Medically reviewed by Drugs.com. Last updated on Aug 26, 2020.
Applies to the following strengths: 15 mg; 45 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer
140 mg/m2 IV over 3 hours every 3 weeks (the dosage for patients with a BSA exceeding 2.2 m2 should be calculated based on a 2.2 m2 body surface area)
-Premedicate all patients approximately 1 hour prior to administration of this drug to minimize the chance of a hypersensitivity reaction with an H1 antagonist (e.g., diphenhydramine 50 mg orally or equivalent) and an H2 antagonist (e.g., ranitidine 150 to 300 mg orally or equivalent)
-If a patient experiences a hypersensitivity reaction in one cycle, premedicate in subsequent cycles with a corticosteroid (e.g., dexamethasone 20 mg IV 30 minutes prior to infusing this drug or orally 60 minutes prior to infusion) in addition to the H1 and H2 antagonists. Extension of the infusion time should also be considered.
-In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting). Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.
-As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
-Patients with moderate hepatic impairment should be started at 20 mg/m2, the dosage in subsequent cycles may be escalated up to, but not exceeding, 30 mg/m2 if tolerated. Use in patients with AST or ALT greater than 10 x ULN or bilirubin greater than 3 x ULN is not recommended. Limited data are available for patients with baseline AST or ALT greater than 5 x ULN. Caution should be used when treating these patients.
DOSE ADJUSTMENTS FOR MONOTHERAPY IN PATIENTS WITH HEPATIC IMPAIRMENT:
Mild Hepatic Impairment:
-AST and ALT 2.5 x ULN or less and bilirubin 1 x ULN or less: 40 mg/m2
-AST and ALT 10 x ULN or less: 32 mg/m2
Moderate Hepatic Impairment:
-AST and ALT 10 x ULN or less and bilirubin greater than 1.5 x ULN to 3 x ULN or less: 20 to 30 mg/m2
-AST or ALT 2.5 times the upper limit of normal (ULN) or less or bilirubin 1 x ULN or less: 40 mg/m2
-AST or ALT greater than 2.5 x ULN or bilirubin greater than 1 x ULN: Contraindicated
Patients should be evaluated during therapy by observation and laboratory tests including complete blood cell counts. If toxicities are present therapy should be delayed until recovery.
IXABEPILONE (MONOTHERAPY OR IN COMBINATION WITH CAPECITABINE):
-Grade 2 neuropathy (moderate) lasting 7 days or more: Decrease dose by 20%
-Grade 3 neuropathy (severe) lasting less than 7 days: Decrease dose by 20%
-Grade 3 neuropathy (severe) lasting 7 days or more or disabling neuropathy: Discontinue therapy
-Any Grade 3 toxicity (severe) other than neuropathy: Decrease dose by 20%
-Transient grade 3 arthralgia/myalgia/fatigue/Grade 3 hand-foot syndrome (palmar-plantar erythrodysesthesia): No change in dose
Any grade 4 toxicity (disabling): Discontinue therapy
-Neutrophil less than 500 cells/mm3 for 7 days or more: Decrease dose by 20%
-Febrile neutropenia: Decrease dose by 20%
-Platelets less than 25,000/mm3 or platelets less than 50,000/mm3 with bleeding: Decrease dose by 20%
CAPECITABINE (WHEN USED IN COMBINATION WITH IXABEPILONE):
-Follow capecitabine label.
-Platelets less than 25,000/mm3 or platelets less than 50,000/mm3 with bleeding: Hold for concurrent diarrhea or stomatitis until platelet count is greater than 50,000/mm3 then continue at same dose
-Neutrophil less than 500 cells/mm3 for 7 days or more or febrile neutropenia: Hold for concurrent diarrhea or stomatitis until neutrophil count is greater than 1000 cells/mm3
Dosage adjustments at the beginning of a cycle should be based on nonhematologic toxicity or blood counts from the preceding cycle. Patients should not begin a new cycle of treatment unless the neutrophil count is at least 1500 cells/mm3, the platelet count is at least 100,000 cells/mm3, and the nonhematologic toxicities have improved to Grade 1 or have resolved.
