Shopper Medication Info (CMI) abstract
or pharmacist.
WARNING: Necessary security data is offered in a boxed warning within the full CMI. Learn earlier than utilizing this drugs.
Why am I utilizing Lenalidomide-Teva?
monohydrate). Lenalidomide-Teva is used to deal with sufferers with A number of Myeloma. Lenalidomide-Teva
can be used to deal with sufferers who’ve situations known as myelodysplastic syndromes
(MDS) in whom the bone marrow doesn’t produce sufficient mature blood cells. For extra
data, see Part 1. Why am I utilizing Lenalidomide-Teva? within the full CMI.
What ought to I do know earlier than I take advantage of Lenalidomide-Teva?
the substances listed on the finish of the CMI. Speak to your physician you probably have another medical situations, take another medicines,
or are pregnant or plan to turn into pregnant or are breastfeeding. For extra data, see Part 2. What ought to I do know earlier than I take advantage of Lenalidomide-Teva? within the full CMI.
What if I’m taking different medicines?
How do I take advantage of Lenalidomide-Teva?
might want to take it. Extra directions might be present in Part 4. How do I take advantage of Lenalidomide-Teva? within the full CMI.
What ought to I do know whereas utilizing Lenalidomide-Teva?
|
Issues you must do |
Remind any physician, dentist or pharmacist you go to that you’re utilizing Lenalidomide-Teva.
FEMALE PATIENTS: |
|---|---|
|
Issues you shouldn’t do |
FEMALE PATIENTS:
MALE PATIENTS:
ALL PATIENTS: |
|
Driving or utilizing machines |
Watch out driving or working equipment till you understand how Lenalidomide-Teva impacts |
|
Taking care of your drugs |
Maintain your capsules in a cool dry place the place the temperature stays beneath 25°C. Maintain |
Are there any unwanted effects?
are taking Lenalidomide-Teva. Like all medicines, Lenalidomide-Teva can have aspect
results, though not everyone will get them. Generally they’re severe, a lot of the
time they don’t seem to be. It’s possible you’ll want medical consideration if you happen to get a number of the unwanted effects.
For extra data, together with what to do you probably have any unwanted effects, see Part
6. Are there any unwanted effects? within the full CMI.
|
WARNING: Lenalidomide-Teva (lenalidomide) is structurally associated to ‘thalidomide’, |
Energetic ingredient(s):
lenalidomide
Shopper Medication Info (CMI)
This leaflet supplies necessary details about utilizing Lenalidomide-Teva. You must also converse to your physician or pharmacist if you need additional data
or you probably have any issues or questions on utilizing Lenalidomide-Teva.
The place to search out data on this leaflet:
Why am I utilizing Lenalidomide-Teva?
Lenalidomide-Teva comprises the energetic ingredient lenalidomide.
Lenalidomide-Teva belongs to a bunch of medicines known as immunomodulating brokers that
work by performing on the cells concerned within the physique’s immune system. The immune system
is a part of the physique’s defence which helps to struggle sickness and an infection.
Therapy of A number of Myeloma
Lenalidomide-Teva is used deal with sufferers with A number of Myeloma.
A number of myeloma (MM) is a most cancers of the bone marrow.
Therapy of Myelodysplastic Syndromes
Lenalidomide-Teva can be used to deal with sufferers who’ve situations known as myelodysplastic
syndromes (MDS) in whom the bone marrow doesn’t produce sufficient mature blood cells.
This causes an absence of wholesome blood cells within the physique. There are various kinds of
MDS.
Lenalidomide-Teva is accredited to deal with a kind of MDS the place a part of chromosome 5 is
lacking. One of these MDS is called deletion 5q MDS (or 5q minus). Sufferers with
this sort of MDS usually have low crimson blood cell counts that require therapy with
blood transfusions. It’s hoped that using Lenalidomide-Teva will scale back the
want for blood transfusions.
What ought to I do know earlier than I take advantage of Lenalidomide-Teva?
Warnings
Don’t use Lenalidomide-Teva if:
you’re allergic to lenalidomide, or any of the substances listed on the finish of this
leaflet.
All the time test the substances to verify you need to use this drugs.
you’re pregnant, or assume that you’re pregnant.
