Revlimid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lenalidomide 15mg;  

Available from:

Celgene Limited

INN (International Name):

Lenalidomide 15 mg

Dosage:

15 mg

Pharmaceutical form:

Capsule

Composition:

Active: Lenalidomide 15mg   Excipient: Capsule blue 3628 Capsule white 0999 Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose TekPrint black SW-9008 TekPrint black SW-9009

Units in package:

Blister pack, PVC/PCTFE(Aclar)/Al, 21 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Celgene Chemicals GmbH

Therapeutic indications:

Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE(Aclar)/Al - 21 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE(Aclar)/Al - 28 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2008-01-23

Patient Information leaflet

REVLIMID
®
1
REVLIMID
®
_(lenalidomide) _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Revlimid. 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 Revlimid
against the benefits this medicine is
expected to 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 REVLIMID IS
USED FOR
Revlimid contains an active
substance called lenalidomide.
Revlimid belongs to a group of
medicines called immunomodulating
agents that work by acting on the
cells involved in the body's immune
system. The immune system is part
of the body's defence which helps to
fight illness and infection.
_TREATMENT OF MULTIPLE _
_MYELOMA _
Multiple myeloma (MM) is a cancer
of the bone marrow.
•
Revlimid is used to treat adult
patients who have been
diagnosed with newly diagnosed
Multiple Myeloma (NDMM)
and who have undergone a stem
cell transplant.
•
Revlimid is used in combination
with another medicine called
dexamethasone to treat adult
NDMM patients who are not
eligible for stem cell
transplantation.
•
Revlimid is also used in
combination with
dexamethasone to treat adult
MM patients whose disease has
progressed after one therapy.
_TREATMENT OF _
_MYELODYSPLASTIC SYNDROMES _
Revlimid is also used to treat patients
who have conditions called
myelodysplastic syndromes (MDS)
in whom the bone marrow does not
produce enough mature blood cells.
This causes a lack of healthy blood
cells in the body. There are different
types of MDS.
Revlimid is approved to treat a type
of MDS where part of chromosome 5
is missing. This type of MDS is
known as deletion 5q MDS (or 5q
minus). Patients with this type of
MDS often have low red blood cell
counts that require treatment with
blood transfusions. It is hoped that
the u

Summary of Product characteristics

Revlimid
®
(lenalidomide) capsules – NZ Data Sheet
Celgene V5.0 – 27 January 2022 (CCDS V22)
Page
1
of
37
NEW ZEALAND DATA SHEET
TERATOGENIC EFFECTS:
REVLIMID (LENALIDOMIDE) IS STRUCTURALLY RELATED TO THALIDOMIDE.
THALIDOMIDE IS A KNOWN HUMAN
TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF
LENALIDOMIDE IS TAKEN DURING
PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY.
WOMEN SHOULD BE ADVISED TO
AVOID PREGNANCY WHILST TAKING REVLIMID (LENALIDOMIDE), DURING DOSE
INTERRUPTIONS, AND FOR
4 WEEKS AFTER STOPPING THE MEDICINE.
1
PRODUCT NAME
Revlimid 2.5 mg capsules
*
Revlimid 5 mg capsules
Revlimid 7.5 mg capsules
*
Revlimid 10 mg capsules
Revlimid 15 mg capsules
Revlimid 20 mg capsules
*
Revlimid 25 mg capsules
* Not available in New Zealand.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg capsule contains 2.5 mg lenalidomide.
Each 5 mg capsule contains 5 mg lenalidomide.
Each 7.5 mg capsule contains 7.5 mg lenalidomide.
Each 10 mg capsule contains 10 mg lenalidomide.
Each 15 mg capsule contains 15 mg lenalidomide.
Each 20 mg capsule contains 20 mg lenalidomide.
Each 25 mg capsule contains 25 mg lenalidomide.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Presentation
Revlimid 2.5 mg capsules: White/blue-green size 4 capsules marked
“2.5 mg REV”.
Revlimid 5 mg capsules: White size 2 capsules marked “5 mg REV”.
Revlimid 7.5 mg capsules: White/pale-yellow size 2 capsules marked
“7.5 mg REV”.
Revlimid 10 mg capsules: Yellow/blue-green size 0 capsules marked
“10 mg REV”.
Revlimid 15 mg capsules: White/blue size 0 capsules marked “15 mg
REV”.
Revlimid 20 mg capsules: Powder-blue/blue-green size 0 capsules marked
“20 mg REV”.
Revlimid 25 mg capsules: White size 0 capsules marked “25 mg REV”.
Description
Lenalidomide is an off-white to pale-yellow solid, with a melting
point between 265ºC to 270ºC.
Lenalidomide is generally more soluble in organic solvents but
exhibits the greatest solubility in 0.1N
HCl buffer. The solubil