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INSULIN DILUTING MEDIUM FOR Kirsty water 1 mL/mL Injection, Solution — NDC 83257-0006-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

INSULIN DILUTING MEDIUM FOR Kirsty water 1 mL/mL Injection, Solution — NDC 83257-006-11 (Billing 83257-0006-11)

by Biocon Biologics Inc. · 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

This is a package of INSULIN DILUTING MEDIUM FOR Kirsty water 1 mL/mL Injection, Solution from Biocon Biologics Inc., marketed since Sep 2025 and currently FDA-listed. It is this product's only package size.

NDC 83257-0006-11
🏷️ FDA NDC (as labeled) 83257-006-11 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Water (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0495-2026
Class II · Dec 22, 2025 — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution (Baxter Healthcare Corporation) · FDA recall D-0296-2026
Class II · Aug 26, 2025 — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. (B BRAUN MEDICAL INC) · FDA recall D-0652-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83257-006-11
Product NDC 83257-006
11-digit billing NDC 83257000611
RxCUI 2720523, 2720529, 2720539, 2720541
UNII 059QF0KO0R, D933668QVX
Application # BLA761188
SPL Set ID 3db1d482-7e1f-aec6-79ef-3f305b4d8277
Established class (EPC) Insulin Analog
Chemical class Insulin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-15
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance WATER
Biologic (Purple Book) 351(k) Interchangeable · interchangeable biosimilar
Reference product insulin aspart

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 074380
GCN 39013
HICL code 042240
Ingredient (HICL) Diluent, Insulin Aspart
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5O
Therapeutic class — specific (HIC3) Diluent Solutions
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name DILUTING MEDIUM FOR KIRSTY VL
FDB brand name Diluting Medium For Kirsty Vl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 074380
  • GCN: 39013
  • HICL (First Databank): 042240
  • AHFS class code: 96:00.00.00
  • RxCUI (RxNorm): 2720523
Why two NDCs? The FDA registers this code as 83257-006-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83257-0006-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Insulin Analog class.

Pharmacologic class Insulin Analog
Drug family (ATC) Insulins and analogues for injection, fast-acting, Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DILUTING MEDIUM FOR KIRSTY VL Ingredient Diluent, Insulin Aspart
📗 Our plain-language guide HelloPharmacist
  • It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
  • Why is 'water' listed as the active ingredient on my medicine?
  • No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
  • Is Sterile Water for Injection the same as the eye wash or the irrigation product?
📖 Read our full Water guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83257-0006-11 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE 2025-09-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
INSULIN DILUTING MEDIUM FOR Kirsty 1 mL/mLthis 83257-0006-11 Biocon 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Jul 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 15, 2025 ⏳ ~10.8 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJul 15, 2037
Common questions
Is there a biosimilar for DILUTING MEDIUM FOR KIRSTY VL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 16 mg / 1 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 1.5 mg / 1 mL UNII GGO4Y809LO
    Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
  • 0.65 mg / 1 mL UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 0.997 mg / 1 mL UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBiocon Biologics Inc.
FDA applicationBLA761188 (BLA)
Labeler code83257
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio20 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

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 and Administration ~3 min read ▾

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 ): Dilute KIRSTY to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart-xjhz in infusion systems using polypropylene infusion bags. KIRSTY is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP. Individualize and adjust the dosage of KIRSTY based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.4 ).

Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness ( 2.4 ).

2.1Important Preparation and Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4)]. Inspect KIRSTY visually before use. It should appear clear and colorless.

Do not use KIRSTY if particulate matter or coloration is seen. In patients with visual impairment who rely on audible clicks to dial their dose, use KIRSTY prefilled pen with caution. Do not mix KIRSTY with other insulins when administering using a continuous subcutaneous infusion pump.

2.2Preparation and Administration Instructions for the Approved Routes of Administration Subcutaneous Injection • Inject KIRSTY 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 the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1 , 6.3) ] . • Dial the KIRSTY prefilled pen in 1-unit increments. • Generally use KIRSTY (administered by subcutaneous injection) in regimens with an intermediate-or long-acting insulin. • May dilute KIRSTY with Insulin Diluting Medium for KIRSTY for subcutaneous injection.

