Cabazitaxel EVER Pharma: Uses, Dosage & Side Effects

What Is Cabazitaxel EVER Pharma and What Is It Used For?

Cabazitaxel EVER Pharma contains cabazitaxel, a semi-synthetic taxane that works by binding to tubulin and stabilizing microtubules, which prevents cancer cells from dividing and growing. It is specifically effective against prostate cancer cells that have developed resistance to docetaxel, because cabazitaxel has low affinity for the P-glycoprotein efflux pump that commonly drives taxane resistance.

Cabazitaxel EVER Pharma is a prescription-only chemotherapy medication used to treat metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed during or after docetaxel-based treatment. Prostate cancer remains the second most commonly diagnosed cancer in men worldwide, with an estimated 1.4 million new cases diagnosed annually according to the World Health Organization. While many prostate cancers respond to initial hormonal therapies and first-line chemotherapy, a significant proportion eventually develops resistance, creating an urgent need for effective second-line treatments.

The taxane class of chemotherapy agents, which includes paclitaxel, docetaxel, and cabazitaxel, works by disrupting the normal function of microtubules — dynamic protein filaments that form the mitotic spindle during cell division. During normal cell division, microtubules assemble and disassemble in a carefully regulated cycle. Taxanes bind to beta-tubulin subunits and promote microtubule assembly while simultaneously preventing disassembly. This stabilization of microtubules locks the cell in the mitotic phase, preventing successful cell division and ultimately leading to cell death (apoptosis).

Docetaxel was the first chemotherapy agent to demonstrate an overall survival benefit in metastatic castration-resistant prostate cancer, and it remains the standard first-line chemotherapy for this indication. However, many patients eventually develop resistance to docetaxel. One of the most common resistance mechanisms involves the overexpression of multidrug resistance protein 1 (MDR1), also known as P-glycoprotein (P-gp). This efflux pump actively transports docetaxel out of cancer cells before the drug can reach its intracellular target, rendering the treatment ineffective.

Cabazitaxel was specifically engineered to address this challenge. Unlike docetaxel, cabazitaxel has very low affinity for the P-glycoprotein efflux pump. This means that even in cancer cells that have upregulated P-gp expression and become resistant to docetaxel, cabazitaxel can still accumulate to therapeutic concentrations within the cell and exert its anti-tumor effects. The pivotal TROPIC trial (Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated with a Taxane-Containing Regimen) demonstrated that cabazitaxel significantly improved overall survival compared to mitoxantrone in men with mCRPC who had progressed after docetaxel, with a median overall survival of 15.1 months versus 12.7 months.

Approved Indications

Cabazitaxel EVER Pharma is approved for the following indication based on marketing authorization from the European Medicines Agency (EMA) and equivalent regulatory bodies worldwide:

• Metastatic castration-resistant prostate cancer (mCRPC): Treatment of adult men with mCRPC who have previously been treated with a docetaxel-containing regimen. Cabazitaxel is used in combination with prednisone or prednisolone and ongoing androgen deprivation therapy (ADT).

In clinical practice, cabazitaxel may also be considered as an alternative to docetaxel re-challenge in patients who had an initial response to docetaxel but subsequently progressed. The CARD trial demonstrated that cabazitaxel provided superior outcomes compared to either abiraterone or enzalutamide in patients with mCRPC who had previously received docetaxel and the alternative androgen receptor-targeted agent. This has established cabazitaxel as an important option in the sequential treatment of advanced prostate cancer.

The Role of Prednisone or Prednisolone

As part of your cabazitaxel treatment, your oncologist will prescribe daily oral prednisone or prednisolone (typically 10 mg daily, either as 10 mg once daily or 5 mg twice daily). This corticosteroid co-therapy serves several important functions in combination with cabazitaxel:

• Anti-inflammatory effects: Prednisone helps manage inflammation-related symptoms that are common in advanced prostate cancer, including pain, fatigue, and reduced appetite
• Modest anti-tumor activity: Corticosteroids have a minor but documented effect on prostate-specific antigen (PSA) levels and can contribute to disease control in castration-resistant prostate cancer
• Symptom management: The corticosteroid helps improve general well-being, appetite, and energy levels during chemotherapy treatment
• Part of the established regimen: Prednisone or prednisolone was included in the pivotal clinical trials that established the efficacy and safety of cabazitaxel, and its use is part of the approved treatment protocol

What Should You Know Before Taking Cabazitaxel EVER Pharma?

