LEX® should never be increased to make up for one or more omitted doses.
Treatment with INCRELEX should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with severe primary IGF-1 deficiency or with growth hormone gene deletion and who have developed neutralizing antibodies to growth hormone.
2.2 AdministrationINCRELEX® is administered by subcutaneous injection.
INCRELEX® injection sites should be rotated to a different site (upper arm, thigh, buttock or abdomen) with each injection to help prevent lipohypertrophy.
INCRELEX® should be administered using sterile disposable syringes and needles. The syringes should be of small enough volume so that the prescribed dose can be withdrawn from the vial with accuracy.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
If using syringes that measure dose in units, doses in mg/kg must be converted to units using the following formula: Weight (kg) × Dose (mg/kg) × 1 mL/10 mg × 100 units/1 mL = units/injection.
3 DOSAGE FORMS AND STRENGTHS
INCRELEX® is a sterile solution available at a concentration of 10 mg per mL (40 mg per vial).
4 CONTRAINDICATIONS
Active or Suspected Neoplasia
INCRELEX® is contraindicated in the presence of active or suspected malignancy, and therapy should be discontinued if evidence of malignancy develops.
Known Hypersensitivity
INCRELEX® should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX®, or who have experienced a severe hypersensitivity to INCRELEX® [see Warnings and Precautions (5.2) and Adverse Reactions (6.3)]
Intravenous Administration
Intravenous administration of INCRELEX® is contraindicated.
Closed Epiphyses
INCRELEX® should not be used for growth promotion in patients with closed epiphyses.
5 WARNINGS AND PRECAUTIONS
5.1 HypoglycemiaBecause INCRELEX® has insulin-like hypoglycemic effects it should be administered shortly before or after (± 20 minutes) a meal or snack. Glucose monitoring and INCRELEX® dose titration are recommended until a well tolerated dose is established [see Dosage and Administration (2.1)] and subsequently as medically indicated. Special attention should be paid to small children because their oral intake may not be consistent. Patients should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2 to 3 hours after dosing, particularly during the initiation of INCRELEX® treatment until tolerability and a stable dose have been established [see Adverse Reactions (6.1)]. INCRELEX® should not be administered when the meal or snack is omitted. The dose of INCRELEX® should never be increased to make up for one or more omitted doses.
5.2 Hypersensitivity and Allergic Reactions, including AnaphylaxisAllergic reactions to INCRELEX® have been reported post-marketing. They range from localized (injection site) reactions to systemic reactions, including anaphylaxis requiring hospitalization. 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. [see Contraindications (4) |
