PAZOPANIB-TEVA FC TABLETS 200 MG [SIN17000P]

Product Info

PAZOPANIB-TEVA FC TABLETS 200 MG

[SIN17000P]

4.1 Indications

Renal cell carcinoma (RCC)
Pazopanib-Teva is indicated for the first line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.

Soft tissue sarcoma (STS)
Pazopanib-Teva is indicated for the treatment of adult patients with selective subtypes of Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.

Efficacy and safety has only been established in certain STS histological tumour subtypes (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Dosage Regimen and Administration

Dosage Regimen

General target population
The recommended dose of Pazopanib-Teva is 800 mg orally once daily (see Method of administration).

Dose Modifications

Initial dose reduction should be from 800 mg to 400 mg daily. Subsequent dose modification, either an increase or decrease in dose, should be in 200 mg increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The daily dose of Pazopanib-Teva should not exceed 800 mg.

CYP3A4 inhibitor: The concomitant use of strong CYP3A4 inhibitors may increase Pazopanib concentrations and should be avoided (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). If co-administration of a strong CYP3A4 inhibitor is warranted a dose reduction to 400 mg of Pazopanib is recommended based on pharmacokinetic studies. This dose is predicted to adjust the Pazopanib AUC to the range observed without inhibitors (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inhibitors.

Special populations

• Pediatric patients (below 18 years)
  Pazopanib is not recommended for use in children and adolescents under 18 years (see Warnings and Precautions, Pre-Clinical Safety Data – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Geriatric patients (above 65 years)
  Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

  No alteration of dosage, dosing frequency or route of administration is required in patients over 65 years.

• Renal impairment
  Renal impairment is not expected to have a clinically relevant effect on Pazopanib pharmacokinetics given the low renal excretion of Pazopanib and metabolites (see section CLINICAL PHARMACOLOGY, Pharmacokinetics, Elimination – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment is not expected to influence Pazopanib exposure, and dose adjustment is not necessary in patients with creatine clearance ≥ 30 mL/min. There is no experience of Pazopanib in patients with severe renal impairment or in patients undergoing peritoneal dialysis or hemodialysis; therefore, use of Pazopanib is not recommended in these patients.

• Hepatic impairment
  The safety and pharmacokinetics of Pazopanib in patients with pre-existing hepatic impairment have not been fully established (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  No dose adjustment is required in patients with mild hepatic impairment as defined by alanine aminotransferase (ALT) and bilirubin (see Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  The dose of Pazopanib should be reduced to 200 mg per day in patients with moderate hepatic impairment. (see section Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  Administration of Pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring due to potentially increased exposure to the medicinal product. There are insufficient data in patients with severe hepatic impairment (total bilirubin > 3 times the upper limit of normal [X ULN] regardless of the ALT value), therefore, use of Pazopanib is not recommended in these patients.

Method of administration
Pazopanib should be taken without food (at least one hour before or two hours after a meal) (see sections Interactions and Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Pazopanib should be taken whole with water and must not be broken or crushed (see section CLINICAL PHARMACOLOGY, Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If a dose is missed, it should not be taken if it is less than 12 hours until the next dose.

4.3 Contraindications

Pazopanib is contraindicated in patients with severe hepatic impairment and hypersensitivity to any of the ingredients.