What Is Cabazitaxel (Jevtana)? FDA Approval, Licensing in Turkey, and Reimbursement

• FDA Approved: Yes (First approval date: June 17, 2010)
• Brand Names: Jevtana (the original brand name), Cabatax (a generic available in Turkey), Neutaxan (generic)
• Active Ingredient: Cabazitaxel
• Route of Administration: Intravenous (IV) infusion
• Class: Taxoid, antimicrotubule agent
• Category: Chemotherapy medicine
• Manufacturer: Sanofi-Aventis (manufacturer of the original molecule)
• Distribution in Turkey: Sanofi (Jevtana), Koçak Farma (Cabatax), Gensenta (Neutaxan)
• Cancers for Which It Is Approved: Metastatic castration-resistant prostate cancer, particularly in patients resistant to docetaxel-based treatment

What Is Jevtana?

Jevtana contains cabazitaxel, a semisynthetic taxane derivative, and is an antimicrotubule chemotherapy medicine used to treat metastatic castration-resistant prostate cancer . It is used particularly in patients resistant to docetaxel treatment.

Mechanism of Action:

• Jevtana is a semisynthetic taxane derivative produced using a precursor obtained from yew tree needles.
• The medicine acts by binding to the tubulin protein in cells, promoting microtubule assembly while preventing their breakdown. Because microtubules are cellular structures essential for cell division, this mechanism stops cancer cells from dividing and multiplying.
• Jevtana is particularly active during the mitotic (M) phase of the cell cycle. It blocks cellular functions at this stage, thereby inhibiting tumor growth.

FDA (United States Food and Drug Administration) Approval History

• June 17, 2010: Jevtana (cabazitaxel) was approved by the FDA for patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. The approval was granted through priority review.

Licensing in Turkey

The conditions and therapeutic indications for which Jevtana is licensed in the Republic of Turkey are specified as follows:

Therapeutic Indications:

• Jevtana, in combination with prednisone or prednisolone, is indicated for patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.

Treatment Duration: Treatment continues until disease progression or the development of intolerable toxicity. There is no defined maximum treatment duration, but patients should be monitored regularly and adverse effects taken into account.

Is Jevtana Reimbursed?

The circumstances in which Jevtana is reimbursed by Turkey's Social Security Institution (SGK) are:

• Indication: Reimbursement covers its use with prednisone or prednisolone in adults with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing chemotherapy regimen, with an ECOG performance status of 0-1, and with progression demonstrated by PSA and imaging. SGK covers this treatment for patients who do not respond to docetaxel or whose disease progresses.
• Treatment Duration: SGK reimbursement continues until disease progression or intolerable toxicity develops. Treatment duration may vary according to the patient's response to the medicine and overall health.

Price: As of August 2025, the pharmacy retail price of a JEVTANA 60mg vial is: 73.277.8 TL.

Mechanisms of Resistance:

• Changes in Tubulin: Cabazitaxel stops cancer cells from dividing by binding to microtubules. However, structural changes in the tubulin protein occur in some cancer cells, reducing the medicine's ability to bind to this protein. The cells then develop resistance.
• The P-Glycoprotein Transport System: P-glycoprotein is a transport system that helps expel foreign substances, such as medicines, from cells. Other taxanes are strongly recognized by this system and expelled, reducing their effectiveness. Because cabazitaxel is not expelled as strongly by this transport system, it may remain effective in tumor cells resistant to other taxanes.

Absorption

• Jevtana is administered only intravenously (IV), so it has no oral bioavailability.

Distribution

• Jevtana is distributed widely throughout body tissues and crosses the blood–brain barrier. Plasma protein binding is 89-92%.

