LYUMJEV- insulin lispro-aabc injection, solution LYUMJEV KWIKPEN- insulin lispro-aabc injection, solution LYUMJEV JUNIOR KWIKP

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Insulin lispro (UNII: GFX7QIS1II) (Insulin lispro - UNII:GFX7QIS1II)

Fáanlegur frá:

Eli Lilly and Company

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

LYUMJEV® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LYUMJEV is contraindicated: - during episodes of hypoglycemia. - in patients with hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. Risk Summary Published studies with insulin lispro 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 insulin lispro in animal reproduction studies during organogenesis. No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offsprin

Vörulýsing:

LYUMJEV (insulin lispro-aabc) injection is a clear and colorless solution available as shown in Table 12. a 3 mL cartridge is for use in Eli Lilly and Company's HumaPen® Luxura® HD insulin delivery device. Patients need to check their device manual to determine if the LYUMJEV cartridge is compatible for use in other devices. b Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. The storage conditions for vials, pens, and cartridges are summarized in Table 13. a In-use (opened) vials, whether or not refrigerated, must be used within 28 days. b When stored at room temperature, LYUMJEV can only be used for a total of 28 days including both not in-use (unopened) and in-use (opened) storage time. Storage of LYUMJEV in Insulin Pump Change the LYUMJEV U-100 in the pump reservoir at least every 9 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C). Storage of LYUMJEV in Intravenous Infusion Fluids Diluted LYUMJEV may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) until time of use. The same solution may be stored up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C) [see Dosage and Administration (2.2)].

Leyfisstaða:

Biologic Licensing Application

Vara einkenni

LYUMJEV- INSULIN LISPRO-AABC INJECTION, SOLUTION
LYUMJEV KWIKPEN- INSULIN LISPRO-AABC INJECTION, SOLUTION
LYUMJEV JUNIOR KWIKPEN - INSULIN LISPRO-AABC INJECTION, SOLUTION
LYUMJEV TEMPO PEN - INSULIN LISPRO-AABC INJECTION, SOLUTION
LYUMJEV KWIKPEN - INSULIN LISPRO-AABC INJECTION, SOLUTION
ELI LILLY AND COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYUMJEV SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LYUMJEV.
LYUMJEV (INSULIN LISPRO-AABC) INJECTION, FOR SUBCUTANEOUS OR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
RECENT MAJOR CHANGES
Indications and Usage (1)
10/2022
INDICATIONS AND USAGE
LYUMJEV 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)
Subcutaneous Injection (2.2):
Administer LYUMJEV U-100 or U-200 at the start of a meal or within 20
minutes after starting a meal
subcutaneously into the abdomen, upper arm, thigh, or buttocks.
Rotate injection sites within the same region to reduce 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 LYUMJEV can
be used. Use in accordance
with the insulin pump instructions for use.
Administer LYUMJEV U-100 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 administer LYUMJEV U-200 by continuous subcutaneous infusion.
Intravenous Infusion (2.2):
Administer LYUMJEV U-100 intravenously only under medical supervision.
DO NOT administer
LYUMJEV U-200 by intravenous infusion.
Dilute LYUMJEV U-100