Cabazitaxel Medical Valley
Taxane chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
Cabazitaxel Medical Valley is a taxane-class chemotherapy medicine containing cabazitaxel 60 mg as a concentrate for solution for infusion. It is used in combination with prednisone or prednisolone to treat metastatic castration-resistant prostate cancer (mCRPC) in adult men who have previously received docetaxel-based chemotherapy. This medicine must be administered intravenously in a hospital setting under specialist supervision.
Quick Facts
Key Takeaways
- Cabazitaxel Medical Valley is a second-line taxane chemotherapy specifically designed to treat metastatic prostate cancer that has progressed after docetaxel treatment.
- It is always given as an intravenous infusion in a hospital or specialist clinic setting, combined with oral prednisone or prednisolone.
- Pre-medication with antihistamines, corticosteroids, and an H2 antagonist is required before each infusion to reduce the risk of allergic reactions.
- Neutropenia (low white blood cell count) is the most clinically significant side effect, requiring regular blood count monitoring throughout treatment.
- The TROPIC and PROSELICA trials demonstrated significant survival benefits, establishing cabazitaxel as a standard-of-care option for post-docetaxel mCRPC.
What Is Cabazitaxel Medical Valley and What Is It Used For?
Cabazitaxel Medical Valley contains the active substance cabazitaxel, a semisynthetic taxane derived from a natural precursor extracted from yew tree needles. It belongs to the same broad class of chemotherapy agents as docetaxel and paclitaxel, but has been specifically engineered to retain activity against tumours that have developed resistance to docetaxel. This characteristic makes it a critically important treatment option in the management of advanced prostate cancer.
Prostate cancer is the second most commonly diagnosed cancer in men worldwide, according to the World Health Organization (WHO). While many prostate cancers respond to initial hormonal therapy (androgen deprivation therapy), some tumours eventually stop responding to hormonal treatments and continue to grow despite low testosterone levels. This stage is known as castration-resistant prostate cancer (CRPC). When CRPC has spread to other parts of the body (metastasised), it is classified as metastatic castration-resistant prostate cancer (mCRPC).
For patients with mCRPC, docetaxel-based chemotherapy has been the established first-line chemotherapy option since 2004. However, disease progression during or after docetaxel treatment presents a significant clinical challenge. Cabazitaxel was developed to address this unmet medical need. Its molecular structure includes a modification at two hydroxyl group positions that reduces its affinity for P-glycoprotein, a cellular pump responsible for expelling many chemotherapy drugs from cancer cells. This means cabazitaxel can effectively kill cancer cells that have learned to resist docetaxel through this mechanism.
The European Medicines Agency (EMA) granted marketing authorisation for cabazitaxel in March 2011, based primarily on the results of the landmark TROPIC trial. This phase III randomised controlled trial enrolled 755 patients with mCRPC previously treated with docetaxel, demonstrating a statistically significant improvement in overall survival for patients receiving cabazitaxel plus prednisone compared with mitoxantrone plus prednisone (median overall survival 15.1 months vs. 12.7 months; hazard ratio 0.70; p<0.0001).
Mechanism of Action
Cabazitaxel exerts its antineoplastic effect by binding to tubulin, a structural protein that forms microtubules within cells. Microtubules are essential components of the cell's internal scaffolding (cytoskeleton) and play a critical role during cell division (mitosis). By promoting the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly, cabazitaxel effectively "freezes" the microtubule network. This prevents the cancer cell from completing cell division, ultimately triggering programmed cell death (apoptosis).
Unlike docetaxel, cabazitaxel demonstrates activity in cell lines and tumour models that overexpress drug-efflux pumps, particularly P-glycoprotein (ABCB1) and breast cancer resistance protein (BCRP). This pharmacological property is the key differentiator that makes cabazitaxel effective in the post-docetaxel setting, where tumour cells may have acquired resistance through upregulation of these efflux transporters.
What Should You Know Before Receiving Cabazitaxel Medical Valley?
Contraindications
Cabazitaxel Medical Valley must not be used in the following situations:
- Hypersensitivity: Known severe hypersensitivity to cabazitaxel, other taxanes (including docetaxel or paclitaxel), polysorbate 80, or any of the excipients.
- Neutropenia: Neutrophil count below 1,500 cells/mm³ at baseline. Adequate bone marrow function is essential for safe treatment.
