Insulin Aspart-xjhz
Generic Name: insulin aspart-xjhz
Brand Names:
Insulin Diluting Medium For Kirsty, Kirsty
11 DESCRIPTION Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris . Insulin aspart-xjhz has the empirical formula C 256 H 381 N 65 O 79 S 6 and a molecular weight of 5825.8 Da. Figure 1. Structural formula of insulin aspart-xjhz.
Overview
11 DESCRIPTION Insulin aspart-xjhz is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28 and is produced by recombinant DNA technology utilizing Pichia pastoris . Insulin aspart-xjhz has the empirical formula C 256 H 381 N 65 O 79 S 6 and a molecular weight of 5825.8 Da. Figure 1. Structural formula of insulin aspart-xjhz.
Uses
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
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.
Side Effects
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.
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.
Warnings
5 WARNINGS AND PRECAUTIONS • Never share a KIRSTY prefilled pen, needles or syringes between patients, even if the needle is changed ( 5.1 ). • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ). • Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness ( 5.3 ). 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.
Pregnancy
8.1 Pregnancy Risk Summary Available information from published randomized controlled trials with insulin aspart products use during the second trimester of pregnancy have not reported an association with insulin aspart products and major birth defects or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied KIRSTY (insulin aspart-xjhz) injection 100 units/mL (U-100) is available as a clear and colorless solution in: One 10 mL multiple-dose vial per carton 83257-007-11 Five 3 mL single-patient-use prefilled pens per carton 83257-008-32 The KIRSTY prefilled pen dials in 1-unit increments.
Frequently Asked Questions
What is Insulin Aspart-xjhz used for?▼
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 ).
What are the side effects of Insulin Aspart-xjhz?▼
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.
Can I take Insulin Aspart-xjhz during pregnancy?▼
8.1 Pregnancy Risk Summary Available information from published randomized controlled trials with insulin aspart products use during the second trimester of pregnancy have not reported an association with insulin aspart products and major birth defects or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) .
What are the important warnings for Insulin Aspart-xjhz?▼
5 WARNINGS AND PRECAUTIONS • Never share a KIRSTY prefilled pen, needles or syringes between patients, even if the needle is changed ( 5.1 ). • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ). • Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness ( 5.3 ). 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.