Before receiving cabazitaxel, your doctor will perform comprehensive blood tests to ensure your white blood cell count, liver function, and kidney function are adequate for safe treatment. Cabazitaxel must not be given to patients with severely low neutrophil counts, severe liver impairment, or those with a known allergy to taxanes or polysorbate 80.

Cabazitaxel EVER Pharma is a potent cytotoxic chemotherapy agent, and its administration requires thorough medical assessment before, during, and after each treatment cycle. Understanding the contraindications, warnings, and precautions is essential for ensuring safe treatment and optimal outcomes. Your oncology team will evaluate multiple parameters before determining that you are eligible for cabazitaxel therapy.

Contraindications

You must not receive Cabazitaxel EVER Pharma if any of the following conditions apply:

• Allergy to cabazitaxel or other taxanes: If you have a known hypersensitivity to cabazitaxel, other taxanes (such as paclitaxel or docetaxel), polysorbate 80 (an excipient in the formulation), or any other component of the product. Patients who have experienced severe hypersensitivity reactions to docetaxel require particularly careful evaluation before cabazitaxel is considered.
• Low neutrophil count: Cabazitaxel must not be administered if your neutrophil count is at or below 1,500 cells per cubic millimeter (1,500/mm³). Neutrophils are a critical type of white blood cell that fights bacterial infections, and starting chemotherapy with an already low count would create an unacceptable risk of life-threatening infections.
• Severe liver impairment: Patients with severely impaired liver function must not receive cabazitaxel. The drug is extensively metabolized in the liver, primarily by the CYP3A4/5 enzyme system, and impaired hepatic function can lead to dangerously elevated drug levels, increasing the risk of severe toxicity.
• Recent or planned yellow fever vaccination: Cabazitaxel suppresses the immune system, and live vaccines such as the yellow fever vaccine could cause a potentially fatal systemic infection in immunocompromised patients. All live vaccines are generally contraindicated during cabazitaxel treatment.

Warnings and Precautions

Before each treatment cycle, your oncology team will assess your overall condition and perform laboratory tests to ensure it is safe to proceed. The following conditions and situations require special attention and monitoring during cabazitaxel therapy:

• Bone marrow suppression (myelosuppression): Cabazitaxel frequently causes severe reductions in blood cell counts, particularly neutrophils (neutropenia). This is the most common dose-limiting toxicity. During the first treatment cycle, your blood counts will be monitored weekly. Febrile neutropenia (low neutrophil count combined with fever) is a potentially life-threatening complication that requires immediate hospitalization and intravenous antibiotic therapy. Your doctor may prescribe granulocyte colony-stimulating factor (G-CSF) to help prevent severe neutropenia, particularly if you are at high risk.
• Hypersensitivity reactions: Severe allergic reactions, including anaphylaxis, can occur during cabazitaxel infusion despite premedication. Your infusion will be administered in a setting equipped to manage anaphylaxis, and you will be monitored closely during and immediately after each infusion. If a severe reaction occurs, the infusion will be stopped immediately and appropriate emergency treatment administered.
• Gastrointestinal toxicity: Cabazitaxel can cause severe diarrhea, nausea, and vomiting. In rare cases, it may cause gastrointestinal perforation (a hole forming in the wall of the stomach or intestines) or gastrointestinal bleeding, both of which can be fatal. Dehydration from persistent diarrhea or vomiting can be severe and requires prompt rehydration treatment.
• Kidney problems: Cabazitaxel can cause kidney injury, which may be related to severe dehydration, infections, or the effects of the tumor itself. Patients with pre-existing kidney disease or those who develop kidney problems during treatment require careful monitoring and may need dose adjustments.
• Peripheral neuropathy: Cabazitaxel can cause damage to the peripheral nerves, resulting in numbness, tingling, burning sensations, or weakness in the hands and feet. Patients who already have peripheral neuropathy from previous chemotherapy (e.g., docetaxel) may be at higher risk of worsening symptoms.
• Liver function: Although less hepatotoxic than some other chemotherapy agents, cabazitaxel requires adequate liver function for safe metabolism. Patients with elevated liver enzymes or bilirubin should be closely monitored, and dose reductions may be necessary.

