Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using REVLIMID?
REVLIMID contains the active ingredient lenalidomide. REVLIMID is used to treat patients
with Multiple Myeloma. 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. REVLIMID is used to treat adult patients who have been diagnosed
with and previously treated for Mantle Cell Lymphoma (MCL). For more information,
see Section
1. Why am I using REVLIMID? in the full CMI.
2. What should I know before I use REVLIMID?
Do not use if you have ever had an allergic reaction to lenalidomide or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use REVLIMID? in the full CMI.
3. What if I am taking other medicines?
4. How do I use REVLIMID?
Your doctor will tell you how much REVLIMID to take and for how long you will need
to take it, will monitor your progress, and may adjust your dose of REVLIMID or stop
your treatment based on the results of your blood tests and on your general condition.
Follow all directions given to you by your doctor carefully. They may differ from
the information contained in this leaflet. More instructions can be found in Section
4. How do I use REVLIMID? in the full CMI.
5. What should I know while using REVLIMID?
|
Things you should do
|
Remind any doctor, dentist, pharmacist, or nurse you visit that you are using REVLIMID.
If you are a female patient, tell your doctor immediately if you suspect that you
may be pregnant. You should also immediately stop taking REVLIMID in this case.
|
|
Things you should not do
|
Do not stop taking REVLIMID (unless you suspect that you are pregnant) or change the
dose without first checking with your doctor.
Do not become pregnant or breastfeed whilst taking REVLIMID.
Do not donate semen during treatment or for 7 days after stopping treatment.
Do not have sexual intercourse without using effective means of contraception.
Do not donate blood during treatment or for 1 week after stopping treatment.
|
|
Driving or using machines
|
REVLIMID may cause dizziness or confusion in some people. If you have any of these
symptoms, do not drive, operate machinery or do anything else that could be dangerous.
|
|
Looking after your medicine
|
Keep your capsules in a cool dry place where the temperature stays below 25°C.
Keep your capsules in the original pack until it is time to use them.
|
6. Are there any side effects?
You may experience serious side effects when taking REVLIMID.
|
WARNING: REVLIMID (lenalidomide) is structurally related to 'thalidomide', which is
known to cause severe life-threatening human birth defects (deformed babies) and death
to an unborn baby if taken during pregnancy. If REVLIMID is taken during pregnancy,
it may cause birth defects or death to an unborn baby. Do not take REVLIMID if you
are pregnant or think that you are pregnant.
|
Active ingredient(s):
lenalidomide (len" a lid' oh mide)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using REVLIMID. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using REVLIMID.
Where to find information in this leaflet:
1. Why am I using REVLIMID?
REVLIMID contains the active ingredient 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 defense which helps to fight illness and infection.
REVLIMID is used to treat patients with Multiple Myeloma.
Multiple myeloma (MM) is a cancer of the bone marrow.
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 use of REVLIMID will reduce the need for blood transfusions.
REVLIMID is used to treat adult patients who have been diagnosed with and previously
treated for Mantle Cell Lymphoma (MCL).
MCL is a cancer of the lymph tissue (part of the immune system), affecting a type
of white blood cell called 'B-lymphocytes'. MCL is a disease where B-cells grow in
an uncontrolled way and accumulate in the lymph tissue, bone marrow or blood.
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.
2. What should I know before I use REVLIMID?
Warnings
Do not use REVLIMID if:
you are allergic to lenalidomide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
You are pregnant or think that you are pregnant. REVLIMID may cause birth defects
(deformed babies), and may affect your developing baby if you take it during pregnancy.
You are able to become pregnant, unless you are willing to follow the required pregnancy
prevention measures (outlined in Celgene's i-access® Program - see section 'The i-access® Program').
If you are not sure whether you should start taking this medicine, talk to your doctor.
Follow your doctor's instructions carefully.
You will have been given specific instructions by your doctor particularly on the
potential effects of lenalidomide on unborn babies.
Check with your doctor if you:
If you have not fully understood these instructions, ask your doctor again before
taking REVLIMID.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The i-access
®
program
Your doctor will have enrolled you in the i-access® Program to ensure that lenalidomide is used safely.
REVLIMID (lenalidomide) is structurally related to 'thalidomide', which is known to
cause severe life-threatening human birth defects (deformed babies) and can cause
death to an unborn baby if taken during pregnancy. If REVLIMID is taken during pregnancy,
it may cause birth defects or death to an unborn baby.
