INLYTA axitinib 7mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Send request.
Active ingredient:
axitinib, Quantity: 7 mg
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
Axitinib
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red
Administration route:
Oral
Units in package:
56 tablets, 28 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy
Product summary:
Visual Identification: Red, diamond, film-coated tablet debossed with Pfizer on one side and 7XNB on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-04-30
Summary of Product characteristics
Version: pfpinlyt21019
Supersedes: pfpinlyt11019
Page 1 of 20
AUSTRALIAN
PRODUCT
INFORMATION
–
INLYTA
® (AXITINIB)
1.
NAME OF THE MEDICINE
Axitinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INLYTA is supplied as red film-coated tablets containing 1 mg, 3 mg, 5
mg, or 7 mg of
axitinib.
EXCIPIENT(S) WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
INLYTA 1 MG TABLETS
Red, film-coated, oval tablets, debossed with “Pfizer” on one side
and “1 XNB” on the other.
INLYTA 3 MG TABLETS
Red, film-coated, round tablets, debossed with “Pfizer” on one
side and “3 XNB” on the other.
INLYTA 5 MG TABLETS
Red, film-coated, triangular tablets, debossed with “Pfizer” on
one side and “5 XNB” on the
other.
INLYTA 7 MG TABLETS
Red, film-coated, diamond tablets, 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 patients with advanced renal
cell carcinoma after
failure of one prior systemic therapy.
Version: pfpinlyt21019
Supersedes: pfpinlyt11019
Page 2 of 20
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
RECOMMENDED DOSE
The recommended starting oral dose of INLYTA is 5 mg twice daily.
INLYTA may be taken
with or without food.
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.
DOSAGE ADJUSTMENT
Dose increase or reduction is recommended based on individual safety
and tolerability.
Patients who tolerate the INLYTA starting dose of 5 mg twice daily
with no adverse reactions
>Grade 2 (according to the Common Toxicity Criteria for Adverse Events
[CTCAE]) for two
consecutive weeks, are normotensive, and are not receiving
anti-hypertensive medication, may
have their dose increased to 7 mg twice daily. Subsequently, using the
same criteria, patients
who tolerate the INLYTA dose of 7 mg twice daily, may have their dose
increased to a
maximum
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