(pegvisomant with PREFILLED DILUENT SYRINGE)

Prescribing Information
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8 USE IN SPECIFIC POPULATIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Postmarketing reports of SOMAVERT use in pregnant women are insufficient to establish a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Acromegaly may improve during pregnancy (see Clinical Considerations). In animal reproduction studies, fetotoxicity was observed at a dose that was 6 times the maximum recommended human dose based on body surface area following subcutaneous administration of pegvisomant during organogenesis or during the preimplantation period (see data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryofetal risk

Published data from case reports, case series, and a small interventional study in pregnant women with acromegaly have demonstrated that acromegaly may improve or stabilize without treatment during pregnancy, particularly if acromegaly is treated before pregnancy. In rare cases, acromegaly may worsen during pregnancy. Since IGF-1 levels may change physiologically during pregnancy and interpreting IGF-1 and growth hormone levels in pregnant women with acromegaly may be unreliable, clinical monitoring is recommended.

Data

Animal Data

The effects of pegvisomant on early embryonic development and embryo-fetal development were evaluated in two separate studies, which were conducted in pregnant rabbits with pegvisomant at subcutaneous doses of 1, 3, and 10 mg/kg/day. There was no evidence of teratogenic effects associated with pegvisomant administration during organogenesis. At the 10-mg/kg/day dose (6 times the maximum human therapeutic dose based on body surface area), a reproducible, slight increase in post-implantation loss was observed in both studies.

8.2 Lactation

Risk Summary

Limited information from a case report in published literature reported that the level of pegvisomant in human milk was below the level of detection. There is no information available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SOMAVERT and any potential adverse effects on the breastfed child from SOMAVERT or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

Discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in growth hormone (GH) levels and normalization of insulin-like growth factor 1 (IGF-1) concentration in acromegalic females treated with pegvisomant may lead to improved fertility.

8.4 Pediatric Use

The safety and effectiveness of SOMAVERT in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of SOMAVERT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

SOMAVERT was not studied in patients with renal impairment and the safety and efficacy in these patients is not known.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 7/2023

PATIENT INFORMATION
SOMAVERT (SOM-ah-vert)
(pegvisomant)
for injection, for subcutaneous use

What is SOMAVERT?
SOMAVERT is a prescription medicine used to treat people who have too much growth hormone (acromegaly). SOMAVERT is used to treat people who are not able to be treated or have not already been helped by surgery or radiation.
It is not known if SOMAVERT is safe and effective in children.

Before you use SOMAVERT, tell your healthcare provider about all of your medical conditions, including if you:

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are allergic to pegvisomant or any of the ingredients in SOMAVERT. Do not take SOMAVERT if you are allergic to pegvisomant or any of the ingredients in SOMAVERT. See the end of this Patient Information leaflet for a complete list of ingredients in SOMAVERT.
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have diabetes.
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have or have had liver problems.
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are pregnant or plan to become pregnant. It is not known if SOMAVERT will harm your unborn baby. Tell your healthcare provider if you become pregnant while using SOMAVERT.
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are breastfeeding or plan to breastfeed. It is not known if SOMAVERT passes into your breast milk. You and your healthcare provider should decide how you will feed your baby if you take SOMAVERT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
SOMAVERT may affect the way other medicines work, and other medicines may affect how SOMAVERT works.
Especially tell your healthcare provider if you take:

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insulin or other medicines used to treat diabetes.
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narcotics (opioid medicines). Your healthcare provider may change your dose of SOMAVERT if you take opioids.

If you are not sure, ask your healthcare provider or pharmacist whether you take these medicines.

How should I use SOMAVERT?

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Read the Instructions for Use at the end of this Patient Information for information about the right way to use SOMAVERT.
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Your healthcare provider should do blood tests to check your liver and insulin-like growth factor-1 (IGF-1) levels before you start and while you use SOMAVERT. Your healthcare provider may need to change your dose of SOMAVERT.
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SOMAVERT is given 1 time each day as an injection under your skin (subcutaneous). Some people may need to give 2 injections for their dose each day. Your healthcare provider will tell you if you need to give 2 injections for your dose.
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Your first injection of SOMAVERT should be given by your healthcare provider.
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Your healthcare provider will teach you or your caregiver how to use SOMAVERT.
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If you use too much SOMAVERT, call your healthcare provider right away.
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If you miss a dose of SOMAVERT, just take the next dose at the regular time. Do not take 2 doses at the same time. If you are not sure about your dosing, ask your healthcare provider.

What are the possible side effects of SOMAVERT?
SOMAVERT may cause serious side effects, including:

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changes in your blood sugar level. Your healthcare provider may change your dose of diabetes medicine while you take SOMAVERT.
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liver problems. Stop injecting SOMAVERT right away and call your healthcare provider if you have any of the following symptoms of liver problems:
o
yellowing of your eyes (jaundice)
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dark, amber-colored urine
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feeling very tired (fatigue or exhaustion)
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nausea and vomiting
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pain in your stomach (abdomen)
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generalized swelling
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bruising easily
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skin thickening at your injection site that could lead to lumps (lipohypertrophy)
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allergic reactions. Call your healthcare provider right away if you have any of the following symptoms of a serious allergic reaction:
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swelling of your face, tongue, lips, or throat
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wheezing or trouble breathing
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skin rash, redness, or swelling
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severe itching
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dizziness or fainting

The most common side effects of SOMAVERT include:

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pain
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infection
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nausea
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flu syndrome
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injection site reaction
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diarrhea
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abnormal liver tests. If your liver test results are too high, you may have to have more frequent liver tests

These are not all of the possible side effects of SOMAVERT. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SOMAVERT?

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Before you mix the SOMAVERT powder and the liquid:
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Store SOMAVERT in a refrigerator at 36°F to 46°F (2°C to 8°C).
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The One Day Package and intermediate cartons in the 30-Day Package containing the SOMAVERT vials, may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days.
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In the space provided on the carton, record the date when the carton was removed from the refrigerator and the discard date (30 days after removal from the refrigerator).
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After 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 vials should be thrown away.
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Throw away the SOMAVERT vials after the expiration date printed on the carton or the discard date, whichever is sooner.
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The prefilled syringes maybe stored at a temperature up to 86°F (30°C) until the expiration date printed on the carton. After that time, they should be thrown away.
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Do not freeze SOMAVERT.
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Read the Instructions for Use for the right way to mix SOMAVERT.
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After you mix the SOMAVERT powder and liquid:
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Keep the mixed SOMAVERT at room temperature between 59°F to 77°F (15°C to 25°C).
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Keep SOMAVERT inside the vial or the syringe until you are ready to inject it.
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You must use the mixed SOMAVERT immediately after you mix it.
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If you have not used the mixed SOMAVERT immediately, throw it away.

Keep SOMAVERT and all medicines out of the reach of children.

General information about the safe and effective use of SOMAVERT.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOMAVERT for a condition for which it was not prescribed. Do not give SOMAVERT to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information summarizes the most important information about SOMAVERT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SOMAVERT that is written for health professionals.

What are the ingredients in SOMAVERT?
Active ingredient: pegvisomant, including polyethylene glycol
Inactive ingredients: glycine, mannitol, sodium dihydrogen phosphate monohydrate, and sodium phosphate dibasic anhydrous.

Logo

U.S. License No. 1216


LAB-0783-4.0

For more information, go to www.SOMAVERT.com or call 1-800-645-1280.

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