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KYXATA CARBOplatin 80 mg/8mL Injection — NDC 83831-0141-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

KYXATA CARBOplatin 80 mg/8mL Injection — NDC 83831-141-08 (Billing 83831-0141-08)

by Avyxa Pharma, LLC · 1 VIAL, MULTI-DOSE in 1 CARTON / 8 mL in 1 VIAL, MULTI-DOSE

This is a package of KYXATA CARBOplatin 80 mg/8mL Injection from Avyxa Pharma, LLC, marketed since Sep 2025 and currently FDA-listed. It is this product's only package size.

NDC 83831-0141-08
🏷️ FDA NDC (as labeled) 83831-141-08 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 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

⚠️
Active FDA shortage. Carboplatin Injection is currently reported in shortage by the FDA. Available Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83831-141-08
Product NDC 83831-141
11-digit billing NDC 83831014108
NCPDP billing unit ML — per mL (volume)
RxCUI 597195, 2721602
UNII BG3F62OND5
UPC 0383831142508, 0383831141082
Application # NDA219921
SPL Set ID f91c48da-68d1-4aa7-89b8-d84a3e8b629b
Established class (EPC) Platinum-based Drug
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-10
Route INTRAVENOUS
Dosage form INJECTION
Substance CARBOPLATIN

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

GPI-14 21100015002031
GCN Seq No 038450
GCN 09217
HICL code 003904
Ingredient (HICL) Carboplatin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1A
Therapeutic class — specific (HIC3) Antineoplastic - Alkylating Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name KYXATA 80 MG/8 ML VIAL
FDB brand name Kyxata
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 038450
  • GCN: 09217
  • GPI-14 (Medi-Span): 21100015002031
  • HICL (First Databank): 003904
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 597195
Why two NDCs? The FDA registers this code as 83831-141-08 — 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 → 83831-0141-08. 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 Platinum-based Drug class.

Pharmacologic class Platinum-based Drug
Drug family (ATC) Platinum compounds
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 KYXATA 80 MG/8 ML VIAL Ingredient Carboplatin
📖 What it is MedlinePlus · NLM

Carboplatin is used alone or in combination with other medications to treat cancer of the ovaries (cancer that begins in the female reproductive organs where eggs are formed) that has spread to other parts of the body, not improved, or that has worsened after treatment with other medications or radiation therapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works by stopping or slowing the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a chemotherapy medicine used to treat ovarian cancer. It's used as part of a combination, such as with cyclophosphamide, for initial treatment of advanced disease, and on its...
  • It's given through an IV in a clinic or hospital, usually on day 1 of a cycle that repeats about every 4 weeks. Your team decides the dose, often based on how well your kidneys wor...
  • Nausea and vomiting are common, and your team will give anti-nausea medicine. You may also have low blood counts, tiredness, tingling, and hair loss. Let us know about any side eff...
  • Call for fever or chills, unusual bleeding or bruising, or severe vomiting. Allergic reactions such as hives, wheezing or trouble breathing can happen within minutes, so tell staff...
📖 Read our full Carboplatin Injection guide →
1
Nutrient depletion considerations

Carboplatin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Carboplatin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 eachPer 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.
Medicare Part B allowsASP · J9278 $5.203 / J9278 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)83831-141-08
11-digit billing NDC83831-0141-08
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9278
DescriptorINJECTION, CARBOPLATIN (AVYXA), 1 MG
Billing units / pkg10 units
How the units are derivedThis package is 8 ML; the HCPCS unit is 1 MG, so one package = 10 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83831-0141-08 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 8 mL in 1 VIAL, MULTI-DOSE 2025-09-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CARBOplatin 10 mg/mL 00703-4239-81 Teva 1 vial — AP FDA listed —
CARBOplatin 10 mg/mL 00703-4244-81 Teva 1 vial — AP FDA listed —
CARBOplatin 10 mg/mL 00703-4246-81 Teva 1 vial — AP FDA listed —
CARBOplatin 10 mg/mL 00703-4248-91 Teva 1 vial — AP Discontinued —
Carboplatin 10 mg/mL 16729-0295-12 Accord 1 vial — — FDA listed —
Carboplatin 10 mg/mL 54288-0164-01 BPI 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 54288-0165-01 BPI 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 54288-0166-01 BPI 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 54288-0167-01 BPI 1 vial — AP FDA listed —
Carboplatin 50 mg/5mL 55150-0333-01 Eugia 1 vial — AP FDA listed —
Carboplatin 150 mg/15mL 55150-0334-01 Eugia 1 vial — AP FDA listed —
Carboplatin 450 mg/45mL 55150-0335-01 Eugia 1 vial — AP FDA listed —
Carboplatin 600 mg/60mL 55150-0386-01 Eugia 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 60505-6282-01 Apotex 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 61703-0150-05 Hospira, 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 61703-0262-05 Hospira, 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 61703-0339-18 Hospira, 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 61703-0360-18 Hospira, 1 vial — AP Discontinued —
Carboplatin 10 mg/mL 61703-0600-05 Hospira, 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 63323-0172-60 Fresenius 1 vial — — FDA listed —
Carboplatin 10 mg/mL 68083-0190-01 Gland 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 68083-0191-01 Gland 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 68083-0192-01 Gland 1 vial — AP FDA listed —
Carboplatin 10 mg/mL 68083-0193-01 Gland 1 vial — AP FDA listed —
Carboplatin 50 mg/5mL 82511-0003-05 Teyro 1 vial — AP FDA listed —
Carboplatin 150 mg/15mL 82511-0004-15 Teyro 1 vial — AP FDA listed —
Carboplatin 450 mg/45mL 82511-0005-45 Teyro 1 vial — AP FDA listed —
Carboplatin 600 mg/60mL 82511-0006-60 Teyro 1 vial — AP FDA listed —
Kyxata 80 mg/8mLthis 83831-0141-08 Avyxa 1 vial — — FDA listed —
Kyxata 500 mg/50mL 83831-0142-50 Avyxa 1 vial — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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 & generic status

🏛️
2025
First FDA approval
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2045
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2045. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 8, 2025 RLD RS ⏳ ~18.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12427104 — drug product
US 12427104 — drug product
US 12427104 — drug product
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043 2045
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 12427104 ↗ Drug product — Apr 1, 2045
US 12427104 ↗ Drug product — Apr 1, 2045
US 12427104 ↗ Drug product — Apr 1, 2045
Common questions
Is there a generic version of KYXATA 80 MG/8 ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for KYXATA 80 MG/8 ML VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic 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.

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient 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

LabelerAvyxa Pharma, LLC
Application holderAVYXA HOLDINGS LLC
FDA applicationNDA219921 (NDA)
Labeler code83831
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio29 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.
🚨 Boxed Warning 🎯 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 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 92 words ▾

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle.

( 5.1 ) Immediately withhold KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction. ( 5.1 )

🎯 Indications and Usage 90 words ▾

1 INDICATIONS AND USAGE KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. ( 1.1 ) As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. ( 1.2 )

1.1Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma.

1.2Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Initial Treatment of Advanced Ovarian Carcinoma: KYXATA 300 mg/m 2 -OR- AUC of 4 mg/mL∙min to 6 mg/mL∙min intravenously in combination with cyclophosphamide on Day 1 every 4 weeks for each cycle. ( 2.2 ) Administer up to six cycles or until disease progression or unacceptable toxicity occurs. ( 2.2 ) Recurrent Advanced Ovarian Carcinoma as a Single Agent: KYXATA 360 mg/m 2 - OR - AUC of 4 mg/mL∙min to 6 mg/mL∙min intravenously on Day 1 every 4 weeks for each cycle until disease progression or unacceptable toxicity occurs.

( 2.2 ) Avoid contact of carboplatin with aluminum parts. ( 2.5 )

2.1Premedication and Supportive Medications Administer KYXATA in a setting where cardiopulmonary resuscitation medication and equipment are available [see Warnings and Precautions (5.1) ]. Premedicate patients with antiemetics prior to each infusion of KYXATA for the prevention of nausea and vomiting. Continue antiemetics following infusion as needed [see Warnings and Precautions (5.3) ].

2.2Recommended Dosage Initial Treatment of Advanced Ovarian Carcinoma with Cyclophosphamide KYXATA 300 mg/m 2 -OR- AUC of 4 mg/mL∙min to 6 mg/mL∙min* intravenously in combination with cyclophosphamide 600 mg/m 2 intravenously on Day 1 every 4 weeks for each cycle. *Carboplatin Dose (mg) = Target Area Under the Curve (AUC) (mg/mL/min) x (GFR + 25). Glomerular filtration rate (GFR) is commonly calculated as estimated creatinine clearance (CLcr) using the Cockroft-Gault formula. Administer up to six cycles or until disease progression or unacceptable toxicity occurs.

Refer to cyclophosphamide prescribing information for additional information. For older adults, calculate the dose based on AUC to reduce risk of severe adverse reactions. Individualize the dose and dosing schedule of KYXATA based on the specific regimen administered, response to treatment, and patient risk factors [see Dosage and Administration (2.3 , 2.4) ].

