INLYTA (2013)
Active ingredients: Axitinib
Product Name and Form
Inlyta 1 mg film-coated tablets.
Inlyta 3 mg film-coated tablets.
Inlyta 5 mg film-coated tablets.
Inlyta 7 mg film-coated tablets.
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.
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.
Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3. These receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer. Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival.
Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate
Tablet film-coating:
Hypromellose
Titanium dioxide (E171)
Lactose monohydrate
Triacetin (E1518)
Iron oxide red (E172)
Pack sizes and Marketing
1 mg, 3 mg, 5 mg, 7 mg film-coated tablets: Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 film-coated tablets.
1 mg film-coated tablets: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets.
3 mg, 5 mg, 7 mg film-coated tablets: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.
Not all pack sizes may be marketed.
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Date of first authorisation: 3 September 2012
EU/1/12/777/001
EU/1/12/777/002
EU/1/12/777/003
EU/1/12/777/004
EU/1/12/777/005
EU/1/12/777/006
EU/1/12/777/007
EU/1/12/777/008
EU/1/12/777/009
EU/1/12/777/010
EU/1/12/777/011
EU/1/12/777/012