(lenalidomide) hard capsules
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 . It does not contain all the information that is known about . 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 is supplied as hard capsules. Each capsule contains 5 mg, 10 mg, 15 mg or 25 mg of the active substance lenalidomide. Each pack contains 21 capsules. 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 certain patients who have myelodysplastic syndromes (MDS). Patients with MDS have bone marrow that 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 the type of MDS with a chromosome problem 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.
If you have any questions about how Revlimid works, or why this medicine has been prescribed for you, ask your doctor.
BEFORE YOU TAKE REVLIMID
Revlimid will only be prescribed to you by a doctor who has experience in medicines to treat cancers of the blood.
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 you are allergic to lenalidomide or any of the other ingredients of Revlimid listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. 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. 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 below.
If you are breast-feeding (see more details below).
If any of these apply to you, tell your doctor before you take Revlimid.
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.
Take special care with Revlimid:
You will 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.
Taking other medicines:
Please 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:
You should swallow the Revlimid capsules whole, preferably with water, once a day as directed by your doctor. Revlimid capsules must be taken either one hour before or two hours after eating food. Do not break or chew the capsules. You should take Revlimid at about the same time each day.
Children:
Revlimid is not to be taken by children (ages 0 to 17 years).
Use by pregnant women:
Do not take Revlimid if you are pregnant. In addition, you should not become pregnant while taking Revlimid but, if you do, you should inform your doctor immediately. If you are a woman of child-bearing potential you should 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)
These birth control methods must be used 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.
Use by men:
You should 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.
Use by breast-feeding women:
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.
Use in other cases
If you are older than 65 years, your doctor will give you the regular blood tests described above but may also check your kidney function during your treatment with other tests.
Driving and using machines:
If you experience side effects, such as dizziness, tiredness or blurred vision, take special care when driving or operating machines.
Important information about some of the ingredients of Revlimid:
Revlimid contains lactose. Therefore, Revlimid should not be taken by patients with rare hereditary problems of glucose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
HOW TO TAKE REVLIMID
Always take Revlimid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should swallow the Revlimid capsules whole, preferably with water, once a day as directed by your doctor. Revlimid capsules must be taken either one hour before or two hours after eating food. Do not break or chew the capsules.
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.
You should take Revlimid at about the same time each day for 21 days in a row. You should then stop taking Revlimid for the next 7 days. You should then continue to repeat the above until your doctor tells you to stop.
If you take more Revlimid than you should:
You should tell your doctor immediately.
If you forget to take Revlimid:
If you forget to take Revlimid and less than 12 hours has passed, take your capsule immediately.
If you forget to take Revlimid and more than 12 hours has passed, do not take your capsule. Take your next capsule at the usual time.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much Revlimid (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) 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.
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, tell your doctor, dentist or pharmacist that you are taking Revlimid.
If you become pregnant while taking Revlimid tell your doctor immediately.
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. You should tell your doctor straight away if:
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, palpitations, 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.
You should also tell your doctor straight away, if any of the following side effects affect you severely or you are concerned by any of them:
Diarrhoea, constipation, increase or decrease in appetite, an increase or decrease in weight, taste disturbance, taste loss, difficulty swallowing, dry mouth, nausea, vomiting, flatulence, abdominal pain, abdominal swelling, heartburn, mouth, tongue, lip or gum pain, thirst, vomiting blood, coated tongue, hiccoughs.
Itchiness, rash, redness, dry skin, dry or bleeding lips, hair loss, acne, cracking of the skin, skin discoloration or pigmentation, skin irritation, increased sweating, night sweats, swelling of the face
Headache, drowsiness, tremor, giddiness, lethargy, mental or memory impairment.
Anxiety, difficulty sleeping, alteration in mood or personality, depression, psychosis, hallucinations, delusions, abnormal dreams, confusion, reduced libido, agitation, nervousness, aggression, listlessness.
Itchy, dry or red eyes, blurred vision, conjunctivitis, increased tear production, painful eyes, swelling of the eye or eyelid, eye discharge, crusting and irritation
Hoarseness, 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, night cramps.
Ear discomfort, ringing in the ear or deafness.
Under or over active thyroid, reduction in sex hormone production, low levels of potassium, sodium, calcium, phosphate, magnesium or protein in the blood, gout, raised levels of sugar in the blood, diabetes, craving for salt, excessive facial hair.
Alteration of menstrual periods.
Raised blood pressure.
Swelling of the peripheries or localized swelling.
Kidney failure.
Passing blood in urine or stools.
Difficulty in obtaining an erection.
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.
Do not use Revlimid after the expiry date, which is stated on the blister after 'EXP'. The expiry date refers to the last day of that month.
Do not use any pack that is damaged or shows signs of tampering.
Store below 25°C.
Store in the original package.
Disposal
Medicines should not be disposed of via wastewater or household waste. Any unused Revlimid should be returned to your pharmacist. These measures will help to protect the environment.
PRODUCT DESCRIPTION
What Revlimid looks like
Revlimid 5 mg capsules are hard white to off-white opaque capsules with "5 mg REV" written on them.
Revlimid 10 mg capsules are hard pale yellow opaque body/blue-green opaque cap capsules with "10 mg REV" written on them.
Revlimid 15 mg capsules are hard white to off-white opaque body/powder blue opaque cap capsules with "15 mg REV" written on them.
Revlimid 25 mg capsules are hard white to off-white opaque capsules with "25 mg REV" written on them.
The capsules are provided in packs. Each pack contains three blisters, each with seven capsules, giving a total of twenty-one capsules per pack.
What Revlimid contains
Revlimid hard 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.
Sponsor
Revlimid is supplied in Australia by:
Celgene Pty Limited
Level 7, 607 St Kilda Road,
Melbourne Vic 3004.
Telephone: 03 9539 5500
This leaflet was prepared on 7 November 2008 and updated in April 2010.
Australian Registration Number.
Revlimid 5mg AUST R 132510
Revlimid 10mg AUST R 132514
Revlimid 15mg AUST R 132515
Revlimid 25mg AUST R 132516