Secondary Treatment of Advanced Ovarian Carcinoma as a Single Agent KYXATA 360 mg/m 2 -OR- AUC of 4 mg/mL ∙ min to 6 mg/mL ∙ min* intravenously on Day 1 every 4 weeks for each cycle until disease progression or unacceptable toxicity occurs. * Carboplatin Dose (mg) = Target AUC (mg/mL/min) x (GFR + 25). GFR is commonly calculated as estimated creatinine clearance (CLcr) using the Cockroft-Gault formula. For older adults, calculate the dose based on AUC to reduce risk of severe adverse reactions.

Individualize the dose and dosing schedule of KYXATA based on response to treatment and patient risk factors [see Dosage and Administration (2.3, 2.4) ].

2.3Dosage Modifications for Adverse Reactions For a patients administered a dose based on body surface area as a single agent or combination, dosage modifications are shown in Table 1. Monitor complete blood counts prior to treatment, weekly during treatment, and as clinically indicated [see Warnings and Precautions (5.2) ]. Table 1: Recommended Dosage Modifications for Adverse Reactions for Patients Administered a Dose Based on Body-Surface Area Adverse Reaction Severity Dosage Modification Neutropenia [see Warnings and Precautions (5.2) ] Grade ≥ 4 ANC ≤ 0.5 x 10 9 / L ● Interrupt KYXATA until ≤ Grade 1. ● Reduce dose by 25% Thrombocytopenia [see Warnings and Precautions (5.2) ] Grade ≥ 3 Platelet count ≤ 50 x 10 9 / L ● Interrupt KYXATA until ≤ Grade 1. ● Reduce dose by 25%

2.4Dosage Recommendations for Patients with Renal Impairment For patients administered a dose based on AUC , no dose modification is recommended for renal impairment. For patients administered a dose based on body surface area , the recommended doses for renal impairment are described in Table 2 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. A recommended dose has not been established for patients with creatinine clearance <16 mL/min.

Table 2: Recommended Dose for Patients with Renal Impairment Administered a Dose Based on Body Surface Area Creatinine Clearance (mL/min) R… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 20 mg/2 mL (10 mg/mL), 80 mg/8 mL (10 mg/mL), and 500 mg/50 mL (10 mg/mL) available as clear to pale yellow solution in multiple-dose vials. Injection : 20 mg/2 mL (10 mg/mL), 80 mg/8 mL (10 mg/mL), and 500 mg/50 mL (10 mg/mL) in multiple-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Myelosuppression : Myelosuppression (leukopenia, neutropenia, and thrombocytopenia) can cause severe or fatal infections or hemorrhage. Monitor complete blood counts prior to each treatment cycle, and as clinically indicated. If myelosuppression occurs, modify KYXATA dosage.

( 5.2 ) Nausea and Vomiting : Administer pre-treatment and post-treatment antiemetics as clinically indicated. ( 5.3 ) Peripheral Neuropathy : Peripheral neuropathy, including paresthesia, can occur in patients treated with KYXATA. Monitor for signs and symptoms of peripheral neuropathy and modify the dosage of KYXATA based on severity.

( 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 )

5.1Hypersensitivity Reactions Hypersensitivity, including anaphylaxis, can occur in patients treated with KYXATA. Hypersensitivity reactions occurred in 2% of patients treated with carboplatin and included rash, urticaria, erythema, pruritus, bronchospasm, and hypotension. These adverse reactions may occur within minutes of administration and during any cycle.

There is an increased risk of allergic reactions, including anaphylaxis, in patients previously exposed to platinum-based therapy or after 6 cycles of carboplatin [see Adverse Reactions (6.1) ]. Monitor patients receiving KYXATA for hypersensitivity reactions. Ensure supportive equipment and medications are available to treat severe hypersensitivity reactions.

Severe hypersensitivity reactions may require immediate discontinuation of KYXATA.

5.2Myelosuppression Myelosuppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent may be severe, and can cause fatal infections or hemorrhage in patients treated with KYXATA. Grade 3–4 neutropenia occurred in 16% of the patients treated with carboplatin as a single agent. Grade 3-4 thrombocytopenia occurred in 25% of patients with ovarian cancer.

Febrile neutropenia may occur. Blood product transfusions were required in 26% (44% of pretreated) of patients with ovarian cancer treated with carboplatin as a single agent. Infectious and hemorrhagic complications each occurred in 5% of the patients treated with carboplatin as a single agent.

Fatal adverse reactions occurred in less than 1% of patients treated with carboplatin as a single agent. Patients with impaired kidney function are at increased risk of severe myelosuppression and may require dosage modifications [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ]. Monitor complete blood counts prior to each cycle and as clinically indicated.

