SOMAVERT is a prescription medicine for acromegaly. It is approved for patients whose disease has not been controlled by surgery or radiation or for whom these options are not appropriate. The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood.
SOMAVERT® FAQs | SOMAVERT® (pegvisomant for injection) | Safety Info
Frequently asked questions about SOMAVERT
Whether you are considering, starting, or currently taking SOMAVERT, you may have concerns and questions.
Here you will find answers to frequently asked questions about SOMAVERT.
About SOMAVERT
What is SOMAVERT?
How does SOMAVERT work?
SOMAVERT blocks growth hormone (GH) activity in the liver to help reduce levels of IGF-I. Having less IGF-I in the body may help improve some of the signs and symptoms of acromegaly. SOMAVERT is the only medication that blocks GH activity in the liver.
What can I expect from treatment with SOMAVERT?
The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood.
In a clinical trial, 112 patients with acromegaly were randomized to 4 treatment arms. Thirty-two patients received placebo and 80 patients were treated with SOMAVERT at 1 of 3 doses (10 mg, 15 mg, 20 mg).
Results of this study:
- SOMAVERT significantly lowered IGF-I levels at 12 weeks for all 3 doses (10 mg/day, 15 mg/day, and 20 mg/day)
- The majority of IGF-I reduction occurred within the first 2 weeks for patients taking SOMAVERT
- The percentage of patients who achieved a normal IGF-I level for their age was 10% for those taking a placebo, 39% for those taking 10 mg per day of SOMAVERT, 75% for those taking 15 mg per day of SOMAVERT, and 82% for those taking 20 mg per day of SOMAVERT
- The total score of signs and symptoms of acromegaly (swelling, joint pain, headache, sweating, and weakness) improved in patients who took SOMAVERT compared with those who took a placebo
- 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
In a long-term, open-label extension to the original clinical trial, at the end of 43 weeks, 93% of the 109 patients (including 6 new patients) had a normal IGF-I level during at least 1 doctor visit during the study.
How quickly will SOMAVERT work?
Many patients experienced decreased IGF-I levels within 2 weeks. In the 12-week pivotal study, 75% of the total mean reduction in IGF-I levels occurred within 2 weeks.
In this clinical trial, 112 patients with acromegaly were randomized to 4 treatment arms. Thirty-two patients received placebo and 80 patients were treated with SOMAVERT at 1 of 3 doses (10 mg, 15 mg, 20 mg). SOMAVERT significantly lowered IGF-I levels at 12 weeks for all 3 doses.
How will I know if my IGF-I levels are normal?
At first, you will have blood tests to establish a baseline IGF-I level. After you start SOMAVERT, you may have blood tests every 4 to 6 weeks. This is to check your IGF-I levels. Your doctor may adjust your SOMAVERT dose based on these test results.
How do I know my acromegaly is under control with SOMAVERT?
Your physician may order blood tests to determine your IGF-I levels. In addition, you should monitor your signs and symptoms. If your symptoms continue, talk to your doctor.
SOMAVERT safety and side effects
Who should not use SOMAVERT?
SOMAVERT should not be taken by anyone who is allergic to pegvisomant or any of the ingredients in SOMAVERT.
Please see full Patient Information.
What are the most common side effects of SOMAVERT?
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.
As someone taking SOMAVERT, what do I need to be aware of if I take medicine for diabetes?
Your doctor may need to lower your dose of insulin or other oral diabetes medicine because SOMAVERT has been shown to reduce serum glucose levels and insulin requirements.
Can I use SOMAVERT if I am pregnant?
SOMAVERT has not been studied in pregnant women. If you are pregnant, or plan to become pregnant, talk to your doctor about the risks and benefits of treatment with SOMAVERT.
Starting SOMAVERT
How should I use SOMAVERT?
SOMAVERT is given once a day by injection under the skin. Your healthcare provider will give you your first dose, and you or your caregiver will receive training on how to inject SOMAVERT.
What are my SOMAVERT packaging options?
SOMAVERT is available in the original one-day package or flexible
30-day package.
Original one-day package:
One box contains 1 single-dose SOMAVERT vial, 1 prefilled syringe containing 1 mL of diluent (Sterile Water for Injection, USP), and
1 separate 27-gauge ½-inch safety needle.
30-day package:
One large carton contains 3 intermediate cartons containing a total
of 30 single-dose vials of SOMAVERT, 30 prefilled syringes containing 1 mL of diluent (Sterile Water for Injection, USP), and 30 separate
27-gauge ½-inch safety needles.
How should I store SOMAVERT?
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 it!
After mixing the powder, gently and slowly swirl the liquid. Do not shake. You must use the mixed SOMAVERT immediately or throw it away.
What if I mix my SOMAVERT dose but forget to inject it?
If you do not immediately use the mixed SOMAVERT, throw it away.
What if a mixed SOMAVERT dose does not look clear?
DO NOT use it. The mixed dose should look clear once the powder is dissolved. If the dose looks cloudy, hazy, or colored, or if you see particles or foam, do not throw the vial away. Call your doctor for advice. Please call the Pfizer Bridge Program* at 1-800-645-1280 and tell them what happened and ask for a replacement.
*Certain programs and services powered by Pfizer RxPathways®.
What if I forget to take my SOMAVERT dose?
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.
How can I get SOMAVERT?
Your doctor fills out a SOMAVERT Patient Enrollment Form. Then your doctor sends it to the Pfizer Bridge Program*.
*Certain programs and services powered by Pfizer RxPathways®.
What is the Pfizer Bridge Program?
Patients prescribed SOMAVERT can find help with navigating insurance coverage by calling the Pfizer Bridge Program at 1-800-645-1280. This program can help patients with:
- Copay support for eligible commercially insured patients
- Scheduling nurse training for self-injection
What if my insurance denies paying for my treatment?
If your insurance will not cover SOMAVERT, the Pfizer Bridge Program* will help you determine any options to appeal. If the coverage is not available, the Pfizer Bridge Program can determine if you may be eligible for other options to help pay for your SOMAVERT.
*Certain programs and services powered by Pfizer RxPathways®.
What if I cannot afford my copay for SOMAVERT?
If you need help affording therapy, the Pfizer Bridge Program* can explore additional options including the SOMAVERT Copay Program and any other resources that may be available.
Terms and Conditions apply. Please click here to learn more.
*Certain programs and services powered by Pfizer RxPathways®.
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