Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients (and/or their caregivers) of the following information to aid in the safe and effective use of SOMAVERT:
Advise patients (and/or their caregivers) of the following adverse reactions:
Inform patients (and/or their caregivers) about the storage options prior to reconstitution of the product [see How Supplied/Storage and Handling (16)].
Advise patients to follow the directions for reconstitution provided in the Instructions for Use. Include that spraying the diluent directly onto the powder may cause foaming and that shaking may induce denaturation (destruction) of the active ingredient (therefore do not shake).
U.S. License No. 1216
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
This Patient Information has been approved by the U.S. Food and Drug Administration.
PATIENT INFORMATIONSOMAVERT (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:
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:
If you are not sure, ask your healthcare provider or pharmacist whether you take these medicines.
How should I use SOMAVERT?
What are the possible side effects of SOMAVERT?SOMAVERT may cause serious side effects, including:
The most common side effects of SOMAVERT include:
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?
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 glycolInactive ingredients: glycine, mannitol, sodium dihydrogen phosphate monohydrate, and sodium phosphate dibasic anhydrous.
For more information, go to www.SOMAVERT.com or call 1-800-645-1280.
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are
not part of a clinical trial* for this product, click the link below to submit your
*If you are involved in a clinical trial for this product, adverse
events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related
to a different Pfizer product, please call Pfizer Safety at
You may also contact the U.S. Food and Drug Administration (FDA) directly to report
adverse events or product quality concerns either online at