• Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor (in combination with 5-fluorouracil and leucovorin).
• Advanced colorectal cancer (in combination with 5-fluorouracil and leucovorin)

Unlabeled Use:

• Ovarian cancer that has progressed despite treatment with other agents.

Contraindicated in:

• Hypersensitivity
• Hypersensitivity to other platinum compounds
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment
• HF, bradycardia, concomitant use of QT interval prolonging medications, hypokalemia, and hypomagnesemia
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: ↑ risk of adverse reactions in older adults.

Adverse reactions are noted for the combination of oxaliplatin, 5-fluorouracil and leucovorin

CV: QT interval prolongation, chest pain, edema, thromboembolism, TORSADES DE POINTES.

EENT: visual abnormalities.

F and E: dehydration, hypokalemia.

GI: diarrhea, nausea, vomiting, abdominal pain, anorexia, gastroesophageal reflux, stomatitis.

Hemat: anemia, neutropenia, thrombocytopenia, leukopenia.

Local: injection site reactions.

MS: rhabdomyolysis, back pain.

Neuro: fatigue, neurotoxicity, REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME.

Resp: cough, dyspnea, PULMONARY FIBROSIS.

Misc: ANAPHYLAXIS/ANAPHYLACTOID REACTIONS, fever.

Drug-Drug:

• Concurrent use of nephrotoxic agents may ↑ toxicity.
• Concurrent use of QT interval prolonging medications, including Class Ia antiarrhythmics and Class III antiarrhythimics may ↑ risk of torsades de pointes.

(Generic available)

• Lyophilized powder for injection: 50 mg/vial; 100 mg/vial;
• Solution for injection: 5 mg/mL;

• IV (Adults): Day 1: 85 mg/m² with leucovorin 200 mg/m² at the same time over 2 hr, followed by 5-fluorouracil 400 mg/m² bolus over 2–4 min, then 5-fluorouracil 600 mg/m² as a 22-hr infusion. Day 2: leucovorin 200 mg/m² over 2 hr, followed by 5-fluorouracil 400 mg/m² bolus over 2–4 min, then 5-fluorouracil 600 mg/m² as a 22-hr infusion. Cycle is repeated every 2 wk. Dosage reduction/alteration may be required for neurotoxicity or other serious adverse effects.

Eloxatin

• Inhibits DNA replication and transcription by incorporating platinum into normal cross-linking (cell-cycle nonspecific).

• Death of rapidly replicating cells, particularly malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: alkylating agents

Absorption: IV administration results in complete bioavailability.

Distribution: Extensive tissue distribution.

Protein Binding: >90% (platinum).

Metabolism/Excretion: Undergoes rapid and extensive nonenzymatic biotransformation; excreted mostly by the kidneys.

Half-life: 391 hrs.

• Explain purpose of oxaliplatin to patient. Advise patient to read Patient Information before starting therapy and periodically during therapy in case of changes.
• Inform patients and caregivers of potential for peripheral neuropathy and potentiation by exposure to cold or cold objects. Advise patient to avoid cold drinks, use of ice in drinks or as ice packs, and to cover exposed skin prior to exposure to cold temperature or cold objects. Caution patients to cover themselves with a blanket during infusion, do not breathe deeply when exposed to cold air, wear warm clothing, and cover mouth and nose with a scarf or pull-down ski cap to warm the air that goes to their lungs, do not take things from the freezer or refrigerator without wearing gloves, drink fluids warm or at room temperature, always drink through a straw, do not use ice chips for nausea, be aware that most metals (car doors, mailbox) are cold; wear gloves to touch, do not run air conditioning at high levels in house or car, if hands get cold wash them with warm water. Advise health care professional of how you did since last treatment before next infusion.
• Instruct patient to notify health care professional immediately if signs of reversible posterior leukoencephalopathy syndrome, low blood cell counts (fever, persistent diarrhea, infection) or if persistent vomiting, signs of dehydration, cough or breathing difficulty, thirst, dry mouth, dizziness, decreased urination, signs of infection (fever, temperature of ≥100.5° F, cough that brings up mucus, chills or shivering, burning or pain on urination, pain on swallowing, sore throat, redness or swelling at intravenous site) or signs of allergic reactions occur.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during therapy and for at least 9 mo after final dose and to avoid breast feeding during and for 3 mo after final dose. Advise males with female partners of reproductive potential to use effective contraception for 6 mo after final dose. May impair female and male fertility.

