For doctors
What is it and how is it used?
What Revlimid is
Revlimid belongs to a group of medicines called immunomodulatory medicines, which can modify or regulate the functioning of the immune system.
What Revlimid is used for
Revlimid in combination with dexamethasone is used to treat adult patients who have been diagnosed with multiple myeloma. Multiple myeloma is a type of blood cancer that affects the white blood cells that produce antibodies.
What do you have to consider before using it?
Follow all of your doctor’s instructions carefully, even if they differ from the general information given in this leaflet.
DO NOT TAKE Revlimid
If any of these apply to you, tell your doctor before you take Revlimid.
Take special care with Revlimid
Please talk to your doctor in the following situations:
For women taking Revlimid
Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
If you are able to become pregnant
For men taking Revlimid
Revlimid passes into human semen. If your female partner is pregnant or able to become pregnant, and she doesn’t use effective methods of contraception, you must use condoms, during treatment and 1 week after the end of treatment.
All patients
Before starting the treatment you should tell your doctor if you had blood clots in the past. During the treatment with Revlimid you have an increased risk of developing blood clots in the veins and arteries.
Before and during the treatment with Revlimid you will have regular blood tests as Revlimid may cause a fall in the blood cells that help fight infection and help the blood to clot. Your doctor should ask you to have a blood test:
Before you start treatment you should tell your doctor if you have kidney disease. Your doctor may adjust your dose of Revlimid based on this information.
You should not donate blood during treatment and for 1 week after the end of treatment.
At the end of the treatment you should return all unused capsules to the pharmacist.
Taking other medicines
Please tell your doctor or pharmacist of all other medicines that you are taking or have recently taken, including medicines obtained without a prescription.
Taking Revlimid with food and drink
The Revlimid capsules can be taken either with or without food (see Section 3, “How and when to take the Revlimid capsule”).
Pregnancy
You must not take Revlimid if you are pregnant, as it is expected to be harmful for an unborn baby. In addition, you must not become pregnant while taking Revlimid.
Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see Section 2, “Take special care with Revlimid”).
If you do become pregnant during the treatment with Revlimid, you must stop the treatment and inform your doctor immediately.
For men taking Revlimid, please see section 2 “Take special care with Revlimid”. If your partner becomes pregnant whilst you are taking Revlimid, you should inform your doctor immediately. It is recommended that your partner seeks medical advice.
Breast-feeding
You should not breastfeed when taking Revlimid, as it is not known if Revlimid passes into human milk.
Driving and using machines:
Do not drive or operate machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
Important information about some of the ingredients of Revlimid
Revlimid contains lactose (a type of sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Revlimid.
How is it used?
Revlimid is taken in combination with dexamethasone. Always take Revlimid and dexamethasone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should refer to the package leaflet for dexamethasone for further information on its use and effects.
Revlimid dosage
The usual starting dose is 25 mg once per day. Revlimid is taken in treatment cycles, each cycle lasting 28 days.
Treatment cycle:
Your doctor may adjust your dose of Revlimid or stop your treatment based on the results of your blood tests and on your general condition (see Section 2, Take special care with Revlimid”).
Dexamethasone dosage
The usual starting dose is 40 mg once per day. Dexamethasone is also taken in treatment cycles, each cycle lasting 28 days.
First 4 treatment cycles:
Following treatment cycles:
Your doctor may reduce your dose of dexamethasone based on your general condition (see Section 2, "Take special care with Revlimid”).
How and when to take Revlimid
You should swallow the Revlimid capsules whole, preferably with water, once a day. Do not break, open or chew the capsules. The Revlimid capsules can be taken either with or without food.
You should take Revlimid at about the same time each day.
Duration of the treatment with Revlimid
Revlimid is taken in treatment cycles, each cycle lasting 28 days (see above “Dosage”). You should continue the cycles of treatment until your doctor tells you to stop.
If you take more Revlimid than you should
If you take more Revlimid than was prescribed, tell your doctor immediately.
If you forget to take Revlimid
If you forget to take Revlimid at your regular time and
If you have any further questions on the use of Revlimid, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Revlimid can cause side effects, although not everybody gets them. The frequency of side effects is classified into the following categories:
It is important to note that Revlimid may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets). Revlimid may also cause blood clots in the veins (thrombosis).
