In the U.S.—

• Growth hormone suppressant, acromegaly

Pegvisomant (peg VI soe mant) is used to treat a condition called acromegaly, which is caused by too much growth hormone in the body. Too much growth hormone produced in adults causes the hands, feet, and parts of the face to become large, thick, and bulky. Other problems such as arthritis also can develop. Pegvisomant works by binding to the growth hormone receptor and preventing the actions of too much growth hormone.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parental
• Injection (US)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pegvisomant, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pegvisomant, rubber or latex. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Pegvisomant has not been shown to cause birth defects or other problems in humans. Before taking this medicine, make sure your doctor knows if you are pregnant or if you become pregnant.

Breast-feeding—It is not known whether pegvisomant passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pegvisomant in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pegvisomant in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pegvisomant, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Hypoglycemic agents (e.g., Glyburide), or
• Insulin (e.g., Humulin, Novolin, Iletin)—Pegvisomant may cause low blood sugar; your doctor may need to change the dose of your diabetes medicine

• Narcotic pain medicine (e.g., Demerol, Morphine)—Your doctor may need to change your dose of pegvisomant if you use any of these medicines.

• Diabetes mellitus (sugar diabetes)—Pegvisomant may cause low blood sugar; your doctor may need to change the dose of your diabetes medicine

• Kidney disease, or
• Liver disease—If you have this condition, pegvisomant may remain in the body longer than normal; your doctor may need to change the dose of your medicine

To control the symptoms of your medical problem, this medicine must be taken as ordered by your doctor. Make sure that you understand exactly how to take this medicine.

Directions on how to prepare and inject the medicine are in the package. Read the directions carefully and ask your health care professional for additional explanation, if necessary.

Take within six hours of mixing the pegvisomant powder with the diluent

Do not use the solution if it is discolored or cloudy.

Dosing—

The dose of pegvisomant will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pegvisomant. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form
  • For treating acromegaly:
    • Adults—At first, 40 mg injected by the doctor. Then, 10 mg daily injected by the patient. Higher doses may be needed, as determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

It is very important to tell your doctor if a latex allergy exists.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More Common
  • Bleeding, blistering, burning, coldness, or discoloration of skin at site of injection;  chest pain;  chills;  cough;  feeling of pressure;  fever;  hives;  hoarseness;  infection, inflammation, itching, or lump at site of injection;  lab results that show problems with liver;  lower back or side pain;  painful or difficult urination  
  
  

Get emergency help immediately if any of the following symptoms of overdose occur

• unusual tiredness;  weakness 

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Accidental injury;  bloating or swelling of face, arms, hands, lower legs, or feet;  blurred vision;  burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings;  diarrhea ;  dizziness;  general feeling of discomfort or illness;  headache;  joint pain;  loss of appetite;  muscle aches and pains;  nausea;  nervousness;  pain;  pain or tenderness around eyes and cheekbones;  pounding in the ears;  runny or stuffy nose;  shivering;  shortness of breath or troubled breathing ;  slow or fast heartbeat;  sore throat;  sweating;  tightness of chest or wheezing;  trouble sleeping ;  unusual tiredness;  unusual weight gain or loss;  vomiting;  weakness 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.