Cabazitaxel

What is Cabazitaxel?

• Cabazitaxel (Jevtana) is a microtubule inhibitor used with prednisone to treat hormone-resistant prostate cancer that has spread and that had been treated with docetaxel.

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What are the uses of this medicine?

• Cabazitaxel Jevtana is used with the steroid medicine prednisone.
• Jevtana is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body, and that has worsened (progressed) after treatment with other medicines that included docetaxel.

How does this medicine work?

• Cabazitaxel (cab" a zi tax' el) is a semisynthetic derivative of a natural taxoid and contains a complex diterpenoid molecular structure with a central 8-member taxane ring.
• The taxoids were initially isolated from bark of the Western Yew tree (Taxus breviflora) and found to have antitumor activity in high throughput assays.
• Their mechanism of anticancer activity appears to be due to their binding to intracellular microtubulin which prevents the disassembly of cytoskeletal microtubules, preventing cell division and leading to cell death.
• Cabazitaxel was developed when it was found to have low affinity for P-glycoprotein, a common mediator of docetaxel resistance.
• Thus, cabazitaxel was evaluated initially in patients with docetaxel resistant tumors.
• Cabazitaxel was found to prolong survival in men with castration-resistant, metastatic prostate cancer not responding to docetaxel therapy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients if:

• your white blood cell (neutrophil count) is too low
• you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80.
• you have severe liver problems

What drug interactions can this medicine cause?

• Avoid coadministration of Jevtana with strong CYP3A inhibitors(e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) .
• If patients require coadministration of a strong CYP3A inhibitor, consider a 25% Jevtana dose reduction.

Is this medicine FDA approved?

• It was approved for this use in combination with oral prednisolone in the United States in 2010.

How should this medicine be used?

Premedication Regimen: Administer intravenously 30 minutes before each dose of Jevtana:

• Antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent antihistamine)
• Corticosteroid (dexamethasone 8 mg or equivalent steroid)
• H2 antagonist
• Antiemetic prophylaxis (oral or intravenous) is recommended as needed.

Recommended dosage:

• Jevtana 20 mg/m2 administered every three weeks as a one-hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout Jevtana treatment.
• A dose of 25 mg/m2 can be used in select patients at the discretion of the treating healthcare provider.
• Cabazitaxel must be diluted to a concentration of 10 mg/mL before administration and should be given with oral prednisolone in a dose of 10 mg daily throughout the period of cabazitaxel treatment.

Administration:

• Jevtana will be given to you by an intravenous (IV) infusion into your vein.
• Your treatment will take about 1 hour.
• Jevtana is usually given every 3 weeks. Your healthcare provider will decide how often you will receive Jevtana.
• Your healthcare provider will also prescribe another medicine called prednisone for you to take by mouth every day during treatment with Jevtana.
• Your healthcare provider will tell you how and when to take your prednisone.
• It is important that you take prednisone exactly as prescribed by your healthcare provider. If you forget to take your prednisone, or do not take it on schedule, make sure to tell your healthcare provider or nurse.
• Before each infusion of Jevtana, you may receive other medicines to prevent or treat side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single dose vial 60 mg/1.5 mL, supplied with diluent (5.7 mL) for Jevtana

This medicine is available in fallowing brand namesː Jevtana

What side effects can this medication cause?

The most common side effects of this medicine include:

• Low red blood cell count (anemia)
• Low blood platelet count
• diarrhea
• nausea
• tiredness
• weakness
• vomiting
• blood in urine
• constipation
• decreased appetite
• back pain
• stomach (abdominal) pain
• fertility problems in males

Jevtana may cause serious side effects including:

• Low white blood cells
• Severe allergic reactions
• Severe stomach and intestine (gastrointestinal) problems
• leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine,
• Kidney failure
• Lung or breathing problems

What special precautions should I follow?

• Jevtana is contraindicated in patients with neutrophils ≤1,500/mm3. Monitor blood counts frequently to determine if dosage modification or initiation of G-CSF is needed. Closely monitor patients with hemoglobin <10 g/dL.
• Patients ≥65 years of age are more likely to experience certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely.
• Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of Jevtana. Premedicate with corticosteroids and H2 antagonists. Discontinue infusion immediately if hypersensitivity is observed and treat as indicated.
• Nausea, vomiting and severe diarrhea, at times, may occur. Mortality related to diarrhea has been reported. Rehydrate and treat with antiemetics and antidiarrheals as needed. If experiencing Grade ≥3 diarrhea, dosage should be modified. Deaths have occurred due to gastrointestinal hemorrhage, perforation and neutropenic enterocolitis. Delay or discontinue Jevtana and treat as indicated.
• In the randomized clinical trial (TROPIC), renal failure of any grade occurred in 4% of the patients being treated with Jevtana, including four cases with fatal outcome. Identify cause and manage aggressively.
• Cystitis, radiation cystitis, and hematuria may occur. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis. Interrupt or discontinue Jevtana and provide medical or surgical supportive care, as needed, in patients experiencing severe hemorrhagic cystitis.
• Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported. Delay or discontinue Jevtana and treat as indicated.
• Jevtana is contraindicated in patients with severe hepatic impairment. Administer Jevtana at a dose of 20 mg/m2 in patients with mild hepatic impairment. Administer Jevtana at a dose of 15 mg/m2 in patients with moderate hepatic impairment.
• Based on findings in animal reproduction studies and its mechanism of action, Jevtana can cause fetal harm when administered to a pregnant woman. Advise males with female partners of reproductive potential to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• bone marrow suppression
• gastrointestinal disorders
• death

Treatment of overdosage:

• There is no known antidote for Jevtana overdose.
• In case of overdose, the patient should be kept in a specialized unit where vital signs, chemistry and particular functions can be closely monitored.
• Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
• Other appropriate symptomatic measures should be taken, as needed.

Can this medicine be used in pregnancy?

• The safety and efficacy of Jevtana have not been established in females.
• There are no human data on the use of Jevtana in pregnant women to inform the drug-associated risk.

Can this medicine be used in children?

• The safety and effectiveness of Jevtana in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: cabazitaxel
• Inactive ingredients: polysorbate 80, citric acid monohydrate

Who manufactures and distributes this medicine?

• Manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ A SANOFI COMPANY

Jevtana is a registered trademark of sanofi-aventis.

What should I know about storage and disposal of this medication?

• Jevtana injection and Diluent for Jevtana:
• Store at 25°C (77°F); excursions permitted between 15°C–30°C (59°F–86°F).
• Do not refrigerate.
• Jevtana is a cytotoxic anticancer drug.
• Follow applicable special handling and disposable procedures

• Dailymed label info on Cabazitaxel
• FDA Cabazitaxel

Cabazitaxel Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

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• Dailymed label info on Cabazitaxel
• FDA Cabazitaxel

Cabazitaxel Resources
Latest articles Most recent articles Ongoing trials	Wikipedia