This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions
1. Name of the medicinal product
Inlyta 1 mg film-coated tablets
Inlyta 3 mg film-coated tablets
Inlyta 5 mg film-coated tablets
Inlyta 7 mg film-coated tablets
2. Qualitative and quantitative composition
1 mg film-coated tablets
Each film-coated tablet contains 1 mg of axitinib.
3 mg film-coated tablets
Each film-coated tablet contains 3 mg of axitinib.
5 mg film-coated tablets
Each film-coated tablet contains 5 mg of axitinib.
7 mg film-coated tablets
Each film-coated tablet contains 7 mg of axitinib.
Excipients with known effect :
1 mg film-coated tablets
Each film-coated tablet contains 33.6 mg of lactose monohydrate.
3 mg film-coated tablets
Each film-coated tablet contains 35.3 mg of lactose monohydrate.
5 mg film-coated tablets
Each film-coated tablet contains 58.8 mg of lactose monohydrate
7 mg film-coated tablets
Each film-coated tablet contains 82.3 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
1 mg: Red oval film-coated tablet debossed with “Pfizer” on one side and “1 XNB” on the other.
3 mg: Red round film-coated tablet debossed with “Pfizer” on one side and “3 XNB” on the other.
5 mg: Red triangular film-coated tablet debossed with “Pfizer” on one side and “5 XNB” on the other.
7 mg: Red diamond shaped film-coated tablet debossed with “Pfizer” on one side and “7 XNB” on the other.
4. Clinical particulars
4.1 Therapeutic indications
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
4.2 Posology and method of administration
Treatment with Inlyta should be conducted by a physician experienced in the use of anticancer therapies.
Posology
The recommended starting dose of axitinib is 5 mg twice daily.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs that cannot be managed by concomitant medicinal products or dose adjustments.
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
Dose adjustments
Dose increase or reduction is recommended based on individual safety and tolerability.
Patients who tolerate the axitinib starting dose of 5 mg twice daily with no adverse reactions > Grade 2 (i.e. without severe adverse reactions according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) for two consecutive weeks may have their dose increased to 7 mg twice daily unless the patient's blood pressure is > 150/90 mmHg or the patient is receiving antihypertensive treatment. Subsequently, using the same criteria, patients who tolerate an axitinib dose of 7 mg twice daily may have their dose increased to a maximum of 10 mg twice daily.
Management of some adverse reactions may require temporary or permanent discontinuation and/or dose reduction of axitinib therapy (see section 4.4). When dose reduction is necessary, the a