ADMELOG 100 U/mL

insulin lispro · INJECTION, SOLUTION · Sanofi-Aventis U.S. LLC

2 Recalls on RecordCurrently in Shortage

Plain English

ADMELOG is a injection, solution containing insulin lispro at 100 U/mL, taken subcutaneous. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name: ADMELOG
Generic Name: insulin lispro
NDC Code (Product): 0024-5925
Manufacturer: Sanofi-Aventis U.S. LLC
Strength: 100 U/mL
Dosage Form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Marketing Status
Application #: BLA209196
Drug Class: Insulin Analog [EPC]
Marketing Start: 12/11/2017

Recall History

2 Recalls on Record

Class II04/11/2023

Sanofi-Aventis U.S. LLC

Lack of Assurance of Sterility: Malformed crimped collar seal

OngoingVoluntary: Firm initiated

Class II07/05/2018

Sanofi-Aventis U.S. LLC

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood glucose increased2,265 reports

drug ineffective782 reports

incorrect dose administered762 reports

hypoglycaemia644 reports

visual impairment577 reports

nausea565 reports

dyspnoea544 reports

blood glucose decreased451 reports

product dose omission issue450 reports

off label use438 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

Dosage & Administration

2 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 o…

Contraindications

4 CONTRAINDICATIONS 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) ]. Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to insulin lispro or any of the excipients in ADMELOG. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with ADMELOG. Table 2: Clinically Significant Drug Interactions with ADMELOG Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when ADMELOG is concomitantly administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of ADMELOG Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when ADMELOG is concomitantly administered with these drugs. Drugs That …

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions associated with ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in practice. Adverse Reactions with Subcutaneous Injections of ADMELOG Two clinical trials with ADMELOG were conducted: one in patients with type 1 diabetes and one in patients with type 2 diabetes [see Clinical Studies (14) ] . The data in Table 1 reflect the exposure of 252 patients with type 1 diabetes to ADMELO…

Frequently Asked Questions

What is ADMELOG used for?

ADMELOG contains insulin lispro. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is ADMELOG a controlled substance?

ADMELOG is not classified as a controlled substance by the DEA.

What is the generic name for ADMELOG?

The generic name for ADMELOG is insulin lispro. There are 12 other brand versions of insulin lispro.

What is the NDC code for ADMELOG 100 U/mL?

The NDC (National Drug Code) for ADMELOG 100 U/mL is 0024-5925, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0024-5925

Package NDC

0024-5925-00

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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