Revlimid

(lenalidomide)
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Revlimid. It does not contain all the information that is known about Revlimid. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

WHAT REVLIMID IS USED FOR

Revlimid belongs to a group of medicines called immunomodulating agents.
Revlimid is used in combination with another drug called dexamethasone to treat adult patients who have been diagnosed with Multiple Myeloma or MM (cancer of the bone marrow). It is prescribed for patients whose disease has progressed after one therapy.
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 that can function properly 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. Patients with this type of MDS often have low red blood cell counts that require treatment with blood transfusions and it is hoped that the use of Revlimid will reduce the need for these.
Ask your doctor if you have any questions about how Revlimid works, or why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
Revlimid will only be prescribed to you by a doctor who has experience in medicines to treat cancers of the blood.

BEFORE YOU TAKE REVLIMID

When you must not take it:

If any of these apply to you, tell your doctor before you take Revlimid:
If you are allergic to lenalidomide or any of the other ingredients of Revlimid listed at the end of this leaflet. If you think you may be allergic, ask your doctor for advice.
If you are, or suspect that you may be pregnant, or are able to become pregnant.
If you are able to become pregnant.
This medicine may affect your baby if you take it while you are pregnant. Tell your doctor if you are pregnant or intend to become pregnant. See more details in section 'Before you start to take it'.
Some of the symptoms of an allergic response may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or others parts of the body
rash, itching or hives on the skin.

Before you start to take it:

Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Your doctor will ask you to have regular blood tests during treatment with Revlimid.
Your doctor should ask you to have a blood test every week for the first 8 weeks of treatment with Revlimid and at least every month after that. 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. If you are older than 65 years, in addition to these blood tests your doctor may also check your kidney function with other tests.
Do not give Revlimid to children in the ages 0 to 18 years.
There is no experience in treating children and adolescents with Revlimid.
Do not take Revlimid if you are pregnant. In addition, do not become pregnant while taking Revlimid but, if you do, tell your doctor immediately. If you are a woman of childbearing potential, use effective means of contraception which should also be discussed with your doctor.
Effective methods of contraception include the following:
Implant
Levonorgestrel-releasing intrauterine system (IUS)
Medroxyprogesterone acetate depot
Tubal sterilisation
Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Ovulation inhibitory progesterone-only pills (i.e. desogestrel).
Use these birth control methods for at least 4 weeks before starting Revlimid treatment, during Revlimid treatment, during treatment interruption, and for at least 4 weeks after Revlimid treatment has stopped.
Combined oral contraceptive pills are not recommended as they can increase the risk of blood clots blocking blood vessels in patients with multiple myeloma being treated with this medicine.
Use by men: Use barrier methods of contraception (e.g. condoms) if your partner is of child-bearing potential and for 1 week after treatment has stopped.
Revlimid passes into semen.
Do not breast-feed if you are taking this medicine.
It is not known if Revlimid is excreted in human milk. Therefore, do not breast-feed while you are receiving Revlimid but, if you do, you should inform your doctor immediately.
If you experience side effects, such as dizziness, tiredness or blurred vision, take special care when driving or operating machines during treatment with this medicine.
Do not take Revlimid if you have the rare hereditary problems of glucose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Revlimid contains lactose.

Taking other medicines:

Tell your doctor or pharmacist if you are taking any other medicines or have recently taken any other medicines, including any medicines that you buy without a prescription from a pharmacy, supermarket or health-food shop.

HOW TO TAKE REVLIMID

Follows all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.

How much to take:

For the treatment of MM, the usual starting dose is 25 mg once per day for 21 out of 28 days. 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.
For the treatment of MDS, the recommended starting dose is 10 mg once per day for 21 out of 28 days. 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.

How to take it:

Swallow the Revlimid capsules whole, preferably with water, once a day as directed by your doctor.
Do not open, break or chew the capsules.

When to take it:

Take your medicine either one hour before or two hours after eating food.

How long to take it:

Continue taking Revlimid at about the same time each day for 21 days in a row and stop taking Revlimid for the next 7 days. Repeat taking Revlimid for 21 days and stopping for 7 days until your doctor tells you to stop.

If you forget to take Revlimid:

If it is less than 12 hours before your next dose, skip the dose you missed and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much Revlimid (overdose)

In Australia, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Revlimid. Do this even if there are no signs of discomfort or poisoning.
In New Zealand, immediately contact the National Poison Centre on 0800 POISON or 0800 764 766 for advice.
Keep the telephone numbers for these places handy.
If you have any further questions on the use of Revlimid, ask your doctor or pharmacist.

WHILE YOU ARE TAKING REVLIMID

Revlimid is available under a restricted distribution program called i-access®. Only physicians and pharmacists registered with this program can prescribe and dispense the product. In addition, Revlimid will only be given to patients who are registered and meet all the conditions of the program.

