BASAGLAR KwikPen 100 [iU]/mL

Insulin glargine · INJECTION, SOLUTION · Eli Lilly and Company

No Recall HistoryCurrently in Shortage

Plain English

BASAGLAR KwikPen is a injection, solution containing insulin glargine at 100 [iU]/mL, taken subcutaneous. Manufactured by Eli Lilly and Company.

Key Facts

Brand Name: BASAGLAR KwikPen
Generic Name: Insulin glargine
NDC Code (Product): 0002-7715
Manufacturer: Eli Lilly and Company
Strength: 100 [iU]/mL
Dosage Form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Marketing Status
Application #: BLA205692
Drug Class: Insulin Analog [EPC]
Marketing Start: 12/16/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

blood glucose increased7,016 reports

incorrect dose administered2,488 reports

drug ineffective2,056 reports

visual impairment1,929 reports

hypoglycaemia1,780 reports

blood glucose decreased1,621 reports

accidental underdose1,540 reports

nausea1,491 reports

injection site pain1,401 reports

diarrhoea1,349 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for treating diabetic ketoacidosis. ( 1 ) Limitations of Use BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, prior insulin use. ( 2.2 , 2.3 , 2.4 ) Administer subcutaneously once daily at any time of day, but at the same time every day. ( 2.2 ) Rotate injection sites into the abdominal area, thigh, or deltoid to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) Closely monitor glucose when converting to BASAGLAR and during initial weeks thereafter. ( 2.2 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) 2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . Visually inspect BASAGLAR prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. Administer BASAGLAR subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amylo…

Contraindications

4 CONTRAINDICATIONS BASAGLAR is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . In patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR [see Warnings and Precautions ( 5.5 )] . During episodes of hypoglycemia. ( 4 ) Hypersensitivity to BASAGLAR or any of its excipients. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with BASAGLAR Table 6: Clinically Significant Drug Interactions with BASAGLAR 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 reductions and increased frequency of glucose monitoring may be required when BASAGLAR is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of BASAGLAR 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 increases and increased frequency of glucose monitoring may be required when BASAGLAR is co-administered with these drugs. Drugs That May Increase or Decr…

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 commonly (≥5%) associated with insulin glargine products are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. Two clinical trials with BASAGLAR were conducted: one in type 1 diabetes and one in type 2 diabetes. The type 1 diabetes population had the following characteristics: Mean age was 41 years and mean duration of diabetes w…

Frequently Asked Questions

What is BASAGLAR KwikPen used for?

BASAGLAR KwikPen contains Insulin glargine. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is BASAGLAR KwikPen a controlled substance?

BASAGLAR KwikPen is not classified as a controlled substance by the DEA.

What is the generic name for BASAGLAR KwikPen?

The generic name for BASAGLAR KwikPen is Insulin glargine. There are 12 other brand versions of Insulin glargine.

What is the NDC code for BASAGLAR KwikPen 100 [iU]/mL?

The NDC (National Drug Code) for BASAGLAR KwikPen 100 [iU]/mL is 0002-7715, listed by Eli Lilly and Company.

Product NDC

0002-7715

Package NDC

0002-7715-59

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

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