Cabazitaxel accton solvate

Cabazitaxel accton solvate belongs to the general group of medicines called antineoplastics. It is used for the treatment of advanced prostate cancer. It works by interfering with the growth of cancer cells, which are eventually destroyed. Cabazitaxel accton solvate is given under the supervision of a healthcare professional and should not be self-administered. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. You should avoid drinking alcohol as it may increase your risk of liver damage. The most common side effects of this medicine include Low red blood cell count, low platelet count, diarrhea, back pain, and hair loss. If they do not go away or get worse, tell your doctor. There may be ways of preventing or reducing these effects. It is very strong medicine and some people may develop serious side effects while taking it. This medicine may lower your ability to fight infections and lead to problems with your blood, liver or kidneys. Your doctor will advise you regular blood tests to check for these. Before taking it, tell your doctor if you have liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. It may harm your baby. You and your partner should avoid becoming pregnant or fathering a child for several months after your treatment with it has stopped. Your doctor may perform several tests such as blood tests, and physical examinations both before and during treatment with this medicine. Cabazitaxel accton solvate is an anti-cancer medication. It works by damaging the genetic material (DNA) of the cancer cells and stops their growth and multiplication.

• Prostate cancer

Microtubule inhibitor; binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly; this results in microtubule stabilization, which results in the inhibition of mitotic and interphase cellular functions.

Adult Dose: The individual dosage is based on calculation of the Body Surface Area (BSA) and is 25 mg/m² administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout treatment. Prolonged grade > 3 neutropenia : Delay treatment until neutrophil count is > 1,500 cells/mm3, then reduce dosage to 20 mg/m2. Febrile neutropenia : Delay treatment until improvement or resolution, and until neutrophil count is > 1,500 cells/mm3, then reduce dosage to 20 mg/m2. Grade 3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement : Delay treatment until improvement or resolution, then reduce dosageto 20 mg/m2. Elderly patients: Patients > 65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely. Hepatic impairment: Mild hepatic impairment (total bilirubin > 1 to ? 1.5 x upper limit of normal (ULN) or AST >1.5 x ULN): Reduce dose to 20 mg/m² Moderate hepatic impairment (total bilirubin > 1.5 to ? 3 x ULN and AST = any): 15 mg/m² Severe hepatic impairment (total bilirubine >3 x ULN): Contraindicated Child Dose: Safety and efficacy not established Renal Dose: Renal Impairment: Cabazitaxel is minimally excreted through the kidney. No dose adjustment is necessary in patients with mild renal impairment [creatinine clearance (CrCl): 50-80 mL/min]. Limited data are available for patients with moderate (CrCl: 30-50 mL/min) and no data are available for patients with severe renal impairment (CrCl <30 mL/min) or end stage renal disease; therefore, these patients should be treated with caution and monitored carefully during treatment.

Your doctor or nurse will give you this medicine. Kindly do not self administer.

If you miss a dose of Cabazitaxel accton solvate, please consult your doctor.

Common: • Vomiting • Back pain • Weakness • Low blood platelets • Hair loss • Abdominal pain • Loss of appetite • Anemia (low number of red blood cells) • Diarrhea • Stomatitis (Inflammation of the mouth) • Blood in urine • Constipation • Cough • Taste change • Breathing problems • Decreased white blood cell count (neutrophils) • Nausea

[UNSAFE] Cabazitaxel accton solvate may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.

-Patients with neutrophil counts of > 1,500/mm3. -Patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

Increased conc w/ strong CYP3A inhibitors (eg ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) & decreased conc w/ CYP3A inducers (eg phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarb). Serious or fatal infections w/ live or live attenuated vaccines. Risk of interaction w/ OATP1B1 substrates (eg statins, valsartan, repaglinide) during 1-hr & 20 min after infusion.

[UNSAFE] It is unsafe to consume alcohol with Cabazitaxel accton solvate.

[CONSULT YOUR DOCTOR] Cabazitaxel accton solvate is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

[CONSULT YOUR DOCTOR] Cabazitaxel accton solvate is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

[SAFE IF PRESCRIBED] Cabazitaxel accton solvate is safe to use in patients with kidney disease. No dose adjustment of Cabazitaxel accton solvate is recommended. Caution is advised in patients with severe kidney disease and end stage kidney disease as the information available is limited for use of this medicine in these patients. [CAUTION] Cabazitaxel accton solvate should be used with caution in patients with liver disease. Dose adjustment of Cabazitaxel accton solvate may be needed. Please consult your doctor. Use of Cabazitaxel accton solvate is not recommended in patients with severe liver disease.