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Oxaliplatin 5 mg/mL Injection, Solution, Concentrate — NDC 61703-0363-22 package photo

Oxaliplatin 5 mg/mL Injection, Solution, Concentrate

by Hospira, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSE
NDC 61703-0363-22
🏷️ FDA NDC (as labeled) 61703-363-22 billing pads the product segment with a zero
This package
Contains20 mL in 1 vial, single-dose Medicaid pays$4.98 / unit · 12 mo Per package$99.65 / 20 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 10 mL 61703-0363-18
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Aug 27, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2015. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61703-363-22
Product NDC 61703-363
11-digit billing NDC 61703036322
NCPDP billing unit ML — per mL (volume)
RxCUI 1736776, 1736781
UNII 04ZR38536J
Application # ANDA078813
SPL Set ID e51a62ba-d163-4c57-835c-8c86cf097e40
Established class (EPC) Platinum-based Drug
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2015)
Marketing start 2009-08-10
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance OXALIPLATIN
GCN Seq No 059163
GCN 24701
HICL code 016687
Ingredient (HICL) Oxaliplatin
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 OXALIPLATIN 100 MG/20 ML VIAL
FDB brand name Oxaliplatin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 61703-363-22 — 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 → 61703-0363-22. 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.

🏭 Manufacturer & labeler

LabelerHospira, Inc.
Application holderHOSPIRA WORLDWIDE PTY
FDA applicationANDA078813 (ANDA)
Labeler code61703
First marketedAug 2009
Product typeHuman Prescription Drug
Portfolio317 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.

🩺 Clinical

Label name OXALIPLATIN 100 MG/20 ML VIAL Ingredient Oxaliplatin
📖 What it is MedlinePlus · NLM

Oxaliplatin is used with other medications to treat advanced colon or rectal cancer (cancer that begins in the large intestine). Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumor. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by killing cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Oxaliplatin is a chemotherapy drug that works by damaging the DNA inside cancer cells, stopping them from growing and dividing. It's always used alongside two other drugs — fluorou...
  • Why am I getting oxaliplatin — what is it actually doing for my cancer?
  • That's called peripheral neuropathy, and it's one of the most common side effects with oxaliplatin — so you're not imagining it, and you're not alone. There are two types. The firs...
  • I keep hearing about the tingling and numbness — what's that about, and will it go away?
📖 Read our full Oxaliplatin Injection guide →
1
Nutrient depletion considerations

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

🧪 Full Oxaliplatin 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.

🧪 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.

  • 0.0123 mg / 1 mL 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.
  • 0.03 mg / 1 mL UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • 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.

3 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.