Diluting one part KIRSTY to: • Nine parts diluent will yield a concentration one-tenth that of KIRSTY (equivalent to U-10). • One part diluent will yield a concentration one-half that of KIRSTY (equivalent to U-50). Discard any unused diluent after opening the vial of Insulin Diluting Medium for KIRSTY. Continuous Subcutaneous Infusion (Insulin Pump) Can use this KIRSTY product with the continuous subcutaneous insulin infusion pumps labeled for use with KIRSTY or NOVOLOG.

Refer to the insulin 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 KIRSTY in accordance with the insulin pump system’s instructions for use. Train patients using continuous subcutaneous insulin fusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump fail… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 52 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) is a clear and colorless solution available as: • 10 mL multiple-dose vial • 3 mL single-patient-use prefilled pen Injection: 100 units/mL (U-100) of insulin aspart-xjhz available as: 3 mL single-patient-use prefilled pen ( 3 ) 10 mL multiple-dose vial ( 3 )

⛔ Contraindications 59 words ▾

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.

⚠️ Warnings and Cautions ~3 min read ▾

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 ). • Medication Errors: Accidental mix-ups between insulin products can occur.

Instruct patients to check insulin labels before injection ( 5.4 ). • Hypersensitivity reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Discontinue KIRSTY, treat, and monitor if indicated ( 5.5 ). • Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated ( 5.6 ). • Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs) : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs ( 5.7 ). • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer KIRSTY by subcutaneous injection if pump malfunction occurs ( 5.8 ).

5.1Never Share a KIRSTY Prefilled Pen, Needles or Syringes Between Patients KIRSTY prefilled pens should never be shared between patients, even if the needle is changed. Patients using KIRSTY vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3) ] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6.1 , 6.3) ].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction of all insulins, including insulin aspart products. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7) ] , or in patients who experience recurrent hypoglycemia. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.

As… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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.

6.1Clinical 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 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks.

The mean age was 39 years. Fifty-one percent were male, 94% were Caucasian, 2% were Black and 4% were other races. The mean body mass index (BMI) was 25.6 kg/m 2 .

The mean duration of diabetes was 15.7 years and the mean HbA 1c at baseline was 7.9%. The data in Table 2 reflect the exposure of 91 patients with type 2 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks. The mean age was 57 years.

Sixty-three percent were male, 76% were Caucasian, 9% were Black and 15% were other races. The mean BMI was 29.7 kg/m 2 . The mean duration of diabetes was 12.7 years and the mean HbA 1c at baseline was 8.1%.

Common adverse reactions were defined as events that occurred in ≥5%, excluding hypoglycemia, of the population studied. Common adverse events that occurred at the same rate or greater for insulin aspart-treated patients than in comparator-treated patients during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively. Table 1: Adverse reactions that occurred in ≥ 5% of Type 1 Diabetes Mellitus Adult Patients treated with insulin aspart and at the same rate or greater on insulin aspart than on comparator Insulin Aspart + NPH (%) (n= 596) Regular Human Insulin + NPH (%) (n= 286) Headache 12 10 Injury accidental 11 10 Nausea 7 5 Diarrhea 5 3 Table 2: Adverse reactions that occurred in ≥ 5% of Type 2 Diabetes Mellitus Adult Patients treated with insulin aspart and at the same rate or greater on insulin aspart than on comparator Insulin Aspart + NPH (%) (n= 91) Human Regular Insulin + NPH (%) (n= 91) Hyporeflexia 11 7 Onychomycosis 10 5 Sensory disturbance 9 7 Urinary tract infection 8 7 Chest pain 5 3 Headache 5 3 Skin disorder 5 2 Abdominal pain 5 1 Sinusitis 5 1 Severe Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including insulin aspart products .

The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for insulin aspart with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice. Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

The incidence of severe hypoglycemia in: Adult and pediatric patien… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 KIRSTY Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when KIRSTY is concomitantly administered with these drugs.

Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine, and reserpine Intervention: Increased frequency of glucose monitoring may be required when KIRSTY is concomitantly administered with these drugs. • Drugs that may increase the risk of hypoglycemia: 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 ( 7 ). • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, 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 ( 7 ). • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine ( 7 ). • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine ( 7 ). * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

Biosimilarity of KIRSTY has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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 ) . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively.

Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptual HbA 1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptual HbA 1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart products during the late 2 nd trimester of pregnancy did not identify an association of insulin aspart products with major birth defects or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials.

Animal Data Fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats.

In an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents).

No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered secondary to maternal hypoglycemia.

8.2Lactation Risk Summary There are no data on the presence of insulin aspart products in human milk, the effects on the breastfed infant, or the effect… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy 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 ) . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively.

Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptual HbA 1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptual HbA 1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart products during the late 2 nd trimester of pregnancy did not identify an association of insulin aspart products with major birth defects or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials.

Animal Data Fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats.

In an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents).

No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered secondary to maternal hypoglycemia.

🧒 Pediatric Use 78 words ▾

8.4Pediatric Use The safety and effectiveness of KIRSTY to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of KIRSTY for this indication is supported by evidence from an adequate and well-controlled study of insulin aspart in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1) ] .

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use Of the total number of patients (n=1,375) treated with insulin aspart in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. One-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). The HbA 1c response to insulin aspart, as compared to regular human insulin, did not differ by age.

🆘 Overdosage 81 words ▾

10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3 , 5.6) ] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary activity of insulin, including insulin aspart products, is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

12.2Pharmacodynamics Pharmacodynamics of insulin aspart After Subcutaneous Administration The pharmacodynamic profile of insulin aspart given subcutaneously in 22 patients with type 1 diabetes is shown in Figure 2. The maximum glucose-lowering effect of insulin aspart occurred between 1 and 3 hours after subcutaneous injection (0.15 units/kg). The duration of action for insulin aspart is 3 to 5 hours.

The time course of action of insulin and insulin analogs such as insulin aspart products may vary considerably in different individuals or within the same individual. The parameters of insulin aspart activity (time of onset, peak time and duration) as designated in Figure 2 should be considered only as general guidelines. The rate of insulin absorption and onset of activity is affected by the site of injection, exercise, and other variables [see Warnings and Precautions (5.3) ] .

Figure 2. Serial mean serum glucose collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Figure 2.

Serial mean serum glucose collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes Pharmacodynamics of insulin aspart After Intravenous Administration A double-blind, randomized, two-way crossover study in 16 patients with type 1 diabetes demonstrated that intravenous infusion of insulin aspart resulted in a blood glucose profile that was similar to that after intravenous infusion with regular human insulin.

Insulin aspart or human insulin was infused until the patient’s blood glucose decreased to 36 mg/dL, or until the patient demonstrated signs of hypoglycemia (rise in heart rate and onset of sweating), defined as the time of autonomic reaction (R) (see Figure 3). Figure 3. Mean blood glucose profiles following intravenous infusion of insulin aspart (hatched curve) and regular human insulin (solid curve) in 16 patients with type 1 diabetes.

R represents the time of autonomic reaction. Figure 3. Mean blood glucose profiles following intravenous infusion of insulin aspart (hatched curve) and regular human insulin (solid curve) in 16 patients with type 1 diabetes.

R represents the time of autonomic reaction.

12.3Pharmacokinetics Pharmacokinetics of subcutaneous administration of insulin aspart is presented below Absorption and Bioavailability In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), the median time to maximum concentration of insulin aspart in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively. The relative bioavailability of insulin aspart (0.15 units/kg) compared to regular human insulin indicates that the two insulins are absorbed to a similar extent.

In a clinical trial in patients with type 1 diabetes, insulin aspart and regular human insulin, both administered subcutaneously at a dose of 0.15 units/kg body weight, reached mean maximum concentrations of 82 and 36 mU/L , respectively. Distribution Insulin aspart has a low binding affinity to plasma proteins (<10%), similar to that seen with regular human insulin. Figure 4.

Serial mean serum free insulin concentration collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a m… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 52 words ▾

12.1Mechanism of Action The primary activity of insulin, including insulin aspart products, is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How 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.

16.2Recommended Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused KIRSTY in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze KIRSTY and do not use KIRSTY if it has been frozen.

Do not expose KIRSTY to excessive heat or light. Do not withdraw KIRSTY into a syringe and store for later use. Always remove and discard the needle after each injection from the KIRSTY prefilled pen and store without a needle attached.

