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Frequently Asked Questions

Frequently Asked Questions
 

Here you will find answers to frequently asked questions for both acromegaly and IGF-I levels and for the prescription medicine SOMAVERT.

Acromegaly FAQs

  1. Q: What is acromegaly?

    A: Acromegaly is a rare disease caused by a benign (non-cancerous) tumor of the pituitary gland. Only 60 out of 1 million people have acromegaly. When a person has too much growth hormone (GH), they have swelling and growth of some soft tissue and organs.

  2. Q: What symptoms can acromegaly cause?

    A: The pain and discomfort of acromegaly show up in many ways. Some of these may include:

    • Joint pain (for example, in knees or hips)
    • Headaches
    • Fatigue (weakness)
    • Sweating
    • Swelling of the hands and feet (wider shoes)
    • Increased ring size

    Acromegaly can be associated with many more symptoms. Speak with your doctor to learn more about its signs and symptoms. Many of these symptoms are similar to the symptoms of other conditions. That may make acromegaly hard to diagnose.

  3. Q: What causes acromegaly?

    A: Too much GH causes the liver to produce more than the normal amount of a protein called insulin-like growth factor-I (IGF-I). It is this extra IGF-I that causes the swelling and growth of soft tissues and organs.

  4. Q: What is IGF-I?

    A: IGF-I is a protein everyone has in their bodies. The body uses IGF-I to promote tissue growth, especially during childhood. As a person gets older, the level of IGF-I goes down. The normal level of IGF-I in the body depends on a person’s age and gender so not all people have the same level of IGF-I.  

  5. Q: Why are IGF-I levels important in acromegaly?

    A: The normal level of IGF-I in the body depends on a person’s age and gender so not all people have the same level of IGF-I. If your IGF-I level is too high, this may indicate that your acromegaly is active. You may also experience symptoms, such as:

    • Joint pain (for example, in knees or hips)
    • Headaches
    • Fatigue (weakness)
    • Sweating more than normal
    • Swelling of the hands and feet (wider shoes)
    • Increased ring size
  6. Q: How will I know if I have acromegaly?

    A: To find out if you have acromegaly, a doctor will run blood tests to measure your levels of GH and IGF-I. If these levels are too high, you may need a scan called an MRI. The MRI can help find and measure the tumor that is causing too much GH and IGF-I in your body.

  7. Q: How is acromegaly treated?

    A: For most people with acromegaly, treatment starts by removing the benign tumor on the pituitary gland. This is done through surgery. Radiation may be used sometimes to shrink the tumor if surgery is not an option or has not been effective. Following surgery or radiation, a patient’s GH and IGF-I levels may drop, but not always to normal levels. Many patients are also treated with medication to control their IGF-I levels.

SOMAVERT FAQs

  1. Q: What is SOMAVERT?

    A: SOMAVERT is a prescription medicine for acromegaly. It is approved for patients who have not responded to 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.

  2. Q: How does SOMAVERT work?

    A: SOMAVERT blocks growth hormone (GH) from signaling the body to produce more IGF-I than needed.

  3. Q: What can I expect from treatment with SOMAVERT?

    A: The goal of treatment with SOMAVERT is to have 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 one 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 measured 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 majority of IGF-I normalization occurred within the first 2 weeks for patients taking SOMAVERT
    • In the same 12-week study, of the 57 patients who reached a normal IGF-I level and had at least one sign or symptom of acromegaly at that time, 91% reported improvement in these signs and symptoms at the time of normalization or thereafter.

      *These data are from a clinical trial that involved 112 patients with acromegaly. 32 patients received a placebo. 80 were treated with SOMAVERT at one of 3 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; and 82% of those on 20 mg per day of SOMAVERT.

    • In a long-term extension to the original clinical trial, the majority of patients treated with SOMAVERT reached normal IGF-I levels for their age
      • In fact, at the end of 43 weeks, 93% of patients had a normal IGF-I level at some point during the study

    These data come from the extensions to the original clinical study of 109 patients (including 6 new patients).

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

    A: At first, you will have to 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. Once your IGF-I levels are normalized, you may only need to have tests once every 6 months. The maximum daily maintenance dose should not exceed 30 mg.

  5. Q: Who should not use SOMAVERT?

    A: SOMAVERT should not be taken by anyone who is allergic to any of its ingredients. Please see full patient information.

  6. 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 reduce serum glucose levels and insulin requirements.

  7. 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 become pregnant, talk to your doctor about the risks and benefits of treatment with SOMAVERT. 

  8. Q: How should I use SOMAVERT?

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

  9. 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.

  10. 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.

    *Certain programs and services powered by Pfizer RxPathways®.

  11. 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, hazy, or colored, or if you see particles or foam, 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.

    *Certain programs and services powered by Pfizer RxPathways®.

  12. 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 a forgotten injection. If you have any questions about using SOMAVERT, ask your doctor.

  13. 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®.*

    *Certain programs and services powered by Pfizer RxPathways®.

  14. Q: What is the Pfizer Bridge Program?

    A: The Pfizer Bridge Program®* provides many different services that help you, such as:

    • Filling your prescription
    • Evaluating your insurance coverage
    • Receiving information about treatment
    • Receiving injection training
    • And requesting educational materials

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

    Learn more about the Pfizer Bridge Program now.

    *Certain programs and services powered by Pfizer RxPathways®.

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

    A: If your insurance will not pay for SOMAVERT, the Pfizer Bridge Program®* will work with you and your doctor to determine any options to help you get coverage through your insurance. If coverage is not available, the Pfizer Bridge Program can determine if you may be eligible for the Patient Assistance Program.

    *Certain programs and services powered by Pfizer RxPathways®.

  16. Q: What if I cannot afford my copay for SOMAVERT?

    A: If you need help affording therapy, the Pfizer Bridge Program®* can explore additional options including the SOMAVERT Copay/Coinsurance Program and any other resources that may be available.

    Please see full Prescribing Information and Patient Package Insert.

    *Certain programs and services powered by Pfizer RxPathways®.

 
 
 

Important Safety Information and Indication