💲 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 $4.98 $99.65 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9263 $0.055 / J9263 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)61703-363-22
11-digit billing NDC61703-0363-22
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9263
DescriptorInjection, oxaliplatin, 0.5 mg
Billing units / pkg200 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxaliplatin 5 mg/mL 00955-1731-10 Winthrop 1 vial — — Discontinued —
Oxaliplatin 5 mg/mL 00955-1733-20 Winthrop 1 vial — — Discontinued —
oxaliplatin 5 mg/mL 16729-0332-03 Accord 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 68083-0176-01 Gland 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 68083-0177-01 Gland 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 68083-0314-01 Gland 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 00781-3317-80 Sandoz 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 60505-6287-02 Apotex 1 vial — — FDA listed —
Oxaliplatin 5 mg/mL 72266-0162-01 FOSUN 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 00781-9315-70 Sandoz 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 00781-9317-80 Sandoz 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 71288-0149-95 Meitheal 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 72603-0301-01 NorthStar 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 72603-0320-01 Northstar 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 00781-3315-70 Sandoz 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 55150-0331-01 Eugia 1 vial — — FDA listed —
Oxaliplatin 5 mg/mL 55150-0332-01 Eugia 1 vial — — FDA listed —
Oxaliplatin 5 mg/mL 71288-0101-10 Meitheal 1 vial — AP FDA listed —
oxaliplatin 5 mg/mL 25021-0233-10 Sagent 1 vial — — FDA listed —
Oxaliplatin 5 mg/mL 71288-0171-11 Meitheal 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 72266-0161-01 FOSUN 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 43066-0014-01 Baxter 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 71288-0172-21 Meitheal 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 72603-0101-01 NorthStar 1 vial — AP FDA listed —
oxaliplatin 5 mg/mL 42677-0337-10 Shandong 10 vials — AP FDA listed —
Oxaliplatin 5 mg/mL 67457-0442-20 Mylan 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 68001-0468-36 BluePoint 1 vial — — FDA listed —
Oxaliplatin 5 mg/mL 72603-0420-01 Northstar 1 vial — AP FDA listed —
Oxaliplatin 5 mg/mL 60505-6132-06 Apotex 1 vial — — FDA listed —
Oxaliplatin 5 mg/mLthis 61703-0363-22 Hospira, 1 vial — AP Discontinued —
Oxaliplatin 5 mg/mL 63323-0750-10 Fresenius 1 vial — AP Discontinued —
Oxaliplatin 5 mg/mL 67457-0469-10 Mylan 1 vial — AP FDA listed —
oxaliplatin 5 mg/mL 42677-0336-10 Shandong 10 vials — AP FDA listed —
Oxaliplatin 5 mg/mL 43066-0018-01 Baxter 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2009
On the market since
Aug 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 61703-0363-22, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
643
Units reimbursed last 4 qtrs
18.6K
Gross reimbursed last 4 qtrs
$92.7K
Avg / prescription
$144.11
Avg / unit
$4.9824
Latest quarter Q4 2025
77Rx
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 288 Rx Managed care · 355 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 360 units · 31.8 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 9,377 units · 47.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 405 units · 12.6 per 100k residents IA Illinois: no data reported IL Indiana: 1,675 units · 24.4 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,695 units · 12.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 710 units · 15.7 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
12.047.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 47.9 /100k
2 Montana 31.8 /100k
3 Indiana 24.4 /100k
4 Kentucky 15.7 /100k
5 Iowa 12.6 /100k
6 California 12.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial61703-0363-18 883 Rx · $1,278,950
1 vial this page61703-0363-22 643 Rx · $92,664
Drug total (last 4 qtrs): 1,526 Rx · 36,572 units · $1,371,614 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Oxaliplatin — 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 Oxaliplatin. 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
$226.2K
Claims incl. refills
835
Beneficiaries
400
Spend / beneficiary
$565.53
Spend / claim
$270.91
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61703-0363-18 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18) / 10 mL in 1 VIAL, SINGLE-DOSE 2009-08-10 Discontinued by firm
61703-0363-22 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSE 2009-08-10 Discontinued by firm

This pack accounts for about 42% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 61703-0363-22?
NDC 61703-0363-22 is listed by the FDA — 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Oxaliplatin 5 mg/mL Injection, Solution, Concentrate?
Bill NDC 61703-0363-22 — the 11-digit billing format is 61703036322. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 61703-363-22, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61703-0363-22, written without dashes as 61703036322. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61703-0363-22, the first segment (61703) is the labeler code FDA assigned to Hospira, Inc.; the middle segment (0363) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (61703-0363-18). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hospira, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9263 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 133 words ▾

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs [see Contraindications (4) ] . Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ].

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning . Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs.

Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment. ( 4 , 5.1 )

🎯 Indications and Usage 88 words ▾

1 INDICATIONS AND USAGE Oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for: • adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. • treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: • adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.

( 1 ) • treatment of advanced colorectal cancer. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Administer Oxaliplatin 85 mg/m 2 as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle. Administer fluorouracil and leucovorin on Day 2 as recommended. ( 2.1 ) • Adjuvant Treatment : Continue treatment for up to 12 cycles or unacceptable toxicity.

( 2.1 ) • Advanced Colorectal Cancer : Continue treatment until disease progression or unacceptable toxicity. ( 2.1 )

2.1Recommended Dosage Administer Oxaliplatin in combination with fluorouracil and leucovorin every 2 weeks. • For adjuvant treatment, continue treatment for up to 12 cycles or unacceptable toxicity. • For advanced colorectal cancer, continue treatment until disease progression or unacceptable toxicity. Day 1 Administer Oxaliplatin 85 mg/m 2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion.

Day 2 Administer leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2 to 4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion. Refer to the prescribing information for fluorouracil and leucovorin for additional information.

2.2Dose Modifications for Adverse Reactions Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities, such as non-life‑threatening infusion-related reactions. Permanently discontinue Oxaliplatin for any of the following: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.4) ] • Confirmed interstitial lung disease or pulmonary fibrosis [see Warnings and Precautions (5.5) ] • Rhabdomyolysis [see Warnings and Precautions (5.8) ] Refer to the fluorouracil and leucovorin prescribing information for dosage modifications for adverse reactions.

