Version May 2024
Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. Cabazitaxel is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m2.
Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension, and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the cabazitaxel infusion and administration of appropriate therapy. Patients should receive premedication. Cabazitaxel is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.
Note: Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features; primary prophylaxis with G-CSF should be considered in all patients receiving a dose of 25 mg/m2. Premedicate ≥30 minutes prior to each dose of cabazitaxel with an antihistamine (eg, diphenhydramine IV 25 mg or equivalent), a corticosteroid (eg, dexamethasone 8 mg IV or equivalent), and an IV H2 antagonist. Per the manufacturer, antiemetic prophylaxis (oral or IV) is also recommended.
Prostate cancer, metastatic: IV: 20 mg/m2 once every 3 weeks (in combination with prednisone) (Ref). A dose of 25 mg/m2 once every 3 weeks (in combination with prednisone) may be used in select patients at the discretion of the prescriber.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥15 mL/minute: No dosage adjustment necessary.
CrCl <15 mL/minute and end-stage renal disease: Use with caution; monitor closely.
Mild impairment (total bilirubin >1 to ≤1.5 times ULN or AST ≥1.5 times ULN): Administer 20 mg/m2; use with caution and monitor closely.
Moderate impairment (total bilirubin >1.5 to ≤3 times ULN and any AST): Reduce dose to 15 mg/m2 (based on tolerability; efficacy of this dose is not known); use with caution and monitor closely.
Severe impairment (total bilirubin >3 times ULN): Use 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 (full 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: If receiving cabazitaxel 20 mg/m2 and a dose reduction is required, decrease the dose to 15 mg/m2. If receiving cabazitaxel 25 mg/m2, the dose should decrease to 20 mg/m2; one additional dose reduction to 15 mg/m2 may be considered.
Hematologic toxicity:
Neutropenia ≥ grade 3 for >1 week despite WBC growth factors: Delay treatment until ANC >1,500/mm3 and then reduce dose by one dose level with continued WBC growth factor secondary prophylaxis.
Neutropenic fever or neutropenic infection: Delay treatment until improvement/resolution and ANC >1,500/mm3 and then reduce dose by one dose level with continued WBC growth factor secondary prophylaxis.
Nonhematologic toxicity:
Severe hypersensitivity: Discontinue immediately.
Diarrhea ≥ grade 3 or persistent despite appropriate medication, fluids, and electrolyte replacement: Delay treatment until improves or resolves and then reduce dose by one dose level.
Hemorrhagic cystitis (severe): Interrupt or discontinue cabazitaxel; may require medical/surgical supportive care.
Peripheral neuropathy (grade 2): Delay treatment until improves or resolves and then reduce dose by one dose level.
Peripheral neuropathy ≥ grade 3: Discontinue treatment.
Pulmonary symptoms (new or worsening): Interrupt cabazitaxel treatment, monitor closely and promptly investigate and manage symptoms. May require discontinuation (carefully evaluate the potential benefits of treatment resumption).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported for combination therapy with prednisone.