ox-A-li-pla-tin

NDC Code^*

• 0703- Teva Parenteral Medicines, Inc.
  • 0703-3985- Oxaliplatin
    • 0703-3985-01- 1 VIAL, SINGLE-USE in 1 CARTON (0703-3985-01) > 10 mL in 1 VIAL, SINGLE-USE

• 0703- Teva Parenteral Medicines, Inc.
  • 0703-3986- Oxaliplatin
    • 0703-3986-01- 1 VIAL, SINGLE-USE in 1 CARTON (0703-3986-01) > 20 mL in 1 VIAL, SINGLE-USE

• 0781- Sandoz Inc
  • 0781-3315- Oxaliplatin
    • 0781-3315-70- 1 VIAL, SINGLE-USE in 1 CARTON (0781-3315-70) > 10 mL in 1 VIAL, SINGLE-USE

• 0781- Sandoz Inc
  • 0781-3317- Oxaliplatin
    • 0781-3317-80- 1 VIAL, SINGLE-USE in 1 CARTON (0781-3317-80) > 20 mL in 1 VIAL, SINGLE-USE

• 0781- Sandoz Inc
  • 0781-9315- Oxaliplatin
    • 0781-9315-70- 1 VIAL, SINGLE-USE in 1 CARTON (0781-9315-70) > 10 mL in 1 VIAL, SINGLE-USE

• 0781- Sandoz Inc
  • 0781-9317- Oxaliplatin
    • 0781-9317-80- 1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80) > 20 mL in 1 VIAL, SINGLE-USE

• 0955- Winthrop U.S.
  • 0955-1725- OXALIPLATIN
    • 0955-1725-10- 1 VIAL, GLASS in 1 CARTON (0955-1725-10) > 10 mL in 1 VIAL, GLASS

• 0955- Winthrop U.S.
  • 0955-1727- OXALIPLATIN
    • 0955-1727-20- 1 VIAL, GLASS in 1 CARTON (0955-1727-20) > 20 mL in 1 VIAL, GLASS

• 0955- Winthrop U.S.
  • 0955-1731- OXALIPLATIN
    • 0955-1731-10- 1 VIAL, GLASS in 1 CARTON (0955-1731-10) > 10 mL in 1 VIAL, GLASS

• 0955- Winthrop U.S.
  • 0955-1733- OXALIPLATIN
    • 0955-1733-20- 1 VIAL, GLASS in 1 CARTON (0955-1733-20) > 20 mL in 1 VIAL, GLASS

• 16714- NorthStar RxLLC
  • 16714-727- oxaliplatin
    • 16714-727-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-727-01) > 10 mL in 1 VIAL, SINGLE-DOSE

• 16714- NorthStar RxLLC
  • 16714-728- oxaliplatin
    • 16714-728-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-728-01) > 20 mL in 1 VIAL, SINGLE-DOSE

• 16729- Accord Healthcare Inc.
  • 16729-332- OXALIPLATIN
    • 16729-332-03- 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03) > 10 mL in 1 VIAL, SINGLE-DOSE

• 16729- Accord Healthcare Inc.
  • 16729-332- OXALIPLATIN
    • 16729-332-05- 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-05) > 20 mL in 1 VIAL, SINGLE-DOSE

• 25021- Sagent Pharmaceuticals
  • 25021-233- oxaliplatin
    • 25021-233-10- 1 VIAL in 1 CARTON (25021-233-10) > 10 mL in 1 VIAL

• 25021- Sagent Pharmaceuticals
  • 25021-233- oxaliplatin
    • 25021-233-20- 1 VIAL in 1 CARTON (25021-233-20) > 20 mL in 1 VIAL

• 43066- Baxter Healthcare Corporation
  • 43066-014- Oxaliplatin
    • 43066-014-01- 1 VIAL, SINGLE-USE in 1 CARTON (43066-014-01) > 10 mL in 1 VIAL, SINGLE-USE

• 43066- Baxter Healthcare Corporation
  • 43066-018- Oxaliplatin
    • 43066-018-01- 1 VIAL, SINGLE-USE in 1 CARTON (43066-018-01) > 20 mL in 1 VIAL, SINGLE-USE

• 45963- Actavis Pharma, Inc.
  • 45963-611- Oxaliplatin
    • 45963-611-53- 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE

• 45963- Actavis Pharma, Inc.
  • 45963-611- Oxaliplatin
    • 45963-611-59- 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-59) > 20 mL in 1 VIAL, SINGLE-DOSE

