EVEROLIMUS TARO 2.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EVEROLIMUS

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L04AA18

Pharmaceutical form:

TABLETS

Composition:

EVEROLIMUS 2.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SYNTHON CHILE LTDA, CHILE

Therapeutic area:

EVEROLIMUS

Therapeutic indications:

- For the treatment of patients with SEGA associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Everolimus Taro is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.The safety and effectiveness of Everolimus Taro in the treatment of patients with carcinoid tumors have not been established.- For the treatment of hormone receptor – positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- Everolimus Taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of Everolimus Taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes.- Everolimus Taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.- Treatment of unresectable, locally advanced or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Authorization date:

2021-08-04

Patient Information leaflet

Page 1 of 10
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
EVEROLIMUS TARO 2.5 MG,
EVEROLIMUS TARO 5 MG, EVEROLIMUS TARO 10 MG
TABLETS
TABLETS
TABLETS
ACTIVE INGREDIENT:
ACTIVE INGREDIENT:
ACTIVE INGREDIENT:
Each tablet contains:
Each tablet contains:
Each tablet contains:
everolimus 2.5 mg
everolimus 5 mg
everolimus 10 mg
Inactive ingredients and allergens: See section 2 under 'Important
information regarding
some of this medicine's ingredients' and section 6 'Further
Information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have further
questions, consult your
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.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Everolimus Taro 2.5, 5 and 10 mg tablets are intended for:
•
Treatment of patients with a subependymal giant cell astrocytoma
(SEGA), a type of
brain tumor associated with tuberous sclerosis complex (TSC) for whom
surgery is
not appropriate.
•
Treatment of adult patients with a kidney tumor known as
angiomyolipoma (AML)
when the kidney tumor does not require immediate surgery. This type of
tumor is
associated with a genetic condition known as tuberous sclerosis
complex.
•
Treatment of advanced hormone receptor-positive and HER2-negative
breast cancer,
in conjunction with exemestane, in postmenopausal women without
symptomatic
metastatic disease spread to internal organs, after recurrence or
progression of the
disease following treatment with nonsteroidal aromatase inhibitors.
•
Treatment of advanced kidney cancer [advanced renal cell carcinoma
(RCC)], where
other treatments that target vascular endothelial growth factor
(VEGF-targeted
therapy) have not helped stop your disease.
•
Treatment of locally advanced, metastatic or