How To Diagnose | SOMAVERT® (pegvisomant for injection) | Safety Info

Diagnosing acromegaly

To find out if you have acromegaly, your doctor may perform one or more tests. These may include:

A blood test for IGF-I levels

This is the first test for acromegaly. High IGF-I levels are almost always due to acromegaly.

A blood test for GH levels

A series of blood samples are taken over several hours. This test requires avoiding food overnight, skipping breakfast, and drinking a glucose (sugar) solution in the morning.

A magnetic resonance imaging (MRI) scan of the head

If there is reason to believe there is a benign tumor in the pituitary gland, this test will help your doctor see and measure the tumor.

Picture of Jennifer, an actual acromegaly patient, smiling

“When I was first diagnosed, I didn’t have any support.

I had never heard of acromegaly before then…I didn’t know what was going to happen.”

–Jenifer, a patient with acromegaly

Actual acromegaly patient.

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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.

ISI