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Tev-Tropin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tev-Tropin [somatropin (rDNA origin) for injection] is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes. It is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome. It is a form of human growth hormone. Common side effects include headache, nausea, vomiting, fatigue, muscle pain, or weakness.
The recommended dosage of Tev-Tropin is up to 0.1 mg/kg (0.3 lU/kg) of body weight administered 3 times per week by subcutaneous injection. Tev-Tropin may interact with insulin or oral diabetes medicines, steroids, cyclosporine, seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women. Tell your doctor all medications and supplements you use. Tev-Tropin should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Tev-Tropin [somatropin (rDNA origin) for injection] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tev-Tropin in Detail - Patient Information: Side Effects
If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;
- sudden and severe pain behind your eyes, vision changes;
- swelling in your head, face, hands, or feet; or
- numbness or tingling in your wrist, hand, or fingers.
Less serious side effects may include:
- headache, feeling tired;
- redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;
- pain in your arms or legs, joint stiffness or pain;
- muscle pain; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
Read the entire detailed patient monograph for Tev-Tropin (Somatropin, rDNA Origin, for Injection) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tev-Tropin FDA Prescribing Information: Side Effects
The following adverse reactions have been observed during appropriate use of somatropin: headaches (children and adults), gynecomastia (children) and pancreatitis (children and adults). See WARNINGS section.
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influences by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Tev-Tropin with the incidence of antibodies to other products may be misleading. With respect to growth hormone, antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases, when binding capacity exceeds 2 mg/L, growth attenuation has been observed.
None of the patients with anti-GH antibodies in the clinical studies experienced decreased linear growth response to Tev-Tropin or any other associated adverse event. Injection site reactions (e.g., pain, bruise) occurred in 8 of the 164 treated patients.
Leukemia has been reported in a small number of patients treated with other growth hormone products. It is uncertain whether this risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors.
New-onset type 2 diabetes mellitus has been reported.
Read the entire FDA prescribing information for Tev-Tropin (Somatropin, rDNA Origin, for Injection) »
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