Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other section of the labeling include: • Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus [see Warnings and Precautions (5.1) ] • Liver Toxicity [see Warnings and Precautions (5.2) ] • Cross-Reactivity with GH Assays [see Warnings and Precautions (5.3) ] • Lipohypertrophy [see Warnings and Precautions (5.4) ] • Systemic Hypersensitivity [see Warnings and Precautions (5.5) ] Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies.
One patient was rechallenged with SOMAVERT, and the recurrence of elevated transaminase levels suggested a probable causal relationship between administration of the drug and the elevation in liver enzymes.
A liver biopsy performed on the second patient was consistent with chronic hepatitis of unknown etiology.
In both patients, the transaminase elevations normalized after discontinuation of the drug.
Elevations in ALT and AST levels were not associated with increased levels of TBIL and ALP, with the exception of two patients with minimal associated increases in ALP levels (i.e., less than 3 times ULN).
The transaminase elevations did not appear to be related to the dose of SOMAVERT administered, generally occurred within 4 to 12 weeks of initiation of therapy, and were not associated with any identifiable biochemical, phenotypic, or genetic predictors.
Most common reported adverse reactions (>6%) are infection, pain, nausea, diarrhea, abnormal liver tests, flu syndrome, injection site reaction.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5 WARNINGS AND PRECAUTIONS • Hypoglycemia : Monitor blood glucose in patients with diabetes mellitus and reduce anti-diabetic drug therapy as necessary.
( 5.1 ) • Liver Toxicity: Should have more frequent liver tests and/or discontinue SOMAVERT.
( 5.2 ) • Systemic Hypersensitivity : Monitor closely when re-initiating SOMAVERT in patients with systemic hypersensitivity.
( 5.5 ) 5.1 Hypoglycemia Associated With GH Lowering in Patients With Diabetes Mellitus GH opposes the effects of insulin on carbohydrate metabolism by decreasing insulin sensitivity;
thus, glucose tolerance may improve in some patients treated with SOMAVERT.
Like all medications, Somavert can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: