Main use Active ingredient Manufacturer
Multiple myeloma Lenalidomide Celgene Ltd

How does it work?
Revlimid capsules contain the active ingredient lenalidomide, which is a type of medicine called an immunomodulating agent. It affects the way the immune system works. Lenalidomide is used to treat multiple myeloma, which is a cancer of a type of white blood cell in the bone marrow. In multiple myeloma, white blood cells called plasma cells multiply in an uncontrolled way.

The way in which lenalidomide works is not yet completely understood. However, it has several actions. Firstly, it stops the cancerous plasma cells from multiplying. It also enhances the action of cells in the immune system called natural killer cells. These naturally attack abnormal cells, including cancerous cells.

In order to grow, cancerous cells need a blood supply that provides them with nutrients and oxygen. They also need this blood supply to spread. Cancerous cells stimulate blood vessels to grow into the tumour. Another action of lenalidomide is to stop this development of new blood vessels.

Revlimid is only prescribed by specialist consultants. It is used in combination with dexamethasone for the treatment of multiple myeloma in people who have already received at least one previous therapy.

This medicine can decrease the production of healthy blood cells, leaving people susceptible to infection. Regular blood tests are therefore needed to monitor levels of blood cells. The dose for each treatment cycle will vary and depend on blood test results and general health of the individual.

What is it used for?
Cancer of the plasma cells in the bone marrow (multiple myeloma).
This medicine is licensed for use in combination with dexamethasone to treat people who have had at least one prior therapy for their multiple myeloma.

Warning!
Revlimid capsules should be swallowed whole with water and not crushed or chewed. They can be taken with or without food.
Revlimid capsules should be taken at the same time each day, in order to maintain effective levels of the medicine in your blood. If you forget to take a dose at your usual time you can take it up to 12 hours after it was due. If you are more than 12 hours late taking a dose you should not take a capsule for that day. Take your next dose at your usual time the following day.
This medicine, as well as the multiple myeloma disease itself, can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting and increase the risk of bleeding. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
This medicine may be harmful to an unborn baby. For this reason, women taking this medicine who could get pregnant must use a highly effective method of contraception (such as an injected or implanted form) to prevent pregnancy. You will be given advice on which forms are suitable for you. Contraception should be started four weeks before your treatment begins and continued all the time you are taking this medicine. You should continue to use contraception to prevent pregnancy for at least four weeks after your treatment is finished. You will need to have a pregnancy test before treatment with this medicine is started, every four weeks throughout the treatment and four weeks after the treatment is finished. You should consult your doctor immediately if you think you could be pregnant.
It is not known if this medicine passes into semen. However, as it could potentially cause birth defects in a developing baby, men taking this medicine whose partner is pregnant or could get pregnant must use a condom during their treatment, and for one week after treatment is finished.
As part of the Pregnancy Prevention Programme for this medicine, only pharmacies that are registered with the manufacturer are allowed to dispense Revlimid. All prescriptions for the medicine must be accompanied by a Prescription Authorisation Form. Where appropriate, this will state that there has been a recent negative pregnancy test. There must be no more than three daysbetween the dates of the negative pregnancy test and the prescription. Ideally, the pregnancy test, prescribing, and dispensing will take place on thesame day. However, the prescription must be dispensed within seven days of the prescription date. If you are of child-bearing age your pharmacist will not dispense more than four weeks supply of this medicine at a time. In addition, pharmacists may not dispense more than 12 weeks’ supply for men, and for women who cannot become pregnant.
You must not donate blood or semen during treatment or for one week after finishing treatment with this medicine.
This medicine increases the risk of getting a blood clot in a vein (eg deep vein thrombosis (DVT) or pulmonary embolism). For this reason, you should let your doctor know immediately if you get any of the following symptoms during treatment: stabbing pains and/or unusual swelling or redness in one leg, pain on breathing or coughing, coughing up blood, sudden breathlessness or sudden severe chest pain. Your doctor may want you to take additional medicines to help prevent blood clots, eg heparin or warfarin. If you are prescribed warfarin to prevent blood clots, your blood clotting time (INR) should be regularly monitored.
This medicine is prescribed for individuals and must not be shared with others. Any unused capsules must be returned to a pharmacy for safe disposal.
Use with caution in
Elderly people.
Decreased kidney function.
People with a history of blood clots in the veins (eg deep vein thrombosis (DVT) or pulmonary embolism).
Decreased number of white blood cells in the blood (neutropenia).
Decreased number of platelets in the blood (thrombocytopenia).
Any disease of the nerves (neuropathy).
Underactive thyroid gland (hypothyroidism).
People with extensive cancer before the treatment is started.
Not to be used in
Pregnancy.
Women who could get pregnant (unless using a recommended method of contraception).
Breastfeeding.
Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Revlimid capsules contain lactose).
The manufacturer has not studied this medicine in children and adolescents under 18 years of age. It is not recommended for this age group.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine has not been studied in pregnant women. However, it is related to thalidomide and could potentially cause serious birth defects in an unborn baby. It must not be used during pregnancy. Women who could get pregnant must use a highly effective method of contraception (such as an injected or implanted form) to prevent pregnancy. You will be given advice on which forms are suitable for you. Contraception should be started four weeks before your treatment begins and continued all the time you are taking this medicine. You should continue to use contraception to prevent pregnancy for at least four weeks after your treatment is finished. You will need to have a pregnancy test before treatment with this medicine is started, every four weeks throughout the treatment and four weeks after treatment is finished. You should consult your doctor immediately if you think you could be pregnant.
It is not known if this medicine passes into semen. However, as it could potentially cause birth defects in a developing baby, men taking this medicine whose partner is pregnant or who could get pregnant must use a condom during their treatment and for one week after treatment is finished.
It is not known if this medicine passes into breast milk. However, the medicine could potentially have serious side effects on a nursing baby if it did pass into the breast milk. For this reason, mothers who need treatment with this medicine should not breastfeed their babies during treatment. Seek further medical advice from your doctor.
Label warnings
This medication is to be swallowed whole, not chewed.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Decrease in the number of a type of white blood cell (neutrophil) in the blood (neutropenia).
Fatigue, weakness or loss of strength (asthenia).
Disturbances of the gut, such as constipation, diarrhoea, nausea and vomiting, indigestion, abdominal pain.
Muscle cramps.
Skin reactions such as rash, itching, dry skin, red skin, sweating.
Changes in weight.
Difficulty sleeping (insomnia).
Swollen ankles (peripheral oedema).
Changes in your heart rate or rhythm, awareness of your heartbeat (palpitations).
Headaches.
Tremor.
Difficulty in breathing (dyspnoea).
Problems with the nerves, for example causing changes in sensation such as pins and needles (paraesthesia) or numbness (hypoaesthesia).
Bacterial, viral or fungal infections, sometimes serious.
Blood clots in the veins (eg, DVT, pulmonary embolism - see warning section above).
A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
High blood glucose level (hyperglycaemia).
Changes in the eye(s), such as redness, itching, dry eye or blurred vision.
Kidney failure.
Psychiatric disorders, eg mood changes, anxiety, confusion, hallucinations.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

If you are taking digoxin for heart disease your doctor may want you to have regular blood tests to monitor the level of digoxin in your blood during treatment with this medicine. This is because lenalidomide may increase the amount of digoxin in the blood.

There may be an increased risk of blood clots in the veins if the following medicines are taken in combination with lenalidomide:

combined oral contraceptives (the pill)
hormone replacement therapy (HRT)
medicines that stimulate red blood cell production, eg erythropoietin (epoetin).
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK thatcontain lenalidomide as the active ingredient.