Dosage Modifications for Adjuvant Treatment Dosage modifications for adverse reactions for adjuvant treatment are presented in Table 1. Table 1: Dosage Modifications for Adjuvant Treatment in Patients with Stage III Colon Cancer Adverse Reactions Severity Oxaliplatin Dosage Modifications Peripheral Sensory Neuropathy [see Warnings and Precautions (5.2) ] Persistent Grade 2 Consider reducing Oxaliplatin dose to 75 mg/m 2 . Persistent Grade 3 Consider discontinuing Oxaliplatin.

Grade 4 Discontinue Oxaliplatin. Myelosuppression [see Warnings and Precautions (5.3) , Adverse Reactions (6.1) ] Grade 4 neutropenia or febrile neutropenia Delay the next dose until neutrophils greater than or equal to 1.5 × 10 9 /L and platelets greater than or equal to 75 × 10 9 /L. Reduce Oxaliplatin dose to 75 mg/m 2 .

Grade 3–4 thrombocytopenia Gastrointestinal Adverse Reactions [see Adverse Reactions (6.1) ] Grade 3–4 After recovery, reduce Oxaliplatin dose to 75 mg/m 2 along with a dose reduction of fluorouracil to 300 mg/m 2 as an intravenous bolus and 500 mg/m 2 as a 22-hour continuous infusion. Dosage Modifications for Advanced Colorectal Cancer Dosage modifications for adverse reactions for advanced colorectal cancer are presented in Table 2. Table 2: Dosage Modifications for Advanced Colorectal Cancer Adverse Reactions Severity Oxaliplatin Dosage Modifications Neuropathy [see Warnings and Precautions (5.2) ] Persistent Grade 2 Consider reducing Oxaliplatin dose to 65 mg/m 2 .

Persistent Grade 3 Consider discontinuing Oxaliplatin. Grade 4 Discontinue Oxaliplatin. Myelosuppression [see Warnings and Precautions (5.3) , Adverse Reactions (6.1) ] Grade 4 neutropenia or febrile neutropenia Delay the next dose until neutrophils greater than or equal to 1.5 × 10 9 /L and platelets greater than or equal to 75 × 10 9 /L.

Reduce O…

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/10 mL or 100 mg/20 mL clear, colorless solution in a single-dose vial. Injection: 50 mg (5 mg/mL) or 100 mg (5 mg/mL) in a single-dose vial ( 3 )

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . • History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs. ( 4 , 5.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Peripheral Sensory Neuropathy : Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue Oxaliplatin as recommended.

( 5.2 ) • Severe Myelosuppression : Delay Oxaliplatin until neutrophils are greater than or equal to 1.5 × 10 9 /L and platelets are greater than or equal to 75 × 10 9 /L. Withhold Oxaliplatin for sepsis or septic shock. Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3–4 thrombocytopenia as recommended.

( 5.3 ) • Posterior Reversible Encephalopathy Syndrome (PRES) : Permanently discontinue Oxaliplatin in patients who develop PRES. ( 5.4 ) • Pulmonary Toxicity : Withhold Oxaliplatin until investigation excludes interstitial lung disease or pulmonary fibrosis. ( 5.5 ) • Hepatotoxicity : Monitor liver function tests at baseline, before each subsequent cycle, and as clinically indicated.

( 5.6 ) • QT Interval Prolongation and Ventricular Arrythmias : Avoid in patients with congenital long QT syndrome. Monitor electrocardiograms in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities prior to initiating Oxaliplatin and periodically during treatment.

( 5.7 ) • Rhabdomyolysis : Permanently discontinue Oxaliplatin if rhabdomyolysis occurs. ( 5.8 ) • Hemorrhage : Increase frequency of monitoring in patients who are receiving Oxaliplatin with fluorouracil/leucovorin and oral anticoagulants. ( 5.9 ) • Embryo-Fetal Toxicity : Can cause fetal harm.

Advise pregnant women of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception. ( 5.10 , 8.1 , 8.3 )

5.1Hypersensitivity Reactions Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Grade 3–4 hypersensitivity reactions, including anaphylaxis, occurred in 2% to 3% of patients with colon cancer who received Oxaliplatin. Hypersensitivity reactions, including rash, urticaria, erythema, pruritus, and rarely, bronchospasm and hypotension, were similar in nature and severity to those reported with other platinum-based drugs.