Drug Interactions Before Starting Treatment

Before receiving your first cabazitaxel infusion, inform your oncologist and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medications, dietary supplements, and herbal remedies. Certain drugs can significantly affect how cabazitaxel is metabolized in your body, potentially increasing toxicity or reducing efficacy. Of particular importance are strong CYP3A4 inhibitors (such as ketoconazole) and strong CYP3A4 inducers (such as rifampicin, phenytoin, or St. John’s Wort).

Pregnancy, Breastfeeding, and Fertility

Cabazitaxel EVER Pharma is a cytotoxic drug that can cause serious harm to a developing fetus. Although cabazitaxel is indicated only for adult male patients, the following precautions are essential to protect partners and family members:

• Use of condoms: Men receiving cabazitaxel must use a condom during sexual intercourse throughout treatment and for at least 6 months after the last dose. Cabazitaxel may be present in semen and could pose a risk to a partner or developing fetus
• Avoid fathering a child: Do not attempt to conceive a child during treatment and for at least 6 months after your last cabazitaxel infusion, as the drug may damage sperm and affect fetal development
• Fertility preservation: Cabazitaxel may impair male fertility. Discuss sperm banking with your oncology team before starting treatment if preserving fertility is important to you
• Not for use in women: Cabazitaxel EVER Pharma is not indicated for use in women. It should not be used during pregnancy or breastfeeding under any circumstances

Driving and Operating Machinery

Cabazitaxel can cause fatigue, dizziness, and general weakness that may impair your ability to drive or operate machinery safely. If you experience any of these symptoms, do not drive or use tools or machinery until you feel well enough. You are personally responsible for assessing your fitness to drive or perform tasks requiring alertness. The effects of fatigue and other side effects from cabazitaxel treatment may persist for several days after each infusion cycle.

Important Information About Excipients

Cabazitaxel EVER Pharma contains several excipients that patients should be aware of:

• Polysorbate 80: A component that can rarely cause hypersensitivity reactions in sensitive individuals
• Ethanol (alcohol): Each vial contains a significant amount of alcohol. The 4.5 ml vial contains approximately 889 mg of ethanol (equivalent to approximately 22.5 ml of beer or 9.4 ml of wine). The 5 ml vial contains approximately 988 mg, and the 6 ml vial contains approximately 1,185 mg of ethanol. While these amounts are unlikely to cause noticeable effects in most adults, this information is important for patients with alcohol dependence or those taking medications that interact with alcohol. Discuss this with your doctor or pharmacist
• Macrogol and citric acid: Additional excipients used in the formulation

How Does Cabazitaxel EVER Pharma Interact with Other Drugs?

Cabazitaxel is primarily metabolized by the liver enzyme CYP3A4/5. Strong inhibitors of this enzyme (such as ketoconazole) can increase cabazitaxel levels and toxicity, while strong inducers (such as rifampicin, carbamazepine, or St. John’s Wort) can decrease cabazitaxel levels and reduce its effectiveness. Additionally, cabazitaxel may affect the blood levels of certain statins, blood pressure medications, and diabetes drugs.

Drug interactions with cabazitaxel primarily occur through the cytochrome P450 3A (CYP3A4/5) enzyme system, which is the main metabolic pathway for cabazitaxel in the liver. Medications that inhibit or induce CYP3A4/5 can significantly alter cabazitaxel blood levels, potentially increasing toxicity or reducing therapeutic efficacy. In addition, cabazitaxel itself can affect the transport and metabolism of certain other medications through interactions with organic anion-transporting polypeptides (OATP1B1) and multidrug resistance-associated proteins.

It is critically important that you inform your oncologist and hospital pharmacist about all medications you are currently taking, including over-the-counter drugs, herbal products, and dietary supplements, before each treatment cycle. Some interactions may require dose adjustments, temporary discontinuation of interacting medications, or the selection of alternative drugs.

Major Interactions

The following drug interactions are considered clinically significant and may require dosage modifications, avoidance of the combination, or intensified monitoring:

Other Notable Interactions

Cabazitaxel may also affect the blood levels or activity of the following medications. While these interactions may be less severe, your doctor should still be informed if you are taking any of these drugs:

What Is the Correct Dosage of Cabazitaxel EVER Pharma?