>10%:
Gastrointestinal: Abdominal pain (6% to 17%), anorexia (16%), constipation (18% to 20%), decreased appetite (13% to 19%), diarrhea (31% to 47%), dysgeusia (7% to 11%), nausea (25% to 34%), vomiting (15% to 22%)
Genitourinary: Hematuria (14% to 21%), urinary tract infection (7% to 11%)
Hematologic & oncologic: Anemia (98% to 100%; grades 3/4: 10% to 14%), leukopenia (80% to 96%; grades 3/4: 29% to 69%), neutropenia (67% to 94%; grades 3/4: 42% to 82%), thrombocytopenia (35% to 48%; grades 3/4: 3% to 4%)
Infection: Infection (28% to 38%)
Nervous system: Fatigue (25% to 37%), peripheral neuropathy (13%; grades 3/4: <1%), peripheral sensory neuropathy (7% to 11%; grades 3/4: <1%)
Neuromuscular & skeletal: Arthralgia (7% to 11%), asthenia (15% to 20%), back pain (11% to 16%)
Respiratory: Cough (6% to 11%), dyspnea (5% to 12%)
Miscellaneous: Fever (5% to 12%)
1% to 10%:
Cardiovascular: Cardiac arrhythmia (5%), hypotension (5%), peripheral edema (7% to 9%)
Dermatologic: Alopecia (3% to 10%)
Endocrine & metabolic: Dehydration (5%), weight loss (4% to 9%)
Gastrointestinal: Dyspepsia (10%), mucosal swelling (inflammation: 6%), stomatitis (5% grades 3/4: <1%)
Genitourinary: Cystitis (1% to 2%; including radiation cystitis), dysuria (4% to 7%)
Hematologic & oncologic: Febrile neutropenia (2% to 9%; grades 3/4: 2% to 9%), neutropenic infection (3% to 7%; grades 3/4: 2% to 6%)
Hepatic: Increased serum alanine aminotransferase (grade 3/4: ≤1%), increased serum aspartate aminotransferase (grade 3/4: ≤1%), increased serum bilirubin (grade 3/4: ≤1%)
Nervous system: Dizziness (4% to 8%), headache (4% to 8%), pain (5%)
Neuromuscular & skeletal: Limb pain (5% to 7%), muscle spasm (7%), ostealgia (8%)
Renal: Renal failure syndrome (4%)
Frequency not defined:
Cardiovascular: Septic shock
Endocrine & metabolic: Electrolyte disorder
Hypersensitivity: Hypersensitivity reaction (can be severe hypersensitivity reaction; includes bronchospasm, erythema of skin, hypotension, skin rash)
Infection: Sepsis
Postmarketing:
Gastrointestinal: Enterocolitis, gastritis, gastrointestinal hemorrhage, gastrointestinal perforation, intestinal obstruction, neutropenic enterocolitis
Genitourinary: Hemorrhagic cystitis (radiation recall)
Respiratory: Acute respiratory distress syndrome, interstitial pneumonitis, interstitial pulmonary disease
Severe hypersensitivity to cabazitaxel or any component of the formulation, or to other medications formulated with polysorbate 80; neutrophil count ≤1,500/mm3; severe hepatic impairment (total bilirubin >3 times × ULN).
Canadian labeling: Additional contraindications (not in the US labeling): Concomitant vaccination with yellow fever vaccine.
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: [US Boxed Warning]: Deaths due to neutropenia have been reported. Monitor blood counts frequently. Cabazitaxel is contraindicated in patients with neutrophil count ≤1,500/mm3. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m2. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features (eg, older patients, poor performance status, history of neutropenic fever, extensive prior radiation, poor nutrition status, other serious comorbidities). Neutropenia, anemia, thrombocytopenia, and/or pancytopenia may occur; grade 3 and 4 neutropenia were observed in over 80% of patients treated with cabazitaxel in a clinical trial. Deaths due to neutropenia, neutropenic fever, or infection have been reported, and some have occurred during the first 30 days of therapy; the incidence of fatal neutropenic events was lower with the 20 mg/m2 dose. Treatment delay and dose reduction is recommended following neutropenic fever or prolonged neutropenia. Administration of WBC growth factors may reduce the risk of complications due to neutropenia; secondary prophylaxis and therapeutic WBC growth factors should be considered in all patients at increased risk for neutropenic complications. Closely monitor patients with hemoglobin <10 g/dL. Monitor complete blood counts weekly during cycle 1 and prior to subsequent treatment cycles, or as clinically indicated.
• Gastrointestinal toxicity: Nausea, vomiting and diarrhea may occur. Diarrhea may be severe and may result in dehydration and electrolyte imbalance; fatalities have been reported. Per the manufacturer, antiemetic prophylaxis is recommended. Antidiarrheal medication and fluid and electrolyte replacement may be necessary. Diarrhea ≥ grade 3 may require treatment delay and or dosage reduction. GI hemorrhage and perforation, enterocolitis, neutropenic enterocolitis, and ileus (some fatal) have also been observed. Use with caution in patients at risk of developing GI complications (eg, elderly patients, those with neutropenia or a prior history of pelvic radiation [the incidence of GI adverse reactions] increases, adhesions, GI ulceration or bleeding, concomitant use of steroids, NSAIDs, antiplatelet or anticoagulant medications). Evaluate promptly if symptoms such as abdominal pain and tenderness, fever, persistent constipation, and diarrhea (with or without neutropenia) occur. May require treatment interruption and/or therapy discontinuation.
