Consumer Medicine Information (CMI) summary
The
full CMI 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 Lenalidomide-Teva?
Lenalidomide-Teva contains the active ingredient lenalidomide (as lenalidomide hydrochloride
monohydrate). Lenalidomide-Teva is used to treat patients with Multiple Myeloma. Lenalidomide-Teva
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. For more
information, see Section
1. Why am I using Lenalidomide-Teva? in the full CMI.
2. What should I know before I use Lenalidomide-Teva?
Do not use if you have ever had an allergic reaction to Lenalidomide-Teva 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 Lenalidomide-Teva? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Lenalidomide-Teva?
Your doctor will tell you how much Lenalidomide-Teva to take and for how long you
will need to take it. More instructions can be found in Section
4. How do I use Lenalidomide-Teva? in the full CMI.
5. What should I know while using Lenalidomide-Teva?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Lenalidomide-Teva.
FEMALE PATIENTS:
Tell your doctor immediately if you become pregnant or suspect that you may be pregnant.
You should also immediately stop taking Lenalidomide-Teva in this case
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Things you should not do
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FEMALE PATIENTS:
Do not become pregnant whilst taking Lenalidomide-Teva. 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 1
week after stopping treatment. 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
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Driving or using machines
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Be careful driving or operating machinery until you know how Lenalidomide-Teva affects
you
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Looking after your medicine
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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
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6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Lenalidomide-Teva. Like all medicines, Lenalidomide-Teva 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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
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WARNING: Lenalidomide-Teva (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 Lenalidomide-Teva is taken
during pregnancy, it may cause birth defects or death to an unborn baby. Do not take
Lenalidomide-Teva if you are pregnant or think that you are pregnant.
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Active ingredient(s):
lenalidomide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Lenalidomide-Teva. 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 Lenalidomide-Teva.
Where to find information in this leaflet:
1. Why am I using Lenalidomide-Teva?
Lenalidomide-Teva contains the active ingredient lenalidomide.
Lenalidomide-Teva 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 defence which helps to fight illness and infection.
Treatment of Multiple Myeloma
Lenalidomide-Teva is used treat patients with Multiple Myeloma.
Multiple myeloma (MM) is a cancer of the bone marrow.
Treatment of Myelodysplastic Syndromes
Lenalidomide-Teva 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.
Lenalidomide-Teva 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 Lenalidomide-Teva will reduce the
need for blood transfusions.
2. What should I know before I use Lenalidomide-Teva?
Warnings
Do not use Lenalidomide-Teva 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.
Lenalidomide-Teva 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 Program - see section
4. How do I use Lenalidomide-Teva?
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
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 Pregnancy Prevention Program
Lenalidomide-Teva (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 Lenalidomide-Teva
is taken during pregnancy, it may cause birth defects or death to an unborn baby.
To avoid exposure to unborn babies, Lenalidomide-Teva is available only under a special
distribution program which 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 Lenalidomide-Teva.
Some of the requirements of Pregnancy Prevention Program are outlined in the following
sections. Your doctor will discuss all the details with you.
FOR WOMEN TAKING LENALIDOMIDE-TEVA
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 Lenalidomide-Teva
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 Lenalidomide-Teva 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 Lenalidomide-Teva
treatment, during treatment and treatment interruption, and for at least 4 weeks after
Lenalidomide-Teva 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 Lenalidomide-Teva 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 Lenalidomide-Teva is excreted in human milk. Therefore, you should
discuss with your doctor whether to discontinue breast-feeding while you are receiving
this medicine.
FOR MEN TAKING LENALIDOMIDE-TEVA
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 Lenalidomide-Teva 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.
FOR ALL PATIENTS TAKING LENALIDOMIDE-TEVA
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 Lenalidomide-Teva.
Do not donate blood during Lenalidomide-Teva 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.
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 Lenalidomide-Teva.
Your doctor may adjust your dose of Lenalidomide-Teva 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 Lenalidomide-Teva 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 may interfere with Lenalidomide-Teva and affect how it works.
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 Lenalidomide-Teva.
4. How do I use Lenalidomide-Teva?
How much to take
Your doctor will tell you how much Lenalidomide-Teva to take and for how long you
will need to take it.
For treatment of NDMM in combination with bortezomib and dexamethasone, the usual
starting dose of Lenalidomide-Teva is 25 mg once daily. Your doctor will tell you
if you are to take Lenalidomide-Teva for 14 continuous days of a 21-Day cycle or for
21 continuous days of a 28-Day cycle. Your doctor will also tell you the duration
and the quantity of the other medicines to be taken in combination with Lenalidomide-Teva.
After the initial treatment of about 24 weeks, you may have a stem cell transplant
or your doctor may ask you to take 25 mg of Lenalidomide-Teva once daily for 21 days
of a 28-Day cycle continuously.
