Generic Name: pegvisomant (peg-VI-soe-mant)
Brand Name: Somavert
Pegvisomant is used for:
Treating acromegaly in patients who have not responded to surgery, radiation therapy, or other medical procedures, or who are not candidates for those treatments.
Pegvisomant is a growth hormone receptor antagonist. It works by blocking the effects of growth hormone.
Do NOT use pegvisomant if:
- you are allergic to any ingredient in pegvisomant, including polyethylene glycol
Contact your doctor or health care provider right away if any of these apply to you.
Before using pegvisomant:
Some medical conditions may interact with pegvisomant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have diabetes, a tumor or other growths, or a history of liver problems or abnormal liver function tests
Some MEDICINES MAY INTERACT with pegvisomant. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Narcotic (opioid) pain medicines (eg, codeine) because they may decrease pegvisomant's effectiveness
- Insulin or other medicines to treat diabetes because the risk of their side effects may be increased by pegvisomant
This may not be a complete list of all interactions that may occur. Ask your health care provider if pegvisomant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use pegvisomant:
Use pegvisomant as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with pegvisomant. Talk to your pharmacist if you have questions about this information.
- Pegvisomant is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using pegvisomant at home, a health care provider will teach you how to use it. Be sure you understand how to use pegvisomant. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- Pegvisomant must be mixed before you use it. Follow your doctor's instructions on how to mix pegvisomant.
- Do not shake pegvisomant after mixing it. Hold the vial between the palms of both hands and gently roll it to dissolve the powder.
- Pegvisomant should be clear after it is mixed. Do not use pegvisomant if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Use pegvisomant within 6 hours after mixing it. Throw away any unused medicine left in the vial after your dose. If you do not use pegvisomant within 6 hours after you mix it, throw it away.
- Choose a different injection site each day (eg, upper arm, upper thigh, stomach area, buttocks) to help prevent lumps at the injection sites.
- Do not inject pegvisomant into an area that has a rash, broken skin, bruising, or lumps.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of pegvisomant, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If you are not sure about your dosing, ask your health care provider.
Ask your health care provider any questions you may have about how to use pegvisomant.
Important safety information:
- Pegvisomant may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use pegvisomant with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose without checking with your doctor.
- Diabetes patients - Pegvisomant may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Pegvisomant may interfere with certain lab tests, including some growth hormone level tests. Be sure your doctor and lab personnel know you are taking pegvisomant.
- Lab tests, including insulin-like growth factor blood levels and liver function, may be performed while you use pegvisomant. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Pegvisomant should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using pegvisomant while you are pregnant. It is not known if pegvisomant is found in breast milk. If you are or will be breast-feeding while you use pegvisomant, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of pegvisomant:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; diarrhea; dizziness; flu-like symptoms (eg, mild fever or chills, headache, muscle aches, tiredness); nausea; pain, redness, or itching at the injection site; runny or stuffy nose; sinus pain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; fainting; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling; chest pain; fever, chills, or persistent cough or sore throat; severe or persistent headache or dizziness; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual tiredness, severe or persistent nausea or stomach pain, loss of appetite, bruising easily); thickening of the skin or lumps at the injection site; unusual weight gain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased fatigue.Proper storage of pegvisomant:
Before mixing, store pegvisomant in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After mixing, keep pegvisomant at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep pegvisomant out of the reach of children and away from pets.
- If you have any questions about pegvisomant, please talk with your doctor, pharmacist, or other health care provider.
- Pegvisomant is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take pegvisomant or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pegvisomant. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pegvisomant. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pegvisomant.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.