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ixabepilone (Rx)Brand and Other Names:Ixempra

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 15mg/vial
  • 45mg/vial
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Breast Cancer

Metastatic or locally advanced

After failure to anthracyclines

40 mg/m² IV infusion over 3 hr q3week; not to exceed 88 mg/dose 

Monitor: CBC, LFTs

Premedication

Give H1-blocker and H2-blocker 1 hour prior to infusion

If patient had hypersensitivity to drug in prior infusion, also premedicate with corticosteroid

Concomitant CYP3A4

Consider dose reduction to 20 mg/m² 

Increase dose 1 week after inhibitor discontinuation

Hepatic Impairment

AST/ALT <2.5 times upper limit of normal and Bilirubin < 1 time upper limit of normal: 40 mg/m²

AST/ALT <10 times upper limit of normal and Bilirubin < 1.5 times upper limit of normal: 32 mg/m²

AST/ALT <10 times upper limit of normal and Bilirubin 1.5-3 times upper limit of normal: 20-30 mg/m²

Do NOT use with capecitabine if AST/ALT >2.5 times upper limit of normal or bilirubin >1 time upper limit of normal

Monotherapy not recommended if AST/ALT >10 times upper limit of normal or bili >3 times upper limit of normal

Safety and efficacy not established

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Interactions

Interaction Checker

ixabepilone 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%

            Fatigue (63%)

            Asthenia (63%)

            Neuropathy (63%)

            Leukopenia (49%)

            Alopecia (48%)

            Nausea (42%)

            Stomatitis (29%)

            Vomiting (29%)

            Diarrhea (22%)

            Myalgia (20%)

            Arthralgia (20%)

            Inflammatory disease of mucous membrane (19%)

            Anorexia (19%)

            Constipation (16%)

            Abdominal pain (13%)

            Dysgeusia

            Mucositis

            1-10%

            Nail changes (9%)

            Hand-foot syndrome (8%)

            Neutropenia (3%)

            Anemia

            Dizziness

            Dyspnea

            Edema

            Gastroesophageal reflux disease

            Thrombocytopenia

            Frequency Not Defined

            Left ventricular cardiac dysfunction

            Myocardial ischemia

            Supraventricular arrhythmia

            Hypersensitivity reaction (severe)

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            Warnings

            Black Box Warnings

            This drug in combination with capecitabine is contraindicated in patients with AST or ALT > 2.5 times the upper limit of normal (ULN) or bilirubin >1 times ULN due to increased risk of toxicity and neutropenia-related death

            Contraindications

            History of hypersensitivity to Cremophor EL or its derivatives

            ANC <1.5 K/m³ or Platelets <100 K/m³

            Ixabepilone/capecitabine combo contraindicated if AST/ALT >2.5 times ULN or bilirubin >1 time ULN

            Cautions

            Risk of usual chemotherapy ADRs (esp peripheral neuropathy and myelosuppression)

            Avoid grapefruit juice

            Strong CYP3A4 inducers (eg, rifampin) decrease ixabepilone AUC by 43% compared to ixabepilone treatment alone

            Avoid pregnancy

            History of cardiac disease

            May cause neuropathy, primarily sensory; neuropathy is cumulative, generally reversible, and should be managed by dose adjustment and delays

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, do not nurse

            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

            Microtubule inhibitor of epothilone group; promotes tubulin polymerization and stabilizes microtubular function, causing cell cycle (G2/M) arrest and subsequently apoptosis

            Pharmacokinetics

            Half-life elimination: 52 hr

            Peak plasma time: 3 hr

            Protein bound: 67-77%

            Vd: >1000 L

            Metabolism: Liver CYP3A4

            Excretion: Feces (65%); urine (21%)

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            Administration

            IV Preparation

            If kit refrigerated, warm kit at room temp for 30 min (dissolves precipitate in diluent if any and produces clear diluent)

            Reconstitute vials with supplied diluent: 15 mg with the 8 mL diluent; 45 mg with the 23.5 mL diluent (final conc 2 mg/mL)

            Aseptically withdraw diluent and add to drug vial; swirl and invert to completely dissolve

            Reconstituted solution stable for 1 hr at room temp and light

            Dilute further in LR ~250 mL in DEHP-free bag

            Stable for up to 6 hr at room temp and light (including 3 hr infusion time, ie upto 3 hr idle storage+3 hr infusion)

            IV Administration

            Use 0.2-1.2 micron inline filter

            Use DEHP-free infusion apparatus

            Infuse over 3 hr

            Storage

            Store original kit refrigerated and unopened

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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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