- Severe hepatic impairment: Patients with total bilirubin greater than 3 times the upper limit of normal (ULN), or AST and/or ALT greater than 1.5 times ULN.
- Vaccination: Concurrent vaccination with live or live-attenuated vaccines is contraindicated due to the immunosuppressive effects of cabazitaxel.
Warnings and Precautions
Cabazitaxel must only be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Adequate treatment facilities for managing complications, particularly severe neutropenia and hypersensitivity reactions, must be readily available.
Bone marrow suppression: Neutropenia is the most clinically significant adverse effect. The risk of neutropenic complications (febrile neutropenia, neutropenic infection, neutropenic sepsis) is increased in patients with risk factors such as age over 65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation therapy, poor nutritional status, or other serious comorbidities. Prophylactic use of granulocyte colony-stimulating factor (G-CSF) should be considered in high-risk patients from the first cycle onwards, in accordance with current ASCO/EORTC/ESMO guidelines.
Hypersensitivity reactions: Severe hypersensitivity reactions, including generalised rash, erythema, hypotension, and bronchospasm, can occur. Pre-medication is mandatory before each cycle (see dosage section). Patients should be closely monitored during and after each infusion, particularly during the first and second infusions. Severe reactions require immediate discontinuation and appropriate therapy.
Gastrointestinal disorders: Severe diarrhoea, including potentially life-threatening cases with dehydration, electrolyte imbalance, and renal failure, has been reported. Patients should be advised to contact their healthcare team promptly if severe diarrhoea develops. Appropriate rehydration and anti-diarrhoeal therapy should be initiated early. Treatment delay or dose reduction may be necessary.
Renal disorders: Renal failure cases have been reported, usually associated with sepsis, dehydration, or obstructive uropathy. Renal function should be monitored regularly. Adequate hydration should be maintained throughout treatment.
Respiratory disorders: Interstitial pneumonia/pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS) have been reported. If new or worsening pulmonary symptoms develop, cabazitaxel should be interrupted pending evaluation.
Pregnancy and Breastfeeding
Cabazitaxel is indicated only for adult males with prostate cancer. However, the following reproductive safety information is important:
- Contraception in males: Male patients should use effective contraception during treatment and for at least 4 months after the last dose due to potential genotoxicity.
- Fertility: Based on non-clinical findings, cabazitaxel may impair male fertility. Men should be advised to seek counselling about sperm preservation before starting treatment.
- Exposure during pregnancy: Pregnant women or women of childbearing potential should avoid handling or being exposed to cabazitaxel. In the event of accidental exposure, medical advice should be sought immediately.
Elderly Patients
Patients aged 65 years and over are at increased risk of adverse effects, including neutropenia and febrile neutropenia. In the TROPIC trial, patients aged 65 or above had a higher incidence of grade 3-4 neutropenia (97.3%) compared with younger patients (92.7%). The PROSELICA trial provided evidence supporting the use of a lower dose (20 mg/m²) as a viable option, which may be particularly relevant for elderly patients. Close monitoring and consideration of primary prophylaxis with G-CSF are recommended in this population.
How Does Cabazitaxel Medical Valley Interact with Other Drugs?
Cabazitaxel is extensively metabolised in the liver, primarily by the cytochrome P450 enzyme CYP3A4, with a minor contribution from CYP3A5. This means that other medicines that inhibit or induce these enzymes can significantly alter cabazitaxel blood levels, potentially leading to increased toxicity or decreased efficacy. Understanding these interactions is critical for safe and effective treatment.
In a dedicated drug interaction study, co-administration of cabazitaxel with ketoconazole (a strong CYP3A4 inhibitor) increased the area under the curve (AUC) of cabazitaxel by approximately 20%. While this increase was considered moderate, caution is warranted, and strong CYP3A4 inhibitors should generally be avoided during cabazitaxel treatment.