• 45963- Actavis Pharma, Inc.
  • 45963-637- Oxaliplatin
    • 45963-637-49- 1 VIAL, SINGLE-USE in 1 CARTON (45963-637-49) > 10 mL in 1 VIAL, SINGLE-USE

• 45963- Actavis Pharma, Inc.
  • 45963-638- Oxaliplatin
    • 45963-638-58- 1 VIAL, SINGLE-USE in 1 CARTON (45963-638-58) > 20 mL in 1 VIAL, SINGLE-USE

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-046- Oxaliplatin
    • 47335-046-40- 1 VIAL, SINGLE-USE in 1 CARTON (47335-046-40) > 10 mL in 1 VIAL, SINGLE-USE

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-047- Oxaliplatin
    • 47335-047-40- 1 VIAL, SINGLE-USE in 1 CARTON (47335-047-40) > 20 mL in 1 VIAL, SINGLE-USE

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-176- Oxaliplatin
    • 47335-176-40- 1 VIAL, SINGLE-USE in 1 CARTON (47335-176-40) > 10 mL in 1 VIAL, SINGLE-USE

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-178- Oxaliplatin
    • 47335-178-40- 1 VIAL, SINGLE-USE in 1 CARTON (47335-178-40) > 20 mL in 1 VIAL, SINGLE-USE

• 50742- Ingenus Pharmaceuticals, LLC
  • 50742-405- Oxaliplatin
    • 50742-405-10- 1 VIAL, SINGLE-USE in 1 CARTON (50742-405-10) > 10 mL in 1 VIAL, SINGLE-USE

• 50742- Ingenus Pharmaceuticals, LLC
  • 50742-406- Oxaliplatin
    • 50742-406-20- 1 VIAL, SINGLE-USE in 1 CARTON (50742-406-20) > 20 mL in 1 VIAL, SINGLE-USE

• 51991- Breckenridge Pharmaceutical, Inc.
  • 51991-218- Oxaliplatin
    • 51991-218-98- 1 VIAL, SINGLE-DOSE in 1 CARTON (51991-218-98) > 10 mL in 1 VIAL, SINGLE-DOSE

• 51991- Breckenridge Pharmaceutical, Inc.
  • 51991-219- Oxaliplatin
    • 51991-219-98- 1 VIAL, SINGLE-DOSE in 1 CARTON (51991-219-98) > 20 mL in 1 VIAL, SINGLE-DOSE

• 55150- AuroMedics Pharma LLC
  • 55150-331- Oxaliplatin
    • 55150-331-01- 1 VIAL in 1 CARTON (55150-331-01) > 10 mL in 1 VIAL

• 55150- AuroMedics Pharma LLC
  • 55150-332- Oxaliplatin
    • 55150-332-01- 1 VIAL in 1 CARTON (55150-332-01) > 20 mL in 1 VIAL

• 60505- Apotex Corp.
  • 60505-6132- oxaliplatin
    • 60505-6132-6- 1 VIAL in 1 CARTON (60505-6132-6) > 10 mL in 1 VIAL

• 60505- Apotex Corp.
  • 60505-6132- oxaliplatin
    • 60505-6132-7- 1 VIAL in 1 CARTON (60505-6132-7) > 20 mL in 1 VIAL

• 61703- Hospira, Inc.
  • 61703-363- Oxaliplatin
    • 61703-363-18- 1 VIAL, SINGLE-USE in 1 CARTON (61703-363-18) > 10 mL in 1 VIAL, SINGLE-USE

• 61703- Hospira, Inc.
  • 61703-363- Oxaliplatin
    • 61703-363-22- 1 VIAL, SINGLE-USE in 1 CARTON (61703-363-22) > 20 mL in 1 VIAL, SINGLE-USE

• 63323- Fresenius Kabi USA, LLC
  • 63323-750- Oxaliplatin
    • 63323-750-10- 1 VIAL in 1 BOX (63323-750-10) > 10 mL in 1 VIAL

• 63323- Fresenius Kabi USA, LLC
  • 63323-750- Oxaliplatin
    • 63323-750-20- 1 VIAL in 1 BOX (63323-750-20) > 20 mL in 1 VIAL

• 67184- Qilu Pharmaceutical Co., Ltd.
  • 67184-0508- Oxaliplatin
    • 67184-0508-1- 1 VIAL, SINGLE-USE in 1 CARTON (67184-0508-1) > 10 mL in 1 VIAL, SINGLE-USE

• 67184- Qilu Pharmaceutical Co., Ltd.
  • 67184-0509- Oxaliplatin
    • 67184-0509-1- 1 VIAL, SINGLE-USE in 1 CARTON (67184-0509-1) > 20 mL in 1 VIAL, SINGLE-USE

