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oxaliplatin (Rx)Brand and Other Names:Eloxatin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injectable solution

  • 50mg/vial
  • 100mg/vial
  • 200mg/vial
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Advanced Colorectal Cancer

Day 1: Oxaliplatin 85 mg/m² IV + leucovorin 200 mg/m² IV infused over 2 hr, THEN 

5-FU 400 mg/m² IV bolus over 2-4 minutes, THEN

5-FU 600 mg/m² IV infusion in D5W (500 mL) over 22 hr

Day 2: Same regimen WITHOUT oxaliplatin

Repeat every 2 weeks

Adjuvant Treatment in Stage III Colon Cancer

12 cycles, every 2 weeks, according to the dose schedule above, for a total of 6 months

Adjuvant use follows tumor resection

Ovarian Cancer (Orphan)

Orphan indication sponsor

  • Debio Pharm S.A.; Rue des Terreaux 17 CH-1000; Switzerland

Dose Modification

If persistent Grade 2 neuropathy, decrease dose to 75 mg/m² 

If persistent Grade 3 neuropathy, consider discontinuing oxaliplatin

After recovery from grade 3/4 GI or grade 3/4 hematological toxicity: Decrease dose to 75 mg/m² , AND decrease 5-FU by 20% (300 mg/m² bolus, 500 mg/m² infusion)

Renal Impairment

Exposure of unbound platinum tends to increase in renally impaired patients

Mild (CrCl 50-80 mL/min): No dosage adjustment required

Moderate (CrCl 30-49 mL/min): No dosage adjustment required

Severe (CrCl <30 mL/min): Reduce starting dose

Safety and efficacy not established

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Interactions

Interaction Checker

oxaliplatin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Peripheral neuropathy (76%)

            Anemia (64%)

            Nausea (64%)

            Fatigue (61%)

            Diarrhea (46%)

            Vomiting (37%)

            Abdominal pain (31%)

            Constipation (31%)

            Thrombocytopenia (30%)

            Fever (25%)

            Anorexia (20%)

            Leukopenia (13%)

            Dyspnea (13%)

            Cough (11%)

            1-10%

            Edema (10%)

            Neutropenia (7%)

            Pharyngolaryngeal dysesthesia (1-2%)

            <1%

            Pulmonary fibrosis

            Posterior leukoencephalopathy syndrome

            Frequency Not Defined

            Anaphylactic-like reaction (uncommon)

            Pulmonary fibrosis (uncommon)

            Postmarketing Reports

            Body as a whole: Angioedema, anaphylactic shock

            Central and peripheral nervous system disorders: Loss of deep tendon reflexes, dysarthria, Lhermitte’s sign, cranial nerve palsies, fasciculations, convulsion, RPLS

            Hearing and vestibular system disorders: Deafness

            Infusion reactions/hypersensitivity: Laryngospasm

            Liver and gastrointestinal system disorders: Severe diarrhea/vomiting resulting in hypokalemia, colitis (including Clostridium difficile diarrhea), metabolic acidosis; ileus; intestinal obstruction, pancreatitis; veno-occlusive disease of liver (ie, sinusoidal obstruction syndrome), perisinusoidal fibrosis which rarely may progress

            Platelet, bleeding, and clotting disorders: immuno-allergic thrombocytopenia prolongation of prothrombin time and of INR in patients receiving anticoagulants

            Red blood cell disorders: Hemolytic uremic syndrome, immuno-allergic hemolytic anemia

            Renal disorders: Acute tubular necrosis, acute interstitial nephritis, acute renal failure

            Respiratory system disorders: Pulmonary fibrosis, and other interstitial lung diseases (sometimes fatal)

            Cardiovascular toxicity

            Rhabdomyolysis

            Septic shock

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to diagnose and manage complications

            Anaphylactic-like reactions have been reported and may occur within minutes of administration. Epinephrine, corticosteroids, and antihistamines have been used to treat these symptoms

            Contraindications

            Hypersensitivity to oxaliplatin, other platinum compounds

            Pregnancy

            Cautions

            Caution in renal impairment, elderly, neuropathy, neurotoxic agents

            For 3-4 days, avoid contact with ice/cold food/objects, avoid breathing cold air

            Avoid contact with aluminum needles or equipment

            Avoid pregnancy

            Pulmonary fibrosis may occur

            Concomitant use with fluorouracil may increase gastrointestinal effects

            Grade 3 or 4 neutropenia reported in patients with colorectal cancer treated in combination with 5-flurouracil (5-FU) and leucovorin; delay oxaliplatin therapy until neutrophils are at 1.5 x 10^9/L; withhold oxaliplatin for sepsis or septic shock; reduce dose after recovery from Grade 4 neutropenia or febrile neutropenia

            Cardiovascular toxicity reported; ECG monitoring recommended if therapy initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities; correct hypokalemia or hypomagnesemia prior to initiating oxaliplatin and monitor these electrolytes periodically during therapy; avoid oxaliplatin in patients with congenital long QT syndrome

            Reversible posterior leukoencephalopathy syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) reported in clinical trials and postmarketing experience

            Rhabdomyolysis, including fatal cases reported; discontinue oxaliplatin if any signs or symptoms of rhabdomyolysis occur

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Platinum coordination compound that inhibits DNA synthesis; cross-links and denatures strands of DNA; disrupts DNA function by covalently binding to DNA bases

            Pharmacokinetics

            Peak plasma time: 2 hr

            Concentration: 1.21 mcg/mL

            Protein bound: >90%; platinum accumulates in RBCs

            Vd: 440 L

            Half-life: 391 hr

            Clearance: 10.1 L/hr

            Excretion: Urine (54%); feces (2%)

            Dialyzable: no

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            Administration

            IV Incompatibilities

            Alkaline medications or media (eg, basic solutions of 5-FU)

            IV Preparation

            Reconstitute by adding 10 mL (for 50 mg vial) or 20 mL (for 100 mg vial) of SWI or D5W. Dilute required amount of reconstituted solution in an infusion solution of 250-500 mL of D5W. Do NOT use NS or chloride-containing solutions

            Reconstituted solution may be refrigerated up to 24 hr at 2-8°C (36-46°F). After final dilution with 250-500 mL D5W, the shelf life is 6 hr at room temp [20-25°C (68-77°F)] or up to 24 hr under refrigeration at 2-8°C (36-46°F)

            Eloxatin is not light sensitive

            Do not use aluminum-containing needles or IV administration sets that may come in contact with carboplatin (aluminum can react causing precipitate formation and loss of potency)

            IV Administration

            Flush infusion line with D5W prior to administration of oxaliplatin or any concomitant drug

            Inspect visually for particulate matter and discoloration prior to administration and discard if present

            Use separate bags for oxaliplatin and leucovorin (administered through Y-site)

            See adult dosing for infusion and bolus rate

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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