LEVEMIR- insulin detemir implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN DETEMIR (UNII: 4FT78T86XV) (INSULIN DETEMIR - UNII:4FT78T86XV)

Available from:

Dispensing Solutions, Inc.

INN (International Name):

INSULIN DETEMIR

Composition:

INSULIN DETEMIR 14.2 mg in 1 mL

Administration route:

SOFT TISSUE

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEVEMIR is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. LEVEMIR is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.

Product summary:

LEVEMIR is available in the following package sizes: each presentation containing 100 Units of insulin detemir per mL (U-100). *LEVEMIR PenFill® cartridges are for use with Novo Nordisk 3 mL PenFill® cartridge compatible insulin delivery devices and NovoFine® disposable needles.

Authorization status:

New Drug Application

Summary of Product characteristics

LEVEMIR - INSULIN DETEMIR IMPLANT
DISPENSING SOLUTIONS, INC.
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LEVEMIR (INSULIN DETEMIR [RDNA ORIGIN] INJECTION)
DESCRIPTION
LEVEMIR
(insulin detemir [rDNA origin] injection) is a sterile solution of
insulin detemir for use as
an injection. Insulin detemir is a long-acting basal insulin analog,
with up to 24 hours duration of action,
produced by a process that includes expression of recombinant DNA in
_Saccharomyces cerevisiae_
followed by chemical modification.
Insulin detemir differs from human insulin in that the amino acid
threonine in position B30 has been
omitted, and a C14 fatty acid chain has been attached to the amino
acid B29. Insulin detemir has a
molecular formula of C
H
O N S and a molecular weight of 5916.9. It has the following
structure:
LEVEMIR is a clear, colorless, aqueous, neutral sterile solution. Each
milliliter of LEVEMIR contains
100 U (14.2 mg/mL) insulin detemir, 65.4 mcg zinc, 2.06 mg m-cresol,
16.0 mg glycerol, 1.80 mg
phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride,
and water for injection.
Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
LEVEMIR has a pH of
approximately 7.4.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The primary activity of insulin detemir is the regulation of glucose
metabolism. Insulins, including
insulin detemir, exert their specific action through binding to
insulin receptors.
Receptor-bound insulin lowers blood glucose by facilitating cellular
uptake of glucose into skeletal
muscle and fat and by inhibiting the output of glucose from the liver.
Insulin inhibits lipolysis in the
adipocyte, inhibits proteolysis, and enhances protein synthesis.
PHARMACODYNAMICS
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Insulin detemir is a soluble, long-acting basal human insulin analog
with a relatively flat action profile.
The mean duration of action of insulin detemir ranged from 5.7 hours
at the lowest dose to 23.2 hours at
the highest dose (sampling period 24 hours).
The prolonged action of LEVEMIR is mediated by the slow systemic
absorption of i