"An investigational long-acting form of recombinant human growth hormone (rhGH) given twice a month has achieved efficacy and safety at 2 years, new data show.
The novel long-acting recombinant human growth hormone fusion protein somav"...
[somatropin (rDNA origin) injection]
Norditropin is a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.
Norditropin is supplied as a sterile solution for subcutaneous injection in ready-to-administer prefilled pens with a volume of 1.5 mL or 3 mL.
Each Norditropin Cartridge contains the following (see Table 2):
|Component||5 mg/1.5 mL||10 mg/1.5 mL||15 mg/1.5 mL||30 mg/3 mL|
|Somatropin||5 mg||10 mg||15 mg||30 mg|
|Histidine||1 mg||1 mg||17 mg||3.3 mg|
|Poloxamer 188||4.5 mg||4.5 mg||4.5 mg||9.0 mg|
|Phenol||4.5 mg||4.5 mg||4.5 mg||9.0 mg|
|Mannitol||60 mg||60 mg||58 mg||117 mg|
|HCl/NaOH||as needed||as needed||as needed||as needed|
|Water for Injection||up to 1.5 mL||up to 1.5 mL||up to 1.5 mL||up to 3.0 mL|
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 injection (Norditropin)?
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: 7/8/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Norditropin Information
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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