PART III: CONSUMER INFORMATION
PrTHALOMID®
Thalidomide Capsules House Standard
This leaflet is part III of a three-part "Product Monograph" published when THALOMID® (thalidomide capsules) was
approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about THALOMID®. Contact your doctor or
pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
THALOMID® can only be given to patients who are
registered in and meet all conditions of the RevAid® program.
RevAid® is a controlled distribution program of
THALOMID®.
What the medication is used for:
THALOMID® is used in combina tion with melpha la n a nd
prednisone in the trea tment of pa tients with previously untrea ted Multiple Myeloma (MM) who a re 65 yea rs of a ge or older.
What THALOMID® does:
THALOMID® is thought to work in multiple wa ys to stop or slow
the growth of ca ncer cells.
When it should not be used:
Do not ta ke THALOMID® if:
• You are pregnant. Even a single dose (1 capsule of any strength of THALOMID®) ta ken by a pregna nt woma n ca n
cause severe birth defects.
• You are at risk of becoming pregnant
• You become pregnant during THALOMID® trea tment
• You are breastfeeding
• You are a male patient and are unable to follow or comply with the contra ceptive mea sures of the RevAid Progra m • You are allergic to thalidomide, lenalidomide or
poma lidomide or a ny of the other ingredients in THALOMID®.
What the medicinal ingredient is:
tha lidomide
What the nonmedicinal ingredients are:
Ea ch ca psule conta ins pregela tinized sta rch a nd ma gnesium stea ra te in a gela tin ca psule. The a dditiona l composition of the different ca psule strengths is provided in the ta ble below.
Summary of dosage forms Strength Color Imprint Pack
size Non-medicinal ingredients 50 mg White opa que CELGENE / 50 mg Do Not Get Pregna nt logo 28 ca psules tita nium dioxide, bla ck ink 100 mg Ta n opa que CELGENE / 100 mg Do Not Get Pregna nt logo 28 ca psules bla ck iron oxide, yellow iron oxide, tita nium dioxide, bla ck ink 200 mg Blue opa que CELGENE / 200 mg Do Not Get Pregna nt logo 28 ca psules FD&C Blue #2, tita nium dioxide, white ink
What dosage forms it comes in:
THALOMID® is a va ila ble a s ca psules. Ea ch ca psule conta ins
50 mg, 100 mg or 200 mg of tha lidomide.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions THALOMID® should only be prescribed by a doctor
experienced in the use of anti-cancer drugs and registered with the RevAid® controlled distribution program.
Serious side effects with the use of THALOMID® include: • birth defects (deformed babies), or death of an unborn
baby and spontaneous abortion
• peripheral neuropathy (damage to peripheral nerves
resulting in numbness, tingling, loss of sensation and pain)
• blood clots in the veins and arteries
• In some cases, a higher risk of liver problems which may
lead to death.
• severe allergic reaction called anaphylaxis
THALOMID® is only available under a controlled
distribution program called RevAid®.
BEFORE you use THALOMID® ta lk to your doctor or
pha rma cist if you:
• a re pregna nt or a re pla nning to get pregna nt • a re brea stfeeding
• ha ve blood problems • ha ve liver problems
• ha ve or ha ve ha d hea rt problems (fa inting spell (syncope), slow hea rt bea t)
• ha ve ha d a seizure
• ta ke other medica tions tha t ma ke you feel sleepy
• feel numbness, tingling or pa in or a burning feeling in your feet or ha nds
• ha ve a history of hypersensitivity (a n a llergic rea ction) to tha lidomide, or a ny ingredient in THALOMID®. In ra re
ca ses, severe a llergic rea ctions (a na phyla ctic rea ction a nd/or a ngioedema ) ha ve been reported in pa tients ta king
THALOMID®. Ta lk to your doctor immedia tely if you ha ve
symptoms of a llergic rea ctions.
• smoke, ha ve high blood pressure or high cholesterol levels. • ha ve ha d previous hepa titis B or C virus infection (a vira l
infection of the liver).
THALOMID® may cause birth defects. In order to take this
drug you must meet the following conditions:
1. Fema les who ca n get pregna nt:
• Discuss contraception (birth control) with your health care provider.
• Use at least two effective methods of contraception at the sa me time.