The storage conditions are summarized in the following table: Table 9. Storage conditions for vial and KIRSTY prefilled pen KIRSTY presentation Not in-use (unopened) Room Temperature (up to 30°C [86°F]) Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]) In-use (opened) Room Temperature (up to 30°C [86°F]) 10 mL multiple-dose vial 28 days Until expiration date 28* days (refrigerated/room temperature) 3 mL single- patient-use prefilled pen 28 days Until expiration date 28 days (Do not refrigerate) * For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time.

Storage in External Insulin Pump: Change the KIRSTY in the pump reservoir at least every 7 days or according to the pump user manual instructions for KIRSTY or NOVOLOG, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F). Storage of Diluted KIRSTY KIRSTY diluted with Insulin Diluting Medium for KIRSTY to a concentration equivalent to U-10 or equivalent to U-50 prepared as indicated under Dosage and Administration (2.2) may remain in patient use at temperatures up to 30°C (86°F) for 28 days.

Discard any unused diluent after opening the vial of Insulin Diluting Medium for KIRSTY. Storage of KIRSTY in Intravenous Infusion Fluids Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature for 12 hours. Some insulin will be initially adsorbed to the material of the infusion.

📋 Description 155 words ▾

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. KIRSTY (insulin aspart-xjhz) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m -cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP.

KIRSTY has a pH of 7.0-7.8. Hydrochloric acid 1% and/or sodium hydroxide 1% may be added to adjust pH. Figure 1.

Structural formula of insulin aspart-xjhz

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a KIRSTY Prefilled Pen Device Between Patients Advise patients that they must never share a KIRSTY prefilled pen with another person even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using KIRSTY vials not to share needles or syringes with another person.

Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)] . Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of KIRSTY therapy.

Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions (5.3)] . Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia.

Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery. Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2)] . Hypoglycemia with Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions (5.3)] .

Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with insulin aspart products. Inform patients of the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.4)] . Patients Using Continuous Subcutaneous Insulin Pumps Train patients in both intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.

This KIRSTY product can be used with continuous subcutaneous insulin infusion pumps labeled for use with KIRSTY or NOVOLOG -refer to the insulin 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. See recommended infusion sets in the insulin pump user manual. Instruct patients to replace insulin in the reservoir at least every 7 days or according to the user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed according to the manufacturer’s user manual.

By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative. Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F). Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.

Instruct patients of the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)] . Instruct patients of the risk of hypoglycemia from pump malfunction.

If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)] . KIRSTY™ is a trademark of Biocon Biologics UK P… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetics of subcutaneous administration of insulin aspart is presented below Absorption and Bioavailability In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), the median time to maximum concentration of insulin aspart in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively. The relative bioavailability of insulin aspart (0.15 units/kg) compared to regular human insulin indicates that the two insulins are absorbed to a similar extent.

In a clinical trial in patients with type 1 diabetes, insulin aspart and regular human insulin, both administered subcutaneously at a dose of 0.15 units/kg body weight, reached mean maximum concentrations of 82 and 36 mU/L , respectively. Distribution Insulin aspart has a low binding affinity to plasma proteins (<10%), similar to that seen with regular human insulin. Figure 4.

Serial mean serum free insulin concentration collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Metabolism and Elimination In a randomized, double-blind, crossover study 17 healthy Caucasian male subjects between 18 and 40 years of age received an intravenous infusion of either insulin aspart or regular human insulin at 1.5 mU/kg/min for 120 minutes. The mean insulin clearance was similar for the two groups with mean values of

1.2 L/h/kg for the insulin aspart group and

1.2L/h/kg for the regular human insulin group. After subcutaneous administration in normal male volunteers (n=24), insulin aspart was eliminated with an average apparent half-life of 81 minutes. Specific Populations Pediatric Patients The pharmacokinetic and pharmacodynamic properties of insulin aspart and regular human insulin were evaluated in a single dose study in 18 pediatric patients with type 1 diabetes in 2 age groups: 6-12 years, n=9 and 13-17 years (Tanner grade ≥ 2), n=9.