If myelosuppression occurs, modify KYXATA dosage when required [see Dosage and Administration (2.3) ].

5.3Nausea and Vomiting KYXATA can induce emesis, which can be more severe in patients previously receiving emetogenic therapy, and is dose-dependent. Administer pre-treatment and post-treatment antiemetics as clinically indicated [see Dosage and Administration (2.1) ]. Monitor and manage patients with antiemetics, or fluid replacement, as clinically indicated.

Consider withholding or delaying KYXATA if nausea or vomiting is severe or intolerable and is not responsive to antiemetics.

5.4Peripheral Neuropathy Peripheral neuropathy, including paresthesia, can occur in patients treated with KYXATA. Peripheral neuropathy occurred in 4% of patients receiving carboplatin as a single agent (6% of pretreated patients with ovarian cancer). Peripheral neuropathy occurred in 10% of patients older than 65 who were previously treated with carboplatin.

Prolonged treatment, treatment with other platinum-containing therapies, or use in combination with other drugs that cause peripheral neuropathy may increase the incidence or severity of peripheral neuropathy. Monitor for signs and symptoms of peripheral neuropathy. Withhold, reduce, or discontinue KYXATA depending on the severity and persistence of peripheral neuropathy as cli… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Myelosuppression [see Warnings and Precautions (5.2) ] Nausea and Vomiting [see Warnings and Precautions (5.3) ] Peripheral Neuropathy [see Warnings and Precautions (5.4) ] Most common adverse reactions, including laboratory abnormalities, in patients with advanced ovarian cancer who received KYXATA in combination with cyclophosphamide (≥30%) are leukopenia, neutropenia, nausea and vomiting, anemia, thrombocytopenia, hypomagnesemia, other gastrointestinal adverse reactions, alopecia, asthenia, and pain.

( 6.1 ) Most common adverse reactions, including laboratory abnormalities, in patients with recurrent ovarian cancer who received KYXATA as a single agent (≥30%) are nausea and vomiting, anemia, neutropenia, thrombocytopenia, hyponatremia, hypomagnesemia, hyperphosphatasemia, and hypocalcemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Initial Treatment of Advanced Ovarian Cancer The safety of KYXATA in combination with cyclophosphamide for initial treatment of advanced ovarian cancer was evaluated in two randomized controlled studies conducted by NCIC and SWOG [see Clinical Studies (14.1) ].

Patients in the carboplatin arm received carboplatin in combination with cyclophosphamide and patients in the active-comparator arm received cisplatin in combination with cyclophosphamide. Tables 3 and 4 summarize the adverse reactions and laboratory abnormalities in the NCIC study, respectively. Table 3: Adverse Reactions (≥ 5%) in Patients with Advanced Ovarian Cancer - NCIC Study * Values are in percent of evaluable patients.

Adverse Reaction Carboplatin in combination with cyclophosphamide (N=224) (%)* Cisplatin in combination with cyclophosphamide (N=223) (%)* Gastrointestinal (GI) Nausea and vomiting 93 98 Vomiting 84 97 Other GI adverse reactions 50 62 Mucositis 10 9 Skin and Subcutaneous Tissue Alopecia 50 62 General Asthenia 40 33 Pain 36 37 Cardiovascular 15 19 Infection 14 12 Hypersensitivity 12 9 Hemorrhage 10 4 Genitourinary 10 10 Respiratory 8 9 Neurologic Central neurotoxicity 28 40 Peripheral neuropathies 16 42 Ototoxicity 13 33 Other sensory disorders 6 10 Table 4: Laboratory Abnormalities in Patients with Advanced Ovarian Cancer - NCIC Study * Values are in percent of evaluable patients.

Laboratory Abnormality Carboplatin in combination with cyclophosphamide (N=224)* Cisplatin in combination with cyclophosphamide (N=223)* (%) (%) Hematology Decreased neutrophils <2000 cells/mm 3 97 96 Decreased neutrophils <1000 cells/mm 3 81 79 Decreased hemoglobin <11 g/dL 91 91 Decreased hemoglobin <8 g/dL 18 12 Decreased platelets <100,000/mm 3 70 29 Decreased platelets <50,000/mm 3 41 6 Chemistry Decreased magnesium 63 88 Increased blood urea nitrogen 17 31 Increased AST 17 13 Decreased potassium 16 22 Decreased calcium 16 19 Decreased sodium 10 20 Increased serum creatinine 5 13 Increased bilirubin 5 3 Tables 5 and 6 summarize the adverse reactions and laboratory abnormalities in the SWOG study, respectively.