Oxaliplatin is contraindicated in patients with hypersensitivity reactions to platinum-based drugs [see Contraindications (4) ] . Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment for management of hypersensitivity reactions.

5.2Peripheral Sensory Neuropathy Oxaliplatin can cause acute and delayed neuropathy. Reduce the dose or permanently discontinue Oxaliplatin for persistent neurosensory reactions based on the severity of the adverse reaction [see Dosage and Administration (2.2) ] . Acute Neuropathy Acute neuropathy typically presents as a reversible, primarily peripheral sensory neuropathy that occurs within hours or 2 days following a dose, resolves within 14 days, and frequently recurs with further dosing.

The symptoms can be precipitated or exacerbated by exposure to cold temperature or cold objects and they usually present as transient paresthesia, dysesthesia and hypoesthesia in the hands, feet, perioral area, or throat. Jaw spasm, abnormal tongue sensation, dysarthria, eye pain, and a feeling of chest pressure have also been observed. The acute, reversible pattern of sensory neuropathy was observed in about 56% of patients who received Oxaliplatin with fluorouracil/leucovorin.

In any individual cycle, acute neuropathy occurred in approximately 30% of patients. For grade 3 peripheral sensory neuropathy, the median time to onset was 9 cycles for adjuvant treatment and 6 cycles for previously treated advanced colorectal cancer. An acute syndrome of pharyngolaryngeal dysesthesia occurred in 1% to 2% (grade 3–4) of patients previously untreated for advanced colorectal c…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Peripheral Sensory Neuropathy [see Warnings and Precautions (5.2) ] • Severe Myelosuppression [see Warnings and Precautions (5.3) ] • Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.4) ] • Pulmonary Toxicity [see Warnings and Precautions (5.5) ] • Hepatotoxicity [see Warnings and Precautions (5.6) ] • QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions (5.7) ] • Rhabdomyolysis [see Warnings and Precautions (5.8) ] • Hemorrhage [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, 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 practice. More than 1,100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer were treated in trials with Oxaliplatin. The most common adverse reactions in patients with stage II or III colon cancer receiving adjuvant treatment were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis.

The most common adverse reactions in previously untreated and treated patients with advanced colorectal cancer were peripheral sensory neuropathies, fatigue, neutropenia, nausea, emesis, and diarrhea . Adjuvant Treatment The safety of Oxaliplatin in combination with fluorouracil (FU)/leucovorin (LV) was evaluated in patients with stage II or III colon cancer, who had undergone complete resection of the primary tumor in the adjuvant treatment trial [see Clinical Studies (14.1) ]. Fatal adverse reactions in patients who received Oxaliplatin in the combination arm included sepsis/neutropenic sepsis (n=3), intracerebral hemorrhage (n=2), and eosinophilic pneumonia (n=1).

Thromboembolic events occurred in 6% (grade 3–4, 1.2%) of patients in the Oxaliplatin arm. Grade 3 or 4 adverse reactions occurred in 70% of patients in the Oxaliplatin arm. Grade 3–4 gastrointestinal bleeding occurred in 0.2% of patients.

Febrile neutropenia occurred in 0.7% and documented infection with concomitant grade 3–4 neutropenia occurred in 1.1%. Discontinuation due to an adverse reaction occurred in 15% of the patients in the Oxaliplatin arm. Tables 5, 6, and 7 summarize the adverse reactions reported in patients with colon cancer receiving adjuvant treatment.

Table 5: Adverse Reactions Reported in Patients with Colon Cancer Receiving Adjuvant Treatment (greater than or equal to 5% of all patients and with greater than or equal to 1% grade 3–4) Adverse Reaction Event coded in WHO-ART dictionary Oxaliplatin + FU/LV N=1,108 FU/LV N=1,111 All Grades (%) Grade 3–4 (%) All Grades (%) Grade 3–4 (%) Neurology Peripheral Sensory Neuropathy 92 12 16 <1 Gastrointestinal Nausea 74 5 61 2 Diarrhea 56 11 48 7 Vomiting 47 6 24 1 Stomatitis 42 3 40 2 Anorexia 13 1 8 <1 Constitutional Symptoms/Pain Fatigue 44 4 38 1 Abdominal Pain 18 1 17 2 Dermatology/Skin Skin Disorder 32 2 36 2 Injection Site Reaction Includes thrombosis related to the catheter 11 3 10 3 Fever/Infection Fever 27 1 12 1 Infection 25 4 25 3 Allergy/Immunology Allergic Reaction 10 3 2 <1 Table 6: Adverse Reactions Reported in Patients with Colon Cancer Receiving Adjuvant Treatment (greater th…

🔄 Drug Interactions 138 words ▾

7 DRUG INTERACTIONS

7.1Drugs that Prolong the QT Interval QT interval prolongation and ventricular arrhythmias can occur with Oxaliplatin [see Warnings and Precautions (5.7) ] . Avoid coadministration of Oxaliplatin with medicinal products with a known potential to prolong the QT interval.