Lenalidomide-Teva might trigger beginning defects (deformed infants), and should have an effect on your growing
child if you happen to take it throughout being pregnant.
Prevention Program – see part 4. How do I take advantage of Lenalidomide-Teva?
Test along with your physician if you happen to:
have another medical situations
take any medicines for another situation
you perceive these dangers and how one can monitor for them. See extra data
underneath Part 6. Are there any unwanted effects?
Being pregnant and breastfeeding
Test along with your physician if you’re pregnant or intend to turn into pregnant.
Speak to your physician if you’re breastfeeding or intend to breastfeed.
The Being pregnant Prevention Program
Lenalidomide-Teva (lenalidomide) is structurally associated to ‘thalidomide’, which is
identified to trigger extreme life- threatening human beginning defects (deformed infants) and
may cause loss of life to an unborn child if taken throughout being pregnant. If Lenalidomide-Teva
is taken throughout being pregnant, it might trigger beginning defects or loss of life to an unborn child.
To keep away from publicity to unborn infants, Lenalidomide-Teva is obtainable solely underneath a particular
distribution program which is designed to make sure that this drugs is at all times prescribed
and brought within the beneficial means.
Importantly, solely sufferers who’re formally enrolled on this program and conform to
absolutely adjust to all the necessities of this program can obtain Lenalidomide-Teva.
A few of the necessities of Being pregnant Prevention Program are outlined within the following
sections. Your physician will talk about all the main points with you.
FOR WOMEN TAKING LENALIDOMIDE-TEVA
Earlier than beginning this therapy, your physician will talk about your potential to turn into
pregnant, even if you happen to assume that is unlikely e.g. in case your durations have stopped.
If you’ll be able to turn into pregnant:
Your physician will talk about the potential danger to unborn infants if Lenalidomide-Teva
is taken throughout being pregnant.
You may be required to have being pregnant assessments earlier than therapy, each 4 weeks throughout
therapy, and 4 weeks after stopping therapy.
It’s best to begin your Lenalidomide-Teva therapy as quickly as you get it from the pharmacy
following a detrimental being pregnant check.
Use dependable technique of contraception for a minimum of 4 weeks earlier than beginning Lenalidomide-Teva
therapy, throughout therapy and therapy interruption, and for a minimum of 4 weeks after
Lenalidomide-Teva therapy has stopped.
Your physician will inform you what technique of contraception to make use of.
Efficient strategies of contraception embrace the next:
Implant
Levonorgestrel-releasing intrauterine system (IUS)
Medroxyprogesterone acetate depot
Tubal sterilisation
Sexual activity with a vasectomised male companion solely; vasectomy should be confirmed
by two detrimental semen analyses
Ovulation inhibitory progesterone-only capsules (i.e. desogestrel).
Mixed oral contraceptive capsules should not beneficial as they will enhance the danger
of blood clots blocking blood vessels in sufferers with MM being handled with this
drugs.
You could cease taking Lenalidomide-Teva and inform your physician immediately if:
You miss or assume you might have missed a interval, or you might have uncommon menstrual bleeding,
or suspect you’re pregnant.
You’ve heterosexual intercourse with out utilizing dependable technique of contraception.
Talk about along with your physician if you happen to ought to breast-feed while taking this drugs.
It’s not identified if Lenalidomide-Teva is excreted in human milk. Subsequently, you must
talk about along with your physician whether or not to discontinue breast-feeding if you are receiving
this drugs.
FOR MEN TAKING LENALIDOMIDE-TEVA
Earlier than beginning this therapy, talk about along with your physician in case your companion is ready to
turn into pregnant.
In case your companion is ready to turn into pregnant, use barrier strategies of contraception (e.g.
condoms) even if you’re vasectomised, throughout Lenalidomide-Teva therapy, throughout
therapy interruption, and for a minimum of 7 days after therapy has stopped.
Inform your physician instantly in case your companion turns into pregnant while you’re taking
this drugs.
Don’t donate semen throughout therapy or throughout therapy interruption, or for 7 days
after stopping therapy.
FOR ALL PATIENTS TAKING LENALIDOMIDE-TEVA
Talk about along with your physician you probably have or have had any of the next medical situations:
Coronary heart assault, blood clots, hypertension or excessive ldl cholesterol
Frequent bleeding or bruising
Frequent infections
Hepatitis B virus an infection
Peripheral neuropathy (numbness, tingling, weak point, irregular co-ordination or ache
in your palms and toes)
Thyroid issues
Irregular kidney operate
Liver issues e.g. liver infections
Allergic reactions to thalidomide or lenalidomide.
