Version May 2024
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.
Note: Do not initiate a new treatment cycle unless neutrophils are ≥1,500/mm3 and platelets are ≥100,000/mm3. For dose calculation, BSA is capped at a maximum of 2.2 m2.
Premedication: 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).
Breast cancer, metastatic or locally advanced: 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 (Pérez 2007; Thomas 2007).
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, renal excretion is minimal. CrCl >30 mL/minute does not have a clinically meaningful effect on ixabepilone pharmacokinetics. No need for dosage adjustment is expected (Krens 2019).
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 (ASCO [Griggs 2021]). 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 (refer to Capecitabine monograph).
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): $2,323.60
45 mg (per each): $6,970.78
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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 (ESMO/EONS [Pérez Fidalgo 2012]).
Hazardous agent (NIOSH 2016 [group 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 2016; 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.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
CNS Depressants: Ixabepilone may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Ixabepilone. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the 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 the serum concentration of Ixabepilone. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the 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 the serum concentration of Ixabepilone. Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Disulfiram: May enhance the adverse/toxic effect of Products Containing Ethanol. Management: Do not use disulfiram with dosage forms that contain ethanol. Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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 diminish the therapeutic effect 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
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect 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: Products Containing Ethanol may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, a disulfiram-like reaction may occur and CNS depressant effects may be increased. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid combination
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Ornidazole: May enhance the adverse/toxic effect of Products Containing Ethanol. Specifically, a disulfiram-like reaction may occur. Risk X: Avoid combination
Palifermin: May enhance the adverse/toxic effect 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 diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
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, ixabepilone may cause fetal harm if administered during pregnancy. 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.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
