CERTICAN TABLETS 0.75 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

EVEROLIMUS

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

L04AA18

Dosage:

0.75 MG

Pharmaceutical form:

TABLET

Composition:

EVEROLIMUS 0.75 MG

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharmaceutical Manufacturing LLC (DP Intermediate Manufacturer)

Authorization status:

ACTIVE

Authorization date:

2006-04-18

Patient Information leaflet

CERTICAN


Selective immunosuppressive agent
DESCRIPTION AND
COMPOSITION
PHARMACEUTICAL FORM(S)
TABLETS AND DISPERSIBLE TABLETS.
The tablets and the dispersible tablets are white to yellowish,
marbled,
round, flat with a bevelled edge.
ACTIVE SUBSTANCE
TABLETS
Certican
®
tablets contain 0.25 mg, 0.5 mg, 0.75 mg or 1.0 mg everolimus
DISPERSIBLE TABLETS
Certican
®
dispersible tablets contain 0.1 mg or 0.25 mg everolimus
Certain dosage strengths and dosage forms may not be available in all
countries.
ACTIVE MOIETY
Everolimus
EXCIPIENTS
TABLETS:
Butylated hydroxytoluene (E321), magnesium stearate, lactose
monohydrate,
hypromellose, crospovidone, lactose anhydrous.
DISPERSIBLE TABLETS:
Butylated hydroxytoluene (E321), magnesium stearate, lactose
monohydrate, hypromellose, crospovidone, lactose anhydrous, colloidal
anhydrous silica.
Pharmaceutical formulations may vary between countries.
INDICATIONS
KIDNEY AND HEART TRANSPLANTATION
Certican is indicated for the prophylaxis of organ rejection in adult
patients at low to
moderate immunological risk receiving an allogeneic renal or cardiac
transplant. In kidney
and
heart
transplantation,
Certican
should
be
used
in
combination
with
ciclosporin
for
microemulsion and corticosteroids.
LIVER TRANSPLANTATION
Certican is indicated for the prophylaxis of organ rejection in adult
patients receiving a hepatic
transplant. In liver transplantation, Certican should be used in
combination with tacrolimus
and corticosteroids.
DOSAGE REGIMEN AND ADMINISTRATION
Treatment
with Certican
should
only be initiated
and maintained by physicians
who are
experienced in immunosuppressive therapy following organ
transplantation and who have
access
to
everolimus whole blood levels monitoring. Everolimus should be used in
combination with ciclosporin for microemulsion and corticosteroids
with ciclosporin
exposure reduced over time post-transplantation.
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ADULTS
KIDNEY AND HEART TRANSPLANTATION
An initial dose regimen of 0.75 mg b.i.d., which is recommende

Summary of Product characteristics

Certican May 2022.SIN
Page 1 of 29
CERTICAN

Selective immunosuppressive agent
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
TABLETS
The tablets are white to yellowish, marbled, round, flat with a
bevelled edge.
ACTIVE SUBSTANCE
TABLETS
Certican
®
tablets contain 0.25 mg, 0.5 mg, 0.75 mg everolimus
Certain dosage strengths and dosage forms may not be available in all
countries.
ACTIVE MOIETY
Everolimus
EXCIPIENTS
TABLETS:
Butylated hydroxytoluene (E321), magnesium stearate, lactose
monohydrate,
hypromellose, crospovidone, lactose anhydrous.
INDICATIONS
KIDNEY AND HEART TRANSPLANTATION
Certican is indicated for the prophylaxis of organ rejection in adult
patients at low to moderate
immunological risk receiving an allogeneic
renal or cardiac transplant.
In kidney and heart
transplantation, Certican should be used in combination with
ciclosporin for microemulsion and
corticosteroids.
LIVER TRANSPLANTATION
Certican is indicated for the prophylaxis of organ rejection in adult
patients receiving a hepatic
transplant. In liver transplantation, Certican should be used in
combination with tacrolimus
and corticosteroids.
DOSAGE REGIMEN AND ADMINISTRATION
Treatment
with Certican
should
only
be initiated
and
maintained
by physicians
who
are
experienced in immunosuppressive therapy following organ
transplantation and who have
access
to
everolimus whole blood level monitoring. Everolimus should be used in
combination with ciclosporin for microemulsion and corticosteroids
with ciclosporin
exposure reduced over time post-transplantation.
DOSAGE REGIMEN
Certican May 2022.SIN
Page 2 of 29
GENERAL TARGET POPULATION
ADULTS
KIDNEY AND HEART TRANSPLANTATION
An initial dose regimen of 0.75 mg b.i.d., which is recommended for
the general kidney and
heart transplant population, should be administered as soon as
possible after transplantation.
LIVER TRANSPLANTATION
The dose of 1.0 mg b.i.d is recommended for the hepatic transplant
population with the initial
dose approximately 4 weeks after transplantation.
_Dosing considerations