PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) Zimbabwe · MCAZ

CABAZITAXEL MYLAN

CABAZITAXEL

2021/9.3/6203 SOLUTION; INJECTION 60MG/1.5ML antineoplastic and immunomodulating agents INN generic

What it does

Cabazitaxel is a chemotherapy medicine used to treat advanced prostate cancer that has spread.

Commonly used for: prostate cancer (advanced), hormone-resistant prostate cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
2021/9.3/6203
Registration date
2021-11-08
Expiry date
2027-12-31
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
CABAZITAXEL
Dosage form
SOLUTION; INJECTION
Strength
60MG/1.5ML
Pack size
-
Therapeutic class
-
ATC class (WHO)
L01CD - Taxanes
RxNorm RxCUI
996051
Manufacturer / MAH
Mylan Laboratories
Country of origin
-
Manufacturer location
Jigani, Karnataka 560105, India

Source: Medicines Control Authority of Zimbabwe · fetched 2026-04-18 08:22:05 · updated 2026-10-21 04:30:03

Drug Interactions

29
Check interactions

Pharmacodynamic Warnings

Cabazitaxel appears in TABLE 12: Drugs that cause peripheral neuropathy

Cabazitaxel appears in TABLE 15: Drugs that cause myelosuppression

Severe (5)

Cabazitaxel - decreases exposure

Mitotaneispredictedtodecreasetheexposuretotaxanes (cabazitaxel).Avoid.oStudy →AlsoseeTABLE15p.1520

Severe Study

Cabazitaxel - decreases exposure

Rifabutinispredictedtodecreasetheexposuretotaxanes (cabazitaxel).Avoid.oTheoretical

Severe Theoretical

Cabazitaxel - decreases exposure

Rifampicin is predicted to decrease the exposure to taxanes (cabazitaxel). Avoid.

Severe Study

Cabazitaxel - decreases exposure

StJohn’swortispredictedtodecreasetheexposuretotaxanes (cabazitaxel).Avoid.rTheoretical

Severe Theoretical

Cabazitaxel - decreases exposure

Rifamycins (rifabutin) are predicted to decrease the exposure to cabazitaxel. Avoid.

Severe Theoretical

Unknown (24)

Angiotensin- - affects exposure

Cabazitaxel is predicted to affect the exposure to angiotensin-II receptor antagonists (valsartan). Manufacturer advises take 12 hours before or 3 hours after cabazitaxel.

Unknown Theoretical

Antihistamines,non-Sedating - affects exposure

Cabazitaxel is predicted to affect the exposure to antihistamines, non-sedating (fexofenadine). Manufacturer advises take 12 hours before or 3 hours after cabazitaxel.

Unknown Theoretical

Atorvastatin - affects exposure

Cabazitaxel is predicted to affect the exposure to statins (atorvastatin, pravastatin, rosuvastatin, simvastatin). Manufacturer advises take 12 hours before or 3 hours after cabazitaxel.

Unknown Theoretical

Cabazitaxel - increases exposure

Dronedaroneispredictedtoincreasetheexposuretotaxanes (cabazitaxel).oTheoretical

Unknown Theoretical

Cabazitaxel - increases exposure

Antifungals, azoles (fluconazole, isavuconazole, posaconazole) are predicted to increase the exposure to taxanes (cabazitaxel).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Medicines Control Authority of Zimbabwe (Zimbabwe). Always consult a qualified healthcare professional before using any medication.

About this medicine

Cabazitaxel is a chemotherapy medicine used to treat advanced prostate cancer that has spread.

What it treats

  • prostate cancer (advanced)
  • hormone-resistant prostate cancer

How it works

Cabazitaxel works by stopping the growth of cancer cells, helping to shrink tumors and slow down the disease.

Who it's for

This medication is for adults with advanced prostate cancer, especially when other treatments haven't worked.

Cautions

  • • Be cautious if you take medications that cause nerve damage.
  • • Be cautious if you take medications that affect blood cell production.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Cabazitaxel

BNF-referenced

Cabazitaxel is a chemotherapeutic agent classified as a taxane. It is primarily used in the treatment of hormone refractory metastatic prostate cancer in patients who have previously undergone treatment with a docetaxel-containing regimen. The drug functions by stabilizing microtubules, thereby inhibiting cancer cell division and proliferation. Its unique ability to penetrate the blood-brain barrier makes it effective against a range of tumors, including those resistant to other chemotherapy agents.

