SUNITINIB TARO 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SUNITINIB

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L01XE04

Pharmaceutical form:

HARD CAPSULE

Composition:

SUNITINIB 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PHARMACARE PREMIUM LTD., MALTA

Therapeutic area:

SUNITINIB

Therapeutic indications:

Sunitinib taro is indicated for:• Treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. • Treatment of advanced renal cell carcinoma.• Treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pNET) with disease progression.

Authorization date:

2021-07-28

Patient Information leaflet

Page 1 of 6
Sunitinib Taro, PIL, Israel
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Sunitinib Taro 12.5 mg
Sunitinib Taro 25 mg
Sunitinib Taro 37.5 mg
Sunitinib Taro 50 mg
Hard capsules
Active ingredient
Sunitinib 12.5 mg, 25 mg, 37.5 mg, 50 mg
Inactive ingredients and allergens: See section 2 under 'Important
information about some of
this medicine's ingredients' and section 6 'Further information’.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them even if it seems to you that their illness is similar to
yours.
This medicine is intended for adults above the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?

For treatment of gastrointestinal stromal tumor (GIST)
after disease progression on or
intolerance to imatinib mesylate.

For treatment of advanced renal cell carcinoma (aRCC).

For treatment of differentiated pancreatic neuroendocrine tumors
(pNET), that have
progressed or cannot be removed with surgery.
Therapeutic group:
Targeted tyrosine kinase receptor inhibitor.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine (see section 6).
Special warnings about using this medicine
Before treatment with Sunitinib Taro, tell the doctor if:

You are pregnant or planning to become pregnant, breastfeeding or
planning to
breastfeed.

You have had a cerebral or cardiac event (e.g., any sort of heart
attack, including
myocardial infarction, heart failure, bypass surgery, heart muscle
disease
Page 2 of 6
Sunitinib Taro, PIL, Israel
(cardiomyopathy), unstable angina pectoris) and/or pulmonary embolism
during the 12
months before commencing