To avoid exposure to unborn babies, REVLIMID has restricted availability under a Pregnancy
Prevention Program (i-access®). This program is designed to ensure that this medicine is always prescribed and
taken in the recommended way. Importantly, only patients who are formally enrolled
in this program and agree to fully comply with all the requirements of this program
can receive REVLIMID.
Some of the requirements of the i-access® Program are outlined in the following sections. Your doctor will discuss all the
details with you.
1. For women taking REVLIMID
Before starting this treatment, your doctor will discuss your potential to become
pregnant, even if you think this is unlikely e.g., if your periods have stopped.
If you are able to become pregnant:
Your doctor will discuss the potential risk to unborn babies if REVLIMID is taken
during pregnancy.
You will be required to have pregnancy tests before treatment, every 4 weeks during
treatment, and 4 weeks after stopping treatment.
You should start your REVLIMID treatment as soon as you get it from the pharmacy following
a negative pregnancy test.
Use reliable means of contraception for at least 4 weeks before starting REVLIMID
treatment, during treatment and treatment interruption, and for at least 4 weeks after
REVLIMID treatment has stopped.
Your doctor will tell you what method of contraception to use.
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).
Combined oral contraceptive pills are not recommended as they can increase the risk
of blood clots blocking blood vessels in patients with MM being treated with this
medicine.
You must stop taking REVLIMID and inform your doctor straight away if:
You miss or think you have missed a period, or you have unusual menstrual bleeding,
or suspect you are pregnant.
You have heterosexual intercourse without using reliable means of contraception.
Discuss with your doctor if you should breast-feed whilst taking this medicine.
It is not known if REVLIMID is excreted in human milk. Therefore, you should discuss
with your doctor whether to discontinue breast-feeding while you are receiving this
medicine.
2. For men taking REVLIMID
Before starting this treatment, discuss with your doctor if your partner is able to
become pregnant.
If your partner is able to become pregnant, use barrier methods of contraception (e.g.,
condoms) even if you are vasectomised, during REVLIMID treatment, during treatment
interruption, and for at least 7 days after treatment has stopped.
Tell your doctor immediately if your partner becomes pregnant whilst you are taking
this medicine.
Do not donate semen during treatment or during treatment interruption, or for 7 days
after stopping treatment.
3. For all patients taking REVLIMID
Discuss with your doctor if you have or have had any of the following medical conditions:
Heart attack, blood clots, high blood pressure or high cholesterol
Frequent bleeding or bruising
Frequent infections
Hepatitis B virus infection
Peripheral neuropathy (numbness, tingling, weakness, abnormal co-ordination or pain
in your hands and feet)
Thyroid problems
Abnormal kidney function
Liver problems e.g., liver infections
Allergic reactions to thalidomide or lenalidomide
If you have not told your doctor about any of the above, tell him/her before you start
taking REVLIMID.
Do not donate blood during REVLIMID treatment or during treatment interruption, and
for at least 1 week after stopping treatment.
In Australia, patients with certain cancers are permanently excluded from donating
blood.
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.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Your doctor will ask you to have regular blood tests during treatment with REVLIMID.
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 this medicine to a child or adolescent under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
It is important to note that a small number of patients with MM may develop additional
types of cancer (regardless of their type of therapy). At this stage, it cannot be
excluded that this risk may be slightly increased with REVLIMID treatment. Therefore,
your doctor will carefully evaluate the benefit and risk when you are prescribed this
medicine.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and REVLIMID may interfere with each other. These include:
medicines used to prevent pregnancy, such as oral contraceptives
medicines used to treat symptoms of menopause e.g., hormone replacement therapy
medicines used for heart problems e.g., digoxin
medicines used to thin the blood e.g., warfarin.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect REVLIMID.
4. How do I use REVLIMID?
How much to take/use
Follow all directions given to you by your doctor carefully. They may differ from
the information contained in this leaflet.
Your doctor will tell you how much REVLIMID to take and for how long you will need
to take it.
Your doctor will monitor your progress, and may adjust your dose of REVLIMID or stop
your treatment based on the results of your blood tests and on your general condition.
When to take / use REVLIMID
Take your medicine either one hour before or two hours after eating food.
How to take REVLIMID
Swallow the capsules whole, preferably with water, once a day as directed by your
doctor.
Do not open, break or chew the capsules.
