JEVTANA® CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION 60MG/1.5ML [SIN14043P]

Product Info

JEVTANA® CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION 60MG/1.5ML

[SIN14043P]

Therapeutic Indications
JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen.

Posology and Method of Administration
The use of JEVTANA should be confined to units specialised in the administration of cytotoxics and it should only be administered under the supervision of a physician experienced in the use of anticancer chemotherapy. Facilities and equipment for the treatment of serious hypersensitivity reactions like hypotension and bronchospasm must be available (see section Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Premedication
The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity

• antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent),

• corticosteroid (dexamethasone 8 mg or equivalent), and

• H2 antagonist (ranitidine or equivalent) (see section Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.

Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure.

Posology
The recommended dose of JEVTANA is 25 mg/m² administered as a 1 hour intravenous infusion every 3 weeks in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.

Dose Adjustments
Dose modifications should be made if patients experience the following adverse reactions (Grades refer to Common Terminology Criteria for Adverse Events (CTCAE 4.0)):

If patients continue to experience any of these reactions at 20 mg/m², further dose reduction to 15mg/m² or discontinuation of JEVTANA may be considered. Data in patients below the 20 mg/m² dose are limited.

Special Populations
Patients with Hepatic Impairment
Cabazitaxel is extensively metabolised by the liver. Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or Aspartate Aminotransferase (AST) >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m². Administration of cabazitaxel to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety.
In patients with moderate hepatic impairment (total bilirubin >1.5 to ≤ 3.0 x ULN), the maximum tolerated dose (MTD) was 15 mg/m². If the treatment is envisaged in patients with moderate hepatic impairment the dose of cabazitaxel should not exceed 15 mg/m². However, limited efficacy data are available at this dose.
Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN) (see sections Contraindications, Special Warnings and Precautions for Use and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with Renal Impairment
Cabazitaxel is minimally excreted through the kidney. No dose adjustment is necessary in patients with renal impairment, not requiring hemodialysis. Patients presenting end-stage renal disease (creatinine clearance (CL_CR< 15 mL/min/1.73 m²), by their condition and the limited amount of data available should be treated with caution and monitored carefully during treatment (see sections Special Warnings and Precautions for Use and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly
No specific dose adjustment for the use of cabazitaxel in elderly patients is recommended (see also sections Special Warnings and Precautions for Use, Undesirable Effects and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant Medicinal Products Use
Concomitant medicinal products that are strong inducers or strong inhibitors of CYP3A should be avoided. However, if patients require co-administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see sections Special Warnings and Precautions for Use and Interaction with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric Population
There is no relevant use of JEVTANA in the paediatric population.
The safety and the efficacy of JEVTANA in children and adolescents below 18 years of age have not been established.

Method of Administration
JEVTANA is for intravenous use.
For instructions on preparation and administration of the medicinal product, see section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
PVC infusion containers and polyurethane infusion sets should not be used.
JEVTANA must not be mixed with any other medicinal products than those mentioned in section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

• Hypersensitivity to cabazitaxel, to other taxanes, to polysorbate 80 or to any of the excipients listed in List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Neutrophil counts less than 1,500/mm³.

• Severe hepatic impairment (total bilirubin >3 x ULN).

• Concomitant vaccination with yellow fever vaccine (see section Interaction with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).