LORVIQUA lorlatinib 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lorlatinib, Quantity: 100 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; 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: Oval (8.5 x 17 mm) lavender film coated tablet, debossed with 'Pfizer' on one side and 'LLN 100' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-11-19

Patient Information leaflet

LORVIQUA
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING LORVIQUA?
Lorviqua contains the active ingredient lorlatinib. Lorviqua is used
to treat a rare type of lung cancer that is caused by defects in a
gene called anaplastic lymphoma kinase (ALK).
For more information, see Section 1. Why am I using Lorviqua? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LORVIQUA?
Do not use if you have ever had an allergic reaction to Lorviqua or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you take any other medicines, or before
starting any new medicines as Lorviqua can interact with some
medicines. Talk to your doctor if you have any other medical
conditions, or are pregnant or plan to become pregnant or are
breastfeeding. Do not give this medicine to a child.
For more information, see Section 2. What should I know before I use
Lorviqua? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lorviqua and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE LORVIQUA?
•
Lorviqua is taken orally (by mouth) once a day. You are encouraged to
swallow the tablet whole (do not chew, crush or split),
and take it at approximately the same time each day
•
Your doctor will advise how much Lorviqua to take prior to starting
treatment
More instructions can be found in Section 4. How do I use Lorviqua? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LORVIQUA?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or dentist you visit that you are using
Lorviqua
•
Tell your doctor immediately if you become pregnant while using this
medicine, or if you develop changes
in your heartbeat, lightheadedness,

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.
▼

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