7.2Use with Nephrotoxic Products Because platinum-containing species are eliminated primarily through the kidney, clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds [see Clinical Pharmacology (12.3) ]. Avoid coadministration of Oxaliplatin with medicinal products known to cause nephrotoxicity.

7.3Use with Anticoagulants Prolonged prothrombin time and INR occasionally associated with hemorrhage have been reported in patients who received Oxaliplatin with fluorouracil/leucovorin while on anticoagulants [see Warnings and Precautions (5.9) , Adverse Reactions (6.2) ] . Increase frequency of monitoring in patients who are receiving Oxaliplatin with fluorouracil/leucovorin and oral anticoagulants.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Females : Advise female patients of reproductive potential to use effective contraception while receiving Oxaliplatin and for 9 months after the final dose. ( 8.3 ) • Males : Based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving Oxaliplatin and for 6 months after the final dose ( 13.1 ).

8.1Pregnancy Risk Summary Based on its direct interaction with DNA, Oxaliplatin can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of Oxaliplatin. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see Data ) .

Advise a pregnant woman 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 Pregnant rats were administered oxaliplatin at less than one-tenth the recommended human dose based on body surface area during gestation days (GD)1–5 (preimplantation), GD 6–10, or GD 11–16 (during organogenesis).

Oxaliplatin caused developmental mortality (increased early resorptions) when administered on days GD 6–10 and GD 11–16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days GD 6–10.

8.2Lactation Risk Summary There are no data on the presence of oxaliplatin or its metabolites in human or animal milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Oxaliplatin and for 3 months after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating Oxaliplatin [see Use in Specific Populations (8.1) ] . Contraception Oxaliplatin can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Females Advise female patients of reproductive potential to use effective contraception while receiving Oxaliplatin and for 9 months after the final dose.

Males Based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving Oxaliplatin and for 6 months after the final dose [see Nonclinical Toxicology (13.1) ] . Infertility Based on animal studies, Oxaliplatin may impair fertility in males and females [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of oxaliplatin in pediatrics have not been established. Safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors. In a multicenter, open-label, non-comparative, non-randomized study (ARD5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma.

The dose limiting toxicity (DLT) was sensory neuropathy at a dose of 110 mg/m 2 . The main adverse reactions were: paresthesia (60%, grade 3–4: 7%), fever (40%, grade 3–4: 7%), and thrombocytopenia (40%, grade 3–4: 27%). No responses were observed.

In an open-label non-randomized study (DFI7434), oxaliplatin was administered to 26 pediatric patients with metastatic or unresectable solid tumors, mainly neuroblastoma and ganglioneuroblastoma. The DLT was sensory neuropathy at a dose of 160 mg/m 2 . No responses were observed.

In an open-label, single-agent study (ARD5021), oxaliplatin was administered to 43 pediatric patients with recurrent or refractory embryonal CNS tumors. The most common adverse r…

🤰 Pregnancy 179 words ▾

8.1Pregnancy Risk Summary Based on its direct interaction with DNA, Oxaliplatin can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of Oxaliplatin. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see Data ) .

Advise a pregnant woman 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 Pregnant rats were administered oxaliplatin at less than one-tenth the recommended human dose based on body surface area during gestation days (GD)1–5 (preimplantation), GD 6–10, or GD 11–16 (during organogenesis).

Oxaliplatin caused developmental mortality (increased early resorptions) when administered on days GD 6–10 and GD 11–16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days GD 6–10.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of oxaliplatin in pediatrics have not been established. Safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors. In a multicenter, open-label, non-comparative, non-randomized study (ARD5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma.

The dose limiting toxicity (DLT) was sensory neuropathy at a dose of 110 mg/m 2 . The main adverse reactions were: paresthesia (60%, grade 3–4: 7%), fever (40%, grade 3–4: 7%), and thrombocytopenia (40%, grade 3–4: 27%). No responses were observed.

