Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 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) ] Slipped Capital Femoral Epiphysis [see Warnings and Precautions (5.5) ] Progression of Preexisting Scoliosis [see Warnings and Precautions (5.6) ] Malignant Neoplasia [see Warnings and Precautions (5.7) ] Benzyl Alcohol [see Warnings and Precautions (5.8) ] Common INCRELEX-related adverse reactions in clinical trials include: hypoglycemia, local and systemic hypersensitivity, tonsillar hypertrophy ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc.
at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because 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 Administrative Site Conditions: lipohypertrophy, bruising Infections and Infestations: otitis media, serous otitis media Respiratory, Thoracic and Mediastinal Disorders: snoring, tonsillar hypertrophy Nervous System Disorders: headache, dizziness, convulsions Gastrointestinal Disorders: vomiting Ear and Labyrinth Disorders: hypoacusis, fluid in middle ear, ear pain, abnormal tympanometry Investigations: cardiac murmur Musculoskeletal and Connective Tissue Disorders: arthralgia, pain in extremity Blood and Lymphatic System Disorders: thymus hypertrophy Surgical and Medical Procedures: ear tube insertion Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy.
Most cases of hypoglycemia were mild or moderate in severity.
Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasions and 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasions.
Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment.
5 WARNINGS AND PRECAUTIONS Hypoglycemia: Severe hypoglycemia leading to hypoglycemic seizures has been observed with INCRELEX treatment.
Administer INCRELEX shortly before or after a meal or snack, because it has insulin-like hypoglycemic effects.
( 5.1 ) Hypersensitivity and Allergic Reactions, including Anaphylaxis: A low number of cases indicative of anaphylaxis requiring hospitalization have been reported.
Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.
( 5.2 ) Intracranial Hypertension : Funduscopic examination is recommended at the initiation and periodically during the course of INCRELEX therapy.
Like all medications, Increlex can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: