LENVIMA lenvatinib 4mg hard capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lenvatinib mesilate, Quantity: 4.9 mg (Equivalent: lenvatinib, Qty 4 mg)

Available from:

Eisai Australia Pty Ltd

INN (International Name):

lenvatinib mesilate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: iron oxide yellow; propylene glycol; potassium hydroxide; mannitol; iron oxide black; titanium dioxide; hypromellose; purified talc; iron oxide red; calcium carbonate; microcrystalline cellulose; hyprolose; Shellac

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Endometrial carcinoma LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,Differentiated thyroid cancer (DTC) LENVIMA is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (RAI) refractory differentiated thyroid cancer (DTC).,Renal cell carcinoma (RCC) LENVIMA, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).,LENVIMA, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,Hepatocellular carcinoma (HCC) LENVIMA is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Product summary:

Visual Identification: The 4 mg capsule is a yellowish-red body and a yellowish-red cap, marked in black ink with [lunate epsilon symbol] on the cap and LENV 4 mg on the body.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-01-28

Patient Information leaflet

Eisai Australia Pty Ltd
Version 3.1
1
LENVIMA
®
_ _
LENVATINIB (AS LENVATINIB MESILATE) HARD CAPSULES_ _
_(len-va-ti-nib) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Lenvima.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST. KEEP THIS LEAFLET
WITH THE MEDICINE.
You may need to read it again.
WHAT LENVIMA IS
USED FOR
Lenvima is used to treat thyroid
cancer in adults when
radioactive iodine treatment has
not helped to stop your disease.
It is also used in combination
with everolimus to treat patients
with advanced kidney cancer
(advanced renal cell carcinoma)
where other treatments have not
helped stop the disease.
It is also used to treat liver
cancer (hepatocellular
carcinoma)
It contains the active ingredient
lenvatinib (as lenvatinib
mesilate).
Lenvima blocks the action of
proteins called receptor tyrosine
kinases (RTKs), which are
involved in the development of
new blood vessels that supply
oxygen and nutrients to cells and
help them to grow. These
proteins can be present in high
amounts in cancer cells, and by
blocking their action Lenvima
may slow the rate at which the
cancer cells multiply and the
tumour grows and by helping to
cut off the blood supply that the
cancer needs.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor’s prescription.
Lenvima should be used with
caution in patients who:

have high blood pressure

have a history of heart
problems or stroke

are over 65 years of age

have had recent surgery or
radiotherapy

have liver or kidney
problems.
Lenvima is not recommended
for use in children and
teenagers. The effects of
Lenv

Summary of Product characteristics

Lenvima PI Version 3.1
Page 1
AUSTRALIAN PRODUCT INFORMATION – LENVIMA
® (LENVATINIB)
HARD CAPSULE
1
NAME OF THE MEDICINE
Lenvatinib as lenvatinib mesilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LENVIMA 4 mg hard capsule contains 4 mg lenvatinib (as mesilate).
Each LENVIMA 10 mg hard capsule contains 10 mg lenvatinib (as
mesilate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Hard capsule.
LENVIMA 4 mg hard capsule: A yellowish-red body and yellowish-red cap,
approximately
14.3 mm in length, marked in black ink with “Є” on the cap, and
“LENV 4 mg” on the body.
LENVIMA 10 mg hard capsule: A yellow body and yellowish-red cap,
approximately 14.3
mm in length, marked in black ink with “Є” on the cap, and
“LENV 10 mg” on the body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LENVIMA is indicated for the treatment of patients with progressive,
locally advanced or
metastatic, radioactive iodine refractory differentiated thyroid
cancer.
LENVIMA is indicated in combination with everolimus for the treatment
of adult patients
with advanced renal cell carcinoma whose disease has progressed
following one prior
vascular endothelial growth factor targeted therapy.
LENVIMA is indicated for the first-line treatment of patients with
unresectable
hepatocellular carcinoma (HCC).
Lenvima PI Version 3.1
Page 2
4.2
D
OSE AND METHOD OF ADMINISTRATION
LENVIMA treatment should be supervised by a health care professional
experienced in the
use of anticancer therapies.
STARTING DOSE IN RAI – REFRACTORY DTC
The recommended dose of LENVIMA is 24 mg (two 10 mg capsules plus one
4 mg capsule)
taken once daily. The daily dose is to be modified as needed according
to the dose/toxicity
management plan (see dose adjustment section below).
Treatment should continue as long as there is clinical benefit or
until unacceptable toxicity
occurs.
STARTING DOSE IN ADVANCED RENAL CELL CARCINOMA
The recommended daily dose of LENVIMA is 18 mg (one 10 mg capsule and
two 4 mg
ca