LORVIQUA lorlatinib 25 mg tablet bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

lorlatinib, Quantity: 25 mg

可用日期:

Pfizer Australia Pty Ltd

药物剂型:

Tablet, film coated

组成:

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

给药途径:

Oral

每包单位数:

30

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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.

產品總結:

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

授权状态:

Registered

授权日期:

2019-11-19

产品特点

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.
▼

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