"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.
There have been reports of fatalities after initiating therapy with growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with growth hormone. If, during treatment with growth hormone, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with growth hormone should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively (see CONTRAINDICATIONS). Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin Depot is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
Nutropin Depot (somatropin (rdna origin) for inj) should be prescribed by physicians experienced in the diagnosis and management of patients with GHD.
For patients with diabetes mellitus, the insulin dose may require adjustment when GH therapy is instituted. Because GH may reduce insulin sensitivity, particularly in obese individuals, patients should be observed for evidence of glucose intolerance. Patients with diabetes or glucose intolerance should be monitored closely during GH therapy.
Patients with a history of an intracranial lesion should be examined frequently for progression or recurrence of the lesion. In pediatric patients, clinical literature has demonstrated no relationship between GH replacement therapy and central nervous system (CNS) tumor recurrence or new extracranial tumors.
Progression of scoliosis can occur in patients who experience rapid growth. Because GH increases growth rate, patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis. GH has not been shown to increase the incidence of scoliosis.
Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with GH products. Symptoms usually occurred within the first 8 weeks of the initiation of GH therapy. In all reported cases, IH-associated signs and symptoms resolved after termination of therapy or a reduction of the GH dose. Funduscopic examination of patients is recommended at the initiation and periodically during the course of GH therapy.
As with any protein, local or systemic allergic reactions may occur. Parents/Patients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur (see ADVERSE REACTIONS).
Untreated hypothyroidism prevents optimal response to GH. Changes in thyroid hormone laboratory measurements may develop during GH treatment. Therefore, patients should have periodic thyroid function tests and should be treated with thyroid hormone when indicated.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been conducted with Nutropin Depot (somatropin (rdna origin) for inj) .
Pregnancy Category C
Animal reproduction studies have not been conducted with Nutropin Depot (somatropin (rdna origin) for inj) . It is also not known whether Nutropin Depot (somatropin (rdna origin) for inj) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nutropin Depot (somatropin (rdna origin) for inj) should be given to a pregnant woman only if clearly needed.
It is not known whether GH is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nutropin Depot (somatropin (rdna origin) for inj) is administered to a nursing mother.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/5/2009
Additional Nutropin Depot Information
- Nutropin Depot Drug Interactions Center: somatropin subq
- Nutropin Depot Side Effects Center
- Nutropin Depot Overview including Precautions
- Nutropin Depot FDA Approved Prescribing Information including Dosage
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