LYUMJEV KwikPen 100 [iU]/mL
Insulin lispro-aabc · INJECTION, SOLUTION · Eli Lilly and Company
LYUMJEV KwikPen is a injection, solution containing insulin lispro-aabc at 100 [iU]/mL, taken subcutaneous. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- LYUMJEV KwikPen
- Generic Name
- Insulin lispro-aabc
- NDC Code (Product)
0002-8207- Manufacturer
- Eli Lilly and Company
- Strength
- 100 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761109
- Drug Class
- Insulin Analog [EPC]
- Marketing Start
- 06/15/2020
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LYUMJEV ® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LYUMJEV ® 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 administration instructions. ( 2.1 , 2.2 ) Subcutaneous Injection ( 2.2 ): Administer LYUMJEV U-100 or U-200 at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. Rotate injection sites within the same region to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Should generally be used in regimens with an intermediate or long-acting insulin. Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if LYUMJEV can be used. Use in accordance with the insulin pump instructions for use. Administer LYUMJEV U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not administer LYUMJEV U-200 by continuous subcutaneous infusion. Intravenous Infusion ( 2.2 ): Administer LYUMJEV U-100 intravenously only under medical supervision. DO NOT administer LYUMJEV U-200 by intravenous in…
Contraindications
4 CONTRAINDICATIONS LYUMJEV is contraindicated: during episodes of hypoglycemia. in patients with hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. During episodes of hypoglycemia. ( 4 ) Hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with LYUMJEV. Table 6. Clinically Significant Drug Interactions with LYUMJEV 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 LYUMJEV is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of LYUMJEV 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 LYUMJEV is co-administered with these drugs. Drugs That May Increase or Decreas…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] . Adverse reactions observed with LYUMJEV include hypoglycemia, injection/infusion site reactions, allergic reactions, rash, pruritus, lipodystrophy, 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 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 actually observed in clinical practice. Adverse Reaction Database – Adult Patients with Type 1 and Type 2 Diabetes The data in Table 1 reflect the exposure of 780 adult patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical …
Frequently Asked Questions
What is LYUMJEV KwikPen used for?
LYUMJEV KwikPen contains Insulin lispro-aabc. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is LYUMJEV KwikPen a controlled substance?
LYUMJEV KwikPen is not classified as a controlled substance by the DEA.
What is the generic name for LYUMJEV KwikPen?
The generic name for LYUMJEV KwikPen is Insulin lispro-aabc. There are 5 other brand versions of Insulin lispro-aabc.
What is the NDC code for LYUMJEV KwikPen 100 [iU]/mL?
The NDC (National Drug Code) for LYUMJEV KwikPen 100 [iU]/mL is 0002-8207, listed by Eli Lilly and Company.