Version July 2025
Ixabepilone in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 times the ULN or bilirubin >1 times ULN due to an increased risk of toxicity and neutropenia-related death.
Dosage guidance:
Safety : Premedicate with an H1-antagonist (diphenhydramine 50 mg orally or equivalent) and an H2 antagonist ~1 hour prior to infusion. Patients with a history of ixabepilone hypersensitivity should also be premedicated with corticosteroids (eg, dexamethasone 20 mg orally 1 hour before or IV 30 minutes before infusion).
Clinical considerations : Do not initiate a new treatment cycle unless neutrophils are ≥1,500/mm3 and platelets are ≥100,000/mm3.
Breast cancer, metastatic or locally advanced: Note: For dose calculation, BSA is capped at a maximum of 2.2 m2.
IV: 40 mg/m2 once every 3 weeks (maximum dose: 88 mg) either as monotherapy or in combination with capecitabine; continue until disease progression or unacceptable toxicity (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, kidney excretion is minimal. CrCl >30 mL/minute does not have a clinically meaningful effect on ixabepilone pharmacokinetics. No need for dosage adjustment is expected (Ref).
Note: The alcohol content in ixabepilone should also be taken into account if administered to patients with hepatic impairment.
Ixabepilone monotherapy (initial cycle; adjust doses for subsequent cycles based on toxicity; excludes patients with elevated total bilirubin due to Gilbert disease):
AST and ALT ≤2.5 times ULN and bilirubin ≤1 times ULN: No dosage adjustment necessary.
AST and ALT >2.5 to ≤10 times ULN and bilirubin >1 to ≤1.5 times ULN: Reduce ixabepilone dose to 32 mg/m2.
AST and ALT ≤10 times ULN and bilirubin >1.5 to ≤3 times ULN: Reduce ixabepilone dose to 20 to 30 mg/m2 (initiate treatment at 20 mg/m2, may escalate up to a maximum of 30 mg/m2 in subsequent cycles if 20 mg/m2 is tolerated).
AST or ALT >10 times ULN or bilirubin >3 times ULN: Avoid ixabepilone use.
Combination therapy of ixabepilone with capecitabine:
AST and ALT ≤2.5 times ULN and bilirubin ≤1 times ULN: There are no dosage adjustments provided in the manufacturer’s labeling.
AST or ALT >2.5 times ULN or bilirubin >1 times ULN: Ixabepilone is contraindicated.
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved AND if performance status has markedly improved or is considered adequate (Ref). Note: According to the prescribing information, patients with a BSA >2.2 m2 should be dosed based upon a maximum BSA of 2.2 m2.
Determine dosage modifications at the start of a cycle based on toxicities (hematologic and nonhematologic) from the previous cycle. Delay new cycles until neutrophils are ≥1,500/mm3, platelets are ≥100,000/mm3, and nonhematologic toxicities have resolved or improved to grade 1. If toxicities recur, reduce dose an additional 20%. Capecitabine may also require dosage adjustments when used in combination with ixabepilone.
Hematologic:
Neutrophils <500/mm3 for ≥7 days: Reduce ixabepilone dose by 20% with the next cycle.
Neutropenic fever: Reduce ixabepilone dose by 20% with the next cycle.
Platelets <25,000/mm3 (or <50,000/mm3 with bleeding): Reduce ixabepilone dose by 20% with the next cycle.
Nonhematologic:
Hypersensitivity, severe: Stop ixabepilone infusion and manage with supportive treatment (eg, epinephrine, corticosteroids) as clinically indicated. If hypersensitivity reaction occurs, premedicate with a corticosteroid (in addition to H1 and H2 antagonists) in subsequent cycles and consider extending the infusion time.
Neuropathy:
Grade 2 (moderate) lasting ≥7 days: Withhold ixabepilone until resolved or improved to grade 1, then reduce ixabepilone dose by 20% with the next cycle.
Grade 3 (severe) lasting <7 days: Withhold ixabepilone until resolved or improved to grade 1, then reduce ixabepilone dose by 20% with the next cycle.
Grade 3 (severe) lasting ≥7 days or disabling neuropathy: Discontinue ixabepilone.
Grade 3 toxicity (severe; other than neuropathy): Withhold ixabepilone until resolved or improved to grade 1, then reduce ixabepilone dose by 20% with the next cycle.
Grade 3 arthralgia/myalgia or fatigue (transient): Withhold ixabepilone until resolved or improved to grade 1, then continue ixabepilone at current dose.
Grade 3 hand-foot syndrome (palmar-plantar erythrodysesthesia): Withhold ixabepilone until resolved or improved to grade 1, then continue ixabepilone at current dose.
Grade 4 toxicity (disabling): Discontinue ixabepilone.
