LENALIDOMIDE SANDOZ lenalidomide 25 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lenalidomide, Quantity: 25 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: propylene glycol; croscarmellose sodium; titanium dioxide; lactose; Gelatin; microcrystalline cellulose; iron oxide black; Shellac; potassium hydroxide; magnesium stearate

Administration route:

Oral

Units in package:

14 capsules, 21 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Multiple Myeloma (MM),LENALIDOMIDE SANDOZ is indicated for the treatment of multiple myeloma.,Myelodysplastic Syndromes (MDS),LENALIDOMIDE SANDOZ is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,Mantle Cell Lymphoma (MCL),LENALIDOMIDE SANDOZ is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

Product summary:

Visual Identification: Hard gelatine capsule, with an opaque white body and opaque white cap with L9NL and 25 printed radial on body.,Capsule size 0; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-11-30

Patient Information leaflet

LENALIDOMIDE SANDOZ
®
1
LENALIDOMIDE
SANDOZ
®
_(lenalidomide) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions
about
LENALIDOMIDE
SANDOZ. 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
SANDOZ
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
LENALIDOMIDE
SANDOZ IS USED
FOR
LENALIDOMIDE SANDOZ
contains an active substance called
lenalidomide. LENALIDOMIDE
SANDOZ 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 SANDOZ is used
to
treat
patients
with
Multiple
Myeloma.
_TREATMENT OF MYELODYSPLASTIC _
_SYNDROMES _
LENALIDOMIDE SANDOZ 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.
LENALIDOMIDE
SANDOZ
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
use
of
LENALIDOMIDE
SANDOZ will reduce the
need for blood transfusions.
TREATMENT OF MANTLE CELL
LYMPHOMA
LENALIDOMIDE SANDOZ is used
to treat adult
patients who have been diagnosed
with and previously treated for
Mantle Cell Lymphoma (MCL).
MCL is a cancer of the lymph tissue
(part of the immune sys

Summary of Product characteristics

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Page 1 of 52
AUSTRALIAN PRODUCT INFORMATION
LENALIDOMIDE SANDOZ
® (LENALIDOMIDE) CAPSULES
DO NOT USE LENALIDOMIDE SANDOZ DURING PREGNANCY.
TERATOGENIC EFFECTS: LENALIDOMIDE SANDOZ (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 SANDOZ (LENALIDOMIDE),
DURING
DOSE INTERRUPTIONS, AND FOR 4 WEEKS AFTER STOPPING THE MEDICATION
.
1.
NAME OF THE MEDICINE
Lenalidomide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg capsule contains 5 mg lenalidomide and 66.4 mg of lactose.
Each 10 mg capsule contains 10 mg lenalidomide and 132.9 mg of
lactose.
Each 15 mg capsule contains 15 mg lenalidomide and 199.3 mg of
lactose.
Each 25 mg capsule contains 25 mg lenalidomide and 332.2 mg of
lactose.
_Excipients with known effect:_
contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
Description
Lenalidomide is an off-white to pale-yellow solid, with a melting
point between 265ºC and
270ºC. Lenalidomide is generally more soluble in organic solvents but
exhibits the greatest
solubility in 0.1N HCl buffer. The solubility of lenalidomide in water
and at pH 1.21 is < 1.5
mg/mL and 18 mg/mL, respectively.
Lenalidomide has an asymmetric carbon atom and can therefore exist as
the optically active
forms S(-) and R(+). Lenalidomide is produced as a racemic mixture
with a net optical rotation
of zero.
3.
PHARMACEUTICAL FORM
LENALIDOMIDE SANDOZ (lenalidomide) 5 mg capsules: opaque white body
and opaque
white cap with “L9NL” and “5” printed radial on body. Capsule
size: 2
LENALIDOMIDE SANDOZ (lenalidomide) 10 mg capsules: opaque yellow body
and opaque
green cap with “L9NL” and “10” printed radial on body. Capsule
size: 0.
LENALIDOMIDE SANDOZ (lenalidomide) 15 mg capsules: opaque white