Metabolism

• Jevtana is extensively metabolized in the liver (more than 95%), primarily by CYP3A4 and CYP3A5. It is also metabolized to a lesser extent by CYP2C8. Approximately 20 different metabolites form in the body.
• Approximately 24% of the administered dose is excreted unchanged (in its original form), while a large proportion (76%) is excreted as metabolites. Renal excretion is low, with less than 4% of the administered dose excreted through the kidneys. The terminal half-life is approximately 77 hours. After a 1-hour infusion, 80% of the administered dose is eliminated within 2 weeks.

Dose Range

• Recommended Dose: The recommended dose of Jevtana is 20 mg/m² as a 1-hour intravenous infusion every 3 weeks. Treatment is given with oral prednisone at 10 mg daily.
• Maximum Dose: A high dose (25 mg/m²) may be administered only to clinically suitable patients who can tolerate it.

Drug Interactions

• CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, may slow cabazitaxel metabolism and increase blood levels of the medicine. This may enhance its effects but also increase the risk of adverse effects.
• CYP3A4 inducers, such as phenytoin, carbamazepine, rifampicin, phenobarbital, and St. John’s Wort, may accelerate cabazitaxel metabolism and lower blood levels. This may reduce the medicine's effectiveness and prevent the expected treatment outcome.

Conditions Requiring Caution

1. Hypersensitivity Reactions: Use is contraindicated in patients with severe hypersensitivity reactions to cabazitaxel or medicines containing polysorbate 80.
2. Hematological Monitoring: Complete blood counts should be performed weekly during treatment, and patients at risk of neutropenia should be monitored closely. G-CSF prophylaxis should be considered particularly in patients with risk factors: age over 65, poor performance status, poor nutritional status, or a history of extensive radiotherapy.
3. Preparation Before Treatment (Premedication): Before treatment, patients should receive premedication with an antihistamine, a corticosteroid, and H2 antagonists to prevent allergic reactions.
4. Severe Hypersensitivity Reactions: Severe allergic reactions may occur during treatment, in which case treatment must be stopped immediately. Jevtana must not be administered again to patients who have previously experienced severe hypersensitivity.
5. Hepatic Impairment: It should be used cautiously in patients with mild hepatic dysfunction. In patients with moderate hepatic impairment, the dose should be reduced to 15 mg/m². Use is contraindicated in patients with severe hepatic impairment.
6. Renal Impairment: No dose adjustment is required in patients with mild, moderate, or severe renal impairment. However, it should be used cautiously in patients with end-stage kidney disease or those requiring dialysis because no data are available.
7. Pregnancy and Contraception: Jevtana is in pregnancy category D. Male patients should use effective contraception during treatment and for 4 months after the last dose.

Adverse Effects

1. Myelosuppression (Bone Marrow Suppression): This is the most important dose-limiting adverse effect and may cause severe neutropenia. Thrombocytopenia (a low platelet count) and anemia (a low red blood cell count) may also occur.
2. Hypersensitivity Reactions: Hypersensitivity reactions such as widespread skin rash, flushing, erythema, low blood pressure, shortness of breath, and bronchospasm may develop during treatment. They generally occur within the first minutes of infusion and are most common during the first and second infusions.
3. Gastrointestinal Adverse Effects: Diarrhea, nausea, vomiting, constipation, abdominal pain, altered taste, and loss of appetite are the most common gastrointestinal adverse effects.
4. Fatigue and Asthenia (Weakness): Fatigue and a general sense of weakness are common adverse effects.
5. Neurotoxicity: Neurological symptoms may occur, particularly peripheral neuropathy, dizziness, and headache.
6. Muscle and Joint Pain: Myalgia and arthralgia (muscle and joint pain) are common adverse effects.
7. Cardiac Toxicity: Cardiac adverse effects such as arrhythmias, low blood pressure (hypotension), and peripheral edema (swelling) may occur.
8. Hair Loss (Alopecia): Hair loss (alopecia) occurs in approximately 10% of patients.
9. Urinary Adverse Effects: Hematuria (blood in the urine) and dysuria (painful urination) are common adverse effects. Renal failure may also occur rarely.