APIDRA- insulin glulisine injection, solution APIDRA SOLOSTAR- insulin glulisine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN GLULISINE (UNII: 7XIY785AZD) (INSULIN GLULISINE - UNII:7XIY785AZD)

Available from:

sanofi-aventis U.S. LLC

INN (International Name):

insulin glulisine

Composition:

insulin glulisine 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA is contraindicated: - during episodes of hypoglycemia - in patients with known hypersensitivity to insulin glulisine or to any of the excipients in APIDRA; systemic allergic reactions have occurred with APIDRA [see Adverse Reactions (6.1)] . Risk Summary Available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . Animal reproduction studies have been conducted with insulin glulisine in rats and rabbits using regular human insulin as a comparator. Insulin glulisine was given to female rats throughout pregnancy at subcutaneous doses up to 10 units/kg/day (2 times the average human dose, based on body surface area comparison) and to rabbits during org

Product summary:

APIDRA injection, 100 units/mL (U-100), is a clear and colorless solution available as: Pen needles are not included in the packs. SoloStar is compatible with all pen needles from Becton Dickinson and Company, Ypsomed, and Owen Mumford. The APIDRA SoloStar prefilled pen dials in 1-unit increments. Dispense in the original sealed carton with the enclosed Instructions for Use. Do not freeze. Do not use after the expiration date (see carton and container). Storage conditions are summarized in the following table: Use in an External Insulin Pump Change the APIDRA in the pump reservoir at least every 48 hours, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C). Intravenous Use Diluted APIDRA in infusion bags in normal saline solution (0.9% Sodium Chloride Injection, USP) are stable at room temperature for 48 hours [see Dosage and Administration (2.2)] .

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

APIDRA- INSULIN GLULISINE INJECTION, SOLUTION
APIDRA SOLOSTAR- INSULIN GLULISINE INJECTION, SOLUTION
SANOFI-AVENTIS U.S. LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APIDRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APIDRA.
APIDRA (INSULIN GLULISINE) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
APIDRA is a rapid-acting human insulin analog indicated to improve
glycemic control in adult and pediatric
patients with diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for important administration
instructions. (2.1, 2.2)
Individualize and adjust the dosage of APIDRA based on route of
administration, individual's metabolic
needs, blood glucose monitoring results, and glycemic control goal.
(2.3)
Dosage adjustments may be needed when switching from another insulin,
with changes in physical
activity, changes in concomitant medications, changes in meal
patterns, changes in renal or hepatic
function or during acute illness. (2.3)
_Subcutaneous Injection:_ (2.2)
Inject within 15 minutes before a meal or within 20 minutes after
starting a meal into the abdomen,
thigh, or upper arm.
Rotate injection sites within the same region to reduce the risk of
lipodystrophy and localized
cutaneous amyloidosis.
Should generally be used in regimens with an intermediate or
long-acting insulin.
_Continuous Subcutaneous Infusion (Insulin Pump):_ (2.2)
Refer to the insulin infusion pump user manual to see if APIDRA can be
used. Use in accordance with
the insulin pump instructions for use.
Administer by continuous subcutaneous infusion using an insulin pump
in a region recommended in
the instructions from the pump manufacturer.
Rotate infusion sites within the same region to reduce the risk of
lipodystrophy and localized
cutaneous amyloidosis.
Do not mix with other insulins or diluents in the pump.
_Intravenous Administration:_ Administer only under medical
supervision af