The recommended dose of cabazitaxel is 25 mg per square meter of body surface area (mg/m²), administered as a 1-hour intravenous infusion every 3 weeks. Your oncologist will calculate your specific dose based on your height and weight. Cabazitaxel is always given with premedication and in combination with daily oral prednisone or prednisolone.

Cabazitaxel EVER Pharma must be prepared and administered exclusively by healthcare professionals trained in the handling of cytotoxic agents in a hospital or specialized outpatient oncology clinic. The dose is individualized based on the patient’s body surface area (BSA), which is calculated from height and weight. Strict adherence to the preparation, dilution, and administration protocols is essential for patient safety.

Adults

How Cabazitaxel Is Prepared and Administered

Cabazitaxel EVER Pharma is a concentrated solution that requires dilution before administration. The preparation process must be performed by trained personnel using appropriate cytotoxic handling precautions. Key steps include:

• Step 1 — Dose calculation: Your oncologist calculates the required dose based on your body surface area (m²), determined by your height and weight
• Step 2 — Withdrawal of concentrate: The required volume of cabazitaxel concentrate (10 mg/ml) is aseptically drawn from the vial using a graduated syringe
• Step 3 — Dilution: The concentrate is diluted in either 5% glucose solution or 0.9% sodium chloride solution to achieve a final concentration between 0.10 mg/ml and 0.26 mg/ml
• Step 4 — Inspection: The diluted solution is visually inspected for particulate matter or crystallization before administration. If crystals are observed, the solution must be discarded
• Step 5 — Infusion: The prepared solution is administered as a 1-hour intravenous infusion. PVC-free infusion containers and tubing without polyurethane must be used

Dose Modifications

Your oncologist may adjust the cabazitaxel dose based on your response and tolerability. Common reasons for dose reduction include:

Children and Adolescents

Cabazitaxel EVER Pharma is not approved for use in children or adolescents. The safety and efficacy of cabazitaxel in pediatric populations have not been established. This medication is exclusively indicated for adult male patients with metastatic castration-resistant prostate cancer.

Elderly Patients

No specific dose adjustment is required for elderly patients based solely on age. However, elderly patients (aged 65 years and older) constituted a significant proportion of participants in the pivotal clinical trials, and they were found to be more susceptible to certain adverse effects, particularly neutropenia, febrile neutropenia, fatigue, diarrhea, and dehydration. Elderly patients should be monitored more closely, and prophylactic G-CSF support should be considered from the first treatment cycle in patients aged 65 and above, as recommended by international guidelines (ESMO, NCCN).

Missed or Delayed Dose

Cabazitaxel is administered on a fixed 3-weekly cycle in a hospital setting, so missed doses at home are not applicable. However, treatment cycles may be delayed if:

• Your blood counts have not recovered sufficiently between cycles (particularly neutrophils)
• You are experiencing ongoing toxicity from the previous cycle
• You develop an intercurrent illness (such as an infection) that needs to resolve before the next cycle

If a treatment cycle is delayed, your oncologist will schedule the next infusion as soon as it is safe to proceed. The 3-weekly interval is the minimum recommended time between cycles, not a fixed schedule.

Overdose

Because cabazitaxel is administered by healthcare professionals in a controlled hospital setting, accidental overdose is rare. However, if an overdose occurs, the expected complications include severe bone marrow suppression (with very low blood cell counts), gastrointestinal toxicity (severe diarrhea, nausea, and vomiting), and neurological effects. There is no specific antidote for cabazitaxel overdose. Treatment is supportive, focusing on management of neutropenia with G-CSF, prevention and treatment of infections, fluid and electrolyte replacement, and monitoring of organ function.

What Are the Side Effects of Cabazitaxel EVER Pharma?

Like all chemotherapy agents, cabazitaxel can cause side effects. The most common serious side effect is neutropenia (low white blood cell count), which can lead to life-threatening infections. Other frequent side effects include anemia, fatigue, diarrhea, nausea, and blood in the urine. Your oncology team will monitor you closely and can manage most side effects with supportive care and dose adjustments.

