LORVIQUA lorlatinib 25 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lorlatinib, Quantity: 25 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LORVIQUA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by a validated test.

Product summary:

Visual Identification: 8 mm round tan film coated tablet, debossed with "Pfizer" on one side and "25" and "LLN" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-11-19

Summary of Product characteristics

Version: pfplorvt11221
Supersedes: pfplorvt10521
Page 1 of 24
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION -
LORVIQUA
® (LORLATINIB)
1.
NAME OF THE MEDICINE
Lorlatinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg of lorlatinib.
Excipient with known effect: 1.58 mg of lactose per film-coated
tablet.
Each 100 mg film-coated tablet contains 100 mg of lorlatinib.
Excipient with known effect: 4.20 mg of lactose per film-coated
tablet.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet, film coated.
25 mg: 8 mm round tan film-coated tablet, debossed with “Pfizer”
on one side and “25” and
“LLN” on the other side.
100 mg: oval (8.5 × 17 mm) lavender film-coated tablet, debossed with
“Pfizer” on one side and
“LLN 100” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LORVIQUA is indicated for the treatment of patients with anaplastic
lymphoma kinase
(ALK)-positive locally advanced or metastatic non-small cell lung
cancer (NSCLC), as
determined by a validated test.
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Version: pfplorvt11221
Supersedes: pfplorvt10521
Page 2 of 24
4.2
DOSE AND METHOD OF ADMINISTRATION
ALK-positive status should be established using a validated ALK assay
prior to initiation of
lorlatinib therapy.
RECOMMENDED DOSING
The recommended dose of LORVIQUA is 100 mg taken orally once daily.
Continue treatment
for as long as the patient is deriving clinical benefit from therapy.
LORVIQUA may be taken with or without food (see Section 5.2).
Patients should be encouraged to take their dose of LORVIQUA at
approximately the same time
each day. Tablets should be swallowed whole (tablets should not be
chewed, crushed or split
prior to swallowing). No tablet should be ingested if it is broke