Major Interactions
| Drug/Class | Type | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | Strong CYP3A4 inhibitor | Increases cabazitaxel AUC by ~20% | Avoid; use alternative antifungal |
| Itraconazole | Strong CYP3A4 inhibitor | Expected to increase cabazitaxel exposure | Avoid; consider dose reduction if essential |
| Ritonavir / Cobicistat | Strong CYP3A4 inhibitor | Significantly increases cabazitaxel exposure | Avoid concomitant use |
| Rifampicin | Strong CYP3A4 inducer | Decreases cabazitaxel AUC significantly | Avoid; may reduce efficacy |
| Phenytoin | Strong CYP3A4 inducer | Decreases cabazitaxel exposure | Avoid or consider alternative anticonvulsant |
| Carbamazepine | Strong CYP3A4 inducer | Decreases cabazitaxel exposure | Avoid; use alternative anticonvulsant |
| St John's Wort | CYP3A4 inducer (herbal) | Decreases cabazitaxel exposure | Avoid during treatment |
| Live vaccines | Immunisation | Risk of systemic vaccine-related disease | Contraindicated during treatment |
Minor Interactions
Moderate CYP3A4 inhibitors such as aprepitant, erythromycin, fluconazole, verapamil, and diltiazem may modestly increase cabazitaxel exposure. While concomitant use is not strictly contraindicated, enhanced monitoring for adverse effects is recommended. Grapefruit juice should also be avoided as it can inhibit intestinal CYP3A4, though the clinical significance for an intravenously administered drug is likely minimal.
Cabazitaxel is also a substrate of the drug transporter P-glycoprotein (P-gp). However, at clinically relevant concentrations, it is unlikely to inhibit P-gp-mediated transport of other drugs. In vitro studies have shown that cabazitaxel does not inhibit CYP enzymes at clinically relevant concentrations, so it is unlikely to significantly affect the metabolism of other medicines.
Patients receiving concomitant warfarin should have their INR monitored more frequently during cabazitaxel treatment. Although a direct pharmacokinetic interaction has not been established, the overall impact of chemotherapy on vitamin K metabolism and nutritional status may alter warfarin requirements.
What Is the Correct Dosage of Cabazitaxel Medical Valley?
Cabazitaxel Medical Valley must only be administered in a specialist oncology setting by healthcare professionals experienced in the use of antineoplastic agents. The dose is calculated based on body surface area (BSA), which takes into account the patient's height and weight. Treatment is given in repeated cycles, with each cycle lasting three weeks (21 days).
Adults
Standard Dose Regimen
Cabazitaxel: 25 mg/m² BSA administered as a one-hour intravenous infusion on Day 1 of each 21-day cycle.
Alternative dose: 20 mg/m² BSA, supported by the PROSELICA trial which demonstrated non-inferior overall survival compared to 25 mg/m² with a more favourable safety profile.
Prednisone/Prednisolone: 10 mg orally administered daily throughout the treatment period.
Mandatory Pre-medication (Before Each Cycle)
The following pre-medication must be administered at least 30 minutes before each cabazitaxel infusion:
- Antihistamine: Dexchlorpheniramine 5 mg, diphenhydramine 25 mg, or equivalent
- Corticosteroid: Dexamethasone 8 mg or equivalent
- H2 antagonist: Ranitidine or equivalent
- Antiemetic: May be given as needed
| Patient Group | Recommended Dose | Cycle Length | Special Considerations |
|---|---|---|---|
| Adults (standard risk) | 25 mg/m² IV | Every 21 days | Monitor CBC weekly in cycle 1 |
| Adults (high risk / elderly) | 20 mg/m² IV | Every 21 days | Consider G-CSF prophylaxis from cycle 1 |
| Mild hepatic impairment | 20 mg/m² IV (max) | Every 21 days | Close monitoring; dose adjustment may be needed |
| Moderate hepatic impairment | 15 mg/m² IV (max) | Every 21 days | Limited data; use with caution |
| Severe hepatic impairment | Contraindicated | N/A | Do not administer |
Children
Cabazitaxel Medical Valley is not indicated for use in children and adolescents under 18 years of age. There is no relevant use of cabazitaxel in the paediatric population for the treatment of metastatic castration-resistant prostate cancer. Safety and efficacy have not been established in this age group.
Elderly Patients
No specific dose adjustment is required based on age alone. However, elderly patients (aged 65 and above) are at higher risk of adverse effects, particularly neutropenia. The PROSELICA trial results support the use of the 20 mg/m² dose in patients where a more conservative approach is appropriate, including many elderly patients. Primary G-CSF prophylaxis should be considered in patients aged 65 and older, in line with international guidelines (ASCO, EORTC, ESMO).
Dose Modifications for Toxicity
Dose modifications may be required based on individual patient tolerance. The following guidelines apply:
- Febrile neutropenia or prolonged grade 3-4 neutropenia (>1 week): Delay treatment until neutrophils recover to ≥1,500/mm³, then reduce dose by one dose level (25→20 mg/m² or 20→15 mg/m²). Use G-CSF prophylaxis in subsequent cycles.