Cardiac ischemia or impaired cardiac function: Consider discontinuing ixabepilone.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Dermatologic: Alopecia (48%)
Gastrointestinal: Abdominal pain (13%), anorexia (19%), constipation (16%), diarrhea (22%; grade 3: 1%), nausea (42%; grade 3: 2%), stomatitis (≤29%; grades 3/4: 6%), vomiting (29%; grade 3: 1%)
Hematologic & oncologic: Leukopenia (grade 3: 36%; grade 4: 13%), neutropenia (grade 3: 31%; grade 4: 23%)
Nervous system: Asthenia (≤56%), fatigue (≤56%), headache (11%), peripheral sensory neuropathy (62%; grades 3/4: 14%)
Neuromuscular & skeletal: Arthralgia (≤49%), musculoskeletal pain (20%), myalgia (≤49%)
1% to 10%:
Cardiovascular: Chest pain (5%), edema (9%)
Dermatologic: Desquamation (2%), hyperpigmentation (2%), nail disease (9%), palmar-plantar erythrodysesthesia (8%), pruritus (6%), skin rash (9%)
Endocrine & metabolic: Dehydration (2%), hot flash (6%), weight loss (6%)
Gastrointestinal: Dysgeusia (6%), gastroesophageal reflux (6%)
Hematologic & oncologic: Anemia (grade 3: 6%; grade 4: 2%), febrile neutropenia (3%; grade 3: 3%), thrombocytopenia (grade 3: 5%; grade 4: 2%)
Hypersensitivity: Hypersensitivity reaction (5%)
Infection: Infection (with neutropenia: 5%)
Nervous system: Dizziness (7%), insomnia (5%), pain (8%), peripheral motor neuropathy (10%; grade 3: 1%)
Ophthalmic: Increased lacrimation (4%)
Respiratory: Cough (2%), dyspnea (9%), upper respiratory tract infection (6%)
Miscellaneous: Fever (8%)
Postmarketing: Miscellaneous: Radiation recall phenomenon
History of severe hypersensitivity to polyoxyethylated castor oil (Cremophor EL) or its derivatives or any other component of the formulation; neutrophil count <1,500/mm3 or platelet count <100,000/mm3; combination therapy with ixabepilone and capecitabine in patients with AST or ALT >2.5 times ULN or bilirubin >1 times ULN.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Bone marrow suppression: Dose-dependent myelosuppression, particularly neutropenia, may occur with ixabepilone; may be severe, life threatening, or fatal. Grade 4 neutropenia has occurred; neutropenic fever and infection have been reported. The risk for neutropenic complications is increased with hepatic dysfunction, especially when used in combination with capecitabine.
• Cardiac adverse events: Myocardial ischemia, ventricular dysfunction, and supraventricular arrhythmias have occurred with ixabepilone.
• Hypersensitivity: Diluent contains polyoxyethylated castor oil (Cremophor EL), which is associated with hypersensitivity reactions. Premedicate as recommended. Severe hypersensitivity reactions, including anaphylaxis, have been reported. Signs of hypersensitivity reactions include bronchospasm, dyspnea, flushing, and rash.
• Peripheral neuropathy: Peripheral neuropathy (sensory and motor) has occurred with ixabepilone (as a single agent or in combination with capecitabine). Signs/symptoms of neuropathy include burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain. A majority of patients with neuropathy experienced either improvement or no worsening following dose reduction; in some studies, documented improvement to baseline or grade 1 was noted for most patients 12 weeks after onset. Patients with preexisting peripheral neuropathy or diabetes may be at increased risk of developing severe neuropathy. Patients with ≥ grade 2 neuropathy were excluded from clinical trials.
Disease-related concerns:
• Diabetes: Patients with diabetes may be at increased risk for severe peripheral neuropathy.
• Hepatic impairment: Patients with baseline AST or ALT >2.5 times ULN or bilirubin >1.5 times ULN experienced greater toxicity with ixabepilone (either in combination with capecitabine or as monotherapy), compared to patients with baseline AST, ALT, or bilirubin below those levels. The overall frequency of grade 3 or 4 adverse reactions, neutropenic fever, serious adverse reactions, and toxicity-related fatalities is increased in patients with hepatic impairment. The alcohol content in ixabepilone should be taken into account when administered to patients with hepatic impairment.
Dosage form specific issues:
• Alcohol content: Ixabepilone contains alcohol, which may affect the central nervous system. Consider alcohol content (~8.4 g/m2 ethanol in each 40 mg/m2 ixabepilone dose) in situations where alcohol intake should be avoided or minimized. Patients should avoid driving or operating machinery immediately after infusion.
• Polyoxyethylated castor oil: Diluent contains polyoxyethylated castor oil (Cremophor EL), which is associated with hypersensitivity reactions.
Special populations:
• Older age: Toxicities or serious adverse events may be increased with ixabepilone in combination with capecitabine in patients ≥65 years of age (compared to patients <65 years of age).
