the injection.
The pegvisomant powder must be mixed with the supplied sterile water for injection before each dose. Instructions regarding mixing the solution are included with the product. Follow them closely.
In general, 1 mL of the Sterile Water for Injection should be injected into the vial of pegvisomant, aiming the stream of liquid against the glass wall of the vial. Then, gently roll the vial between the palms of both hands to dissolve the powder. Do not shake the vial. Shaking the vial could damage the proteins in the medication and decrease its effectiveness.
After mixing, the solution should be clear and should not contain any particles. If the solution is cloudy or contains particles, do not inject it.
After mixing the solution, the medication should be administered as soon as possible or within 6 hours.
Administer only one dose from each vial. Throw away any remaining medication after administering one dose.The stopper on the vial of Somavert contains latex. Do not use this product without first talking to your doctor if you are allergic to latex.
It is important to use pegvisomant regularly to get the most benefit.
Your doctor will want you to have blood tests and/or other medical evaluations during treatment with pegvisomant to monitor progress and side effects. It is especially important to monitor liver function and insulin-like growth factor (IGF-I) with regularly scheduled blood tests.Store unmixed pegvisomant in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius).
If you miss a dose of pegvisomant, skip the missed dose and use only the next regularly scheduled dose the next day. Do not use a double dose of this medication.
Seek emergency medical attention or contact your doctor immediately if an overdose of pegvisomant is suspected.
Symptoms of a pegvisomant overdose may include fatigue.
There are no restrictions on food, beverages, or activity during treatment with pegvisomant unless otherwise directed by your healthcare provider.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
liver problems (may be detected by blood tests or symptoms such as yellowing of the skin or eyes, vomiting, abdominal pain, unusual fatigue, loss of appetite, itching, clay-colored stools, or dark urine).
Other, less serious side effects may be more likely to occur. Continue to take pegvisomant and talk to your doctor if you experience
discomfort at the injection site;
nausea or diarrhea;
water retention or slight weight gain.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Acromegaly:
Initial dose: 40 mg by subcutaneous injection.Maintenance dose: 10 to 30 mg by subcutaneous injection daily.
Before taking pegvisomant, tell your doctor if you are taking any of the following medicines:
any medicine taken by mouth to treat diabetes such as glyburide (Diabeta, Glynase, Micronase), glipizide (Glucotrol), glimepiride (Amaryl), rosiglitazone (Avandia), pioglitazone (Actos), and others; or
a narcotic pain or cough medication such as codeine (Tylenol #3, others), hydrocodone (Vicodin, Lorcet, others), oxycodone (Percocet, others), morphine (MS Contin, MSIR, OxyContin, others), fentanyl (Duragesic, others), and others.
You may not be able to take pegvisomant, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with pegvisomant. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.