If powder from inside the capsules leaks out and contacts the skin, wash the skin
immediately and thoroughly with soap and water. If lenalidomide contacts the mucous
membranes e.g., the eyes, flush thoroughly with water.
If you forget to use 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 are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much REVLIMID
If you think that you have used too much REVLIMID, you may need urgent medical attention.
You should immediately:
In Australia, phone the Poisons Information Centre
(by calling
13 11 26), or
In New Zealand, phone the National Poisons Centre (telephone 0800 POISON or 0800 764
766)
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using REVLIMID?
Things you should do
Female patients
Tell your doctor immediately if you become pregnant or suspect that you may be pregnant.
You should also immediately stop taking REVLIMID in this case.
All patients
Tell any other doctors, dentists, pharmacists, or nurses who are treating you that
you are taking REVLIMID.
If you are about to start on any new medicine, remind your doctor, dentist or pharmacist
that you are taking REVLIMID.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do some blood tests regularly and will check your general condition
to make sure the medicine is working and to prevent unwanted side effects.
Things you should not do
Female patients
Do not become pregnant whilst taking REVLIMID.
Do not have sexual intercourse without using effective means of contraception described
to you by your doctor.
Male patients
Do not donate sperm during treatment or treatment interruption, or for at least 7
days after stopping treatment.
REVLIMID can pass into human semen.
Do not have sexual intercourse without using effective means of contraception described
to you by your doctor.
All patients
Do not donate blood during treatment or treatment interruption, or for at least 1
week after stopping treatment.
In Australia, patients with some types of cancer are permanently excluded from donating
blood.
Do not stop taking REVLIMID (unless you suspect that you are pregnant) 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 this medicine to anyone else, even if they have the same condition as
you.
Do not take this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how REVLIMID
affects you.
REVLIMID may cause dizziness, tiredness or blurred vision in some people. If you have
any of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may interfere with the way this medicine works.
Looking after your medicine
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.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
Medicines should not be disposed of via wastewater or household waste. These measures
will help to protect the environment.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
|
Serious side effects
|
What to do
|
|
Heart palpitations or fast heart beat, chest pains, dizziness or fainting, shortness
of breath, weakness, or reduced ability to exercise.
These could be symptoms of atrial fibrillation (irregular heart beat) or tachycardia
(fast heart beat).
Bleeding (including nose-bleeds) or bruising more easily than normal.
REVLIMID can reduce the number of platelets, which are responsible for making the
blood clot properly. Your doctor may monitor your blood cell numbers during treatment
with REVLIMID.
Tiredness, headaches, shortness of breath, dizziness and looking pale.
REVLIMID can reduce the number of red blood cells that carry oxygen around the body.
Numbness, tingling, pins and needles or weakness of the arms and legs.
This may be due to nerve damage.
Blurred vision or difficulty seeing.
This could be due to a cataract in your eye(s).
Passing large amounts of urine, excessive thirst, and having a dry mouth and skin.
These could be symptoms of high blood sugar or diabetes.
Abnormal eye movements, convulsions, mood changes or irregular heart rhythms.
These could be due to low levels of minerals such as potassium, calcium, magnesium
or sodium.
Tender swollen lymph nodes, low-grade fever, pain, or rash.
This could be due to worsening of your tumour (for patients with MCL).
Shortness of breath, wheezing or difficulty breathing; swelling of the face, lips,
mouth, tongue or other parts of the body; rash, itching or hives on the skin.
These could be symptoms of an allergic reaction.
Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals; painful
red area on the skin that spreads quickly; peeling of the skin. You may have a high
temperature, chills and muscle ache at the same time.
These could be due to rare but severe skin reactions such as Stevens-Johnson Syndrome,
Toxic Epidermal Necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms.
Blurred vision; severe headache; weakness or numbness in the face, arm or leg; trouble
speaking or understanding; loss of balance.
This may be due to a stroke which could be a result of blood clots in the blood vessels
of your brain.
Sudden pain in your chest or difficulty in breathing.
This may be due to a heart attack or blood clots in the artery leading to your lungs.
These blood clots can happen during treatment, or after treatment has stopped.
Chest pain, severe weakness, rapid or irregular heartbeat, and/or sudden, severe shortness
of breath and coughing up pink, foamy mucus.
This could be due to heart failure, a condition where the heart muscle cannot pump
blood strongly enough to supply blood throughout the body.
Pain or swelling in your legs, especially in your lower leg or calves.
