Cabazitaxel Sandoz
Cabazitaxel (as monohydrate) — Taxane Chemotherapy for Advanced Prostate Cancer
Cabazitaxel Sandoz is a taxane chemotherapy medicine used to treat metastatic castration-resistant prostate cancer (mCRPC) in men who have previously received docetaxel-based chemotherapy. It works by disrupting the cancer cell's ability to divide and grow. Cabazitaxel is always given as an intravenous infusion at a hospital, in combination with daily oral corticosteroids (prednisone or prednisolone).
Quick Facts
Key Takeaways
- Cabazitaxel Sandoz is a second-line chemotherapy for metastatic prostate cancer that has progressed after docetaxel treatment.
- It is administered as a one-hour intravenous infusion every three weeks in a hospital setting, always combined with oral corticosteroids.
- The most serious risk is severe neutropenia (dangerously low white blood cell count), requiring blood tests before every treatment cycle.
- Cabazitaxel is effective in docetaxel-resistant cancers because it is not affected by the P-glycoprotein drug resistance mechanism.
- Patients must use contraception during treatment and for four months afterward, as cabazitaxel may be present in semen and can harm a developing fetus.
What Is Cabazitaxel Sandoz and What Is It Used For?
Cabazitaxel Sandoz contains the active substance cabazitaxel (as monohydrate). It belongs to a group of anticancer medicines called taxanes, which work by interfering with the structural components of cancer cells that are essential for cell division. Specifically, cabazitaxel binds to tubulin proteins and promotes the formation of microtubules while preventing their disassembly. This stabilization of microtubules blocks the cancer cell's ability to separate its chromosomes during division, ultimately triggering cell death through a process called apoptosis.
The primary indication for Cabazitaxel Sandoz is the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who have previously received chemotherapy with a docetaxel-containing regimen. Castration-resistant prostate cancer refers to cancer that continues to grow despite hormone therapy that suppresses testosterone to very low (castrate) levels. Metastatic disease means the cancer has spread beyond the prostate to other parts of the body, most commonly to bones, lymph nodes, lungs, or liver.
What distinguishes cabazitaxel from its predecessor docetaxel is its unique chemical structure. While both drugs are taxanes, cabazitaxel was specifically designed to have poor affinity for P-glycoprotein (P-gp), an efflux pump that cancer cells often upregulate to develop resistance to docetaxel. This means cabazitaxel can remain effective even when cancer cells have become resistant to docetaxel, making it a valuable second-line treatment option. The landmark TROPIC trial demonstrated that cabazitaxel significantly improves overall survival compared to mitoxantrone in men with mCRPC who had progressed after docetaxel therapy.
As part of your treatment regimen, you will also take a corticosteroid (prednisone 10 mg daily or prednisolone 10 mg daily) by mouth every day throughout the duration of cabazitaxel therapy. The corticosteroid helps manage certain side effects and complements the anticancer activity of cabazitaxel. Your oncologist will provide detailed instructions regarding this combination therapy.
Cabazitaxel Sandoz is manufactured by Sandoz A/S and is available as a generic equivalent to the original brand Jevtana. It contains 10 mg of cabazitaxel per milliliter of concentrate, supplied in vials of 45 mg (4.5 ml) or 60 mg (6 ml) for dilution before intravenous administration.
What Should You Know Before Taking Cabazitaxel Sandoz?
Contraindications
Cabazitaxel Sandoz must not be administered in the following circumstances:
- You are allergic to cabazitaxel, other taxanes (such as docetaxel or paclitaxel), polysorbate 80, or any of the other ingredients
- Your neutrophil count (a type of white blood cell) is too low — equal to or below 1,500 cells per cubic millimeter
- You have severely impaired liver function
- You have recently received or are about to receive a yellow fever vaccine
If any of these conditions apply, your oncologist will not proceed with cabazitaxel treatment. Before each treatment cycle, you will undergo blood tests to verify that your white blood cell count, liver function, and kidney function are adequate for safe administration. These routine monitoring tests are essential and cannot be skipped.
Warnings and Precautions
Your medical team will closely monitor you throughout cabazitaxel treatment, but it is critical that you promptly report certain symptoms. Contact your oncologist or seek immediate medical attention if you experience any of the following:
- Fever: This may be the earliest sign of a life-threatening infection called febrile neutropenia. During cabazitaxel treatment, your white blood cell count will likely decrease significantly, reducing your body's ability to fight infections. Your oncologist may prescribe granulocyte colony-stimulating factor (G-CSF) to help maintain adequate blood cell counts.