- Grade 3 diarrhoea or diarrhoea requiring IV hydration: Delay treatment until improvement or resolution, then reduce dose by one level.
- Grade 2 peripheral neuropathy: Delay until improvement to grade ≤1, then reduce dose.
- Any grade 3-4 non-haematological toxicity: Delay until resolution to grade ≤1, then reduce dose.
Patients requiring dose reduction below 15 mg/m² should discontinue cabazitaxel treatment.
Missed Dose
Since cabazitaxel is administered in a clinical setting every three weeks, missed doses are managed by the treating oncology team. If a treatment cycle is delayed due to toxicity or logistical reasons, the next dose should be given as soon as conditions permit, and subsequent cycles should maintain the 21-day interval. There is no need to "double up" or make up for a missed cycle.
Overdose
There is no specific antidote for cabazitaxel overdose. The primary complications expected from overdose are exaggerated pharmacological effects, particularly bone marrow suppression (severe neutropenia) and gastrointestinal toxicity. In the event of overdose, the patient should be hospitalised and receive supportive care, including G-CSF therapy, close haematological monitoring, and management of infections. Antibiotic prophylaxis may be warranted.
What Are the Side Effects of Cabazitaxel Medical Valley?
Like all chemotherapy medicines, cabazitaxel can cause side effects, although not everybody gets them. In clinical trials, the most frequently reported adverse effects were haematological toxicities (particularly neutropenia) and gastrointestinal disturbances. Understanding the frequency and nature of these side effects is important for patients and their families to recognise symptoms early and seek appropriate medical attention.
The side effect profile of cabazitaxel has been well characterised through multiple clinical trials, including the pivotal TROPIC trial (n=371 cabazitaxel-treated patients) and the PROSELICA trial (n=1,200 patients). The following categorisation is based on pooled safety data from these and other studies, using the standard medical frequency convention.
Very Common
Affects more than 1 in 10 patients (>10%)
- Neutropenia (low white blood cells) – up to 94% of patients
- Anaemia (low red blood cells)
- Leucopenia (low total white blood cells)
- Thrombocytopenia (low platelet count)
- Diarrhoea
- Fatigue and asthenia (weakness)
- Nausea
- Vomiting
- Constipation
- Abdominal pain
- Haematuria (blood in urine)
- Back pain
- Decreased appetite
- Arthralgia (joint pain) and myalgia (muscle pain)
- Peripheral neuropathy (numbness/tingling)
- Alopecia (hair loss)
Common
Affects 1 to 10 in 100 patients (1–10%)
- Febrile neutropenia
- Urinary tract infection
- Dysgeusia (altered taste)
- Dyspnoea (shortness of breath)
- Cough
- Dehydration
- Peripheral oedema (swelling)
- Pyrexia (fever)
- Dizziness
- Headache
- Mucosal inflammation (mouth sores)
- Dysuria (painful urination)
- Renal failure
- Cardiac arrhythmia
Uncommon
Affects 1 to 10 in 1,000 patients (0.1–1%)
- Neutropenic sepsis
- Interstitial pneumonia/pneumonitis
- Gastrointestinal perforation
- Gastrointestinal haemorrhage
- Colitis and enterocolitis
- Severe hypersensitivity/anaphylaxis
- Interstitial lung disease
- Cystitis
Rare
Affects fewer than 1 in 1,000 patients (<0.1%)
- Acute respiratory distress syndrome (ARDS)
- Radiation recall dermatitis
- Cerebrovascular events
Contact your healthcare team or go to the nearest emergency department immediately if you experience: fever above 38°C (especially within 7-14 days after treatment), signs of infection (sore throat, chills, burning on urination), severe or persistent diarrhoea, blood in stools, severe breathing difficulties, signs of allergic reaction (rash, swelling, difficulty breathing), or chest pain.
Managing Common Side Effects
Neutropenia: This is the most clinically significant side effect. Your oncology team will perform regular blood tests (complete blood count) to monitor your white blood cell levels. If neutropenia is severe, treatment may be delayed, the dose reduced, or G-CSF (granulocyte colony-stimulating factor) may be administered to help your bone marrow produce more white blood cells. During periods of low neutrophil counts, it is important to practice good hand hygiene, avoid crowded places, and avoid contact with people who have infections.