Table 5: Adverse Reactions (≥ 5%) in Patients with Ovarian Cancer – SWOG Study * Values are in percent of evaluable patients. Adverse Reaction Carboplatin in combination with cyclophosphamide (N=171) (%)* Cisplatin in combination with cyclophosphamide (N=171) (%)* Gastrointestinal (GI) Nausea and vomiting 94 96 Vomiting 82 91 Other GI side effects 40 48 General Pain 54 52 Alopecia 43 57 Asthenia 43 46 Cardiovascular 23 30 Respiratory 12 11 Genitourinary 11 13 Hypers… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 35 words ▾

7 DRUG INTERACTIONS Aminoglycosides : Avoid concomitant use with aminoglycosides. ( 7.1 )

7.1Use with Aminoglycosides Avoid concomitant use of aminoglycosides with KYXATA. Concomitant use of KYXATA with aminoglycosides increased renal toxicity and ototoxicity.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment : Reduce the dose for patients with creatinine clearance of 16 to 59 mL/min who will be administered a dose based on body surface area. ( 8.6 , 2.4 ) Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animals and its mechanism of action [see Clinical Pharmacology (12.1) ] , KYXATA can cause fetal harm when administered to a pregnant woman. Available data from case reports with carboplatin use in pregnant women are insufficient to inform a drug-associated risk. Administration of carboplatin to pregnant rats caused adverse developmental outcomes, including embryo-lethality and structural abnormalities (see Data) .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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. Data Animal Data Carboplatin administered to pregnant rats was embryo-lethal and teratogenic.

8.2Lactation Risk Summary There are limited data on the presence of carboplatin or its metabolites in human milk, its effects on a breastfed child, or its effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with KYXATA and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential KYXATA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating KYXATA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with KYXATA and for 6 months after the last dose.

Males Based on genotoxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment with KYXATA and for 3 months after the last dose [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of KYXATA in pediatric patients have not been established . Pediatric patients may be at risk of hearing loss if KYXATA is administered at higher than recommended dosages or in combination with other ototoxic agents.

8.5Geriatric Use Of the 395 patients treated with carboplatin in combination with cyclophosphamide, 141 (36%) were over 65 years of age, and 22 (6%) were 75 years and older [see Clinical Studies (14.1) ]. No overall differences in effectiveness were observed between these patients and younger patients. Elderly patients treated with carboplatin were more likely to develop severe thrombocytopenia or peripheral neuropathy than younger patients [see Warnings and Precautions (5.2 , 5.4) ] Of the 1,942 patients with solid tumors or hematological malignancies from pooled clinical trials that received single-agent carboplatin, 414 (21%) were 65 years of age and older, and a similar incidence of other adverse reactions was seen in these older patients compared to patients less than 65 years of age.

Consider renal function when selecting the KYXATA dose for older adults since they often have decreased renal function. To minimize the risk of toxicity in older adults, calculate the dose based on AUC [see Dosage and Administration (2.3) ].

8.6Renal Impairment For patients administered a dose based on AUC , no dose modification is recommended for renal impairment. For patients administered a dose based on body surface area , reduce the dose if creatinine clearance (CLcr) is 16 to 59 mL/min [see Dosage and Administration (2.4) ] . A recommended dose of KYXATA has not been established for patients with CLcr <16 mL/min.

Patients with impaired renal function are at increased risk of myelosuppression [see Warnings and Precautions (5.2) ] .

🤰 Pregnancy 122 words ▾

8.1Pregnancy Risk Summary Based on findings from animals and its mechanism of action [see Clinical Pharmacology (12.1) ] , KYXATA can cause fetal harm when administered to a pregnant woman. Available data from case reports with carboplatin use in pregnant women are insufficient to inform a drug-associated risk. Administration of carboplatin to pregnant rats caused adverse developmental outcomes, including embryo-lethality and structural abnormalities (see Data) .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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. Data Animal Data Carboplatin administered to pregnant rats was embryo-lethal and teratogenic.

🧒 Pediatric Use 42 words ▾

8.4Pediatric Use The safety and effectiveness of KYXATA in pediatric patients have not been established . Pediatric patients may be at risk of hearing loss if KYXATA is administered at higher than recommended dosages or in combination with other ototoxic agents.

