LENALIDE lenalidomide 25 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lenalidomide, Quantity: 25 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: lactose; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

14, 21 capsules, 28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Multiple Myeloma (MM)- Lenalidomide is indicated for treatment of multiple myeloma.,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.,Mantle Cell Lymphoma (MCL) - Lenalidomide is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

Product summary:

Visual Identification: White/white printed with "NAT" on the cap and "25 mg" on the body of the capsules.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-07-23

Patient Information leaflet

Lenalide
1
LENALIDE CAPSULES
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING LENALIDE?
Lenalide contains the active ingredient Lenalidomide. It is used to
treat patients with Multiple Myeloma, Myelodysplastic
Syndromes (MDS) and newly diagnosed and previously treated Mantle Cell
Lymphoma (MCL).
For more information, see Section 1. Why am I using Lenalide?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LENALIDE?
Do not use if you have ever had an allergic reaction to lenalidomide
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. IT IS EXTREMELY IMPORTANT THAT YOU GET
ENROLLED FOR THE PREGNANCY PREVENTION PROGRAM. YOU
MUST TAKE ALL PRECAUTIONS AND MEASURES TO PREVENT PREGNANCY. For more
information, see Section
2. What should I know
before I use Lenalide? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lenalide and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE LENALIDE?
•
Your doctor will tell you how much Lenalide to take and for how long
you will need to take it, monitor your progress and
may adjust your dose. based on the results of your blood tests and on
your general condition. Swallow the capsules whole
with a full glass of water, once a day as directed by your doctor.
•
Lenalide should be taken either one hour before or two hours after
eating food. Do not open, break or chew the capsules.
If powder from the capsules contact the skin, wash the skin
immediately and thoroughly with soap and water. If
lenalidomide contacts the mucous membranes e.g. the eyes, fl

Summary of Product characteristics

Lenalide (lenalidomide) capsules – AU Product Information
1
AUSTRALIAN PRODUCT INFORMATION
LENALIDE (LENALIDOMIDE) CAPSULES
DO NOT USE LENALIDE DURING PREGNANCY.
TERATOGENIC EFFECTS: LENALIDE (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 LENALIDE
(LENALIDOMIDE), DURING DOSE INTERRUPTIONS, AND FOR 4 WEEKS AFTER
STOPPING THE MEDICATION.
1 NAME OF THE MEDICINE
Australian approved name: lenalidomide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg capsule contains 2.5 mg lenalidomide and 43.33 mg of
lactose (as anhydrous
lactose).
Each 5 mg capsule contains 5 mg lenalidomide and 86.67 mg of lactose
(as anhydrous lactose).
Each 7.5 mg capsule contains 7.5 mg lenalidomide and 130 mg of lactose
(as anhydrous
lactose).
Each 10 mg capsule contains 10 mg lenalidomide and 173.33 mg of
lactose (as anhydrous
lactose).
Each 15 mg capsule contains 15 mg lenalidomide and 260 mg of lactose
(as anhydrous lactose).
Each 20 mg capsule contains 20 mg lenalidomide and 255 mg of lactose
(as anhydrous lactose).
Each 25 mg capsule contains 25 mg lenalidomide and 250 mg of lactose
(as anhydrous 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
Lenalide (lenali