Taking SOMAVERT® (pegvisomant for injection) | Safety Info

How to take SOMAVERT

If you have any questions about your treatment, call your healthcare provider. If there is anything you don't understand in the instructions,
or can't do, call your doctor or call the Pfizer Bridge Program^®^* hotline at 1-800-645-1280.

Read the Patient Information

Read the Patient Information and Instructions for Use that come with SOMAVERT before you start using it and each time you
get a refill, because new information may have been added.

Storage

Store the one-day package or intermediate cartons in 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 SOMAVERT. Please see the full storage information.

Preparing SOMAVERT for injection

SOMAVERT is packaged as a dry powder. Before you use SOMAVERT, you must mix the dry powder with the prefilled diluent
syringe that comes in the SOMAVERT package. Do not use any other liquid to mix the medicine.

Use only one dose from each vial.

Choose an injection site

SOMAVERT is injected under the skin (subcutaneous). Injection sites may include your upper arm, upper thigh, stomach area
(abdomen), and buttocks. Choose your injection site from one of the areas your healthcare provider told you to use. Choose a
different injection site each day to help prevent lumps from developing in your skin.

Don't inject SOMAVERT into an area of your body that has a rash or broken skin, or is bruised or has lumps in your skin.

Consider downloading the SOMAVERT Injection Placemat to help you organize self-injection

The placemat has easy-to-follow, step-by-step instructions you can refer to anytime for a quick reminder on how to perform your injection.

Watch the Injection Training Video

This step-by-step video can help you master the process of mixing and injecting SOMAVERT with the prefilled diluent syringe.

For more assistance, call the Device Support Hotline

If there is anything you don't understand in the instructions, or can't do, call your doctor or call the Device Support Hotline at
1-800-645-1280.

Pfizer Bridge Program* hours are from 9 AM to 7 PM Eastern Time, Monday through Friday.

^*Certain programs and services powered by Pfizer RxPathways^®.

IMPORTANT SAFETY INFORMATION

Medication Guide Full Prescribing Information

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 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.

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IMPORTANT SAFETY INFORMATION

Click to expand

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.

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)

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

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

IMPORTANT SAFETY INFORMATION

Click to expandExpand

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.

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)

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

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.