For the treatment of NDMM after a stem cell transplant, the usual starting dose is
10 mg once daily continuously (28 days of a 28-Day cycle).
For the treatment of MM in combination with dexamethasone (either NDMM in patients
not eligible for stem cell transplantation or MM in patients whose disease has progressed
after one therapy), the usual starting dose is 25 mg once a day for 21 days of a 28-Day
cycle.
For the treatment of MDS, the recommended starting dose is 10 mg once a day for 21
days of a 28-Day cycle.
Your doctor will monitor your progress, and may adjust your dose of Lenalidomide-Teva
or stop your treatment based on the results of your blood tests and on your general
condition.
How to take it
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.
When to take Lenalidomide-Teva
Lenalidomide-Teva should be taken either one hour before or two hours after eating
food.
How long to take Lenalidomide-Teva
Continue taking Lenalidomide-Teva as instructed by your doctor, until your doctor
tells you to stop.
Your doctor will keep a close check on you to make sure you continue to benefit from
Lenalidomide-Teva.
If you forget to take Lenalidomide-Teva
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 take too much Lenalidomide-Teva
If you think that you have used too much Lenalidomide-Teva, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
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 Lenalidomide-Teva?
Things you must do
FEMALE PATIENTS:
Tell your doctor immediately if you become pregnant or suspect that you may be pregnant.
You should also immediately stop taking Lenalidomide-Teva in this case.
ALL PATIENTS:
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking Lenalidomide-Teva.
If you are about to be started on any new medicine, remind your doctor, dentist or
pharmacist that you are taking Lenalidomide-Teva.
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.
Remind any doctor, dentist or pharmacist you visit that you are using Lenalidomide-Teva.
Things you must not do
FEMALE PATIENTS:
Do not become pregnant whilst taking Lenalidomide-Teva.
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 1
week after stopping treatment.
Lenalidomide-Teva 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 Lenalidomide-Teva (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 Lenalidomide-Teva
affects you.
Lenalidomide-Teva 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.
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.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young 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.
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.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Very serious side effects
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Very serious side effects
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What to do
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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.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects.
You may need urgent medical attention or hospitalisation
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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.
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 Lenalidomide-Teva contains
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Active ingredient
(main ingredient)
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Lenalidomide (as lenalidomide hydrochloride monohydrate)
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Other ingredients
(inactive ingredients)
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colloidal anhydrous silica
microcrystalline cellulose
croscarmellose sodium
purified talc
The capsule shells contain gelatin, titanium dioxide , black ink, and the following
colourants:
2.5 mg, 10 mg and 20 mg (indigo carmine aluminium lake, and iron oxide yellow); 7.5
mg (iron oxide yellow); and 15 mg (indigo carmine aluminium lake.
The black printing ink used on the capsules contains shellac, ethanol absolute, isopropyl
alcohol, butan-1-ol, propylene glycol, purified water , strong ammonia solution, potassium
hydroxide, and iron oxide black.
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Do not take this medicine if you are allergic to any of these ingredients.
What Lenalidomide-Teva 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 Lenalidomide-Teva
may not be available as not all strengths and pack sizes are being distributed.
Lenalidomide-Teva 2.5 mg capsules: hard, non-transparent capsules with black mark
2.5 on white body and with green cap.
Lenalidomide-Teva 5 mg capsules: hard, non-transparent capsules with black mark 5
on white body and with white cap.
Lenalidomide-Teva 7.5 mg capsules: hard, non-transparent capsules with black mark
7.5 on white body and with ivory cap.
Lenalidomide-Teva 10 mg capsules: hard, non-transparent capsules with black mark 10
on ivory body and with green cap.
Lenalidomide-Teva 15 mg capsules: hard, non-transparent capsules with black mark 15
on white body and with blue cap.
Lenalidomide-Teva 20 mg capsules: hard, non-transparent capsules with black mark 20
on blue body and with green cap.
Lenalidomide-Teva 25 mg capsules: hard, non-transparent capsules with black mark 25
on white body and with white cap.
Australian Registration Number:
Lenalidomide-Teva 2.5 mg AUST R 340333
Lenalidomide-Teva 5 mg AUST R 340336
Lenalidomide-Teva 7.5 mg AUST R 340345
Lenalidomide-Teva 10 mg AUST R 340337
Lenalidomide-Teva 15 mg AUST R 340338
Lenalidomide-Teva 20 mg AUST R 340334
Lenalidomide-Teva 25 mg AUST R 340335
Who distributes Lenalidomide-Teva
Lenalidomide-Teva is supplied in Australia by:
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
Australia)
This leaflet was updated in August 2022