Indications

  • Hormone refractory metastatic prostate cancer
  • Patients previously treated with a docetaxel-containing regimen

Dosage

Children: Refer to the BNF for Children for specific dosing guidance.

Adults: Consult product literature for specific dosing information. It is typically administered as an intravenous infusion.

Mechanism of action

Cabazitaxel exerts its effects by binding to the N-terminal amino acids of the beta-tubulin subunit, promoting microtubule polymerization and inhibiting disassembly. This leads to the stabilization of microtubules, which prevents normal cell division, ultimately blocking both mitotic and interphase cellular functions and curtailing tumor proliferation.

Pharmacodynamics

Cabazitaxel demonstrates a broad spectrum of antitumor activity, effectively targeting advanced human tumors xenografted in mice, including glioblastomas. It has a low affinity for P-glycoprotein, facilitating its penetration of the blood-brain barrier and rendering it effective against tumors known to be resistant to docetaxel and other chemotherapy agents.

Pharmacokinetics

Cabazitaxel is administered via intravenous infusion and exhibits a complex pharmacokinetic profile. It is metabolized primarily by the liver and has a half-life that allows for dosing adjustments in patients with hepatic impairment. Caution is advised in patients with renal impairment due to limited information on its safety in severe cases. Monitoring of electrolytes is recommended during treatment.

Contra-indications

  • Acute porphyrias
  • Severe renal impairment

Adverse effects

  • Thrombocytopenia
  • Tinnitus
  • Ureteral obstruction
  • Fever
  • Vasodilation
  • Vertigo
  • Vomiting
  • Weight changes
  • Drowsiness
  • Decreased respiratory function
  • Angioedema
  • Extravasation necrosis

Interactions

  • Mitotane (severe decrease in exposure)
  • Rifabutin (severe decrease in exposure)
  • Rifampicin (severe decrease in exposure)
  • St. John's wort (severe decrease in exposure)
  • Rifamycins (severe decrease in exposure)
  • Dronedarone (unknown effect on exposure)
  • Antifungals (azoles) (unknown increase in exposure)
  • Cobicistat (unknown increase in exposure)
  • Crizotinib (unknown increase in exposure)
  • Dabrafenib (unknown decrease in exposure)

Precautions

  • Caution in patients with hepatic impairment (increased risk of accumulation)
  • Monitor electrolytes and correct dehydration
  • Pretreatment with corticosteroids, antihistamines, and H2-receptor antagonists recommended to reduce risk of hypersensitivity reactions

Pregnancy

Avoid use during pregnancy due to teratogenic effects observed in animal studies. Contraceptive advice is required during treatment and for up to 6 months after treatment in men.

Breast-feeding

Discontinue breastfeeding during treatment.

Storage

Store in a cool, dry place, protected from light. Follow specific product storage instructions.

Formulations

  • Cabazitaxel 45mg/4.5ml concentrate for solution for infusion
  • Cabazitaxel 60mg/6ml concentrate for solution for infusion
BNF 85 (British National Formulary) p.1032 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Cabazitaxel

PubChem CID 9854073

Molecular formula: C45H57NO14

Mechanism of action

Microtubules are cytoskeletal polymers that regulate cell shape, vesicle transport, cell signalling, and cell division. They are made up of alpha-tubulin and beta-tubulin heterodimers. Microtubules extend toward the mitotic spindle during mitosis to allow the separation and distribution of chromosomes during cell division. Cabazitaxel binds to the N-terminal amino acids of the beta-tubulin subunit and promotes microtubule polymerization while simultaneously inhibiting disassembly: this results in the stabilization of microtubules, preventing microtubule cell division. Cabazitaxel ultimately blocks mitotic and interphase cellular functions and tumour proliferation.

Pharmacodynamics

Cabazitaxel demonstrates a broad spectrum of antitumour activity against advanced human tumours xenografted in mice, including intracranial human glioblastomas. Cabazitaxel has a low affinity to P-glycoprotein, allowing it to penetrate the blood-brain barrier without being subject to extensive P-gp-mediated active efflux. Cabazitaxel works against docetaxel-sensitive tumours and tumour models resistant to docetaxel and other chemotherapy drugs.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.