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Important Safety Information for Increlex®
INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to GH. Primary IGFD is defined as height and IGF-1 SDS ≤ -3 and normal or elevated growth hormone.
In clinical studies of 71 subjects with Severe Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy.
Almost half of these patients had hypoglycemia prior to IGF-1 treatment. Most cases were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion, and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children. Hypoglycemia was generally avoided when a meal or snack was consumed either shortly before or shortly after administration.
Tonsillar hypertrophy was noted in 11 subjects (15%) in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.
Intracranial hypertension occurred in three subjects. In two subjects, the events resolved without interruption of Increlex® treatment. Increlex® treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.
Please see Full Prescribing Information for additional important information.
Important Safety Information for Somatuline® Depot
Somatuline® Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline® Depot may experience hypoglycemia or hyperglycemia. Glucose levels monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.
Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline® Depot 60mg.
There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline® Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Somatuline® Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.
Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline® Depot may reduce the intestinal absorption of co-administered drugs. Caution should be used.
The most common adverse reactions (incidence > 5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.
Please see Full Prescribing Information for additional important information.
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