LENALICIP lenalidomide 10 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lenalidomide, Quantity: 10 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; Gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; Shellac Glaze-45% (20% esterified) in Ethanol

Administration route:

Oral

Units in package:

14, 28, 21

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Multiple Myeloma (MM) Lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. Lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,Myelodysplastic Syndromes (MDS) Lenalidomide 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.

Product summary:

Visual Identification: White to off white powder filled in size 0 hard gelatin blue green and pale yellow capsule spin printed in black ink with 'Cipla 10 mg' on the cap; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-10-08

Patient Information leaflet

LENALICIP
_ _
_(lenalidomide) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
LENALICIP. 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 LENALICIP 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 LENALICIP
ISUSED FOR
LENALICIP contains an
active substance called
lenalidomide. LENALICIP
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.
•
LENALICIP is used to
treat adult patients who
have been diagnosed
with newly diagnosed
Multiple Myeloma
(NDMM) and who have
undergone a stem cell
transplant.
•
LENALICIP is used in
combination with another
medicine called
dexamethasone to treat
adult NDMM patients
who are not eligible for
stem cell transplantation.
•
LENALICIP is also used
in combination with
dexamethasone to treat
adult MM patients whose
disease has progressed
after one therapy.
_TREATMENT OF _
_MYELODYSPLASTIC SYNDROMES _
LENALICIP 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.
LENALICIP 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
LENALICIP

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LENALICIP (LENALIDOMIDE) CAPSULES
TERATOGENIC EFFECTS:
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, 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.
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.
Excipients with known effect: sugars as lactose
For the full list of excipients, see section 6.1 (List of excipients).
3.
PHARMACEUTICAL FORM
LENALICIP (lenalidomide) 5 mg capsules are off white to pale yellow
coloured crystalline anhydrous
powder filled in size ‘2’ hard gelatin white and white capsule
spin printed in black ink with ‘Cipla 5 mg’
on the cap.
LENALICIP (lenalidomide) 10 mg capsules are off white to pale yellow
coloured crystalline anhydrous
powder filled in size ‘0’ hard gelatin blue green and pale yellow
capsule spin printed in black ink with
‘Cipla 10 mg’ on the cap.
LENALICIP (lenalidomide) 15 mg capsules are off white to pale yellow
coloured crystalline anhydrous
powder filled in size ‘0’ hard gelatin pale blue and white capsule
spin printed in black ink with ‘Cipla
15 mg’ on the cap.
LENALICIP (lenalidomide) 20 mg capsules are off white to pale yellow
coloured crystalline anhydrous
powder filled in size ‘0’ hard gelatin blue green and pale blue
capsule spin printed in black ink with
‘Cipla 20 mg’ on the cap.
LENALICIP (lenalidomide) 25 mg capsules are off white to pale yellow
coloured crystalline anhydrous
powder filled in size ‘0’ hard gelatin white and white capsule
spin pri