• 67184- Qilu Pharmaceutical Co., Ltd.
  • 67184-0510- Oxaliplatin
    • 67184-0510-1- 1 VIAL, SINGLE-USE in 1 CARTON (67184-0510-1) > 40 mL in 1 VIAL, SINGLE-USE

• 67457- Mylan Institutional LLC
  • 67457-442- Oxaliplatin
    • 67457-442-20- 1 VIAL in 1 CARTON (67457-442-20) > 20 mL in 1 VIAL

• 67457- Mylan Institutional LLC
  • 67457-469- Oxaliplatin
    • 67457-469-10- 1 VIAL in 1 CARTON (67457-469-10) > 10 mL in 1 VIAL

• 68001- BluePoint Laboratories
  • 68001-341- oxaliplatin
    • 68001-341-36- 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-341-36) > 10 mL in 1 VIAL, SINGLE-DOSE (68001-341-28)

• 68001- BluePoint Laboratories
  • 68001-341- oxaliplatin
    • 68001-341-37- 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-341-37) > 20 mL in 1 VIAL, SINGLE-DOSE (68001-341-29)

• 68083- Gland Pharma Limited
  • 68083-170- Oxaliplatin
    • 68083-170-01- 10 mL in 1 VIAL (68083-170-01)

• 68083- Gland Pharma Limited
  • 68083-171- Oxaliplatin
    • 68083-171-01- 20 mL in 1 VIAL (68083-171-01)

• 68083- Gland Pharma Limited
  • 68083-176- Oxaliplatin
    • 68083-176-01- 1 VIAL, SINGLE-USE in 1 CARTON (68083-176-01) > 10 mL in 1 VIAL, SINGLE-USE

• 68083- Gland Pharma Limited
  • 68083-177- Oxaliplatin
    • 68083-177-01- 1 VIAL, SINGLE-USE in 1 CARTON (68083-177-01) > 20 mL in 1 VIAL, SINGLE-USE

• 68083- Gland Pharma Limited
  • 68083-314- Oxaliplatin
    • 68083-314-01- 1 VIAL, SINGLE-USE in 1 CARTON (68083-314-01) > 40 mL in 1 VIAL, SINGLE-USE

• 69097- Cipla USA Inc.
  • 69097-274- oxaliplatin
    • 69097-274-37- 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-274-37) > 10 mL in 1 VIAL, SINGLE-DOSE

• 69097- Cipla USA Inc.
  • 69097-353- oxaliplatin
    • 69097-353-78- 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-353-78) > 20 mL in 1 VIAL, SINGLE-DOSE

• 70860- Athenex Pharmaceutical Division, LLC.
  • 70860-201- Oxaliplatin
    • 70860-201-10- 1 VIAL in 1 CARTON (70860-201-10) > 10 mL in 1 VIAL

• 70860- Athenex Pharmaceutical Division, LLC.
  • 70860-201- Oxaliplatin
    • 70860-201-20- 1 VIAL in 1 CARTON (70860-201-20) > 20 mL in 1 VIAL

• 71288- Meitheal Pharmaceuticals Inc.
  • 71288-101- Oxaliplatin
    • 71288-101-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-101-10) > 10 mL in 1 VIAL, SINGLE-DOSE

• 71288- Meitheal Pharmaceuticals Inc.
  • 71288-101- Oxaliplatin
    • 71288-101-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-101-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• 72266- Fosun Pharma USA Inc.
  • 72266-125- Oxaliplatin
    • 72266-125-10- 10 CARTON in 1 BOX (72266-125-10) > 1 VIAL, SINGLE-USE in 1 CARTON (72266-125-01) > 10 mL in 1 VIAL, SINGLE-USE

• 72266- Fosun Pharma USA Inc.
  • 72266-126- Oxaliplatin
    • 72266-126-10- 10 CARTON in 1 BOX (72266-126-10) > 1 VIAL, SINGLE-USE in 1 CARTON (72266-126-01) > 20 mL in 1 VIAL, SINGLE-USE

• 72603- NorthStar Rx LLC
  • 72603-101- Oxaliplatin
    • 72603-101-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-101-01) > 20 mL in 1 VIAL, SINGLE-DOSE

• 72603- NorthStar Rx LLC
  • 72603-301- Oxaliplatin
    • 72603-301-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-301-01) > 10 mL in 1 VIAL, SINGLE-DOSE