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Important Safety Information and Indication

 

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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.

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.

IMPORTANT SAFETY INFORMATION FOR SOMAVERT

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.

Click here for full Prescribing Information.