Diluent supplied in Ixempra Kit contains polyoxyethylated castor oil (Cremophor EL)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Ixempra Kit: 15 mg (1 ea); 45 mg (1 ea) [contains alcohol, usp, polyoxyl/peg-35 castor oil(cremophor el)]
No
Solution (reconstituted) (Ixempra Kit Intravenous)
15 mg (per each): $2,417.47
45 mg (per each): $7,252.42
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IV: Infuse over 3 hours. If the dose is increased (above 40 mg/m2) due to concomitant CYP3A4 inducer use, infuse over 4 hours. Infuse via a DEHP-free administration set; administer with an inline filter with a microporous membrane of 0.2 to 1.2 microns. Administration should be completed within 6 hours of preparation. Monitor for hypersensitivity reaction.
Ixabepilone is an irritant (Ref).
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Breast cancer, metastatic or locally advanced:
Treatment (in combination with capecitabine) of metastatic or locally advanced breast cancer that is resistant to an anthracycline and a taxane, or that is taxane-resistant and when further anthracycline therapy, is contraindicated.
Treatment (as a single agent) of metastatic or locally advanced breast cancer that is resistant or refractory to anthracyclines, taxanes, and capecitabine.
Anthracycline resistance is defined as progression while on treatment or within 3 months in the metastatic setting or within 6 months in the adjuvant setting. Taxane resistance is defined as progression while on treatment or within 4 months in the metastatic setting or within 12 months in the adjuvant setting.
Ixabepilone may be confused with isatuximab.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
CNS Depressants: Ixabepilone may increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of Ixabepilone. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Ixabepilone. Management: Avoid this combination whenever possible. If this combination must be used, a gradual increase in ixabepilone dose from 40 mg/m2 to 60 mg/m2 (given as a 4-hour infusion), as tolerated, should be considered. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Ixabepilone. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Ixabepilone. Management: Avoid use of ixabepilone and strong CYP3A4 inhibitors when possible. If combined, reduce the ixabepilone dose to 20 mg/m2. The previous ixabepilone dose can be resumed 1 week after discontinuation of the strong CYP3A4 inhibitor. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Weak): May increase serum concentration of Ixabepilone. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Disulfiram: May increase adverse/toxic effects of Products Containing Ethanol. Management: Do not use disulfiram with dosage forms that contain ethanol. Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Methotrimeprazine: May increase CNS depressant effects of Products Containing Ethanol. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid
MetroNIDAZOLE (Systemic): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk X: Avoid
MetroNIDAZOLE (Topical): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Secnidazole: Products Containing Ethanol may increase adverse/toxic effects of Secnidazole. Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Grapefruit juice may increase plasma concentrations of ixabepilone. Management: Avoid grapefruit juice.
Evaluate pregnancy status prior to treatment in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for 7 months after the last ixabepilone dose. Patients with partners who could become pregnant should use effective contraception during ixabepilone treatment and for 4 months after the last dose.
Based on the mechanism of action and on findings in animal reproduction studies, in utero exposure to ixabepilone may cause fetal harm. Ixabepilone contains alcohol, which is also associated with adverse fetal effects.
It is not known if ixabepilone is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends discontinuing breastfeeding during treatment and for 2 weeks after the last ixabepilone dose.
Avoid grapefruit juice (may increase plasma concentrations of ixabepilone).
CBC with differential (baseline and frequently during treatment); hepatic function (ALT, AST, bilirubin; baseline and periodic). Evaluate pregnancy status prior to treatment in patients who could become pregnant. Monitor for signs/symptoms of hypersensitivity reactions (dyspnea, bronchospasm, flushing, rash); neuropathy (eg, burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain [closely monitor in patients with diabetes or preexisting neuropathy]); and cardiac ischemia or impaired cardiac function (closely monitor patients with a history of cardiac disease).
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Ixabepilone is an epothilone B analog, which binds to the beta-tubulin subunit of the microtubule, stabilizing microtubular promoting tubulin polymerization and stabilizing microtubular function, thus arresting the cell cycle (at the G2/M phase) and inducing apoptosis. Activity in taxane-resistant cells has been demonstrated.
Distribution: >1,000 L.
Protein binding: 67% to 77%.
Metabolism: Extensively hepatic, via CYP3A4.
Half-life elimination: ~52 hours.
Excretion: Feces (65%; primarily as metabolites; ~2% of the total dose as unchanged drug); urine (21%; ~6% of the total dose as unchanged drug).
Hepatic function impairment: The ixabepilone AUC increased by 22% in patients with mild impairment (bilirubin >1 to 1.5 times ULN and AST < ULN or AST > ULN but bilirubin <1.5 times ULN), increased by 30% in patients with moderate impairment (bilirubin >1.5 to 3 times ULN and any AST), and increased by 81% in patients with severe impairment (bilirubin >3 times ULN and any AST), when compared to patients with normal hepatic function.
