Somatropin

DEA Class; Rx

Common Brand Names; Genotropin, Genotropin Miniquick, Genotropin Pen 12, Humatrope, Norditropin FlexPro, Nutropin, Nutropin AQ NuSpin 20, Nutropin AQ NuSpin 10, Nutropin AQ NuSpin 5, Omnitrope, Saizen, Serostim, Zorbtive, Nutropin AQ Pen 20, Nutropin AQ Pen 10, Zomacton

Indicated for the treatment of growth hormone deficiency, growth failure, or short stature due to various conditions.

Hypersensitivity to metacresol or glycerin (diluent)

Hypersensitivity to benzyl alcohol

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin

Active malignancy

Pediatric patients with closed epiphyses

Active proliferative or severe non-proliferative diabetic retinopathy

Active malignancy, acute complications of open heart or abdominal surgery, multiple trauma, acute respiratory failure

Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death

Norditropin

• Peripheral edema (42%)

• Edema (25%)

• Arthralgia (19%)

• Leg Edema (15%)

• Myalgia (15%)

• Infection (non-viral) (13%)

• Paraesthesia (11%)

• Skeletal Pain (11%)

Humatrope

• Edema (21.2%)

• Arthralgia (17.3%)

• Paresthesia (17.3%)

• Rhinitis (13.5%)

• Pain (13.5%)

• Myalgia (13.5%)

• Peripheral edema (11.5%)

Increased mortality reported among patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure; benefit of treatment continuation should be weighed against potential risk (see Contraindications)

Reports of sudden death after initiating therapy with somatropin documented in pediatric patients with Prader-Willi syndrome who had ≥1 of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection; male patients with ≥1 factors may be at greater risk than females

Monitor blood glucose in patients with other risk factors (eg, obesity, Turner syndrome, family history of diabetes mellitus [DM]) for glucose intolerance during therapy and adjust antidiabetic treatment, as needed; new onset type 2 DM reported, monitor glucose levels periodically; doses of concurrent antihyperglycemic drugs in diabetics may require adjustment

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting reported; symptoms usually occurred within the first 8 weeks after initiation of therapy; all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose; perform funduscopic examination should be performed routinely before initiating treatment to exclude preexisting papilledema, and periodically thereafter

Serious systemic hypersensitivity reactions (eg, anaphylactic reactions, angioedema) reported with postmarketing use of somatropin products; inform patients and caregivers that such reactions are possible and prompt medical attention should be sought if allergic reaction occurs

Cases of pancreatitis reported; pediatric patients possibly at a greater risk compared to adults; published literature indicates that females who have Turner syndrome may be at greater risk than other pediatric patients receiving somatropin products; consider pancreatitis in patients who develop persistent severe abdominal pain

When somatropin is administered SC at same site over long period of time, tissue atrophy may result; may avoid by rotating injection site (see Administration)

Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes

There are no data on presence of somatropin in human milk; limited published literature reports no adverse effects on breastfed infants with maternal administration of somatropin