- Allergic reactions: Severe hypersensitivity reactions, including anaphylaxis, can occur during cabazitaxel infusion. Pre-medication with antihistamines, corticosteroids, and H2 antagonists is routinely administered to reduce this risk. If you have a history of allergic reactions, inform your medical team before treatment.
- Severe or prolonged diarrhea, nausea, or vomiting: These gastrointestinal symptoms can cause dangerous dehydration. Your medical team may need to provide intravenous fluids and adjust your anti-emetic medications.
- Numbness, tingling, burning, or decreased sensation in hands and feet: This peripheral neuropathy is a known side effect of taxane chemotherapy and should be reported so your dose can be adjusted if needed.
- Gastrointestinal bleeding or severe abdominal pain: Cabazitaxel may increase the risk of gastrointestinal perforation (a hole in the intestinal wall), which is a medical emergency. Report any unexplained abdominal pain, bloody stools, or black tarry stools immediately.
- Kidney problems: Report any significant changes in urine volume (increase or decrease), blood in urine, or difficulty urinating.
- Yellowing of skin or eyes, dark urine, severe nausea: These may indicate liver problems that require dose adjustment or treatment discontinuation.
Based on the severity of side effects, your oncologist may decide to reduce your cabazitaxel dose, delay the next treatment cycle, or discontinue therapy entirely. The goal is always to balance anticancer efficacy with manageable toxicity.
Pregnancy, Fertility, and Contraception
Cabazitaxel Sandoz is not indicated for use in women. However, for male patients receiving cabazitaxel, the following precautions are critically important:
- Contraception: Use condoms during sexual intercourse if your partner is or could become pregnant. Cabazitaxel may be present in semen and could potentially harm a developing fetus.
- Duration: Effective contraception must be used during treatment and for at least four months after the last dose of cabazitaxel.
- Fertility: Cabazitaxel may impair male fertility. You should seek advice about sperm preservation before starting treatment if you wish to father children in the future.
Driving and Operating Machinery
Cabazitaxel may cause fatigue, dizziness, or weakness that can impair your ability to drive or operate machinery. Do not drive or use heavy equipment until you know how the medicine affects you. If you experience these symptoms, wait until they resolve before engaging in activities that require alertness and coordination.
Cabazitaxel Sandoz concentrate contains ethanol (alcohol). The 45 mg vial contains approximately 891 mg of ethanol (equivalent to less than 22 ml of beer), and the 60 mg vial contains approximately 1,188 mg of ethanol (equivalent to approximately 30 ml of beer). These small amounts are generally not clinically significant, but patients with alcohol dependence, liver disease, or epilepsy should inform their healthcare provider before treatment.
How Does Cabazitaxel Sandoz Interact with Other Drugs?
Cabazitaxel is primarily metabolized in the liver by the cytochrome P450 enzyme CYP3A4/5. This means that other drugs which significantly inhibit or induce this enzyme can alter cabazitaxel blood levels, potentially increasing toxicity or reducing efficacy. Additionally, cabazitaxel itself may affect the metabolism of certain other medications. It is essential to inform your oncologist about all medicines you are taking, including prescription drugs, over-the-counter medicines, and herbal supplements.
Major Interactions (Avoid Concomitant Use or Use with Caution)
| Interacting Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | Strong CYP3A4 inhibitor | Increases cabazitaxel blood levels by up to 25%, raising toxicity risk | Avoid or use with close monitoring; dose reduction may be needed |
| Rifampicin | Strong CYP3A4 inducer | Significantly decreases cabazitaxel levels, reducing anticancer efficacy | Avoid concomitant use |
| Carbamazepine | Strong CYP3A4 inducer | Decreases cabazitaxel levels | Avoid concomitant use |
| Phenobarbital | Strong CYP3A4 inducer | Decreases cabazitaxel levels | Avoid concomitant use |
| Phenytoin | Strong CYP3A4 inducer | Decreases cabazitaxel levels | Avoid concomitant use |
| St. John's Wort (Hypericum perforatum) | Herbal CYP3A4 inducer | Decreases cabazitaxel levels unpredictably | Avoid completely during treatment |
Other Notable Interactions
Cabazitaxel may also interact with the following medications by affecting their metabolism or transport within the body:
| Interacting Drug | Type | Clinical Significance |
|---|---|---|
| Statins (simvastatin, lovastatin, atorvastatin, rosuvastatin, pravastatin) | Substrate of OATP1B1 | Cabazitaxel may increase statin levels, potentially increasing the risk of muscle-related side effects (myopathy); monitor for muscle pain |
| Valsartan | Substrate of OATP1B1/MRP2 | Cabazitaxel may alter valsartan levels; blood pressure monitoring recommended |
| Repaglinide | Substrate of OATP1B1/CYP2C8 | Cabazitaxel may affect repaglinide levels; blood glucose monitoring recommended in diabetic patients |
You should consult your oncologist before receiving any vaccinations while being treated with cabazitaxel. Live vaccines (such as yellow fever vaccine) are contraindicated because cabazitaxel suppresses the immune system, which could lead to severe or fatal infections from live vaccine strains. Inactivated vaccines may be given but their effectiveness may be reduced.
