REZVOGLAR KWIKPEN 100 [iU]/mL
Insulin glargine-aglr · INJECTION, SOLUTION · A-S Medication Solutions
Rezvoglar Kwikpen is a long-acting insulin injection used to help control blood sugar levels in people with diabetes. It contains insulin glargine-aglr and is given as a subcutaneous injection.
Key Facts
- Brand Name
- REZVOGLAR KWIKPEN
- Generic Name
- Insulin glargine-aglr
- NDC Code (Product)
50090-6439- Manufacturer
- A-S Medication Solutions
- Strength
- 100 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761215
- Drug Class
- Insulin Analog [EPC]
- Marketing Start
- 12/17/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE REZVOGLAR™ is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use REZVOGLAR is not recommended for the treatment of diabetic ketoacidosis. REZVOGLAR™ is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ( 2.1 , 2.2 , 2.3 , 2.4 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) Rotate injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to change to REZVOGLAR from other insulins ( 2.3 , 2.4 ) Closely monitor glucose when switching to REZVOGLAR and during initial weeks thereafter. ( 2.4 ) 2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . Visually inspect REZVOGLAR KwikPen prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. Administer REZVOGLAR subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the…
Contraindications
4 CONTRAINDICATIONS REZVOGLAR is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . in patients with hypersensitivity to insulin glargine products or any of the excipients in REZVOGLAR [see Warnings and Precautions ( 5.5 )] . During episodes of hypoglycemia. ( 4 ) Hypersensitivity to insulin glargine products or any of the excipients in REZVOGLAR. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 8 includes clinically significant drug interactions with REZVOGLAR. Table 8: Clinically Significant Drug Interactions with REZVOGLAR 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), sulfonamide antibiotics. GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when REZVOGLAR is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of REZVOGLAR 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: Dosage increases and increased frequency of glucose monitoring may be required when REZVOG…
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 associated with insulin glargine products include hypoglycemia, allergic reactions, injection site reactions, 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 Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The data in Table 1 reflect the exposure of 2327 patients with type 1 diabetes to insulin glargine or NPH in Studies A, B, C, and D [see Clinical Studies ( 14.2 )] . The type 1 diabetes population had the following characteri…
Frequently Asked Questions
What is REZVOGLAR KWIKPEN used for?
Rezvoglar Kwikpen is a long-acting insulin injection used to help control blood sugar levels in people with diabetes. It contains insulin glargine-aglr and is given as a subcutaneous injection.
Is REZVOGLAR KWIKPEN a controlled substance?
REZVOGLAR KWIKPEN is not classified as a controlled substance by the DEA.
What is the generic name for REZVOGLAR KWIKPEN?
The generic name for REZVOGLAR KWIKPEN is Insulin glargine-aglr. There are 1 other brand versions of Insulin glargine-aglr.
What is the NDC code for REZVOGLAR KWIKPEN 100 [iU]/mL?
The NDC (National Drug Code) for REZVOGLAR KWIKPEN 100 [iU]/mL is 50090-6439, listed by A-S Medication Solutions.