ADMELOG Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Sanofi-Aventis U.S. LLC

Λέξεις κλειδιά

0024-5924 0024-5925 0024-5926

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1. Indications and Usage

ADMELOG is indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

2. Dosage and Administration

2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4)]. Inspect ADMELOG visually before use. It should appear clear and ...

3. Dosage Forms and Strengths

Insulin lispro injection 100 units per mL (U-100) is available as: 10 mL multiple-dose vials 3 mL multiple-dose vials 3 mL single patient use SoloStar prefilled pens

4. Contraindications

ADMELOG is contraindicated: during episodes of hypoglycemia. in patients who are hypersensitive to insulin lispro or to any of the excipients.

5. Warnings and Precautions

5.1 Never Share an ADMELOG SoloStar Pen or Syringe Between Patients ADMELOG SoloStar prefilled pen must never be shared between patients, even if the needle is changed. Patients using ADMELOG vials must ...

6. Adverse Reactions

The following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3)] Hypersensitivity and allergic reactions [see Warnings and Precautions (5.5)] ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Immunogenicity

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with ADMELOG may develop anti-insulin antibodies. The detection of antibody formation is ...

6.3. Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of another insulin lispro product, 100 units/mL. Because these reactions are reported voluntarily from a population ...

7. Drug Interactions

7.1 Drugs that May Increase the Risk of Hypoglycemia The risk of hypoglycemia associated with ADMELOG use may be increased when coadministered with antidiabetic agents, salicylates, sulfonamide antibiotics, ...

8.1. Pregnancy

Risk Summary The limited available data with ADMELOG in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Published studies with another insulin lispro ...

8.2. Lactation

Risk Summary There is no information regarding the presence of insulin lispro in human milk, the effects on the breastfed infant, or the effects on milk production. Endogenous insulin is present in human ...

8.4. Pediatric Use

The safety and effectiveness of ADMELOG have been established in pediatric patients with type 1 diabetes mellitus who are 3 years of age and older. Use of ADMELOG in these age groups is supported by evidence ...

8.5. Geriatric Use

Of the total number of subjects (n=2,834) in eight clinical studies of another insulin lispro product, 100 units/mL, 12% (n=338) were 65 years of age or over. The majority of these had type 2 diabetes. ...

8.6. Renal Impairment

Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent ADMELOG dose adjustment and more frequent blood glucose monitoring [see Clinical Pharmacology (12.3)] ...

8.7. Hepatic Impairment

Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent ADMELOG dose adjustment and more frequent blood glucose monitoring [see Clinical Pharmacology ...

10. Overdosage

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may ...

11. Description

ADMELOG (insulin lispro injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain ...

12.1. Mechanism of Action

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro products. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal ...

12.2. Pharmacodynamics

Subcutaneous Administration The pharmacodynamic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a euglycemic clamp study enrolling 30 patients with type 1 diabetes. ...

12.3. Pharmacokinetics

Absorption The pharmacokinetic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a study enrolling 30 patients with type 1 diabetes. In this study, the mean observed ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard 2-year carcinogenicity studies in animals have not been performed. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and ...

14. Clinical Studies

14.1 Overview of Clinical Studies The safety and effectiveness of ADMELOG have been established based on adequate and well controlled studies of ADMELOG in adult patients with type 1 and type 2 diabetes ...

16.1. How Supplied

ADMELOG: Insulin Lispro Injection 100 units per mL (U-100) is available as: Dosage Unit Package Size NDC # 10 mL multiple-dose vials Carton of 1 0024-5924-10 3 mL multiple-dose vials Carton of ...

16.2. Storage and Handling

Dispense in the original sealed carton with the enclosed Instructions for Use. Do not use after the expiration date. Not in-use (unopened) ADMELOG should be stored in a refrigerator (36°F-46°F [2°C-8°C]), ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share an ADMELOG SoloStar Prefilled Pen or Syringe Between Patients Advise patients that ...