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Revlimid.
If you are about to be started on any new medicine, remind your doctor, dentist or pharmacist that you are taking Revlimid.
If you become pregnant while taking Revlimid tell your doctor immediately.
Keep all your doctor's appointments so that your progress can be checked.

Things you must not do

Do not stop taking Revlimid or change the dose without first checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.
Do not give Revlimid to anyone else, even if they have the same condition as you.
Do not take Revlimid to treat any other complaints unless your doctor or pharmacist tells you to.
Do not donate blood whilst taking Revlimid or for 1 week after you stop treatment.
Men should not donate sperm whilst taking Revlimid or for 1 week after treatment has stopped because Revlimid passes into semen.

SIDE EFFECTS

Like all medicines, Revlimid can have side effects, although not everybody gets them. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you.
Diarrhoea, constipation, decrease in appetite, anorexia, taste disturbance, difficulty swallowing, dry mouth, nausea, vomiting, flatulence, abdominal pain, mouth, tongue, lip or gum pain, vomiting blood.
Itchiness, rash, dry skin, hair loss, changes in skin pigmentation, skin irritation, increased sweating, night sweats, swelling of the face
Headache, tremor, giddiness.
Anxiety, difficulty sleeping, alteration in mood or personality, depression, abnormal dreams, reduced libido, agitation, nervousness.
Itchy, dry or red eyes, blurred vision, conjunctivitis, painful eyes, swelling of the eye or eyelid, eye discharge.
Blocked or runny nose, increased mucous in throat.
Muscle aching, muscle cramps, muscle weakness, bone, back, limb or joint pain, joint stiffness or swelling, arthritis.
Ringing in the ear or deafness.
Alteration of menstrual periods.
Tell your doctor immediately if you notice any of the following.
You develop skin reactions such as rashes and blistering of the skin or mucosa of the lips, eyes, mouth or swelling of these areas;
You experience any symptoms of infection such as fever, chills, sore throat, cough, mouth ulcers, influenza like illness, burning or stinging on passing urine, have to pass urine more often or urgently, have difficulty in passing urine or develop hot red skin, boils or shingles. Revlimid can reduce the number of white cells that fight infection and can lead to a higher susceptibility to infections.
You experience any bleeding (including nose-bleeds) or bruising in the absence of injury, or are more tired than usual. Revlimid can reduce the number of red blood cells that are responsible for carrying oxygen around the body and can also reduce the number of platelets, which are responsible for making the blood clot appropriately.
You develop any symptoms of allergy such as itchy rash, dizziness, difficulty breathing, wheezing or swelling.
You develop any shortness of breath, unusual beating of the heart, feeling faint, chest or leg pain, swelling of the arms or legs, circulation problems or dizziness on standing up.
You develop any numbness, tingling, pins and needles, burning sensation, unsteadiness, speech difficulty or walking difficulty, general weakness or limb weakness, difficulty with movement.
Your skin or eyes appear yellow (symptoms of jaundice).
You develop any loss or disturbance of vision.
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 immediately.

AFTER TAKING REVLIMID

How to store Revlimid

Keep Revlimid out of the reach and sight of children.
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Keep your capsules in the original package until it is time to take them.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, take any unused Revlimid capsules to your pharmacist.

PRODUCT DESCRIPTION

What Revlimid looks like

The capsules are provided in packs. Each pack contains three blisters, each with seven capsules, giving a total of twenty-one (21) capsules per pack.
Revlimid 5 mg capsules are white to off-white opaque capsules with "5 mg REV" written on them.
Revlimid 10 mg capsules are pale yellow opaque body/blue-green opaque cap capsules with "10 mg REV" written on them.
Revlimid 15 mg capsules are white to off-white opaque body/powder blue opaque cap capsules with "15 mg REV" written on them.
Revlimid 25 mg capsules are white to off-white opaque capsules with "25 mg REV" written on them.

Ingredients

Revlimid capsules contain an active ingredient called lenalidomide.
The other ingredients are:
lactose anhydrous
microcrystalline cellulose
croscarmellose sodium, and
magnesium stearate.
The capsule shell is composed of gelatin and titanium dioxide, and may also contain indigo carmine CI73015 and iron oxide yellow CI77492 (10 mg capsules), or indigo carmine CI73015 (15 mg capsules). The printing ink is composed of shellac; propylene glycol; potassium hydroxide and iron oxide black CI77499.

Distributor:

Revlimid is supplied in Australia by:
Celgene Pty Limited
Level 7, 607 St Kilda Road,
Melbourne Vic 3004.
Telephone: 03 9539 5500.
Revlimid is supplied in New Zealand by:
Celgene Limited
Level 7, 28 Brandon Street
Wellington
New Zealand.
This leaflet was updated in September 2011.
Australian Registration Number:
Revlimid 5mg AUST R 132510
Revlimid 10mg AUST R 132514
Revlimid 15mg AUST R 132515
Revlimid 25mg AUST R 132516