🧓 Geriatric Use 163 words ▾

8.5Geriatric Use Of the 395 patients treated with carboplatin in combination with cyclophosphamide, 141 (36%) were over 65 years of age, and 22 (6%) were 75 years and older [see Clinical Studies (14.1) ]. No overall differences in effectiveness were observed between these patients and younger patients. Elderly patients treated with carboplatin were more likely to develop severe thrombocytopenia or peripheral neuropathy than younger patients [see Warnings and Precautions (5.2 , 5.4) ] Of the 1,942 patients with solid tumors or hematological malignancies from pooled clinical trials that received single-agent carboplatin, 414 (21%) were 65 years of age and older, and a similar incidence of other adverse reactions was seen in these older patients compared to patients less than 65 years of age.

Consider renal function when selecting the KYXATA dose for older adults since they often have decreased renal function. To minimize the risk of toxicity in older adults, calculate the dose based on AUC [see Dosage and Administration (2.3) ].

🆘 Overdosage 138 words ▾

10 OVERDOSAGE There is no known antidote for KYXATA overdosage. The anticipated complications of overdosage would be secondary to bone marrow suppression and/or hepatic toxicity. Patients receiving overdosages of carboplatin experienced severe liver function test abnormalities.

Loss of vision, which can be complete for light and colors, has been reported after the use of carboplatin at doses higher than the recommended approved dosage for KYXATA. Vision recovers totally or to a significant extent after discontinuation of carboplatin. Clinically significant hearing loss has been reported to occur in pediatric patients when carboplatin was administered at higher than approved recommended doses for KYXATA and in combination with other ototoxic agents [see Drug Interactions (7) ].

KYXATA is removed by dialysis. Closely monitor patients suspected of receiving an overdose, including for the adverse reactions described above, and administer appropriate supportive treatment.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carboplatin is a platinum-based drug that binds to DNA and forms DNA cross-links. These crosslinks inhibit DNA replication and transcription and trigger cytotoxic processes that lead to cell death.

12.2Pharmacodynamics Carboplatin exposure-response relationships and the time course of pharmacodynamic response have not been fully characterized.

12.3Pharmacokinetics Carboplatin pharmacokinetics were observed in patients with creatinine clearance (CLcr) of about 60 mL/min or greater following a dose of 300 mg/m 2 to 500 mg/m 2 as an intravenous infusion over 30-minutes. The C max and AUC 0-INF increase linearly with dose, although the increase was slightly more than dose proportional. Distribution The volume of distribution is 16 L.

Carboplatin is not bound to plasma proteins. No significant quantities of protein-free, ultrafilterable platinum-containing species other than carboplatin are present in plasma. However, platinum from carboplatin becomes irreversibly bound to plasma proteins.

Elimination The elimination half-life is 2.6 to 5.9 hours and the total body clearance is

4.4L/hour. The elimination half-life of platinum from carboplatin bound to plasma proteins is a minimum of 5 days. Excretion The major route of elimination of carboplatin is renal excretion with 65% of the dose excreted in the urine within 12 hours and 71% within 24 hours.

All of the platinum in the 24-hour urine is present as carboplatin. Specific Populations Renal Impairment: In patients with CLcr below 60 mL/min, the total body and renal clearances of carboplatin decrease as renal function decreases.

🧬 Mechanism of Action 33 words ▾

12.1Mechanism of Action Carboplatin is a platinum-based drug that binds to DNA and forms DNA cross-links. These crosslinks inhibit DNA replication and transcription and trigger cytotoxic processes that lead to cell death.

📦 How Supplied / Storage and Handling 114 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied KYXATA TM (carboplatin) injection is supplied as clear to pale yellow solution in the following presentations: Unit of Sale Strength NDC 83831-140-02 Carton containing 1 multiple-dose vial (Light Blue flip-off seals) 20 mg/2 mL (10 mg/mL) NDC 83831-141-08 Carton containing 1 multiple-dose vial (Green flip-off seals) 80 mg/8 mL (10 mg/mL) NDC 83831-142-50 Carton containing 1 multiple-dose vial (Grey flip-off seals) 500 mg/50 mL (10 mg/mL) Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Protect from light. KYXATA is a hazardous drug. Follow applicable special handling and disposal procedures.

1

📋 Description 116 words ▾

11 DESCRIPTION KYXATA is a platinum-based drug. The chemical name for carboplatin is platinum, diammine [1,1- cyclobutane-dicarboxylato(2-)-0,0']-,(SP-4-2) and carboplatin has the following structural formula: Carboplatin is a white crystalline powder with the molecular formula of C 6 H 12 N 2 O 4 Pt and a molecular weight of 371.26 g/mol. It is sparingly soluble in water and very slightly soluble in acetone and in alcohol.

The pH of a 1% carboplatin solution in water is 5 to 7. KYXATA (carboplatin) injection is supplied as a sterile, clear to pale yellow solution as 20 mg/2 mL, 80 mg/8mL, 500 mg/50 mL in multiple-dose vials for administration by intravenous infusion. Each mL contains 10 mg carboplatin.