In an open-label non-randomized study (DFI7434), oxaliplatin was administered to 26 pediatric patients with metastatic or unresectable solid tumors, mainly neuroblastoma and ganglioneuroblastoma. The DLT was sensory neuropathy at a dose of 160 mg/m 2 . No responses were observed.

In an open-label, single-agent study (ARD5021), oxaliplatin was administered to 43 pediatric patients with recurrent or refractory embryonal CNS tumors. The most common adverse reactions reported were: leukopenia (67%, grade 3–4: 12%), anemia (65%, grade 3–4: 5%), thrombocytopenia (65%, grade 3–4: 26%), vomiting (65%, grade 3–4: 7%), neutropenia (58%, grade 3–4: 16%), and sensory neuropathy (40%, grade 3–4: 5%). In an open-label single-agent study (ARD5530), oxaliplatin was administered to 123 pediatric patients with recurrent solid tumors, including neuroblastoma, osteosarcoma, Ewing sarcoma or peripheral PNET, ependymoma, rhabdomyosarcoma, hepatoblastoma, high grade astrocytoma, brain stem glioma, low grade astrocytoma, malignant germ cell tumor and other tumors.

The most common adverse reactions reported were: sensory neuropathy (52%, grade 3–4: 12%), thrombocytopenia (37%, grade 3–4: 17%), anemia (37%, grade 3–4: 9%), vomiting (26%, grade 3–4: 4%), increased ALT (24%, grade 3–4: 6%), increased AST (24%, grade 3–4: 2%), and nausea (23%, grade 3–4: 3%). The pharmacokinetic parameters of ultrafiltrable platinum were evaluated in 105 pediatric patients during the first cycle. The mean clearance in pediatric patients estimated by the population pharmacokinetic analysis was

4.7L/h (%CV, 41%). Mean platinum pharmacokinetic parameters in ultrafiltrate were C max of 0.75 ± 0.24 mcg/mL, AUC 0–48h of 7.52 ± 5.07 mcg∙h/mL and AUC inf of 8.83 ± 1.57 mcg∙h/mL at 85 mg/m 2 of oxaliplatin and C max of 1.10 ± 0.43 mcg/mL, AUC 0–48h of 9.74 ± 2.52 mcg∙h/mL and AUC inf of 17.3 ± 5.34 mcg∙h/mL at 130 mg/m 2 of oxaliplatin.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use In the adjuvant treatment trial [see Clinical Studies (14.1) ] , 400 patients who received Oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years. The effect of Oxaliplatin in patients greater than or equal to 65 years was not conclusive. Patients greater than or equal to 65 years receiving Oxaliplatin experienced more diarrhea and grade 3–4 neutropenia (45% vs 39%) compared to patients less than 65 years.

In the previously untreated advanced colorectal cancer trial [see Clinical Studies (14.2) ] , 99 patients who received Oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. The same efficacy improvements in response rate, time to tumor progression, and overall survival were observed in the greater than or equal to 65 years patients as in the overall study population. Adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope.

In the previously treated advanced colorectal cancer trial [see Clinical Studies (14.3) ] , 55 patients who received Oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. No overall differences in effectiveness were observed between these patients and younger adults. Adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, and fatigue.

No significant effect of age on the clearance of ultrafiltrable platinum has been observed [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 102 words ▾

10 OVERDOSAGE The maximum dose of oxaliplatin that has been administered in a single infusion is 825 mg. Several cases of overdoses have been reported with Oxaliplatin. Adverse reactions observed following an overdosage were grade 4 thrombocytopenia (less than 25,000/mm 3 ) without bleeding, anemia, sensory neuropathy (including paresthesia, dysesthesia, laryngospasm and facial muscle spasms), gastrointestinal disorders (including nausea, vomiting, stomatitis, flatulence, abdomen enlarged and grade 4 intestinal obstruction), grade 4 dehydration, dyspnea, wheezing, chest pain, respiratory failure, severe bradycardia, and death.

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive species are formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules. Both inter- and intrastrand Pt-DNA crosslinks are formed.

Crosslinks are formed between the N7 positions of two adjacent guanines (GG), adjacent adenine-guanines (AG), and guanines separated by an intervening nucleotide (GNG). These crosslinks inhibit DNA replication and transcription. Cytotoxicity is cell-cycle nonspecific.