STRONG CYP450 3A4 INHIBITORS:
-Use of concomitant strong CYP450 3A4 inhibitors should be avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, voriconazole).
-Grapefruit juice may increase plasma concentrations of this drug and should be avoided.
-If a strong CYP450 3A4 inhibitor must be coadministered, a dose reduction to 20 mg/m2 is suggested. If the strong inhibitor is discontinued, a washout period of approximately 1 week should be allowed before the dose is adjusted upward.
STRONG CYP450 3A4 INDUCERS:
-Use of concomitant strong CYP450 3A4 inducers should be avoided (e.g., phenytoin, carbamazepine, rifampin, rifabutin, dexamethasone, phenobarbital). Selection of an alternative concomitant medication with no or minimal enzyme induction potential should be considered.
-Based on extrapolation from a drug interaction study with rifampin, the following guidance may be considered for dosing in patients requiring coadministration of a strong CYP450 3A4 inducer, if no alternatives are feasible. Once patients have been maintained on a strong CYP450 3A4 inducer, the dose of this drug may be gradually increased from 40 mg/m2 to 60 mg/m2 depending on tolerance. If the dose is increased, this drug should be given as a 4-hour IV infusion. This 60 mg/m2 dose given IV over 4 hours is predicted to adjust the AUC to the range observed without inducers; however, there are no clinical data with this dose adjustment in patients receiving strong CYP450 3A4 inducers.
-Patients whose dose is increased above 40 mg/m2 should be monitored for toxicities.
-If the strong inducer is discontinued, the dose of this drug should be returned to the dose used prior to initiation of the strong CYP450 3A4 inducer.
US BOXED WARNINGS:
WARNING: TOXICITY IN HEPATIC IMPAIRMENT:
-This drug in combination with capecitabine is contraindicated in patients with AST or ALT greater than 2.5 x upper limit of normal (ULN) or bilirubin greater than 1 x ULN due to increased risk of toxicity and neutropenia-related death.
-Hypersensitivity to the active component or any of the ingredients
-In patients with a history of a severe (Grade 3 or 4) hypersensitivity reaction to agents containing Cremophor EL or its derivatives (e.g., polyoxyethylated castor oil)
-In patients who have a neutrophil count less than 1500 cells/mm3 or a platelet count less than 100,000 cells/mm3
-This drug in combination with capecitabine is contraindicated in patients with AST or ALT greater than 2.5 x ULN or bilirubin greater than 1 x ULN
Consult WARNINGS section for additional precautions.
Data not available
-After reconstituting this drug, the solution should be further diluted with infusion fluid as soon as possible but may be stored in the vial (not the syringe) for a maximum of 1 hour at room temperature and room light.
-Once diluted with infusion fluid the solution is stable at room temperature and room light for a maximum of 6 hours. Administration of diluted drug should be completed within this 6-hour period.
-Store in a refrigerator at 2C to 8C (36F to 46F) in the original package.
-Protect from light.
-Prior to constituting this drug, the drug kit should be removed from the refrigerator and allowed to stand at room temperature for approximately 30 minutes.
-When the vials are first removed from the refrigerator, a white precipitate may be observed in the diluent vial. This precipitate will dissolve to form a clear solution once the diluent warms to room temperature.
-The drug kit contains 2 vials, a vial labeled ixabepilone for injection which contains ixabepilone powder and a vial containing diluent.
-Only the supplied diluent may be used for reconstituting this drug.
-See the manufacturer product information for further instructions.
-Lactated Ringer's Injection
-Sodium Chloride 0.9% Injection (pH adjusted with Sodium Bicarbonate Injection, USP)
-Plasmalyte A Injection pH 7.4
-Read the patient information that comes with this drug before you start receiving it and before each injection. There may be new information.
-This drug contains alcohol. If you are dizzy or drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
-Do not drink grapefruit juice while receiving this drug because it may cause you to have too much this drug in your blood and lead to side effects.
-Do not receive this drug if you are pregnant. This drug can harm an unborn baby.
-Contact your healthcare provider immediately if you experience chest pain, difficulty breathing, feel your heart beating (palpitations), or unusual weight gain.
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