You probably have not advised your physician about any of the above, inform him/ her earlier than you
begin taking Lenalidomide-Teva.
Don’t donate blood throughout Lenalidomide-Teva therapy or throughout therapy interruption,
and for a minimum of 1 week after stopping therapy.
In Australia, sufferers with sure cancers are completely excluded from donating
blood.
Inform your physician you probably have allergic reactions to another medicines, meals, preservatives
or dyes.
Your physician will ask you to have common blood assessments throughout therapy with Lenalidomide-Teva.
Your physician might modify your dose of Lenalidomide-Teva or cease your therapy primarily based
on the outcomes of your blood assessments and in your basic situation. If you’re older
than 65 years, along with these blood assessments, your physician might also test your kidney
operate with different assessments.
Don’t give this drugs to a baby or adolescent underneath the age of 18 years.
Security and effectiveness in youngsters youthful than 18 years haven’t been established.
It is very important observe {that a} small variety of sufferers with MM might develop extra
forms of most cancers (no matter their sort of remedy). At this stage, it can’t be
excluded that this danger could also be barely elevated with Lenalidomide-Teva therapy.
Subsequently, your physician will fastidiously consider the profit and danger when you find yourself prescribed
this drugs
What if I’m taking different medicines?
Inform your physician or pharmacist if you’re taking another medicines, together with any
medicines, nutritional vitamins or dietary supplements that you just purchase and not using a prescription out of your pharmacy,
grocery store or well being meals store.
Some medicines might intrude with Lenalidomide-Teva and have an effect on the way it works.
medicines used to stop being pregnant, resembling oral contraceptives
medicines used to deal with signs of menopause e.g. hormone substitute remedy
medicines used for coronary heart issues e.g. digoxin
medicines used to skinny the blood e.g. warfarin.
Test along with your physician or pharmacist if you’re unsure about what medicines, nutritional vitamins
or dietary supplements you’re taking and if these have an effect on Lenalidomide-Teva.
How do I take advantage of Lenalidomide-Teva?
How a lot to take
Your physician will inform you how a lot Lenalidomide-Teva to take and for the way lengthy you
might want to take it.
For therapy of NDMM together with bortezomib and dexamethasone, the same old
beginning dose of Lenalidomide-Teva is 25 mg as soon as each day. Your physician will inform you
if you’re to take Lenalidomide-Teva for 14 steady days of a 21-Day cycle or for
21 steady days of a 28-Day cycle. Your physician may even inform you the length
and the amount of the opposite medicines to be taken together with Lenalidomide-Teva.
After the preliminary therapy of about 24 weeks, you could have a stem cell transplant
or your physician might ask you to take 25 mg of Lenalidomide-Teva as soon as each day for 21 days
of a 28-Day cycle repeatedly.
For the therapy of NDMM after a stem cell transplant, the same old beginning dose is
10 mg as soon as each day repeatedly (28 days of a 28-Day cycle).
For the therapy of MM together with dexamethasone (both NDMM in sufferers
not eligible for stem cell transplantation or MM in sufferers whose illness has progressed
after one remedy), the same old beginning dose is 25 mg as soon as a day for 21 days of a 28-Day
cycle.
For the therapy of MDS, the beneficial beginning dose is 10 mg as soon as a day for 21
days of a 28-Day cycle.
Your physician will monitor your progress, and should modify your dose of Lenalidomide-Teva
or cease your therapy primarily based on the outcomes of your blood assessments and in your basic
situation.
How you can take it
Swallow the capsules entire, ideally with water, as soon as a day as directed by your
physician.
Don’t open, break or chew the capsules.
If powder from contained in the capsules leaks out and contacts the pores and skin, wash the pores and skin
instantly and totally with cleaning soap and water. If lenalidomide contacts the mucous
membranes e.g. the eyes, flush totally with water.
When to take Lenalidomide-Teva
Lenalidomide-Teva ought to be taken both one hour earlier than or two hours after consuming
meals.