What Is the Correct Dosage of Cabazitaxel Sandoz?
Cabazitaxel Sandoz is always administered by trained healthcare professionals in a hospital or specialized oncology clinic. The dose is calculated based on your body surface area (BSA), which your oncologist determines using your height and weight. The concentrate must be diluted before administration and is given through a vein (intravenously) as an infusion over approximately one hour.
Adults
Standard Dosing Regimen
- Recommended dose: 25 mg/m² body surface area
- Reduced dose: 20 mg/m² body surface area (for patients with risk factors or in response to side effects)
- Frequency: Every 3 weeks (one treatment cycle = 21 days)
- Infusion duration: Approximately 1 hour
- Concurrent therapy: Prednisone 10 mg or prednisolone 10 mg orally every day throughout the treatment course
Pre-medication (Required Before Each Infusion)
To reduce the risk of allergic reactions and other adverse effects, the following pre-medications are given at least 30 minutes before each cabazitaxel infusion:
- Antihistamine: (e.g., dexchlorpheniramine 5 mg IV, or diphenhydramine 25 mg IV, or equivalent)
- Corticosteroid: (e.g., dexamethasone 8 mg IV or equivalent)
- H2 antagonist: (e.g., ranitidine IV or equivalent)
- Antiemetic: May also be given to prevent nausea and vomiting
Children
Cabazitaxel Sandoz has no relevant use in children. The safety and efficacy of cabazitaxel in pediatric patients have not been established. Metastatic castration-resistant prostate cancer does not occur in children, so this medicine is exclusively indicated for adult male patients.
Elderly Patients
No specific dose adjustment is required based solely on age. However, elderly patients (particularly those aged 65 years and older) are more likely to experience certain adverse effects, including neutropenia, fatigue, diarrhea, and dehydration. The PROSELICA trial demonstrated that the lower dose of 20 mg/m² may offer a more favorable benefit-risk profile in older patients while maintaining clinically meaningful efficacy. Your oncologist will consider your overall health status, organ function, and comorbidities when determining the appropriate dose.
Dose Modifications for Adverse Reactions
Your oncologist may modify the dose based on how you tolerate the treatment. Common dose modification guidelines include:
- Febrile neutropenia or prolonged neutropenia: Delay the next cycle until neutrophils recover to >1,500/mm³, then reduce dose from 25 to 20 mg/m² (or discontinue if already at 20 mg/m²)
- Grade 3 or higher diarrhea: Delay until resolved, then reduce dose
- Grade 3 or higher peripheral neuropathy: Delay until improved, then reduce dose
- Other grade 3 or higher non-hematologic toxicity: Delay until improved to grade 1 or baseline, then reduce dose
Missed Dose
Since cabazitaxel is administered by healthcare professionals on a scheduled basis, a missed dose is typically rescheduled at the earliest appropriate time. Do not attempt to compensate by receiving a double dose. Your oncologist will determine the best timing for the next infusion based on your blood counts and overall clinical status.
Overdose
There is no specific antidote for cabazitaxel overdose. In the event of an overdose, severe bone marrow suppression and gastrointestinal toxicity are expected. Treatment is supportive: patients would receive G-CSF for neutropenia, broad-spectrum antibiotics for infection, and intravenous fluids for dehydration. Cabazitaxel overdose should be managed in a specialized oncology or intensive care unit.
What Are the Side Effects of Cabazitaxel Sandoz?
Like all chemotherapy medicines, Cabazitaxel Sandoz can cause side effects, although not everyone experiences them. Your oncologist will discuss the potential risks and benefits of treatment with you before starting therapy. The severity and frequency of side effects can vary between individuals and may depend on the dose administered, the number of treatment cycles, and your overall health.
