Lenalidomide Devatis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lenalidomide 2.5mg

Available from:

Devatis Limited

Dosage:

2.5 mg

Pharmaceutical form:

Capsule

Composition:

Active: Lenalidomide 2.5mg Excipient: Croscarmellose sodium Gelatin Indigo carmine Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Titanium dioxide

Prescription type:

Prescription

Therapeutic indications:

Lenalidomide Devatis is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. Lenalidomide Devatis is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Devatis 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/Aclar film with Aluminium foil - 7 capsules - 48 months from date of manufacture, no storage statement needed - Blister pack, PVC/Aclar film with Aluminium foil - 14 capsules - 48 months from date of manufacture, no storage statement needed - Blister pack, PVC/Aclar film with Aluminium foil - 21 capsules - 48 months from date of manufacture, no storage statement needed - Blister pack, PVC/Aclar film with Aluminium foil - 28 capsules - 48 months from date of manufacture, no storage statement needed

Authorization date:

2021-05-08

Patient Information leaflet

Lenalidomide Devatis 2.5 mg, 5 mg, 7.5 mg, 10 mg,
15 mg, 20 mg & 25 mg Capsules
MODULE 1.3.2 CONSUMER MEDICINE INFORMATION (CMI)
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 9
Version: V01/May 2022
LENALIDOMIDE DEVATIS
2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, 20 MG & 25 MG CAPSULES
_Lenalidomide _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
please read this leaflet carefully before you start using Lenalidomide
Devatis Capsules.
This leaflet answers some common questions about Lenalidomide Devatis
Capsules. 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 Lenalidomide Devatis
Capsules against the benefits this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING LENALIDOMIDE DEVATIS CAPSULES,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT LENALIDOMIDE DEVATIS CAPSULES IS USED FOR
LENALIDOMIDE Devatis Capsules contain an active substance called
lenalidomide. Lenalidomide 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.

Lenalidomide Devatis is used to treat adult patients who have been
diagnosed with newly diagnosed
Multiple Myeloma (NDMM)
and who have undergone a stem cell transplant.

Lenalidomide Devatis is used in combination with another medicine
called dexamethasone to treat adult
NDMM patients who are not eligible for stem cell transplantation.

Lenalidomide Devatis is also used in combination with dexamethasone to
treat adult MM patients whose
disease has progressed after one therapy.
_TREATMENT OF MYELODYSPLASTIC SYNDROMES _
Lenalidomide Devatis is also used to treat patients who

Summary of Product characteristics

Lenalidomide Devatis 2.5 mg, 5 mg, 7.5 mg, 10 mg,
15 mg, 20 mg & 25 mg Capsules
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 35
Version: V03/January 2023
NEW ZEALAND DATA SHEET
TERATOGENIC EFFECTS:
LENALIDOMIDE DEVATIS (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 LENALIDOMIDE
DEVATIS, DURING DOSE
INTERRUPTIONS, AND FOR 4 WEEKS AFTER STOPPING THE MEDICINE.
1. PRODUCT NAME
Lenalidomide Devatis 2.5 mg Capsules
Lenalidomide Devatis 5 mg Capsules
Lenalidomide Devatis 7.5 mg Capsules
Lenalidomide Devatis 10 mg Capsules
Lenalidomide Devatis 15 mg Capsules
Lenalidomide Devatis 20 mg Capsules
Lenalidomide Devatis 25 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
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.
EXCIPIENT WITH KNOWN EFFECT:
Each 2.5 mg capsule contains 20 mg of lactose
Each 5 mg capsule contains 40 mg of lactose
Each 7.5 mg capsule contains 60 mg of lactose
Each 10 mg capsule contains 80 mg of lactose
Each 15 mg capsule contains 120 mg of lactose
Each 20 mg capsule contains 160 mg of lactose
Each 25 mg capsule contains 200 mg of lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Presentation
_Lenalidomide Devatis 2.5 mg Capsules _
Size 4 hard gelatine capsules (length: 14.4 mm) with a blue-green cap
and a white body imprinted with “2.5
mg”. Both imprints are black. Capsules are filled with white to
off-white powder.
_Lenalidomide Devatis 5 mg Capsules _
Size 2 h