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Cabazitaxel Dosage

Medically reviewed by Drugs.com. Last updated on Jan 25, 2021.

Applies to the following strengths: 60 mg/1.5 mL

Usual Adult Dose for Prostate Cancer

20 mg/m2 IV over one-hour every three weeks
-Some patients may received a dose of 25 mg/m2 every three weeks

Comments:
-In selected patients, the dose may be increased to 25 mg/m2; primary prophylaxis with G-CSF is recommended in these patients.
-Use in combination with oral prednisone 10 mg once a day.
-Dose is based on calculation of the Body Surface Area (BSA).
-Give premedication regimen at least 30 minutes prior to each administration, including antiemetics prophylaxis as needed.
-Ensure adequate hydration throughout treatment.

Use: In combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen

Renal Dose Adjustments

CrCl 15 mL/min to less than 90 mL/min not requiring hemodialysis: No adjustment necessary
End stage renal dysfunction (CrCl less than 15 mL/min): Use with caution and monitor carefully during treatment.

Liver Dose Adjustments

Mild hepatic dysfunction (total bilirubin greater than 1 to 1.5 times upper limit of normal [x ULN] or AST greater than 1.5 x ULN): Maximum dose 20 mg/m2
Moderate hepatic dysfunction (total bilirubin greater than 1.5 to 3 x ULN and any AST): Maximum tolerated dose 15 mg/m2; however, efficacy of this dose is unknown
Severe hepatic dysfunction (total bilirubin greater than 3 x ULN): Contraindicated

Dose Adjustments

Dose modifications:
-Patients at a 20 mg/m2 dose who require dose reduction should decrease dosage to 15 mg/m2
-Patients at a 25 mg/m2 dose who require dose reduction should decrease dosage to 20 mg/m2
-One additional dose reduction to 15 mg/m2 may be considered

Adjust dosage for the following adverse events:
-Prolonged (more than 1 week) Grade 3 or higher neutropenia despite appropriate medication including G-CSF: Delay treatment until neutrophil count is greater than 1,500 cells/mm3, then reduce dose by one dose level. Use G-CSF for secondary prophylaxis.
-Febrile neutropenia or neutropenic infection: Delay treatment until improvement or resolution, and neutrophil count is greater than 1,500 cells/mm3, then reduce dose by one dose level.
-Grade 3 or higher, or persisting diarrhea despite appropriate medication, fluid, and electrolytes replacement: Delay treatment until improvement or resolution, then reduce dose by one dose level.
-Grade 2 peripheral neuropathy: Delay treatment until improvement or resolution, then reduce dose by one dose level.
-Grade 3 or higher peripheral neuropathy: Discontinue treatment.

Adjust dosage for use with strong CYP450 3A inhibitors:
-Avoid the coadministration of strong inhibitors of CYP450 3A drugs.
-If concomitant use of strong inhibitors of CYP450 3A drugs is inevitable, consider a cabazitaxel 25% dose reduction.

Precautions

US BOXED WARNINGS:
NEUTROPENIA:
-Neutropenic deaths have been reported.
-Monitor for neutropenia with frequent blood cell counts.
-Do not give this drug to patients with neutrophil counts of 1500 cells/mm3 or less.
-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.

HYPERSENSITIVITY:
-Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm.
-Severe hypersensitivity reactions require immediate discontinuation of the infusion and administration of appropriate therapy.
-Patients should receive premedication.
-Do not give this drug to patients who have a history of severe hypersensitivity reactions to this drug or to other drugs formulated with polysorbate 80.

CONTRAINDICATIONS:
-Neutrophil counts of 1500/mm3 or less
-History of severe hypersensitivity reactions to this drug or to other drugs formulated with polysorbate 80
-Severe hepatic impairment (total bilirubin greater than 3 times ULN)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer this drug as a one-hour IV infusion.
-This drug requires two dilutions prior to administration.
-Do not use PVC infusion containers for preparation or infusion.
-Do not use polyurethane infusion sets for administration.
-Use an in-line 0.22 micrometer filter during administration.

Storage requirements:
-Unopened: Store at room temperature; do not refrigerate
-Reconstituted solutions: Use within 8 hours at room temperature OR 24 hours under refrigeration; includes the 1-hour infusion time

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: Do not mix with other medications.

General:
-Administer under the supervision of a physician experienced in the use of antineoplastics.
-Facilities and equipment for the treatment of serious hypersensitivity reactions, like hypotension and bronchospasm, must be available.

Monitoring:
-Hematologic: Neutropenia with frequent blood cell counts
-Genitourinary: Monitor of cystitis
-Pulmonary: Monitor for new or worsening pulmonary symptoms

Patient advice:
-Educate patients about risk of hypersensitivity and to immediately report signs of hypersensitivity reactions.
-Explain the importance of routine blood cell counts.
-Have patients monitor their temperature frequently and immediately report fever.
-Explain the importance of taking corticosteroids as instructed.
-Inform patients of infection, dehydration, and renal failure risk; instruct patients to immediately report fever, significant vomiting or diarrhea, decreased urinary output, and hematuria.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.