KIRSTY 100 [iU]/mL
insulin aspart-xjhz · INJECTION, SOLUTION · Biocon Biologics Inc.
KIRSTY is a injection, solution containing insulin aspart-xjhz at 100 [iU]/mL, taken intravenous. Manufactured by Biocon Biologics Inc..
Key Facts
- Brand Name
- KIRSTY
- Generic Name
- insulin aspart-xjhz
- NDC Code (Product)
83257-008- Manufacturer
- Biocon Biologics Inc.
- Strength
- 100 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761188
- Drug Class
- Insulin Analog [EPC]
- Marketing Start
- 09/15/2025
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 KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. • KIRSTY is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important preparation, administration and dosage instructions ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ). Subcutaneous injection ( 2.2 ): Inject subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm. Rotate injection sites within the same region from one injection to the next 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 KIRSTY or NOVOLOG can be used with the insulin pump, in which case KIRSTY can be used with the pump. Use in accordance with the insulin pump instructions for use. Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not mix with other insulins or diluents in the pump. Intravenous Administration ( 2.2 ): Dilu…
Contraindications
4 CONTRAINDICATIONS KIRSTY is contraindicated • During episodes of hypoglycemia [see Warnings and Precautions (5.3) ] • In patients with hypersensitivity to insulin aspart products or any of the excipients in KIRSTY [see Warnings and Precautions (5.5) ] • During episodes of hypoglycemia ( 4 ). • Hypersensitivity to insulin aspart products or any of the excipients in KIRSTY.
Drug Interactions
7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with KIRSTY 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 analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when KIRSTY is concomitantly administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of KIRSTY 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 KIRSTY is concomitantly administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of…
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) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] • Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions observed with insulin aspart products include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 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 designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The safety of insulin aspart was evaluated in two treat-to-target trials of 6 months duration, conducted in patients with type 1 diabetes or type 2 diabetes [see Clinical Studies (14) ]. The data in Table 1 reflect the exposure of 596 patients with type 1 diab…
Frequently Asked Questions
What is KIRSTY used for?
KIRSTY contains insulin aspart-xjhz. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is KIRSTY a controlled substance?
KIRSTY is not classified as a controlled substance by the DEA.
What is the generic name for KIRSTY?
The generic name for KIRSTY is insulin aspart-xjhz. There are no other listed brand versions of insulin aspart-xjhz.
What is the NDC code for KIRSTY 100 [iU]/mL?
The NDC (National Drug Code) for KIRSTY 100 [iU]/mL is 83257-008, listed by Biocon Biologics Inc..
Other KIRSTY Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)