• Hypersensitivity reactions: [US Boxed Warning]: Severe hypersensitivity reactions, including generalized rash, erythema, hypotension, and bronchospasm may occur. Immediate discontinuation is required if hypersensitivity is severe; administer appropriate supportive medications. Premedicate with an IV antihistamine, corticosteroid, and H2 antagonist prior to infusion. Use in patients with history of severe hypersensitivity to cabazitaxel or other medications formulated with polysorbate 80 is contraindicated. Observe closely during infusion, especially during the first and second infusions; reaction may occur within minutes. Do not rechallenge after severe hypersensitivity reactions.
• Pulmonary toxicity: Interstitial pneumonia/pneumonitis, interstitial lung disease, and acute respiratory distress syndrome have been observed; may be fatal. Patients with underlying pulmonary disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. If new or worsening pulmonary symptoms develop, interrupt cabazitaxel treatment, monitor closely and promptly investigate and manage symptoms. May require discontinuation (carefully evaluate the potential benefits of treatment resumption).
• Renal failure: Renal failure (including rare fatalities) has been reported from clinical trials; generally associated with dehydration, sepsis, or obstructive uropathy. Use with caution in patients with severe renal impairment (CrCl <30 mL/minute) and ESRD.
• Urinary disorders: Cystitis, radiation cystitis, and hematuria may occur in patients with prior history of pelvic radiation; hospitalizations have been reported. Cystitis due to radiation recall may occur late in cabazitaxel treatment. Monitor for signs/symptoms of cystitis in patients who received prior pelvic radiation. Interrupt or discontinue cabazitaxel in patients who experience severe hemorrhagic cystitis; may require medical and/or surgical supportive therapy.
Disease-related concerns:
• Hepatic impairment: Use is contraindicated in patients with severe hepatic impairment (total bilirubin >3 times ULN). Use with caution and monitor closely in patients with mild impairment (total bilirubin >1 to ≤1.5 times ULN or AST >1.5 times ULN) and moderate impairment (total bilirubin >1.5 to ≤3 times ULN and any AST); reduce the initial dose in patients with moderate impairment. Due to extensive hepatic metabolism, cabazitaxel exposure is increased in patients with hepatic impairment.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Special populations:
• Older adult: Patients ≥65 years of age are more likely to experience certain adverse reactions, neutropenia (including grades 3 and 4), and neutropenic fever. Fatigue, asthenia, pyrexia, dizziness, dyspnea, urinary tract infection, dehydration, diarrhea, and constipation also occurred more frequently in elderly patients compared to younger patients. Death due to infection within 30 days of starting treatment and due to causes other than disease progression (within 30 days of the last cabazitaxel dose) was higher in elderly patients versus younger patients.
Other warnings/precautions:
• Preparation for administration: Failure to properly reconstitute the concentrated vial of cabazitaxel with the correct amount of diluent may lead to higher dosage being administered and increased risk of toxicity. Follow manufacturer instructions carefully.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Jevtana: 60 mg/1.5 mL (1.5 mL) [contains alcohol, usp, polysorbate 80]
No
Solution (Jevtana Intravenous)
60 mg/1.5 mL (per mL): $11,095.32
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Jevtana: 60 mg/1.5 mL ([DSC]) [contains alcohol, usp, polysorbate 80]
Generic: 45 mg/4.5 mL (4.5 mL); 60 mg/6 mL (6 mL); 60 mg/1.5 mL (1 ea)
IV: Infuse over 1 hour using a 0.22-micron inline filter. Do not use polyurethane-containing infusion sets for administration. Allow to reach room temperature prior to infusion. Premedicate with an antihistamine, a corticosteroid, and an H2 antagonist at least 30 minutes prior to infusion. Observe closely during infusion (for hypersensitivity). Per the manufacturer, antiemetic prophylaxis (oral or IV) is also recommended.