- Fever (high temperature) — may indicate life-threatening neutropenic infection
- Severe dehydration from prolonged diarrhea, vomiting, or fever
- Severe or persistent abdominal pain — may indicate gastrointestinal perforation, which can be fatal
Very Common
- Decreased red blood cells (anemia) causing tiredness and pallor
- Decreased white blood cells (neutropenia, leukopenia) increasing infection risk
- Decreased platelets (thrombocytopenia) increasing bleeding risk
- Loss of appetite (anorexia)
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Back pain
- Blood in urine (hematuria)
- Fatigue, weakness, or lack of energy (asthenia)
Common
- Febrile neutropenia (low white blood cells with fever and/or infection)
- Urinary tract infections
- Other infections or increased risk of infection
- Peripheral neuropathy (numbness, tingling, burning in hands and feet)
- Taste changes (dysgeusia)
- Headache, dizziness, balance problems
- Shortness of breath (dyspnea), cough
- Abdominal pain, heartburn, stomach discomfort
- Hemorrhoids, rectal bleeding
- Mouth sores, sore throat
- Temporary hair loss (alopecia)
- Joint pain (arthralgia), muscle spasms, muscle pain
- Painful or frequent urination, urinary incontinence
- Kidney problems
- High or low blood pressure
- Blood clots in legs (DVT) or lungs (PE)
- Rapid or irregular heartbeat (arrhythmia)
- Facial flushing
- High blood sugar (hyperglycemia)
- Insomnia, anxiety, mental confusion
- Swelling of feet or legs (peripheral edema)
- Chills
- Nail changes (discoloration or loosening)
Uncommon
- Low blood potassium (hypokalemia)
- Tinnitus (ringing in ears)
- Feeling of warmth in skin
- Skin redness (erythema)
- Radiation recall cystitis (bladder inflammation triggered by prior radiation therapy)
Frequency Not Known
- Interstitial lung disease (lung inflammation with cough and breathing difficulty)
Many of these side effects are manageable with supportive care medications. Your oncologist will prescribe anti-nausea drugs, pain medications, and other supportive therapies as needed. If you experience any side effect that is persistent, severe, or concerning, contact your medical team promptly. Do not attempt to manage serious symptoms on your own.
How Should You Store Cabazitaxel Sandoz?
Cabazitaxel Sandoz is a hospital-administered medicine, so storage is primarily handled by pharmacy and nursing staff. However, understanding the storage requirements is important for ensuring drug quality and safety:
- Unopened vials: Store at or below 25°C (77°F). Do not use after the expiration date printed on the carton and vial label.
- After opening (multi-dose vial): Stable for up to 28 days at room temperature (20–25°C), regardless of light protection. May also be stored in the refrigerator (2–8°C) protected from light.
- After dilution in infusion bag: Chemically stable for up to 3 days at room temperature (20–25°C) or up to 7 days in the refrigerator (2–8°C) protected from light, when diluted in glucose 5% or sodium chloride 0.9% at concentrations between 0.10 mg/ml and 0.26 mg/ml.
- Microbiological recommendation: The diluted infusion solution should be used immediately. If not used immediately, storage should normally not exceed 24 hours at 2–8°C unless dilution was performed under controlled, validated aseptic conditions.
Keep all medicines out of the sight and reach of children. Do not dispose of medicines through household waste or the sewage system. Ask your pharmacist about proper disposal methods to protect the environment. Cabazitaxel is classified as a cytotoxic agent and requires specialized handling and disposal procedures.
What Does Cabazitaxel Sandoz Contain?
Active Ingredient
Each milliliter of Cabazitaxel Sandoz concentrate contains 10 mg of cabazitaxel (in the form of cabazitaxel monohydrate). Two vial sizes are available:
- 45 mg vial: 4.5 ml of concentrate containing cabazitaxel monohydrate equivalent to 45 mg cabazitaxel
- 60 mg vial: 6 ml of concentrate containing cabazitaxel monohydrate equivalent to 60 mg cabazitaxel
Inactive Ingredients (Excipients)
- Polysorbate 80 — a surfactant that helps keep cabazitaxel in solution
- Anhydrous citric acid — a pH buffer to maintain solution stability
- Anhydrous ethanol — a co-solvent (approximately 19.8% v/v)
- Macrogol 300 (PEG 300) — a co-solvent that aids in solubility
Appearance and Packaging
Cabazitaxel Sandoz is a clear, colorless to slightly yellow solution packaged in clear, colorless Type I glass vials. The vials are sealed with a grey chlorobutyl rubber stopper coated with a fluoropolymer, capped with an aluminum seal and a plastic snap-off cap. It is available in packs of 1 or 5 vials (4.5 ml or 6 ml). Not all pack sizes may be marketed in all countries.
Cabazitaxel Sandoz requires only one dilution step before administration (no pre-dilution needed). It must be diluted in either glucose 5% or sodium chloride 0.9% to a final concentration between 0.10 and 0.26 mg/ml. An in-line filter with a 0.22-micrometer pore size must be used during infusion. Do not use PVC infusion containers or polyurethane infusion sets. The diluted solution should be inspected visually before use and discarded if crystallization is observed.
