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(tesamorelin) for Injection, for Subcutaneous Use
EGRIFTA™ contains tesamorelin (as the acetate salt), an analog of human growth hormone-releasing factor (GRF). The peptide precursor of tesamorelin acetate is produced synthetically and is comprised of the 44 amino acid sequence of human GRF. Tesamorelin acetate is made by attaching a hexenoyl moiety, a C6 chain with a double bond at position 3, to the tyrosine residue at the N-terminal part of the molecule. The molecular formula of tesamorelin acetate is C221H366N72O67S • x C2H4O2 (x ≈7) and its molecular weight (free base) is 5135.9 Daltons. The structural formula of tesamorelin acetate is:
EGRIFTA™ is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. After reconstitution with the supplied diluent (Sterile Water for Injection, USP), a solution of EGRIFTA™ is clear and colorless. Each single-use vial of EGRIFTA™ contains 2 mg of tesamorelin as the free base (2.2 mg tesamorelin acetate, anhydrous) and the following inactive ingredient: 100 mg mannitol, USP.
What are the possible side effects of tesamorelin (Egrifta)?
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.
Stop using tesamorelin and call your doctor at once if you have a serious side effect such as:
- swelling in your hands, ankles, or feet;
- pain or stiffness in your muscles or joints;
- pain in your arms or legs;
- wrist pain or numbness;
- numbness or tingling in your hands or fingers;
- pounding heartbeats or fluttering in your chest;
- high blood sugar (increased thirst,...
What are the precautions when taking tesamorelin injection (Egrifta)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, diabetes, tumors, hypothalamus or pituitary gland problems (such as due to head injury, pituitary tumor/surgery).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant,...
Last reviewed on RxList: 11/8/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Egrifta Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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