Therefore you must tell your doctor immediately if you experience:
Very common side effects are given below. You should consult your doctor if you experience any of these:
Common side effects are given below. You should consult your doctor if you experience any of these:
Uncommon side effects are given below. You should consult your doctor if you experience any of these:
•
Rare side effects are given below. You should consult your doctor if you experience any of these:
potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death
Side effects where the frequency is not known are given below. You should consult your doctor if you experience any of these:
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
All unused Revlimid capsules should be returned to the pharmacist.
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For doctors
What is it?
Revlimid is a medicine containing the active substance lenalidomide. It is available as capsules (white: 5 mg; blue-green and yellow: 10 mg; blue and white: 15 mg; white: 25 mg).
What is it used for?
Revlimid is an anticancer medicine. It is used in combination with dexamethasone (an anti-inflammatory medicine) to treat adult patients with multiple myeloma whose disease has been treated at least once in the past. Multiple myeloma is a cancer of the plasma cells in the bone marrow. Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Revlimid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 December 2003.
The medicine can only be obtained with a prescription.
How is it used?
Treatment with Revlimid must be initiated and monitored by doctors who have experience in the management of multiple myeloma.
Revlimid is taken in repeated 28-day cycles: the patient takes the medicine once a day for 21 days, followed by seven days off the medicine. Dexamethasone should be taken at a dose of 40 mg once a day on days 1 to 4, 9 to 12 and 17 to 20 of the first four cycles, and on days 1 to 4 thereafter. The recommended dose of Revlimid is 25 mg a day. This dose should be reduced or treatment interrupted depending on the patient’s condition and the levels of platelets (components in the blood that aid clotting) and of neutrophils (a type of white blood cell). A lower dose should also be used in patients who have moderate or more severe problems with their kidneys. For more information, see the Summary of Product Characteristics (also part of the EPAR).
Revlimid should be taken at around the same time each day. The capsules should be swallowed whole, preferably with water.
How does it work?
The active substance in Revlimid, lenalidomide, is an immunomodulating agent. This means that it affects the activity of the immune system (the body’s natural defences). Lenalidomide works in a number of different ways in multiple myeloma: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells.
How has it been studied?
The effects of Revlimid were first tested in experimental models before being studied in humans. Revlimid was studied in two main studies involving 704 patients with multiple myeloma. In both studies, Revlimid was compared with placebo (a dummy treatment), both taken in combination with dexamethasone. The main measure of effectiveness was how long it took until the disease got worse.
What benefits has it shown during the studies?
Revlimid was more effective than placebo at preventing a worsening of multiple myeloma. The results of the two studies taken together showed that, on average, it took 48.3 weeks for the disease to get worse in patients taking Revlimid, compared with 20.1 weeks in those taking placebo.
What is the risk associated?
The most common side effects with Revlimid (seen in more than 1 patient in 10) are neutropenia (low neutrophil counts), fatigue (tiredness), asthenia (weakness), constipation, muscle cramp, thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), diarrhoea and rash. For the full list of all side effects reported with Revlimid, see the Package Leaflet.
Lenalidomide is expected to be harmful to the unborn child. Therefore, Revlimid must not be used in women who are pregnant. It must also not be used in women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment. Revlimid should not be used by people who may be hypersensitive (allergic) to lenalidomide or any of the other ingredients. For the full list of restrictions, see the Package Leaflet.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in combination with dexamethasone, Revlimid’s benefits are greater than its risks for the treatment of multiple myeloma patients who have received at least one prior therapy. The Committee recommended that Revlimid be given marketing authorisation.
How has it been studied?
The company that makes Revlimid will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining the fact that it is expected to be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient. Each Member State will also ensure that educational materials and patient cards are provided to prescribers and patients.
The company will also set up a pregnancy prevention programme in each Member State and collect information on whether the medicine is used outside its approved indication. The boxes containing Revlimid capsules also include a warning stating that lenalidomide is expected to be harmful to the unborn child.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Revlimid to Celgene Europe Limited on 14 June 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Revlimid is available here.
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Name
Revlimid 25 mg hard capsules
Composition
Each capsule contains 25 mg of lenalidomide.
Excipient:
Each capsule contains 200 mg of anhydrous lactose.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Hard capsule.
White capsules marked “REV 25 mg”.
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