Lenalidomide Azure 10 mg hard capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Lenalidomide

Disponibil de la:

Azure Pharmaceuticals Ltd

Codul ATC:

L04AX04

INN (nume internaţional):

Lenalidomide

Forma farmaceutică:

Capsule, hard

Zonă Terapeutică:

lenalidomide

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2023-03-03

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE AZURE 5 MG HARD CAPSULES
LENALIDOMIDE AZURE 10 MG HARD CAPSULES
LENALIDOMIDE AZURE 15 MG HARD CAPSULES
LENALIDOMIDE AZURE 20 MG HARD CAPSULES
LENALIDOMIDE AZURE 25 MG HARD CAPSULES
lenalidomide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Lenalidomide Azure is and what it is used for
2. What you need to know before you take Lenalidomide Azure
3. How to take Lenalidomide Azure
4. Possible side effects
5. How to store Lenalidomide Azure
6. Contents of the pack and other information
1.
WHAT LENALIDOMIDE AZURE IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE AZURE IS
This medicine contains the active substance ‘lenalidomide’. This
medicine belongs to a group of
medicines which affect how your immune system works.
WHAT LENALIDOMIDE AZURE IS USED FOR
This medicine is used in adults for multiple myeloma.
MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain kind of
white blood cell, called the plasma
cell. These cells collect in the bone marrow and divide, becoming out
of control. This can damage the
bones and kidneys.
Multiple myeloma generally cannot be cured. However, the signs and
symptoms can be greatly reduced
or disappear for a period of time. This is called a ‘response’.
Newly diagnosed multiple myeloma – in patients who have had a bone
marrow transplant
Lenalidomide is used on its own as maintenance therapy after patients
have recovered enough following a
bone marrow transplant.
Newly diagnosed mu

Caracteristicilor produsului

Health Products Regulatory Authority
09 March 2023
CRN00C0DD
Page 1 of 45
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lenalidomide Azure 10 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg of lenalidomide.
Excipient with known effect:
Each 10 mg hard capsule contains 294 mg of lactose (as anhydrous
lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
White to off white powder filled in size '0' hard gelatin blue green
and pale yellow capsule imprinted in black ink with 'Cipla 10
mg' on the cap. Sealed length: 21.70 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lenalidomide as monotherapy is indicated for the maintenance treatment
of adult patients with newly diagnosed multiple
myeloma who have undergone autologous stem cell transplantation.
Lenalidomide as combination therapy with dexamethasone, or bortezomib
and dexamethasone, or melphalan and prednisone
(see section 4.2) is indicated for the treatment of adult patients
with previously untreated multiple myeloma who are not
eligible for transplant.
Lenalidomide in combination with dexamethasone is indicated for the
treatment of multiple myeloma in adult patients who
have received at least one prior therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lenalidomide treatment should be supervised by a physician experienced
in the use of anti-cancer therapies.
Dose is modified based upon clinical and laboratory findings (see
section 4.4).
Dose adjustments, during treatment and restart of treatment, are
recommended to manage grade 3 or 4 thrombocytopenia,
neutropenia, or other grade 3 or 4 toxicity judged to be related to
lenalidomide.
In case of neutropenia, the use of growth factors in patient
management should be considered.
If less than 12 hours has elapsed since missing a dose, the patient
can take the dose. If more than 12 hours has elapsed since
missing a dose at the normal time, the patient should not take the
dose, but take the next dose at th