This may be due to blood clots in the veins of your leg. These can happen during treatment,
or after treatment has stopped.
Fever; severe chills; decreased urination; rapid pulse; rapid breathing; confusion;
nausea; vomiting; diarrhoea; pain or burning when you urinate; hacking cough; phlegm;
sore
mouth or throat; flu-like symptoms; feeling of tension in the nose, cheeks and behind
your eyes; or mouth ulcers.
These could symptoms of sepsis (blood infection) or other serious infections such
as pneumonia.
Passing little or no urine; drowsiness; nausea; vomiting; or breathlessness.
These could be symptoms of kidney disease.
Abdominal pain, dark urine, fever, joint pain, loss of appetite, nausea and vomiting,
yellowing of the skin and/or eyes.
These are symptoms of liver failure, which in some cases, may be due to Hepatitis
B virus infection. Some cases of Hepatitis B virus infection may not result in symptoms
initially.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Other side effects
|
Very common side effects
|
What to do
|
|
Diarrhoea; constipation; feeling sick (also called nausea); vomiting; stomach pain;
indigestion; dehydration; dry mouth; sore mouth: mouth ulcers: difficulty in speaking
toothache; increase or decrease in weight; increase or decrease in appetite; loss
of taste.
Itchiness; rash; redness of the skin; dry skin; bruising; excessive sweating.
Dizziness; fainting; headache; shaking or tremors; unusual weakness; night sweats;
reduced sense of touch.
Difficulty sleeping; depression; anxiety; feeling of confusion.
Back pain; muscle spasms; muscle and/or joint pain; swollen joints; bone pain; muscular
weakness; pain in the extremities; feeling tired; fall.
Swelling of hands, ankles or feet.
|
Speak to your doctor if you have any of these side effects and they worry you.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some side effects (for example, changes in thyroid function, or blood pressure) can
only be found when your doctor does tests from time to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What REVLIMID contains
|
Active ingredient
(main ingredient)
|
Lenalidomide
|
|
Other ingredients
(inactive ingredients)
|
lactose
microcrystalline cellulose
croscarmellose sodium
magnesium stearate.
The capsule shells contain gelatin and titanium dioxide, and may also contain the
following colourants:
2.5 mg capsules: indigo carmine and yellow iron oxide
7.5 mg capsules: yellow iron oxide
10 mg capsules: indigo carmine and yellow iron oxide
15 mg capsules; indigo carmine
20 mg capsules: indigo carmine and yellow iron oxide
The black printing ink contains shellac; ethanol; isopropyl alcohol; purified water;
strong ammonia solution; potassium hydroxide; and black iron oxide
|
|
Potential allergens
|
lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What REVLIMID looks like
The capsules are provided in packs. There are three (3) pack sizes available. A pack
will contain either two blisters, each with seven capsules, giving a total of fourteen
(14) capsules per pack; three blisters, each with seven capsules, giving a total of
twenty-one (21) capsules per pack or four blisters, each with seven capsules, giving
a total of twenty-eight (28) capsules per pack. Some strengths and pack sizes of REVLIMID
may not be available as not all strengths and pack sizes are being distributed.
REVLIMID 2.5 mg capsules have a white body/blue-green opaque cap with "2.5 mg REV"
written on them. (AUST R 229850)
REVLIMID 5 mg capsules are white to off-white opaque capsules with "5 mg REV" written
on them. (AUST R 132510)
REVLIMID 7.5 mg capsules have a white body/pale yellow opaque cap with "7.5 mg REV"
written on them. (AUST R 229851)
REVLIMID 10 mg capsules are pale yellow opaque body/blue-green opaque cap capsules
with "10 mg REV" written on them. (AUST R 132514)
REVLIMID 15 mg capsules are white to off-white opaque body / powder-blue opaque cap
capsules with "15 mg REV" written on them. (AUST R 132515)
REVLIMID 20 mg capsules have a powder blue body/blue-green opaque cap with "20 mg
REV" written on them. (AUST R 229852)
REVLIMID 25 mg capsules are white to off-white opaque capsules with "25 mg REV" written
on them. (132516)
*Not all strengths may be available
Who distributes REVLIMID
REVLIMID is supplied in Australia by:
Celgene Pty Limited
Level 2, 4 Nexus Court
Mulgrave, VIC 3170
Telephone: 1800 CELGENE (1800 235 4363).
REVLIMID® is registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
This leaflet was prepared in August 2023.