SOMAVERT® WITH PREFILLED DILUENT SYRINGE Patient Counseling Information
(pegvisomant with PREFILLED DILUENT SYRINGE)
17 PATIENT COUNSELING INFORMATION
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:
- •
- Not to use SOMAVERT if they are allergic to SOMAVERT or anything in it.
- •
- They will need blood testing to check IGF-1 levels and liver tests before and during treatment with SOMAVERT and that the dose of SOMAVERT may be changed based on the results of these tests.
- •
- SOMAVERT has not been studied in pregnant women and instruct them to notify their healthcare provider as soon as they are aware that they are pregnant.
- •
- It is not known whether SOMAVERT is excreted in human milk and instruct them to notify their healthcare provider if they plan to do so.
- •
- Pregnancy: Inform female patients that treatment with SOMAVERT may result in unintended pregnancy [see Females and Males of Reproductive Potential (8.3)].
Advise patients (and/or their caregivers) of the following adverse reactions:
- •
- The most common reported adverse reactions are injection site reaction, elevations of liver tests, pain, nausea, and diarrhea.
- •
- If they have liver test elevations they may need to have more frequent liver tests and/or discontinue SOMAVERT. Instruct patients to immediately discontinue therapy and contact their physician if they become jaundiced.
- •
- GH-secreting tumors may enlarge in people with acromegaly and that these tumors need to be watched carefully and monitored by MRI imaging.
- •
- Thickening under the skin may occur at the injection site that could lead to lumps and that switching sites may prevent or lessen this.
- •
- If they have diabetes mellitus, they may require careful monitoring and dose reductions of insulin and/or oral hypoglycemic agents while on SOMAVERT.
- •
- If they take opioids, they may need higher SOMAVERT doses to achieve appropriate IGF-1 suppression.
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.
LAB-0782-4.0
Find SOMAVERT® WITH PREFILLED DILUENT SYRINGE medical information:
Find SOMAVERT® WITH PREFILLED DILUENT SYRINGE medical information:
SOMAVERT® WITH PREFILLED DILUENT SYRINGE Quick Finder
Health Professional Information
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
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:
- •
- Not to use SOMAVERT if they are allergic to SOMAVERT or anything in it.
- •
- They will need blood testing to check IGF-1 levels and liver tests before and during treatment with SOMAVERT and that the dose of SOMAVERT may be changed based on the results of these tests.
- •
- SOMAVERT has not been studied in pregnant women and instruct them to notify their healthcare provider as soon as they are aware that they are pregnant.
- •
- It is not known whether SOMAVERT is excreted in human milk and instruct them to notify their healthcare provider if they plan to do so.
- •
- Pregnancy: Inform female patients that treatment with SOMAVERT may result in unintended pregnancy [see Females and Males of Reproductive Potential (8.3)].
Advise patients (and/or their caregivers) of the following adverse reactions:
- •
- The most common reported adverse reactions are injection site reaction, elevations of liver tests, pain, nausea, and diarrhea.
- •
- If they have liver test elevations they may need to have more frequent liver tests and/or discontinue SOMAVERT. Instruct patients to immediately discontinue therapy and contact their physician if they become jaundiced.
- •
- GH-secreting tumors may enlarge in people with acromegaly and that these tumors need to be watched carefully and monitored by MRI imaging.
- •
- Thickening under the skin may occur at the injection site that could lead to lumps and that switching sites may prevent or lessen this.
- •
- If they have diabetes mellitus, they may require careful monitoring and dose reductions of insulin and/or oral hypoglycemic agents while on SOMAVERT.
- •
- If they take opioids, they may need higher SOMAVERT doses to achieve appropriate IGF-1 suppression.
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.
LAB-0782-4.0
Health Professional Information
{{section_name_patient}}
{{section_body_html_patient}}
Resources
Didn’t find what you were looking for? Contact us.
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Report Adverse Event
Pfizer Safety
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 information:
Pfizer Safety Reporting Site*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 (800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.