In vivo studies have shown antitumor activity of oxaliplatin against colon carcinoma. In combination with fluorouracil, oxaliplatin exhibits in vitro and in vivo antiproliferative activity greater than either compound alone in several tumor models (HT29 [colon], GR [mammary], and L1210 [leukemia]).

12.2Pharmacodynamics A pharmacodynamic relationship between platinum ultrafiltrate levels and clinical safety and effectiveness has not been established.

12.3Pharmacokinetics The reactive oxaliplatin derivatives are present as a fraction of the unbound platinum in plasma ultrafiltrate. After a single 2-hour intravenous infusion of Oxaliplatin at a dose of 85 mg/m 2 , pharmacokinetic parameters expressed as ultrafiltrable platinum were C max of 0.814 mcg/mL and volume of distribution of 440 L. Interpatient and intrapatient variability in ultrafiltrable platinum exposure (AUC 0–48hr ) assessed over 3 cycles was 23% and 6%, respectively.

Distribution At the end of a 2-hour infusion of Oxaliplatin, approximately 15% of the administered platinum is present in the systemic circulation. The remaining 85% is rapidly distributed into tissues or eliminated in the urine. The decline of ultrafiltrable platinum levels following Oxaliplatin administration is triphasic, including two distribution phases (t ½α ; 0.43 hours and t ½β ; 16.8 hours).

In patients, plasma protein binding of platinum is irreversible and is greater than 90%. The main binding proteins are albumin and gamma-globulins. Platinum also binds irreversibly and accumulates (approximately 2-fold) in erythrocytes, where it appears to have no relevant activity.

No platinum accumulation was observed in plasma ultrafiltrate following 85 mg/m 2 every two weeks. Elimination The decline of ultrafiltrable platinum concentrations from plasma is characterized by a long terminal elimination phase (t ½γ ; 391 hour). Metabolism Oxaliplatin undergoes rapid and extensive nonenzymatic biotransformation.

There is no evidence of cytochrome P450-mediated metabolism in vitro. Up to 17 platinum-containing derivatives have been observed in plasma ultrafiltrate samples from patients, including several cytotoxic species (monochloro DACH platinum, dichloro DACH platinum, and monoaquo and diaquo DACH platinum) and a number of noncytotoxic, conjugated species. Excretion The major route of platinum elimination is renal excretion.

At five days after a single 2-hour infusion of Oxaliplatin, urinary elimination accounted for about 54% of the platinum eliminated, with fecal excretion accounting for only about 2%. Platinum was cleared from plasma at a rate (10–17 L/h) that was similar to or exceeded the average human glomerular filtration rate (GFR;

7.5L/h). The renal clearance of ultrafiltrable platinum is significantly correlated with GFR. Special Populations Sex There was no significant effect of sex on the clearance of ultrafiltrable platinum.

Patients with renal impairment Patients with normal function (CL cr greater than 80 mL/min) and patients with mild (CL cr =50–80 mL/min) and moderate (CL cr equal to 30–49 mL/min) renal impairment received Oxaliplatin 85 mg/m 2 and those with severe (CL cr less than 30 mL/min) renal impairment received Oxaliplatin 65 mg/m 2 . Mean dose adjusted AUC of unbound platinum was 40%, 95%, and 342% higher for patients with mild, moderate…

🧬 Mechanism of Action 121 words ▾

12.1Mechanism of Action Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive species are formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules. Both inter- and intrastrand Pt-DNA crosslinks are formed.

Crosslinks are formed between the N7 positions of two adjacent guanines (GG), adjacent adenine-guanines (AG), and guanines separated by an intervening nucleotide (GNG). These crosslinks inhibit DNA replication and transcription. Cytotoxicity is cell-cycle nonspecific.

In vivo studies have shown antitumor activity of oxaliplatin against colon carcinoma. In combination with fluorouracil, oxaliplatin exhibits in vitro and in vivo antiproliferative activity greater than either compound alone in several tumor models (HT29 [colon], GR [mammary], and L1210 [leukemia]).

📦 How Supplied / Storage and Handling 175 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Concentrate for solution for infusion: Oxaliplatin Injection, USP is supplied in clear, glass, single-dose vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free aqueous solution at a concentration of 5 mg/mL. Tartaric Acid, NF, Water for Injection, USP and Sodium Hydroxide, NF are used as inactive ingredients and/or in combination as a buffering system. Unit of Sale Concentration NDC 61703-363-18 50 mg/10 mL Carton containing 1 Single-dose vial (5 mg/mL) NDC 61703-363-22 100 mg/20 mL Carton containing 1 Single-dose vial (5 mg/mL) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].