The relative differences in pharmacokinetics and pharmacodynamics in the pediatric patients with type 1 diabetes in both age groups between insulin aspart and regular human insulin were similar to those in healthy adult subjects and adults with type 1 diabetes. Geriatric Patients The pharmacokinetic and pharmacodynamic properties of insulin aspart and regular human insulin were investigated in a single dose study in 18 subjects with type 2 diabetes who were ≥ 65 years of age. The relative differences in pharmacokinetics and pharmacodynamics in geriatric patients with type 2 diabetes between insulin aspart and regular human insulin were similar to those in younger adults.

Male and Female Patients In healthy volunteers given a single subcutaneous dose of insulin aspart 0.06 units/kg, no difference in insulin aspart levels was seen between males and females based on comparison of AUC (0-10h) or C max . Obese Patients A single subcutaneous dose of 0.1 units/kg insulin aspart was administered in a study of 23 patients with type 1 diabetes and a wide range of body mass index (BMI, 22-39 kg/m 2 ). The pharmacokinetic parameters, AUC and C max , of insulin aspart were generally unaffected by BMI in the different groups – BMI 19-23 kg/m 2 (n=4); BMI 23-27 kg/m 2 (n=7); BMI 27-32 kg/m 2 (n=6) and BMI >32 kg/m 2 (n=6).

Clearance of insulin aspart was reduced by 28% in patients with BMI >32 kg/m 2 compared to patients with BMI <23 kg/m 2 . Patients with Renal Impairment A single subcutaneous dose of 0.08 units/kg insulin aspart was administered in a study to subjects with either normal renal function (n=6) creatinine clearance (CLcr) (> 80 mL/min) or mild (n=7; CLcr = 50-80 mL/min), moderate (n=3; CLcr = 30-50 mL/min) or severe (but not requiring hemodialysis) (n=2; CLcr = <30 mL/min) renal impairment. In this study, there was no apparent effect of creatinine clearance values on AUC and C max of insulin aspart.… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Pharmacodynamics of insulin aspart After Subcutaneous Administration The pharmacodynamic profile of insulin aspart given subcutaneously in 22 patients with type 1 diabetes is shown in Figure 2. The maximum glucose-lowering effect of insulin aspart occurred between 1 and 3 hours after subcutaneous injection (0.15 units/kg). The duration of action for insulin aspart is 3 to 5 hours.

The time course of action of insulin and insulin analogs such as insulin aspart products may vary considerably in different individuals or within the same individual. The parameters of insulin aspart activity (time of onset, peak time and duration) as designated in Figure 2 should be considered only as general guidelines. The rate of insulin absorption and onset of activity is affected by the site of injection, exercise, and other variables [see Warnings and Precautions (5.3) ] .

Figure 2. Serial mean serum glucose collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Figure 2.

Serial mean serum glucose collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes Pharmacodynamics of insulin aspart After Intravenous Administration A double-blind, randomized, two-way crossover study in 16 patients with type 1 diabetes demonstrated that intravenous infusion of insulin aspart resulted in a blood glucose profile that was similar to that after intravenous infusion with regular human insulin.

Insulin aspart or human insulin was infused until the patient’s blood glucose decreased to 36 mg/dL, or until the patient demonstrated signs of hypoglycemia (rise in heart rate and onset of sweating), defined as the time of autonomic reaction (R) (see Figure 3). Figure 3. Mean blood glucose profiles following intravenous infusion of insulin aspart (hatched curve) and regular human insulin (solid curve) in 16 patients with type 1 diabetes.

R represents the time of autonomic reaction. Figure 3. Mean blood glucose profiles following intravenous infusion of insulin aspart (hatched curve) and regular human insulin (solid curve) in 16 patients with type 1 diabetes.

R represents the time of autonomic reaction.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Overview of Clinical Studies The safety and effectiveness of subcutaneous insulin aspart were compared to regular human insulin in 596 type 1 diabetes adult, 187 pediatric type 1 diabetes, and 91 adult type 2 diabetes patients using NPH as basal insulin (see Tables 3, 4, 5). The reduction in glycated hemoglobin (HbA 1c ) was similar to regular human insulin. The safety and effectiveness of insulin aspart administered by continuous subcutaneous insulin infusion (CSII) by external pump were compared to buffered regular human insulin (administered by CSII), to lispro (administered by CSII) and compared to insulin aspart injections and NPH injection.

