You Should not take Somatropin 191aa [somatropin (rDNA origin) if you have:
- A critical illness due to complications after open heart surgery, abdominal surgery, serious injuries or have severe breathing problems
- Cancer or undergoing treatment for cancer
- Certain types of eye diseases caused by diabetes
- Allergies to growth hormone or benzyl alcohol, an ingredient in the liquid used to mix Somatropin 191aa
What should I tell my healthcare provider before using Somatropin 191aa? Before using Somatropin 191aa, tell your doctor if you have or are:
- A critical illness due to complications after open heart surgery, abdominal surgery or serious injuries or have severe breathing problems
- Cancer or history of cancer
- Skin lesions
- Diabetes, a family history of diabetes or have been told by your doctor that you are at risk for diabetes
- Multiple hormone deficiencies
- Pregnant or nursing
- Taking any medications, especially cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizure
- Liver or kidney disease
- Over 65 years of age
- Have any other medical condition
What are the possible side effects of Somatropin 191aa? Somatropin 191aa may cause serious side effects including:
Concomitant Antiretroviral Therapy:
In some experimental systems, somatropin has been shown to increase HIV replication in vitro. Because of this possibility for acceleration of virus replication, it is recommended that you continue on your antiretroviral therapy for the duration of Somatropin 191aa treatment.
Impaired Glucose Tolerance/Diabetes:
Cases of new onset impaired glucose tolerance (pre-diabetes), new onset type 2 diabetes mellitus and worsening of current diabetes mellitus have been reported in patients receiving Somatropin 191aa. Some patients developed diabetic complications (ketoacidosis and diabetic coma). In some patients, these conditions improved when Somatropin 191aawas discontinued, while in others, the glucose intolerance persisted.
Intracranial hypertension, a rise in the pressure inside the skull, associated visual changes, headache, nausea, and/or vomiting has been reported.
Fluid Retention/Carpal Tunnel Syndrome:
Water retention may occur in adults during Somatropin 191aatherapy. Increased swelling, particularly in the hands and feet, muscle or joint pain may occur during treatment with Somatropin 191aa. Often these reactions resolve with analgesic therapy, or after decreasing the number of doses.
Carpal tunnel syndrome may occur during treatment with Somatropin 191aaIf the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Somatropin 191aa, it is recommended that treatment be discontinued.
Kaposi's sarcoma, Lymphoma and other Malignancies:
Kaposi's sarcoma (KS), lymphoma, and other malignancies are more common in HIV+ individuals. There was no increase in the incidence of Kaposi's sarcoma, lymphoma, or in the progression of cutaneous Kaposi's sarcoma in clinical studies of Serostim®. Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.
Local and Systemic Reactions:
Injection sites should be changed (rotated) to avoid tissue atrophy. Patients should be informed that local and systemic reactions are possible and that prompt medical attention should be sought if allergic reactions occur.
Inflammation of the pancreas has been reported rarely in adults receiving growth hormone.
The most common side effects of Somatropin 191aa include:
- In clinical trials the most common adverse reactions included swelling (particularly of the hands or feet), muscle pain, joint pain, numbness, and pain in extremities.
- Injection site reactions (pain, numbness, redness, swelling). Change (rotate) your injection site to help lower your risk for injection site reactions.
- Fluid retention
- Bone, joint or muscle pain
- Swelling of the extremities
- Carpal tunnel syndrome
- Breast enlargement
- Increase in blood glucose
- Increase in triglycerides
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
This information is not intended to replace discussions with your doctor. .
Somatropin 191aa is available by prescription only.