FAQs about SOMAVERT

Q: What is SOMAVERT?

A: SOMAVERT (pegvisomant for injection) is a medicine used to treat 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.

Q: How does SOMAVERT work?

A: SOMAVERT blocks growth hormone (GH) action, which lowers the levels of IGF-I (insulin-like growth factor-I) in the blood. Your acromegaly is controlled by blocking both GH action and lowering IGF-I levels.

Q: What can I expect from treatment with SOMAVERT?

A: The goal of treatment with SOMAVERT is to reach a normal IGF-I level in the blood. In 2 clinical trials, the majority of patients treated with SOMAVERT achieved normal IGF-I levels for their age.

• In a long-term study, 92% of patients treated with SOMAVERT achieved normal IGF-I levels at 55 weeks.
• This data comes from a part of a study involving 38 of the original 160 patients who received SOMAVERT. Their dose of SOMAVERT was changed until their IGF-I levels were normal.
• In a short-term study, 82% of patients treated with 20 milligrams (mg) daily of SOMAVERT achieved normal IGF-I levels at 12 weeks.^*
• In this same study, the overall signs and symptoms of acromegaly improved in patients who took SOMAVERT compared with those who took a placebo.
• This study showed how patients rated the change in their symptoms, which included joint pain, headaches, fatigue, sweating, and soft tissue swelling.

*This data is from a clinical trial that involved 112 patients with acromegaly. 31 patients received a placebo. 80 were treated with SOMAVERT at one of three doses. Results for patients achieving normal IGF-I levels for their age were: 10% of patients taking a placebo; 39% of those on 10 mg per day of SOMAVERT; 75% of those on 15 mg per day of SOMAVERT; 82% of those on 20 mg per day of SOMAVERT.

Q: How will I know if my IGF-I levels are normal?

A: Your doctor will use blood tests to monitor your IGF-I levels regularly. Based on your IGF-I levels, your doctor may change your dose of SOMAVERT to maintain normal IGF-I levels.

Q: Who should not use SOMAVERT?

A: It should not be used by those who are allergic to any of its ingredients. For full patient information, click here.

Q: As someone taking SOMAVERT, what do I need to be aware of if I take medicine for diabetes?

A: Your doctor may need to lower your dose of insulin or other oral diabetes medicine because SOMAVERT has been shown to improve serum glucose and insulin levels.

Q: Can I use SOMAVERT if I am pregnant?

A: SOMAVERT has not been studied in pregnant women. If you are pregnant, or plan to be, talk to your doctor about treatment with SOMAVERT.

Q: How should I use SOMAVERT?

A: SOMAVERT is given once a day by injection under the skin. Your first dose will be given by your healthcare provider. He or she will teach you or your caregiver how to inject SOMAVERT.

Q: How should I store SOMAVERT?

A: Store the package of SOMAVERT in a refrigerator. DO NOT FREEZE IT! After mixing the powder and liquid (do not shake), you may keep the mixed medicine at room temperature inside the vial or syringe, but you must inject the mixed SOMAVERT within 6 hours.

Q: What if I mix my SOMAVERT dose but forget to inject it?

A: If it has been more than 6 hours since you mixed it, DO NOT use it. Call the Pfizer Bridge Program at 1-800-645-1280 and tell them what happened. They will tell you what to do.

Q: What if a mixed SOMAVERT dose does not look clear?

A: DO NOT use it. The mixed dose should look clear once the powder is dissolved. If the dose looks cloudy, or if you see color or specks in it, do not throw the vial away. Call the Pfizer Bridge Program at 1-800-645-1280 and tell them you need another vial. They will tell you what to do with the vial you have.

Q: What if I forget to take my SOMAVERT dose?

A: 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 an injection that you forgot.

Q: How can I get SOMAVERT?

A: Your doctor fills out a Statement of Medical Necessity (SMN), which is like a prescription. Then your doctor sends it to the Pfizer Bridge Program (see below).

Q: What is the Pfizer Bridge Program?

A: The Pfizer Bridge Program provides many different services that help you:

• Fill your prescription
• Get insurance reimbursement
• Get information about treatment
• Get injection training
• And much more

The Pfizer Bridge Program includes personalized attention from a Patient Care Consultant (PCC). The PCC can coordinate care between you and your family, your doctor’s office, your insurance company, and your pharmacy.

To find out more about what the Pfizer Bridge Program can do for you,click here.

Q: What if my insurance denies paying for my treatment?

A: If your insurance will not pay for your treatment, the Pfizer Bridge Program uses a fully staffed appeals team to help you get coverage. In addition, an Appeals Support Coordinator follows up on progress. And if you need help affording therapy, the Pfizer Bridge Program can explore additional options, including Co-payment Assistance and a Patient Assistance Program.

Please see full Prescribing Information and Patient Package Insert.

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