EVEROCAN everolimus 0.75 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

everolimus, Quantity: 0.75 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hypromellose; butylated hydroxytoluene; ethanol absolute; acetone; crospovidone; lactose; magnesium stearate; lactose monohydrate

Administration route:

Oral

Units in package:

120's, 60's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Everolimus is indicated for the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant and in adult patients receiving an allogeneic hepatic transplant (see section 4.4 Special warnings and precautions for use).

Product summary:

Visual Identification: White to off white, round shaped tablets debossed with "EVR" on one side and "75" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-04-21

Patient Information leaflet

Everocan
1
EVEROCAN
EVEROLIMUS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING EVEROLIMUS?
Everocan contains the active ingredient everolimus. Everolimus is used
to used to treat adult patients who have had kidney, heart or liver
transplants.
For more information, see Section 1. Why am I using everolimus? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EVEROLIMUS?
Do not use if you have ever had an allergic reaction to everolimus or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT
OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
everolimus? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with everolimus 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 EVEROLIMUS?
KIDNEY AND HEART TRANSPLANTATIONS:
•
The usual starting dose is 0.75 mg EVEROCAN twice daily, taken in the
morning and in the evening together with cyclosporine.
•
The first dose of EVEROCAN will be given as soon as possible after
transplantation.
LIVER TRANSPLANTATION:
•
The general recommended daily dose is 1 mg EVEROCAN twice daily, taken
in the morning and in the evening, together with
tacrolimus.
•
The first dose of EVEROCAN will be given approximately four weeks
after transplantation.
More instructions can be found in Section 4. How do I use everolimus?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EVEROLIMUS?
THINGS
YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
everolimus.
•
Keep all of your doctor's appointments so that your progress can be
checked.
•
Make sure you use a highly effective contraceptive to prevent
pregnancy during treatment with EVEROCAN. If
you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS
YOU
SHOULD NOT DO
•
Do not take

Summary of Product characteristics

Everocan (ver 03) Page 1
AUSTRALIAN PRODUCT INFORMATION – EVEROCAN (EVEROLIMUS) TABLETS
1.
NAME OF THE MEDICINE
Everolimus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Everolimus is a white to faintly yellow powder practically insoluble
in water but soluble in
organic solvents such as ethanol and methanol.
EVEROCAN 0.25 MG:
Each uncoated tablet contains 0.25 mg Everolimus.
EVEROCAN 0.5 MG:
Each uncoated tablet contains 0.5 mg Everolimus.
EVEROCAN 0.75 MG:
Each uncoated tablet contains 0.75 mg Everolimus.
EVEROCAN 1 MG:
Each uncoated tablet contains 1 mg Everolimus.
Excipient with known effect: contain lactose
For the full list of excipients, see section 6.1 List of excipients
.
3.
PHARMACEUTICAL FORM
Uncoated tablet.
EVEROCAN 0.25 MG:
White to off white, round shaped tablets debossed with "EVR" on one
side and "25" on other side.
EVEROCAN 0.5 MG:
White to off white, round shaped tablets debossed with "EVR" on one
side and "50" on other side.
EVEROCAN 0.75 MG:
White to off white, round shaped tablets debossed with "EVR" on one
side and "75" on other side.
EVEROCAN 1 MG:
White to off white, round shaped tablets debossed with "EVR" on one
side
and "100" on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EVEROCAN is indicated for the prophylaxis of organ rejection in adult
patients at mild to
moderate immunological risk receiving an allogeneic renal or cardiac
transplant and in adult
patients
receiving
an
allogeneic
hepatic
transplant
(see section 4.4 Special warnings and precautions for use).
Everocan (ver 03) Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Treatment with EVEROCAN should only be initiated and maintained by
physicians who are
experienced in immunosuppressive therapy following organ
transplantation. Everolimus should
be used in combination with cyclosporin microemulsion and
corticosteroids with cyclosporin
exposure
reduced
over
time
post-transplantation
(see
section
4.2
Dose
and
method
of
administration,
_Therapeutic Drug Monitoring_
).
KIDNEY AND HEART TRANSPLANTATION
An initial