Overall, the reduction in HbA 1c was similar to the comparator.

14.2Clinical Studies in Adult and Pediatric Patients with Type 1 Diabetes with Subcutaneous Injections Type 1 Diabetes - Adults ( see Table 3) Two 24-week, open-label, active-controlled studies were conducted to compare the safety and efficacy of insulin aspart to regular human insulin injection in adult patients with type 1 diabetes. Because the two study designs and results were similar, data are shown for only one study (see Table 3). The mean age of the trial population was 39 years and mean duration of diabetes was 15.7 years.

Fifty-one percent were male. Ninety-four percent were Caucasian, 2% were Black and 4% were Other. The mean BMI was approximately 25.6 kg/m 2 .

Insulin aspart was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals. NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbA 1c were comparable for the two treatment regimens in this study (Table 3).

Table 3. Type 1 Diabetes Mellitus – Adult (insulin aspart plus NPH insulin vs. regular human insulin plus NPH insulin) Insulin Aspart + NPH (n=596) Regular Human Insulin + NPH (n=286) Baseline HbA 1c (%) Values are Mean ± SD 7.9 ±1.1 8.0 ±

1.2Change from Baseline HbA 1c (%) -0.1 ± 0.8 0.0 ±

0.8Treatment Difference in HbA 1c , Mean (95% confidence interval) -0.2 (-0.3, -0.1) Type 1 Diabetes – Pediatric ( see Table 4) The efficacy of insulin aspart to improve glycemic control in pediatric patients with type 1 diabetes mellitus is based on an adequate and well-controlled trial of regular human insulin in pediatric patients with type 1 diabetes mellitus (Table 4). This 24-week, parallel-group study of pediatric patients with type 1 diabetes (n = 283), aged 6 to 18 years, compared two subcutaneous multiple-dose treatment regimens: insulin aspart (n=187) or regular human insulin (n=96).

NPH insulin was administered as the basal insulin. Similar effects on HbA 1c were observed in both treatment groups (Table 4). Subcutaneous administration of insulin aspart and regular human insulin have also been compared in pediatric patients with type 1 diabetes (n=26) aged 2 to 6 years with similar effects on HbA 1c .

Table 4. Pediatric Subcutaneous Administration of insulin aspart in Type 1 Diabetes (24 weeks; n=283) Insulin Aspart + NPH (n=187) Regular Human Insulin + NPH (n=96) Baseline HbA 1c (%) Values are Mean ± SD 8.3 ± 1.2 8.3 ±

1.3Change from Baseline HbA 1c (%) 0.1± 1.0 0.1±

1.1Treatment Difference in HbA 1c , Mean (95% confidence interval) -0.2 (-0.5, 0.1)

14.3Clinical Studies in Adults with Type 2 Diabetes with Subcutaneous Injections Type 2 Diabetes - Adults ( see Table 5) One six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of insulin aspart to regular human insulin in patients with type 2 diabetes (Table 5). The mean age of the trial population was 56.6 years and mean duration of diabetes was 12.7 years. Sixty-three percent were male.

Seventy-six percent were Caucasian, 9% were Black and 15% were Other. The mean BMI was approximately 29.7 kg/m 2 . Insulin aspart was administered by subcutaneous injection immediately prior to meal… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 210 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin aspart products. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with insulin aspart at 10, 50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day, insulin aspart increased the incidence of mammary gland tumors in females when compared to untreated controls.

The relevance of these findings to humans is unknown. Insulin aspart was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes. In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day (approximately 32 times the human subcutaneous dose, based on units/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.

13.2Animal Toxicology and/or Pharmacology In standard biological assays in mice and rabbits, one unit of insulin aspart has the same glucose-lowering effect as one unit of regular human insulin.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 177 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin aspart products. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with insulin aspart at 10, 50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day, insulin aspart increased the incidence of mammary gland tumors in females when compared to untreated controls.

The relevance of these findings to humans is unknown. Insulin aspart was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes. In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day (approximately 32 times the human subcutaneous dose, based on units/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION KIRSTY™ (kir-Stee) (insulin aspart-xjhz) injection, for subcutaneous or intravenous use Do not share your KIRSTY prefilled pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. What is KIRSTY?

