"Jeffrey H. Sloman, United States Attorney for the Southern District of Florida, and David W. Bourne, Special Agent in Charge, U.S. Food and Drug Administration (FDA), Office of Criminal Investigations, Miami Field Office, announced that defendant"...
[somatropin (rDNA origin) injection]
Nutropin AQ [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technology. Nutropin AQ has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of pituitary-derived hGH. Nutropin AQ may contain not more than fifteen percent deamidated GH at expiration. The deamidated form of GH has been extensively characterized and has been shown to be safe and fully active.
Nutropin AQ is a sterile liquid intended for subcutaneous administration. The product is nearly isotonic at a concentration of 5 mg of GH per mL and has a pH of approximately 6.0. Each pen cartridge or NuSpin contain either 5 mg, 10 mg or 20 mg of somatropin formulated in 17.4 mg sodium chloride, 5 mg phenol, 4 mg polysorbate 20, and 10 mM sodium citrate [See HOW SUPPLIED/Storage and Handling].
What are the possible side effects of somatropin?
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...
What are the precautions when taking somatropin (rdna origin) (Nutropin AQ)?
See also Side Effects section.
Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol found in some brands), 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: adrenal gland problems, eye problems (e.g., diabetic retinopathy), recent major surgery/injury, Prader-Willi syndrome, severe breathing problems (acute respiratory failure), diabetes or family history of diabetes, obesity, kidney disease, tumors (cancer, especially of the head/neck), thyroid problems, back problems (scoliosis), a certain...
Last reviewed on RxList: 6/8/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Nutropin AQ Information
Nutropin AQ - User Reviews
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