TYROKA FILM-COATED TABLETS 200 MG [SIN16736P]

Product Info

TYROKA FILM-COATED TABLETS 200 MG

[SIN16736P]

4.1 Therapeutic indications

Renal cell carcinoma (RCC)
Pazopanib is indicated in adults 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 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 section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Pazopanib treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.

Posology

Adults
The recommended dose of pazopanib for the treatment of RCC or STS is 800 mg once daily.

Dose modifications
Initial dose reduction should be from 800 mg to 400 mg daily. Subsequent dose modification (decrease or increase) should be in 200 mg decrements or increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The daily dose of pazopanib should not exceed 800 mg.

Paediatric population
Pazopanib is not recommended for use in children and adolescents under 18 years (see sections 4.4, 5.1 and 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Elderly
There are limited data on the use of pazopanib in patients aged 65 years and older. In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects. Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly patients 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 unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, no dose adjustment is required in patients with creatinine clearance 30 ml/min and above. 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
Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). All patients should have liver function tests to determine whether they have hepatic impairment before starting and during pazopanib therapy (see section 4.4 – 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 of tolerability. 800 mg pazopanib once daily is the recommended dose in patients with mild abnormalities in serum liver tests (defined either as normal bilirubin and any degree of alanine aminotransferase (ALAT) elevation or as an elevation of bilirubin up to 1.5 x upper limit of normal (ULN) regardless of the ALAT value). A reduced pazopanib dose of 200 mg once daily is recommended in patients with moderate hepatic impairment (defined as an elevation of bilirubin >1.5 to 3 x ULN regardless of the ALAT value) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 x ULN regardless of the ALAT value).

See section 4.4 for liver monitoring and dose modification for patients with drug-induced hepatotoxicity – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration

Pazopanib is for oral use. It should be taken without food, at least one hour before or two hours after a meal (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The film-coated tablets should be taken whole with water and not broken or crushed (see section 5.2 – 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 the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.