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💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Inform patients that KYXATA can cause hypersensitivity reactions, including anaphylaxis. and to immediately report signs or symptoms of hypersensitivity reactions to their healthcare provider. Advise patients to seek medical attention immediately if they experience severe symptoms [see Warnings and Precautions (5.1) ].

Myelosuppression Inform patients that KYXATA can cause myelosuppression to immediately report signs or symptoms such as bleeding, easy bruising, symptoms of infection (fever, chills, cough, pain, or burning during urination), fatigue, or shortness of breath to their healthcare provider. Advise patients that complete blood counts will be monitored at baseline, during treatment, and as clinically indicated [see Warnings and Precautions (5.2) ]. Nausea and Vomiting Advise patients about the use of antiemetics to prevent nausea and vomiting and to report persistent or severe symptoms to their healthcare provider [see Warnings and Precautions (5.3) ].

Peripheral Neuropathy Advise patients to report any new paresthesia to their healthcare provider [see Warnings and Precautions (5.4) ]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5) , Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with KYXATA and for 6 months after the last dose [see Use in Specific Populations (8.3) ] .

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with KYXATA and for 3 months after the last dose [see Use in Specific Populations (8.3) ]. Lactation Advise women not to breastfeed during treatment with KYXATA and for 1 week after the last dose [see Use in Specific Populations (8.2) ]. Manufactured for: Avyxa Pharma, LLC New Jersey 07054, USA Made in Switzerland Image

🧬 Pharmacokinetics 17 words ▾

12.2Pharmacodynamics Carboplatin exposure-response relationships and the time course of pharmacodynamic response have not been fully characterized.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer The efficacy of carboplatin was evaluated in additional two randomized, controlled studies conducted by the National Cancer Institute of Canada, Clinical Trials Group (NCIC) and the Southwest Oncology Group (SWOG) in patients with advanced ovarian cancer. Table 9: Overview of the NCIC and SWOG Trials Overview of Pivotal Trials NCIC SWOG Number of patients 447 342 Median age (years) 60 62 Dose of cisplatin 75 mg/m 2 100 mg/m 2 Dose of carboplatin 300 mg/m 2 300 mg/m 2 Dose of cyclophosphamide 600 mg/m 2 600 mg/m 2 Residual tumor <2 cm (number of patients) 39% (174/447) 14% (49/342) The efficacy results from the NCIC Trial are shown below in Table 10.

Table10: Efficacy Results for the NCIC Trial a Kaplan-Meier Estimates b 114 carboplatin and 109 cisplatin patients did not undergo second look surgery in NCIC study. Carboplatin in combination with cyclophosphamide Cisplatin in combination with cyclophosphamide Overall Survival Median OS in months 25.3

22.8Hazard ratio (95% CI) 0.98 (0.78, 1.23) 2-year Survival a 51.9% 40.2% 3-year Survival a 34.6% 33.1% Progression-free Survival Median PFS in months 13.6 14 Hazard ratio (95% CI) 1.10 (0.89, 1.35) 2-year PFS a 31% 31% 3-year PFS a 19% 23% Response Rates Pathologic Complete Response, n (%) b 24/224 (11%) 33/223 (15%) Clinical Response in Measurable Patients (%) 60% 58% The efficacy results from the SWOG trial are shown below in Table 11. Table 11: Efficacy Results for the SWOG Trial a Kaplan-Meier Estimates b 90 carboplatin and 106 cisplatin patients did not undergo second look surgery in SWOG study.

Carboplatin in combination with cyclophosphamide Cisplatin in combination with cyclophosphamide Overall Survival Median OS in months 19.8

18.2Hazard ratio (95% CI) 1.01 (0.78, 1.30) 2-year Survival a 40.2% 39.0% 3-year Survival a 18.3% 24.9% Progression-free Survival Median PFS in months 11.3

10.8Hazard ratio (95% CI) 1.02 (0.81, 1.29) 2-year PFS a 21% 21% 3-year PFS a 8% 14% Response Rates Pathologic Complete Response, n (%) b 17/171 (10%) 17/171 (10%) Clinical Response in Measurable Patients (%) 58% 43%

14.2Use as a Single Agent for Secondary Treatment of Advanced Ovarian Cancer In two prospective, randomized controlled studies in 47 patients with advanced ovarian cancer previously treated with chemotherapy who were treated with carboplatin as a single agent, 13% (6/47) of patients had clinical complete responses. The duration of these responses ranged from 45 to 71+ weeks. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.