KIRSTY is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus. Who should not take KIRSTY? Do not take KIRSTY if you: • are having an episode of low blood sugar (hypoglycemia). • have an allergy to insulin aspart products or any of the ingredients in KIRSTY.

Before taking KIRSTY, tell your healthcare provider about all your medical conditions, including if you are: • pregnant, planning to become pregnant, or are breastfeeding. • taking new prescription or over-the-counter medicines, vitamins, or herbal supplements. Before you start taking KIRSTY, talk to your healthcare provider about low blood sugar and how to manage it. How should I take KIRSTY? • Read the Instructions for Use that come with your KIRSTY . • Take KIRSTY exactly as your healthcare provider tells you to. • KIRSTY starts acting fast.

You should eat a meal within 5 to 10 minutes after you take your dose of KIRSTY. • Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin. • Check your blood sugar levels.

Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. • Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them. • KIRSTY can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump. • Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. o Do not use the exact same spot for each injection. o Do not inject where the skin has pits, is thickened, or has lumps. o Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking KIRSTY? While taking KIRSTY do not: • Drive or operate heavy machinery, until you know how KIRSTY affects you. • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. What are the possible side effects of KIRSTY?

KIRSTY may cause serious side effects that can lead to death, including: Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: • dizziness or light-headedness • sweating • confusion • headache • blurred vision • slurred speech • shakiness • fast heartbeat • anxiety, irritability or mood changes • hunger Your insulin dose may need to change because of: • change in level of physical activity or exercise • weight gain or loss • increased stress • illness • change in diet Other common side effects of KIRSTY may include: • low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have: • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion. These are not all the possible side effects of KIRSTY. Call your doctor for medical advice about side effects.

You may report side effects to FDA… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

I NSTRUCTIONS FOR USE KIRSTY ™ (kir-Stee) (insulin aspart-xjhz) injection, for subcutaneous use 10 mL multiple-dose vial: 100 units/mL (U-100) Read this Instructions for Use before you start taking KIRSTY and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Supplies you will need to give your KIRSTY injection: • 10 mL KIRSTY vial • insulin syringe and needle • alcohol swabs Preparing your KIRSTY dose: • Wash your hands with soap and water. • Before you start to prepare your injection, check the KIRSTY label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin. • KIRSTY should look clear and colorless. Do not use KIRSTY if it is thick, cloudy, or is colored. • Do not use KIRSTY past the expiration date printed on the label.

Step 1: Pull off the tamper resistant cap (See Figure A). Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B). Step 3: Hold the syringe with the needle pointing up.

Pull down on the plunger until the black tip reaches the line for the number of units for your prescribed dose (See Figure C). Step 4: Push the needle through the rubber stopper of the KIRSTY vial (See Figure D). Step 5: Push the plunger all the way in.

This puts air into the KIRSTY vial (See Figure E). Step 6: Turn the KIRSTY vial and syringe upside down and slowly pull the plunger down until the black tip is a few units past the line for your dose (See Figure F). • If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G). Step 7: Slowly push the plunger up until the black tip reaches the line for your KIRSTY dose (See Figure H).

Step 8: Check the syringe to make sure you have the right dose of KIRSTY. Step 9: Pull the syringe out of the vial’s rubber stopper (See Figure I). Giving your injection: Inject your KIRSTY exactly as your healthcare provider has shown you.

Your healthcare provider should tell you if you need to pinch the skin before injecting. KIRSTY can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, infused in an insulin pump (continuous subcutaneous infusion into an area of your body recommended in the instructions that come with your insulin pump), or given through a needle in your arm (intravenously) by your healthcare provider. If you inject KIRSTY, change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.

Do not use the same injection site for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

If you use KIRSTY in an insulin pump, you should change your infusion set and insertion site according to the manufacturer’s user manual. KIRSTY can be used with the continuous subcutaneous insulin infusion pumps labeled for use with KIRSTY or NOVOLOG. Read the insulin pump user manual to see if KIRSTY or NOVOLOG can be used.

KIRSTY should be given into an area of your body recommended in the instructions that come with your insulin pump. Change (rotate) your insertion sites within the area you choose for each insertion to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the insertion sites. Do not insert into the exact same spot for each insertion.