The side effects of cabazitaxel are largely predictable from its mechanism of action as a cytotoxic agent that affects rapidly dividing cells throughout the body, not just cancer cells. Cells in the bone marrow (which produce blood cells), the gastrointestinal lining, hair follicles, and the nervous system are particularly affected. The severity and frequency of side effects vary between individuals and can be influenced by factors such as age, overall health, kidney and liver function, and concurrent medications.

Your oncology team will discuss the expected side effects before starting treatment and will provide supportive care measures to minimize their impact. Regular blood tests and clinical assessments are essential for early detection and management of side effects. Do not hesitate to report any new or worsening symptoms to your treatment team, as early intervention can prevent serious complications.

Reporting Side Effects

Reporting suspected side effects after a medication has been authorized is important for the ongoing monitoring of the benefit-risk balance of the drug. Healthcare professionals are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority. Patients can also report side effects directly in many countries through established reporting systems.

How Should Cabazitaxel EVER Pharma Be Stored?

Cabazitaxel EVER Pharma is stored in the hospital pharmacy under controlled conditions. The unopened vials do not require special storage temperature conditions but must not be frozen. After first opening, multi-dose vials remain stable for 28 days at temperatures below 25°C. After dilution for infusion, the solution should be used within 48 hours at room temperature or 14 days if refrigerated.

As a hospital-administered medication, you will not need to store cabazitaxel at home. However, the following storage information is important for understanding the handling of your medication by the healthcare team:

• Unopened vials: No special storage temperature requirements. Store in the original packaging. Do not freeze
• After first opening (multi-dose vials): Chemically, physically, and microbiologically stable for 28 days at temperatures below 25°C. This multi-dose stability allows efficient use across multiple patients
• After dilution in infusion bag/bottle: Stable for 48 hours below 25°C (including 1 hour of infusion time) or 14 days when refrigerated (including 1 hour of infusion time). From a microbiological standpoint, the solution should be used immediately unless prepared under validated aseptic conditions
• Expiry date: Do not use after the expiry date printed on the outer carton and vial label. The expiry date refers to the last day of that month
• Disposal: Unused medication and waste material should be disposed of in accordance with local requirements for cytotoxic agents. Do not dispose of cabazitaxel through household waste or wastewater

What Does Cabazitaxel EVER Pharma Contain?

Cabazitaxel EVER Pharma is a concentrate for solution for infusion. Each milliliter contains cabazitaxel (as cabazitaxel monohydrate or anhydrous cabazitaxel) equivalent to 10 mg cabazitaxel. The vials are available in 4.5 ml (45 mg), 5 ml (50 mg), and 6 ml (60 mg) sizes, each containing an overfill to ensure the labeled volume can be withdrawn.

Active Ingredient

The active substance is cabazitaxel. Each milliliter of the concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous cabazitaxel equivalent to 10 mg of cabazitaxel. The available vial sizes are:

• 4.5 ml vial: Contains cabazitaxel equivalent to 45 mg cabazitaxel
• 5 ml vial: Contains cabazitaxel equivalent to 50 mg cabazitaxel
• 6 ml vial: Contains cabazitaxel equivalent to 60 mg cabazitaxel

Each vial contains an overfill to ensure the full labeled volume of solution containing 10 mg/ml cabazitaxel can be withdrawn.

Other Ingredients (Excipients)

The other ingredients in Cabazitaxel EVER Pharma are:

• Polysorbate 80: A surfactant that helps keep the cabazitaxel in solution
• Macrogol (polyethylene glycol): A co-solvent used to improve the stability and solubility of the formulation
• Citric acid: Used as a pH buffer to maintain solution stability
• Ethanol, anhydrous: Used as a co-solvent. Each vial contains a significant amount of alcohol (see “Important Information About Excipients” in the section on what you should know before taking this medicine)

Physical Description

Cabazitaxel EVER Pharma concentrate is a clear, yellowish, oily solution supplied in a clear glass vial sealed with a grey bromobutyl rubber stopper, aluminum closure, and a flip-off plastic cap. The vials may be packaged with or without a protective shield. Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder and Manufacturer

The marketing authorization for Cabazitaxel EVER Pharma is held by EVER Valinject GmbH, based in Unterach am Attersee, Austria. The product is manufactured by EVER Pharma Jena GmbH in Jena, Germany. For questions about this medicine, contact the local representative for your country or the marketing authorization holder directly.

Frequently Asked Questions About Cabazitaxel