How lengthy to take Lenalidomide-Teva
Proceed taking Lenalidomide-Teva as instructed by your physician, till your physician
tells you to cease.
Your physician will maintain an in depth test on you to be sure to proceed to learn from
Lenalidomide-Teva.
If you happen to neglect to take Lenalidomide-Teva
Whether it is lower than 12 hours earlier than your subsequent dose, skip the dose you missed and take
the subsequent dose when you find yourself meant to.
In any other case, take it as quickly as you bear in mind, after which return to taking your drugs
as you’d usually.
Don’t take a double dose to make up for the dose you missed.
If you’re unsure what to do, ask your physician or pharmacist.
You probably have hassle remembering when to take your drugs, ask your pharmacist for
some hints.
If you happen to take an excessive amount of Lenalidomide-Teva
If you happen to assume that you’ve got used an excessive amount of Lenalidomide-Teva, you might want pressing medical
consideration.
It’s best to instantly:
cellphone the Poisons Info Centre
(by calling
13 11 26), or
contact your physician, or
go to the Emergency Division at your nearest hospital.
It’s best to do that even when there aren’t any indicators of discomfort or poisoning.
What ought to I do know whereas utilizing Lenalidomide-Teva?
Issues you have to do
FEMALE PATIENTS:
Inform your physician instantly if you happen to turn into pregnant or suspect that you could be be pregnant.
You must also instantly cease taking Lenalidomide-Teva on this case.
ALL PATIENTS:
Inform another docs, dentists, and pharmacists who’re treating you that you’re
taking Lenalidomide-Teva.
If you’re about to be began on any new drugs, remind your physician, dentist or
pharmacist that you’re taking Lenalidomide-Teva.
Maintain your entire physician’s appointments in order that your progress might be checked.
Your physician will do some blood assessments frequently and can test your basic situation
to verify the medication is working and to stop undesirable unwanted effects.
Remind any physician, dentist or pharmacist you go to that you’re utilizing Lenalidomide-Teva.
Issues you have to not do
FEMALE PATIENTS:
Don’t turn into pregnant while taking Lenalidomide-Teva.
Should not have sexual activity with out utilizing efficient technique of contraception described
to you by your physician.
MALE PATIENTS:
Don’t donate sperm throughout therapy or therapy interruption, or for a minimum of 1
week after stopping therapy.
Lenalidomide-Teva can cross into human semen.
Should not have sexual activity with out utilizing efficient technique of contraception described
to you by your physician.
ALL PATIENTS:
Don’t donate blood throughout therapy or therapy interruption, or for a minimum of 1
week after stopping therapy.
In Australia, sufferers with some forms of most cancers are completely excluded from donating
blood.
Don’t cease taking Lenalidomide-Teva (until you believe you studied that you’re pregnant) or
change the dose with out first checking along with your physician.
Don’t let your self run out of medication over the weekend or on holidays.
Don’t give this drugs to anybody else, even when they’ve the identical situation as
you.
Don’t take this drugs to deal with another complaints until your physician or pharmacist
tells you to.
Don’t take this drugs after the expiry date printed on the pack or if
the packaging is torn or exhibits indicators of tampering.
In that case, return it to your pharmacist.
Driving or utilizing machines
Watch out earlier than you drive or use any machines or instruments till you understand how Lenalidomide-Teva
impacts you.
Lenalidomide-Teva might trigger dizziness, tiredness or blurred imaginative and prescient in some individuals.
You probably have any of those signs, don’t drive, function equipment or do something
else that may very well be harmful.
Taking care of your drugs
Maintain your capsules in a cool dry place the place the temperature stays beneath 25°C.
Maintain your capsules within the authentic bundle till it’s time to take them.
Observe the directions within the carton on how one can care for your drugs correctly.
Retailer it in a cool dry place away from moisture, warmth or daylight; for instance, do
not retailer it:
within the toilet or close to a sink, or
within the automotive or on window sills.
Maintain it the place younger youngsters can not attain it.
A locked cabinet a minimum of one-and- a-half metres above the bottom is an efficient place
to retailer medicines.
Eliminating any undesirable drugs
If you happen to not want to make use of this drugs or it’s old-fashioned, take it to any pharmacy
for secure disposal.
Don’t use this drugs after the expiry date.
Are there any unwanted effects?