Do not freeze and protect from light (keep in original outer carton). Discard unused portion. Oxaliplatin is a cytotoxic drug.

Follow applicable special handling and disposal procedures. 1 The use of gloves is recommended. If a solution of Oxaliplatin contacts the skin, wash the skin immediately and thoroughly with soap and water.

If Oxaliplatin contacts the mucous membranes, flush thoroughly with water.

📦 Storage and Handling 84 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Do not freeze and protect from light (keep in original outer carton). Discard unused portion.

Oxaliplatin is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 The use of gloves is recommended.

If a solution of Oxaliplatin contacts the skin, wash the skin immediately and thoroughly with soap and water. If Oxaliplatin contacts the mucous membranes, flush thoroughly with water.

📋 Description 155 words ▾

11 DESCRIPTION Oxaliplatin Injection, USP is a platinum-based drug with the molecular formula C 8 H 14 N 2 O 4 Pt and the chemical name of cis -[(1 R ,2 R )-1,2-cyclohexanediamine- N , N '] [oxalato(2-)- O , O '] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3.

Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution for intravenous use after dilution. Each mL contains 5 mg of Oxaliplatin with 0.03 mg Tartaric Acid, NF and 0.0123 mg Sodium Hydroxide, NF used in combination as a buffering system and Water for Injection, USP.

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise patients of the potential risk of hypersensitivity and that Oxaliplatin is contraindicated in patients with a history of hypersensitivity reactions to oxaliplatin and other platinum-based drugs. Instruct patients to seek immediate medical attention for signs of severe hypersensitivity reaction such as chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips [see Warnings and Precautions (5.1) ] .

Peripheral Sensory Neuropathy Advise patients of the risk of acute reversible or persistent-type neurosensory toxicity. Advise patients to avoid cold drinks, use of ice, and exposure of skin to cold temperature or cold objects [see Warnings and Precautions (5.2) ] . Myelosuppression Inform patients that Oxaliplatin can cause low blood cell counts and the need for frequent monitoring of blood cell counts.

Advise patients to contact their healthcare provider immediately for bleeding, fever, particularly if associated with persistent diarrhea, or symptoms of infection develop [see Warnings and Precautions (5.3) ] . Posterior Reversible Encephalopathy Syndrome Advise patients of the potential effects of vision abnormalities, in particular transient vision loss (reversible following therapy discontinuation), which may affect the patients' ability to drive and use machines [see Warnings and Precautions (5.4) ] . Pulmonary Toxicity Advise patients to report immediately to their healthcare provider any persistent or recurrent respiratory symptoms, such as non-productive cough and dyspnea [see Warnings and Precautions (5.5) ] .

Hepatotoxicity Advise patients to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions (5.6) ] . QT Interval Prolongation Advise patients that Oxaliplatin can cause QTc interval prolongation and to inform their physician if they have any symptoms, such as syncope [see Warnings and Precautions (5.7) ] . Rhabdomyolysis Advise patients to contact their healthcare provider immediately for new or worsening signs or symptoms of muscle toxicity, dark urine, decreased urine output, or the inability to urinate [see Warnings and Precautions (5.8) ] .

Hemorrhage Advise patients that Oxaliplatin may increase the risk of bleeding and to promptly inform their healthcare provider of any bleeding episodes [see Warnings and Precautions (5.9) ] . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1) ] .

Advise females of reproductive potential to use effective contraception during treatment with Oxaliplatin and for 9 months after the final dose [see Use in Specific Populations (8.3) ] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Oxaliplatin and for 6 months after the final dose [see Use in Specific Populations (8.3) , Nonclinical Toxicology (13.1) ] . Lactation Advise women not to breastfeed during treatment with Oxaliplatin and for 3 months after the final dose [see Use in Specific Populations (8.2) ] .

Infertility Advise females and males of reproductive potential that Oxaliplatin may impair fertility [see Use in Specific Populations (8.3) , Nonclinical Toxicology (13.1) ] . Gastrointestinal Advise patients to contact their healthcare provider for persistent vomiting, diarrhea, or signs of dehydration [see Adverse Reactions (6.1) ] . Drug Interactions Inform patients about the risk of drug interactions and the importance of providing a list of prescription and nonprescription drugs to their healthcare provider [see Drug Interactions (7) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61703-0360-18 · Hospira, 61703-0408-25 · Hospira, →
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.