Frequently Asked Questions About Cabazitaxel Sandoz
Cabazitaxel Sandoz is a chemotherapy medicine used to treat metastatic castration-resistant prostate cancer (mCRPC) in adult men who have previously been treated with a docetaxel-containing chemotherapy regimen. It is always given in combination with oral corticosteroids (prednisone or prednisolone 10 mg daily). The drug works by disrupting the cancer cell's ability to divide by stabilizing microtubules, internal structural components that cells need for division.
Cabazitaxel is given as an intravenous (IV) infusion over approximately one hour in a hospital or specialized oncology clinic. It is diluted in glucose 5% or sodium chloride 0.9% before infusion. The standard dose is 25 mg/m² body surface area administered every three weeks. Before each infusion, you receive pre-medication including an antihistamine, a corticosteroid, and an H2 antagonist to minimize the risk of allergic reactions. You cannot take this medicine at home or self-administer it.
The most serious side effects include febrile neutropenia (dangerously low white blood cell count accompanied by fever and infection), severe dehydration from persistent diarrhea or vomiting, gastrointestinal perforation (a hole in the intestinal wall), severe allergic reactions (anaphylaxis), and interstitial lung disease. Febrile neutropenia can be life-threatening and requires immediate hospitalization with broad-spectrum antibiotics. Your oncologist monitors your blood counts before each treatment cycle to minimize this risk.
Cabazitaxel was specifically developed and approved as a second-line chemotherapy for prostate cancer after docetaxel failure. While both drugs are taxanes, cabazitaxel has a unique chemical modification that makes it less susceptible to the P-glycoprotein (P-gp) drug resistance pump. When prostate cancer cells develop resistance to docetaxel (often by upregulating P-gp), cabazitaxel can still effectively enter and kill these resistant cells. The TROPIC trial proved that cabazitaxel significantly improves survival in this post-docetaxel setting. Docetaxel is used first because it has a longer track record and is generally well-tolerated as first-line chemotherapy.
You should always inform your oncologist about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Certain drugs can significantly affect cabazitaxel levels: strong CYP3A4 inhibitors (like ketoconazole) can increase cabazitaxel toxicity, while strong CYP3A4 inducers (like rifampicin, carbamazepine, phenytoin, or St. John's Wort) can reduce its effectiveness. Cabazitaxel may also increase the blood levels of statins, valsartan, and repaglinide. Live vaccines must be avoided during treatment. Your oncologist will carefully review your medication list and make adjustments as needed.
The duration of treatment varies depending on how well the cancer responds and how well you tolerate the medicine. Treatment is given in cycles of every three weeks. In clinical trials, patients typically received up to 10 cycles of cabazitaxel, though some patients continued for more or fewer cycles. Your oncologist will assess your response through regular imaging (such as CT scans or bone scans) and blood tests (including PSA levels) and will decide when to continue or stop treatment based on these results and your overall clinical status.
References
This article is based on the following peer-reviewed sources and official prescribing information:
- de Bono JS, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial (TROPIC). The Lancet. 2010;376(9747):1147-1154. doi:10.1016/S0140-6736(10)61389-X
- Eisenberger M, et al. Phase III study comparing a reduced dose of cabazitaxel (20 mg/m²) and the currently approved dose (25 mg/m²) in postdocetaxel patients with metastatic castration-resistant prostate cancer (PROSELICA). Journal of Clinical Oncology. 2017;35(28):3198-3206. doi:10.1200/JCO.2016.72.1076
- European Medicines Agency (EMA). Cabazitaxel — Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Jevtana (cabazitaxel) — Prescribing Information. Available at: www.accessdata.fda.gov. Accessed January 2026.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 4.2025. Available at: www.nccn.org. Accessed January 2026.
- European Society for Medical Oncology (ESMO). Prostate Cancer: ESMO Clinical Practice Guidelines. Annals of Oncology. 2025;36(3):312-330.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List. Geneva: WHO; 2023.
- British National Formulary (BNF). Cabazitaxel. Available at: bnf.nice.org.uk. Accessed January 2026.
Medical Editorial Team
This article has been written and reviewed by our medical editorial team, comprising licensed specialist physicians in oncology, urology, and clinical pharmacology.
iMedic Medical Editorial Team
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All content follows the iMedic Editorial Standards and is based on international guidelines (ESMO, NCCN, EMA, FDA). Our team has no conflicts of interest and receives no pharmaceutical industry funding.