🧪 Nonclinical Toxicology 39 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity profiles are carcinogenic. Carboplatin is mutagenic both in vitro and in vivo.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 36 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity profiles are carcinogenic. Carboplatin is mutagenic both in vitro and in vivo.

📚 References 7 words ▾

15 REFERENCES "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

SPL PATIENT PACKAGE INSERT This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 09/2025 Patient Information KYXATA TM (Kix-ZAT-ah) (carboplatin) injection for intravenous use What is the most important information I should know about KYXATA?

KYXATA can cause allergic reactions, including serious allergic reactions that can be life-threatening. KYXATA is a platinum-based medicine. Serious allergic reactions can happen in people who take KYXATA and who have had a previous allergic reaction to platinum-based medicines.

Serious allergic reactions can happen within a few minutes of your KYXATA infusion or any time during your treatment with KYXATA. Tell your healthcare provider or get emergency medical help right away if you: ● have trouble breathing ● feel like your throat is closing up Call your healthcare provider right away if you get any of the following signs or symptoms of an allergic reaction: ● rash ● flushed face ● hives ● itching ● swelling of your lips or tongue ● sudden cough ● dizziness or feel faint ● sweating ● chest pain See "What are the possible side effects of KYXATA?" for more information about side effects.

What is KYXATA? KYXATA is a prescription medicine used to treat adults: ● in combination with another chemotherapy medicine, for your first treatment of advanced ovarian cancer. ● alone when your ovarian cancer has come back (recurrent) after you have been treated with prior chemotherapy medicines. It is not known if KYXATA is safe and effective in children.

Before you receive KYXATA tell your healthcare provider about all of your medical conditions, including if you: ● have kidney problems ● are pregnant or plan to become pregnant. KYXATA can harm your unborn baby. Females who are able to become pregnant: ○ Your healthcare provider will check to see if you are pregnant before you start treatment with KYXATA. ○ Use effective birth control (contraception) during treatment with KYXATA and for 6 months after your last dose. ○ Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with KYXATA.

Males with female partners who are able to become pregnant: ○ Use effective birth control (contraception) during treatment with KYXATA and for 3 months after your last dose. ○ Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during your treatment with KYXATA. ● are breastfeeding or plan to breastfeed. It is not known if KYXATA passes into your breast milk. Do not breastfeed during treatment with KYXATA and for 1 week after your last dose of KYXATA.

Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take , including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. How will I receive KYXATA? ● Your healthcare provider will give you KYXATA into your vein as an intravenous (IV) infusion over 30 to 60 minutes. ● Your healthcare provider will give you medicines before each KYXATA infusion to help prevent nausea and vomiting and may continue these medicines after your infusion as needed. ● For advanced ovarian cancer, KYXATA may be given in combination with another chemotherapy medicine on Day 1 of each cycle.

Your healthcare provider will decide how often KYXATA is given based on the other chemotherapy medicine used with KYXATA. ● For recurrent ovarian cancer, KYXATA may be given alone on Day 1 every 4 weeks (1 cycle). ● Your healthcare provider will decide how many treatments you need. ● Your healthcare provider may change your dose of KYXATA, or tell you to stop KYXATA for a short period of time or permanently if you have certain side effects. What are the possible side effects of KYXATA? KYXATA can cause serious side effects, including: See "What is the most important information about KYXATA?" above. ● Low blood cell counts .

Decreased red blood c… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 84 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL KYXATA (CARBOplatin) Injection, 80 mg/8 mL (10 mg/mL) -Vial Label KYXATA (CARBOplatin) Injection, 80 mg/8 mL (10 mg/mL) -Carton Label KYXATA (CARBOplatin) Injection, 500 mg/50 mL (10 mg/mL) -Vial Label KYXATA (CARBOplatin) Injection, 500 mg/50 mL (10 mg/mL) -Carton Label KYXATA (CARBOplatin) Injection, 80 mg/8 mL (10 mg/mL) -Vial Label KYXATA (CARBOplatin) Injection, 80 mg/8 mL (10 mg/mL) -Carton Label KYXATA (CARBOplatin) Injection, 500 mg/50 mL (10 mg/mL) -Vial Label KYXATA (CARBOplatin) Injectionn, 500 mg/50 mL (10 mg/mL) -Carton Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Carboplatin (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Carboplatin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$40.3K
Claims incl. refills
911
Beneficiaries
425
Spend / beneficiary
$94.85
Spend / claim
$44.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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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
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“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 Avyxa Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Avyxa Pharma, LLC 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9278 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 83831-0134-01 · Avyxa 83831-0142-50 · Avyxa →
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.