Cabazitaxel

Cabazitaxel is a prescription medication used for the treatment of prostate cancer.

• Cabazitaxel is available under the following different brand names: Jevtana

Common side effects of Cabazitaxel include:

• fever,
• low blood cell counts,
• numbness or tingling,
• nausea,
• vomiting,
• stomach pain,
• loss of appetite,
• constipation,
• diarrhea,
• weakness,
• tiredness,
• blood in the urine,
• back pain,
• joint pain,
• cough,
• shortness of breath,
• altered sense of taste, and
• hair loss

Serious side effects of Cabazitaxel include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• rash,
• skin redness,
• chest tightness,
• lightheadedness,
• numbness, burning pain, or tingly feeling in the hands or feet,
• sudden chest pain or discomfort,
• wheezing,
• dry cough,
• shortness of breath,
• stomach pain or tenderness,
• severe vomiting,
• diarrhea,
• ongoing constipation,
• blood in the urine,
• urinating more often,
• pain or burning while urinating,
• fever,
• chills,
• muscle pain,
• mouth sores,
• skin sores,
• easy bruising,
• unusual bleeding,
• pale skin,
• cold hands and feet,
• bloody or tarry stools,
• coughing up blood,
• vomiting that looks like coffee grounds,
• little or no urination,
• painful or difficult urination,
• swelling in the hands or feet, and
• tiredness

Rare side effects of Cabazitaxel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Kit

• Each kit contains
  • 60 mg/1.5 mL cabazitaxel injection
  • 5.7 mL diluent

Prostate Cancer

Adult dosage

• 20 mg/m2 IV every 3 weeks, PLUS  
• Prednisone 10 mg orally every day throughout cabazitaxel treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cabazitaxel has severe interactions with no other drugs.
• Cabazitaxel has serious interactions with at least 28 other drugs.
• Cabazitaxel has moderate interactions with at least 62 other drugs.
• Cabazitaxel has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Neutrophil count less than 1,500/mm3
• Hypersensitivity to cabazitaxel or other drugs formulated with polysorbate 80
• Severe hepatic impairment (total bilirubin is more than 3 times ULN)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cabazitaxel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cabazitaxel?”

Cautions

• Extensively metabolized in the liver, hepatic impairment likely to increase serum concentrations
• Bone marrow suppression manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur; neutropenic deaths reported
• Patients above 65 years were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia
• Severe hypersensitivity reactions can occur; premedicate with IV antihistamine, corticosteroid, and H2 antagonist; discontinue infusion immediately if hypersensitivity is observed and treat as indicated
• Gastrointestinal symptoms (nausea, vomiting, diarrhea), including mortality related to diarrhea, have been reported; rehydrate and treat with antiemetics and antidiarrheals as needed; incidence of gastrointestinal adverse reactions is greater in patients who have received prior radiation
• Renal failure, including cases with fatal outcomes, reported
• Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, reported; monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on therapy; interrupt or discontinue treatment in patients experiencing severe hemorrhagic cystitis; medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis
• GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome; the risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelets, or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding
• Extensively metabolized in the liver; contraindicated in patients with severe hepatic impairment and reduce dose in patients with mild and moderate hepatic impairment
• May cause fetal harm when administered to pregnant females
• Respiratory disorders
  • Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome, including fatal outcomes reported
  • Patients with underlying lung disease may be at higher risk for respiratory distress
  • Acute respiratory distress syndrome may occur in the setting of infection
  • Delay or discontinue therapy and treat as indicated
  • If therapy is discontinued, carefully evaluate the risks versus benefits before resumption
• Drug interaction overview
  • CYP3A substrate
  • Strong CYP3A4 inhibitors
  • Avoid coadministration
  • Strong CYP3A4 inhibitors that may alter drug serum levels

Pregnancy and Lactation

• Safety and efficacy not established in females
• No human data available on use in pregnant females
• Contraception
  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after the final dose
• Infertility
  • Fertility in males of reproductive potential may be impaired
• Lactation
  • Not indicated for use in females
  • No data is available on the presence in human milk, its effects on breastfed infants, or milk production
  • Drug or drug metabolites are excreted in the maternal milk of lactating rats