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).
Prostate cancer, metastatic: Treatment of castration-resistant metastatic prostate cancer (in combination with prednisone) in patients previously treated with a docetaxel-containing regimen.
Cabazitaxel may be confused with DOCEtaxel, PACLitaxel
Jevtana may be confused with Xgeva, Xofigo, Xtandi, Zometa, Zytiga
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
Cabazitaxel requires a two-step dilution process prior to administration. The entire contents of the diluent vial must be added to the concentrate during reconstitution to ensure appropriate concentration/dose.
Substrate of CYP2C8 (minor), 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
Anthracyclines: Taxane Derivatives may enhance the adverse/toxic effect of Anthracyclines. Taxane Derivatives may increase the serum concentration of Anthracyclines. Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Management: Consider separating doxorubicin and paclitaxel administration by as much time as possible, using liposomal doxorubicin or epirubicin instead of doxorubicin, or using docetaxel instead of paclitaxel. Monitor closely for cardiovascular and other toxicities. Risk D: Consider therapy modification
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
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 (Strong): May decrease the serum concentration of Cabazitaxel. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Cabazitaxel. Management: Concurrent use of cabazitaxel with strong inhibitors of CYP3A4 should be avoided when possible. If such a combination must be used, consider a 25% reduction in the cabazitaxel dose. Risk D: Consider therapy modification
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
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
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
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
Platinum Derivatives: May enhance the myelosuppressive effect of Taxane Derivatives. Administer Taxane derivative before Platinum derivative when given as sequential infusions to limit toxicity. Management: Administer paclitaxel before cisplatin, when given as sequential infusions, to limit toxicity. Problems associated with other taxane/platinum combinations are possible, although unsubstantiated. Administering the taxane before platinum is likely warranted Risk D: Consider therapy modification
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
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 the levels/effects of cabazitaxel. Management: Monitor for increased effects/toxicity with concomitant use.
Male patients with female partners of reproductive potential should use effective contraception during treatment and for 4 months after the last cabazitaxel dose.
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to cabazitaxel may cause fetal harm.
It is not known if cabazitaxel is present in breast milk.
CBC with differential and platelets (weekly during first cycle, then prior to each treatment cycle and as clinically indicated); hepatic/renal function. Monitor for hypersensitivity reactions (especially during the first and second infusions). Monitor for signs/symptoms of gastrointestinal disorders (eg, nausea, vomiting, diarrhea, gastrointestinal hemorrhage and perforation, ileus, colitis, abdominal pain/tenderness). Monitor for new or worsening pulmonary symptoms; if received prior pelvic radiation, monitor for signs/symptoms of cystitis.
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 (HBsAg), hepatitis B core antibody (anti-HBc), total Ig or IgG, and antibody to hepatitis B surface antigen (anti-HBs) 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.
Cabazitaxel is a taxane derivative which is a microtubule inhibitor; it binds to tubulin promoting assembly into microtubules and inhibiting disassembly which stabilizes microtubules. This inhibits microtubule depolymerization and cell division, arresting the cell cycle and inhibiting tumor proliferation. Unlike other taxanes, cabazitaxel has a poor affinity for multidrug resistance (MDR) proteins, therefore conferring activity in resistant tumors.
Distribution: Vdss: 4,864 L; has greater CNS penetration than other taxanes
Protein binding: 89% to 92%; primarily to serum albumin and lipoproteins
Metabolism: Extensively hepatic; primarily via CYP3A4 and 3A5; also via CYP2C8 (minor)
Half-life elimination: Terminal: 95 hours
Excretion: Feces (76% as metabolites); Urine (~4%)
Hepatic function impairment: Clearance was decreased 39% in patients with severe hepatic impairment (total bilirubin >3 times ULN) as compared to patients with mild impairment (total bilirubin >1 to ≤1.5 times ULN and AST >1.5 times ULN).
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