Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Lenalidomide 10mg;
Celgene Limited
Lenalidomide 10 mg
10 mg
Capsule
Active: Lenalidomide 10mg Excipient: Capsugel yellow 4035 Capsule blue-green 6579 Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose TekPrint black SW-9008 TekPrint black SW-9009
Blister pack, PVC/PCTFE(Aclar)/Al, 21 capsules
Prescription
Prescription
Celgene Chemicals GmbH
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE(Aclar)/Al - 21 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE(Aclar)/Al - 28 capsules - 36 months from date of manufacture stored at or below 25°C
2008-01-23
REVLIMID ® 1 REVLIMID ® _(lenalidomide) _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Revlimid. 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 Revlimid 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 REVLIMID IS USED FOR Revlimid contains an active substance called lenalidomide. Revlimid 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. • Revlimid is used to treat adult patients who have been diagnosed with newly diagnosed Multiple Myeloma (NDMM) and who have undergone a stem cell transplant. • Revlimid is used in combination with another medicine called dexamethasone to treat adult NDMM patients who are not eligible for stem cell transplantation. • Revlimid is also used in combination with dexamethasone to treat adult MM patients whose disease has progressed after one therapy. _TREATMENT OF _ _MYELODYSPLASTIC SYNDROMES _ Revlimid 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. Revlimid 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 u Read the complete document
Revlimid ® (lenalidomide) capsules – NZ Data Sheet Celgene V5.0 – 27 January 2022 (CCDS V22) Page 1 of 37 NEW ZEALAND DATA SHEET TERATOGENIC EFFECTS: REVLIMID (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 REVLIMID (LENALIDOMIDE), DURING DOSE INTERRUPTIONS, AND FOR 4 WEEKS AFTER STOPPING THE MEDICINE. 1 PRODUCT NAME Revlimid 2.5 mg capsules * Revlimid 5 mg capsules Revlimid 7.5 mg capsules * Revlimid 10 mg capsules Revlimid 15 mg capsules Revlimid 20 mg capsules * Revlimid 25 mg capsules * Not available in New Zealand. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Presentation Revlimid 2.5 mg capsules: White/blue-green size 4 capsules marked “2.5 mg REV”. Revlimid 5 mg capsules: White size 2 capsules marked “5 mg REV”. Revlimid 7.5 mg capsules: White/pale-yellow size 2 capsules marked “7.5 mg REV”. Revlimid 10 mg capsules: Yellow/blue-green size 0 capsules marked “10 mg REV”. Revlimid 15 mg capsules: White/blue size 0 capsules marked “15 mg REV”. Revlimid 20 mg capsules: Powder-blue/blue-green size 0 capsules marked “20 mg REV”. Revlimid 25 mg capsules: White size 0 capsules marked “25 mg REV”. Description Lenalidomide is an off-white to pale-yellow solid, with a melting point between 265ºC to 270ºC. Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1N HCl buffer. The solubil Read the complete document