ADMELOG- insulin lispro injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN LISPRO (UNII: GFX7QIS1II) (INSULIN LISPRO - UNII:GFX7QIS1II)

Available from:

Sanofi-Aventis U.S. LLC

INN (International Name):

insulin lispro

Composition:

insulin lispro 100 U in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is contraindicated: - during episodes of hypoglycemia [see Warnings and Precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in ADMELOG [see Warnings and Precautions (5.5)]. Risk Summary Published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . Pregnant rats and rabbits were exposed to another insulin lispro product in animal reproduction studies during organogenesis. Fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. No adverse effe

Product summary:

ADMELOG (insulin lispro) injection 100 units/mL (U-100) is available as a clear and colorless solution in: Each prefilled SoloStar pen is for use by a single patient. The ADMELOG SoloStar prefilled pen dials in 1-unit increments. Dispense in the original sealed carton with the enclosed Instructions for Use. Store ADMELOG according to the table below. Do not freeze and do not use ADMELOG if it has been frozen. Protect from direct heat and light. In-use (opened) ADMELOG vials and ADMELOG SoloStar pens must be used within 28 days or be discarded, even if they still contain ADMELOG. Use in an External Insulin Pump Change the ADMELOG in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C). Diluted ADMELOG for Subcutaneous Injection Diluted ADMELOG may remain in patient use for up to 24 hours when stored in a refrigerator (36°F–46°F [2°C–8°C]) or for up to 4 hours when stored at room temperature (86°F [30°C]). Do not dilute ADMELOG used in an external insulin pump. Admixture for Intravenous Administration Infusion bags prepared with ADMELOG are stable when stored in a refrigerator (36°F–46°F [2°C–8°C]) for 24 hours or may be used at room temperature for up to 4 hours [see Dosage and Administration (2.2)] .

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ADMELOG- INSULIN LISPRO 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
ADMELOG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADMELOG .
ADMELOG (INSULIN LISPRO) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
ADMELOG 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 preparation and
administration instructions. (2.1, 2.2, 2.3,
2.4)
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis. (2.2)
Subcutaneous injection (2.2):
Administer ADMELOG by subcutaneous injection into the abdominal wall,
thigh, upper arm, or
buttocks within 15 minutes before a meal or immediately after a meal.
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis.
Continuous subcutaneous infusion (Insulin Pump) (2.2):
Refer to the insulin infusion pump user manual to see if ADMELOG can
be used. Use in accordance
with the insulin pump instructions for use.
Administer ADMELOG by continuous subcutaneous infusion using an
insulin pump in a region
recommended in the instructions from the pump manufacturer.
Rotate infusion sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis.
Do not mix with other insulins or diluents in the pump.
Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY
after dilution and under
medical supervision. (2.2)
The dosage of ADMELOG must be individualized based on the route of
administration and the patient's
metabolic needs, blood glucose monitoring results and glycemic control
goal. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) is available as: (3)
10 mL multiple-dose vials
3 mL multiple-dose vials
3 mL single-patient-use SoloStar
prefilled pens
CONTRAINDICATIONS
Do not