All medicines can have unwanted effects. If you happen to do expertise any unwanted effects, most of
them are minor and momentary. Nevertheless, some unwanted effects might have medical consideration.
Some unwanted effects (for instance, modifications in thyroid operate, or blood strain) can
solely be discovered when your physician does assessments occasionally to test your progress.
See the data beneath and, if you should, ask your physician or pharmacist if you happen to
have any additional questions on unwanted effects.
Much less severe unwanted effects
Very severe unwanted effects
|
Very severe unwanted effects |
What to do |
|---|---|
|
Shortness of breath, wheezing or issue respiratory; swelling of the face, lips,
Extreme blisters and bleeding within the lips, eyes, mouth, nostril and genitals; painful
Blurred imaginative and prescient; extreme headache; weak point or numbness within the face, arm or leg; hassle
Sudden ache in your chest or issue in respiratory.
Chest ache, extreme weak point, speedy or irregular heartbeat,
Ache or swelling in your legs, particularly in your decrease leg or calves.
Fever; extreme chills; decreased urination; speedy pulse; speedy respiratory; confusion;
Passing little or no urine; drowsiness; nausea; vomiting; or breathlessness.
Belly ache, darkish urine, fever, joint ache, lack of urge for food, nausea and vomiting, |
Name your physician immediately, or go straight to the Emergency Division at your It’s possible you’ll want pressing medical consideration or hospitalisation |
Inform your physician or pharmacist if you happen to discover the rest that could be making you
really feel unwell.
Different unwanted effects not listed right here might happen in some individuals.
Reporting unwanted effects
report unwanted effects to the Therapeutic Items Administration on-line at www.tga.gov.au/reporting-problems . By reporting unwanted effects, you’ll be able to assist present extra data on the protection of
this drugs.
All the time be sure to converse to your physician or pharmacist earlier than you resolve to cease
taking any of your medicines.
Product particulars
This drugs is just obtainable with a physician’s prescription.
What Lenalidomide-Teva comprises
|
Energetic ingredient (essential ingredient) |
Lenalidomide (as lenalidomide hydrochloride monohydrate) |
|---|---|
|
Different substances (inactive substances) |
colloidal anhydrous silica microcrystalline cellulose croscarmellose sodium purified talc The capsule shells include gelatin, titanium dioxide , black ink, and the next 2.5 mg, 10 mg and 20 mg (indigo carmine aluminium lake, and iron oxide yellow); 7.5 The black printing ink used on the capsules comprises shellac, ethanol absolute, isopropyl |
Don’t take this drugs if you’re allergic to any of those substances.
What Lenalidomide-Teva appears like
The capsules are offered in packs. There are three (3) pack sizes obtainable. A pack
will include both two blisters, every with seven capsules, giving a complete of fourteen
(14) capsules per pack; three blisters, every with seven capsules, giving a complete of
twenty-one (21) capsules per pack or 4 blisters, every with seven capsules, giving
a complete of twenty-eight (28) capsules per pack. Some strengths and pack sizes of Lenalidomide-Teva
might not be obtainable as not all strengths and pack sizes are being distributed.
Lenalidomide-Teva 2.5 mg capsules: laborious, non-transparent capsules with black mark
2.5 on white physique and with inexperienced cap.
Lenalidomide-Teva 5 mg capsules: laborious, non-transparent capsules with black mark 5
on white physique and with white cap.
Lenalidomide-Teva 7.5 mg capsules: laborious, non-transparent capsules with black mark
7.5 on white physique and with ivory cap.
Lenalidomide-Teva 10 mg capsules: laborious, non-transparent capsules with black mark 10
on ivory physique and with inexperienced cap.
Lenalidomide-Teva 15 mg capsules: laborious, non-transparent capsules with black mark 15
on white physique and with blue cap.
Lenalidomide-Teva 20 mg capsules: laborious, non-transparent capsules with black mark 20
on blue physique and with inexperienced cap.
Lenalidomide-Teva 25 mg capsules: laborious, non-transparent capsules with black mark 25
on white physique and with white cap.
Australian Registration Quantity:
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 equipped in Australia by:
Teva Pharma Australia Pty Ltd
Degree 1, 37 Epping Highway
Macquarie Park NSW 2113
Australia)
This leaflet was up to date in August 2022