Do not insert where the skin has pits, is thickened, or has lumps. Do not insert where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. The insulin in the reservoir should be changed at least every 7 days or according to the pump user manual, whichever is s… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL 10mL NDC 83257-007-11 Kirsty ™ (insulin aspart-xjhz) injection 100 units/mL (U-100) For intravenous or subcutaneous us e Use only with a U-100 syringe. Rx only One 10 mL Multiple-Dose Vial. Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use then store either refrigerated or at room temperature (up to 30°C [86°F]) and discard after 28 days.

Avoid freezing. Protect from light. Warning: Any change of insulin should be made cautiously and only under medical supervision (see package insert).

Dosage: see Prescribing Information. Discard unused portion of the vial 28 days after first opening. Date of first opening: __/__/__.

Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. The pH is 7.0 to 7.8. Hydrochloric acid and sodium hydroxide may be added to adjust pH.

Manufactured by: Biocon Biologics Inc. 685 Route 202/206, Suite 204, Bridgewater, NJ 08807, U.S.A. U.S.

License No. 2324 Product of Malaysia

PRINCIPAL DISPLAY PANEL 3mL NDC 83257-008-32 Kirsty ™ (insulin aspart-xjhz) injection For Single Patient Use Only 100 units/mL (U-100) For Subcutaneous Use. Dispense in this sealed carton. *Needles not included. Five 3 mL Prefilled Pens Rx only Store refrigerated at 36° to 46°F (2° to 8°C) until first use.

Avoid freezing. Protect from light. After first use of a Kirsty pen, store the pen at room temperature (up to 30°C [86°F]) for up to 28 days.

Warning Any changes of insulin should be made cautiously and only under medical supervision. Kirsty™ Prefilled Pen is for single patient use only. Dosage: see Prescribing Information. *Needles not included.

For Subcutaneous Use. Each mL contains 100 units of insulin aspart-xjhz, and the inactive ingredients dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. The pH is 7.0 to 7.8.

Hydrochloric acid and sodium hydroxide may be added to adjust pH. Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use. Avoid freezing.

Protect from light. After first use of a Kirsty pen, store the pen at room temperature (up to 30°C [86°F]) for up to 28 days. Discard unused portion of the pen 28 days after first opening.

Date of first opening: Pen 1: _____ / _____ / ______. Pen 2: _____ / _____ / ______. Pen 3: _____ / _____ / ______.

Pen 4: _____ / _____ / ______. Pen 5: _____ / _____ / ______. *Embecta Ultra-fine needles are compatible with Kirsty™. These are sold separately and manufactured by Embecta.

Manufactured by: Biocon Biologics Inc. 685 Route 202/206, Suite 204, Bridgewater, NJ 08807, U.S.A. U.S.

License No. 2324 Product of Malaysia

PRINCIPAL DISPLAY PANEL 10mL - Diluting Medium NDC 83257-006-11 Insulin Diluting Medium for Kirsty ™ Use only with Kirsty This product does not contain insulin. 10 mL Single-dose vial Discard unused portion. Each mL of Diluting Medium contains dibasic sodium phosphate (0.997 mg), glycerin (16 mg), m-cresol (1.5 mg), phenol (0.65 mg), and Water for Injection.

Hydrochloric acid and sodium hydroxide may be added to adjust pH. CAUTION: For use by health professionals only to dilute Kirsty or Insulin Aspart (insulin apsart-xjhz) Injection products. Dilutions should be performed under aseptic conditions.

Store unused vials at 2°C to 8°C (36°F to 46°F) and protect from light and heat – do not freeze. Do not use the diluting medium if it does not appear water-clear and colorless or if the cap is loose or missing. The diluted insulin preparation should not be mixed with other insulin preparations in the same syringe.

Do not use the diluting medium in insulin pumps. Never use diluting medium after the expiration date printed on the box or vial label. Keep out of reach of children.

Manufactured by: Biocon Biologics Inc. 685 Route 202/206… [Excerpted — this section continues on DailyMed.]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Biocon Biologics Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Biocon Biologics Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 83257-0005-41 · Biocon 83257-0007-11 · Biocon →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.