About Acromegaly | SOMAVERT® (pegvisomant for injection) | Safety Info

What is acromegaly?

Acromegaly (pronounced: ac-ro-MEG-a-lee) is a rare disease, usually caused by a benign (non-cancerous) tumor, or growth, on the pituitary gland.

The pituitary gland is a tiny organ in your brain. It makes many hormones, including growth hormone (GH).

If you have acromegaly, the tumor on your pituitary gland causes your levels of GH to rise.

High GH levels can lead to the production of too much insulin-like growth factor I (IGF-I), which leads to signs and symptoms of acromegaly.

Hear from other patients with acromegaly

Why do IGF-I levels matter in acromegaly?

Elevated levels of IGF-I can:

Cause your organs and tissues to grow too much
Lead to the appearance of other signs and symptoms of acromegaly

After surgery or radiation, levels of GH may return to normal, but there are some people who may still produce too much GH.

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IMPORTANT SAFETY INFORMATION

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Do not use SOMAVERT^® (pegvisomant for injection) if you are allergic to SOMAVERT or anything that is in it.

Be sure to tell your doctor if you use narcotic painkillers (opioid medicines) because the dose of SOMAVERT may need to be changed.

Blood sugar levels may go down when taking SOMAVERT. Be sure to tell your doctor if you use insulin or other medicines (oral hypoglycemic medicines) for diabetes. The dose of these medicines may need to be reduced when you use SOMAVERT.

Some people who have used SOMAVERT have developed liver problems. These problems generally disappeared when those people stopped taking SOMAVERT.

Stop the drug right away and call your doctor if you get any of these symptoms:

Your skin or the white part of your eyes turns yellow (jaundice)
Your urine turns dark
Your bowel movements (stools) turn light in color
You do not feel like eating for several days
You feel sick to your stomach (nausea)
You have unexplained tiredness
You have pain in the stomach area (abdomen)

Your doctor may do blood tests before and during your treatment with SOMAVERT to check that the IGF-I levels in your blood are normal and/or that your liver is working correctly. Your dose of SOMAVERT may be changed based on the results of these tests.

If you have stopped SOMAVERT because of an allergic reaction, your doctor will carefully monitor what happens if you start SOMAVERT again.

The most common side effects with SOMAVERT are infection, pain, nausea, diarrhea, abnormal liver function tests, flu-like symptoms, and reaction at the injection site. These are not all of the possible side effects of SOMAVERT. For more information, speak to your doctor.

Inject SOMAVERT in a different place on your body each day. This can help prevent skin problems such as lumpiness or soreness.

SOMAVERT has not been studied in pregnant women. It is not known if SOMAVERT passes into the mother’s milk or if it can harm the baby.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

INDICATION

SOMAVERT is a prescription medicine for acromegaly. It is for patients whose disease has not been controlled by surgery or radiation, or patients for whom these options are not appropriate. The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood.

This site is intended only for U.S residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

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