Diarrhoea: Diarrhoea can occur at any time during treatment and may be severe. Stay well hydrated with clear fluids, avoid spicy or fatty foods, and take anti-diarrhoeal medication (such as loperamide) as directed by your healthcare team. If diarrhoea persists for more than 24 hours or is accompanied by fever, contact your doctor promptly.
Nausea and vomiting: Antiemetic medications will typically be prescribed alongside your treatment. Eating small, frequent meals and avoiding strong-smelling foods can help manage nausea. Your pre-medication regimen includes corticosteroids which also have anti-emetic properties.
Fatigue: Fatigue is one of the most common side effects and may be cumulative over treatment cycles. Light physical activity, maintaining a regular sleep schedule, and planning rest periods around your treatment days can help manage fatigue. Report persistent or severe fatigue to your healthcare team.
How Should Cabazitaxel Medical Valley Be Stored?
As an intravenous chemotherapy medicine, Cabazitaxel Medical Valley is stored and prepared exclusively in hospital pharmacy departments or specialised chemotherapy preparation units. Patients do not need to store this medicine at home. However, understanding the storage requirements provides insight into the care taken to ensure the medicine's quality and safety.
The unopened vial of Cabazitaxel Medical Valley concentrate should be stored at temperatures not exceeding 30°C. It must not be refrigerated or frozen. The vial should be kept in the outer carton to protect from light. The concentrate has a shelf life as indicated on the packaging when stored under these conditions.
After the initial dilution step (mixing the concentrate with the supplied solvent), the resulting solution should be used immediately. If not used immediately, the pre-mix solution is stable for up to 1 hour at room temperature. After the second dilution step (adding to an infusion bag of 0.9% sodium chloride or 5% glucose solution), the infusion solution is stable for 8 hours at room temperature (including the one-hour infusion time) or for 48 hours under refrigeration (2-8°C, including the one-hour infusion time).
As with all cytotoxic medicines, cabazitaxel must be handled with appropriate precautions. Healthcare professionals should wear protective clothing including gloves, goggles, and a gown during preparation. All preparation should ideally take place in a dedicated cytotoxic preparation area with appropriate ventilation (biological safety cabinet). Spills must be managed according to institutional cytotoxic spill procedures.
What Does Cabazitaxel Medical Valley Contain?
Cabazitaxel Medical Valley is supplied as a concentrate and solvent for solution for infusion. Understanding the composition is important for healthcare professionals, particularly for identifying potential allergenicity risks and ensuring safe preparation.
Active Substance
Each vial of concentrate contains 60 mg of cabazitaxel. Cabazitaxel is a semisynthetic taxane with the chemical name (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate. Its molecular formula is C45H57NO14 and it has a molecular weight of 835.93 g/mol.
Excipients
- In the concentrate: Polysorbate 80 (an emulsifying agent that aids solubility; also known as Tween 80) and citric acid (as a pH buffer)
- In the solvent: Ethanol 96% (approximately 573 mg per vial of solvent) and water for injections
The solvent contains ethanol (alcohol). At the recommended dose, a patient receives approximately 15% of the volume of ethanol (alcohol) equivalent to approximately 18 mL of beer or 7 mL of wine per treatment. This should be considered in patients with alcohol dependence, epilepsy, liver disease, or pregnant women (note: cabazitaxel is indicated only for men, but accidental exposure should be considered).
Appearance
The cabazitaxel concentrate is a clear, yellow to brownish-yellow oily solution. The solvent is a clear, colourless solution. After mixing, the resulting solution should be inspected visually for particulate matter and discolouration prior to administration. Only clear, particle-free solutions should be used.
Frequently Asked Questions About Cabazitaxel Medical Valley
References
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- Eisenberger M, Hardy-Bessard AC, Kim CS, 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. J Clin Oncol. 2017;35(28):3198-3206. doi:10.1200/JCO.2016.72.1076
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Medical Editorial Team
This article has been written and reviewed by iMedic's medical editorial team, comprising specialist physicians with expertise in oncology, urology, and clinical pharmacology. Our team follows international clinical guidelines from the EMA, FDA, NCCN, and ESMO, and adheres to the GRADE evidence framework to ensure the highest quality of medical information.
Written by medical professionals with expertise in oncology pharmacotherapy and evidence-based medicine. All clinical claims are supported by peer-reviewed literature and current prescribing information.
Independently reviewed by the iMedic Medical Review Board. Verified against current EMA SmPC, FDA prescribing information, NCCN guidelines, and ESMO clinical practice guidelines.