and Adverse Reactions (6.3)]
5.3 Intracranial Hypertension Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting have occurred in patients treated with INCRELEX®. IH-associated signs and symptoms resolved after interruption of dosing. Funduscopic examination is recommended at the initiation and periodically during the course of INCRELEX® therapy. [see Adverse Reactions (6.3)]
5.4 Lymphoid Tissue HypertrophyLymphoid tissue (e.g., tonsillar and adenoidal) hypertrophy associated with complications, such as snoring, sleep apnea, and chronic middle-ear effusions have been reported with the use of INCRELEX®. Patients should have periodic examinations to rule out such potential complications and receive appropriate treatment if necessary. [see Adverse Reactions (6.3)]
5.5 Slipped Capital Femoral EpiphysisSlipped capital femoral epiphysis can occur in patients who experience rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during INCRELEX® therapy should be carefully eva luated.
5.6 Progression of Preexisting ScoliosisProgression of scoliosis may occur in patients who experience rapid growth. Because INCRELEX® increases growth rate, patients with a history of scoliosis who are treated with INCRELEX® should be monitored for progression of scoliosis.
5.7 Benzyl AlcoholBenzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in the labeling:
Hypoglycemia [see Warnings and Precautions (5.1)]
Hypersensitivity and Allergic Reactions, including Anaphylaxis [see Contraindications (4), Warnings and Precautions (5.2)]
Intracranial hypertension (IH) [see Warnings and Precautions (5.3)]
Tonsillar and Adenoidal Hypertrophy and related complications [see Warnings and Precautions (5.4)]
6.1 Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies of 71 subjects with 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 reactions. Adverse reactions to INCRELEX® treatment that occurred in 5% or more of these study participants are listed below by organ class.
Metabolism and Nutrition Disorders: hypoglycemia
General Disorders and Admin |
