Start SOMAVERT® (pegvisomant for injection) | Safety Info

Starting on SOMAVERT

Like any new patient starting on a new medication, you may have a lot of questions about starting SOMAVERT. In addition to talking with your doctor, you can find information about SOMAVERT here.

5 vials of SOMAVERT 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg

Your doctor will track your IGF-I levels

Before taking SOMAVERT for your acromegaly, your doctor should order blood tests. These tests will check your liver and IGF-I levels in your system.

After treatment begins, your doctor may order additional IGF-I blood tests every 4 to 6 weeks to see how SOMAVERT is working or if the dose needs adjusting
Your doctor may also run other tests in order to check your liver

It is important to stick to your treatment plan as prescribed by your doctor. If you are still having symptoms of acromegaly, be sure to talk to your doctor.

The SOMAVERT Injection Placemat provides instructions for taking your SOMAVERT treatment.

Important information to remember

Store the one-day package or intermediate cartons of the 30-day package in a refrigerator at 36°F to 46°F (2°C-8°C) OR at room temperature up to 77°F (25°C) for a single period of up to 30 days. Do not freeze it!
- Once the carton has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 30 days at room temperature, the vial(s) should be discarded
After mixing the powder, gently and slowly swirl the liquid. Do not shake. You must use the mixed SOMAVERT immediately or throw it away
If you forget to give yourself an injection of SOMAVERT, skip that dose. Get back on your schedule the next day

Do not inject a double dose to make up for a forgotten injection
If you have any questions about using SOMAVERT, ask your doctor

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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