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Glossary


Acromegaly (ac-ro-MEG-a-lee)

A disease caused by too much growth hormone in the body. (See next entry.)

Growth Hormone (growth HORE-mone)

Also called "GH." Growth hormone is made and released by the pituitary gland. It helps the body process proteins, which in turn help the body grow. Growth hormone also signals the liver to make another hormone that helps with the growth of bone, cartilage, and muscle.

Hormone (HORE-mone)

A chemical substance produced in the body that controls certain cells or organs. Many hormones are produced by specialized glands, such as the pituitary gland.

Pituitary gland (pi-TOO-i-ter-ee gland)

A small gland at the base of the brain. It helps your body with normal functions like growth in childhood, healthy bones and muscles.

Placebo (Pla-SEE-bow)

A form of the medicine that doesn’t contain the active ingredient.

IGF-I (I-G-F-wun)

A hormone that the body makes in response to growth hormone. IGF-I causes growth, along with other effects. The body needs some IGF-I, but too much causes acromegaly.

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SOMAVERT (pegvisomant for injection) is a prescription medicine for acromegaly. It is for patients whose disease has not been controlled by surgery, radiation, and/or other medical therapies, 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.

Important Safety Information for Patients

Do not use SOMAVERT 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.

Tumors that make growth hormone may grow in people with acromegaly. Studies have shown that the size of these tumors generally does not change for people who use SOMAVERT. Even so, these tumors need to be watched carefully by your doctor. Your doctor may ask you to have a magnetic resonance imaging (MRI) test to monitor the size of your tumor.

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 pain, infection, reaction at the injection site, flu-like symptoms, nausea, and diarrhea. 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.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

This product information is intended only for residents of the United States and Puerto Rico. The products discussed herein may have different labeling in different countries.



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