• Use these two effective methods of contraception: • For at least 4 weeks before starting THALOMID®
trea tment
• During interruptions of THALOMID® trea tment
• During THALOMID® trea tment
• For at least 4 weeks after stopping THALOMID®
trea tment
• You must have two negative pregnancy tests before starting trea tment:
• The first 7-14 days prior to starting treatment • The second within 24 hours of starting treatment. • You must have negative pregnancy tests during treatment:
• Once weekly for the first 4 weeks
• Once every 4 weeks (or once every 2 weeks if your period is irregula r) for the dura tion of trea tment a nd during trea tment interruption
• You must have a final pregnancy test 4 weeks after stopping THALOMID®.
2. Males:
• THALOMID® is present in the sperm of ma les who ta ke this
drug. Use a condom every time you ha ve sexua l intercourse with a woma n who is pregna nt or ca n get pregna nt. This must be done even if you ha ve undergone a successful va sectomy. The condom must be used while:
• You are taking THALOMID®
• During interruptions of treatment
• For 4 weeks after stopping THALOMID®
• Do not donate sperm while taking THALOMID® a nd for
4 weeks a fter stopping THALOMID®.
• Inform your sexual partner who can get pregnant that: • You are taking THALOMID®
• There is a risk of birth defects, stillbirths, and sponta neous a bortions if a fetus is exposed to your sperm.
• You must use a condom.
You should contact your doctor immediately if you think your female partner becomes pregnant while you are taking THALOMID®.
3. All Patients:
THALOMID® may cause birth defects and any method of
birth control can fail. You should contact your doctor immediately if you think you or your female partner may be pregnant. You should also contact your doctor if you miss your period or experience unusual menstrual bleeding.
•
Do not give blood while you ta ke THALOMID® a nd for4 weeks a fter stopping THALOMID®.
•
Do not sha re THALOMID® with other people.Do not ta ke THALOMID® if you a re not enrolled in or do not
meet the requirements of theRevAid® controlled distribution
progra m.
Second ca ncers, na mely a cute myeloid leukemia (AML) a nd myelodyspla stic syndrome (MDS), which a re types of blood ca ncer, ha ve been reported in a sma ll number of pa tients ta king THALOMID® in combina tion with melpha la n a nd
prednisone. Pa tients should ta lk to their doctors if they ha ve a ny concerns a bout their own increa sed risk of getting other ca ncers.
THALOMID® is not recommended for use in children under
19 yea rs of a ge.
If you a re older tha n 75 yea rs of a ge there is a possibly grea ter risk for serious side effects of THALOMID®.
THALOMID® ca uses drowsiness a nd sleepiness. Do not drive
or opera te ma chinery until you know how THALOMID®
a ffects you.
Alcohol ma y increa se drowsiness a nd sleepiness ca used by THALOMID®.
INTERACTIONS WITH THIS MEDICATION
Tell your hea lthca re provider a bout a ll the medicines you ta ke including prescription a nd nonprescription medicines, vita mins a nd herba l supplements. It is possible tha t THALOMID® a nd
other medicines ma y a ffect ea ch other ca using serious side effects, especia lly with sleeping pills, a lcohol, a ntihista mines, hormone repla cement thera py, hormonal contra ceptives, steroids, drugs tha t increa se the risk of periphera l neuropa thy, drugs tha t increa se the risk of bra dyca rdia (slow hea rt ra te), a nd drugs tha t increa se the production of red blood cells.
The risk of ha ving blood clots is increa sed if you ta ke hormone repla cement thera py or hormona l contra ceptives while ta king THALOMID®.
Know the medicines you ta ke. To help you keep tra ck of wha t medicines you ta ke, ma ke a list of them to show your hea lthca re provider a nd pha rmacist.
PROPER USE OF THIS MEDICATION
How do I take THALOMID®?
• Ta ke THALOMID® exa ctly a s prescribed by your
hea lthca re professiona l.
• Keep the ca psules in the pa cka ge until you a re rea dy to ta ke them.
• Ta ke the ca psules a s a single dose before going to bed. This will ma ke you less likely to feel sleepy a t other times. • You should try to ta ke it a t a bout the sa me time ea ch da y. • Ta ke the ca psule directly from the pa cka ge a nd pla ce it in
your mouth. Do not put the ca psule on the counter or onto a dish or other conta iner before ta king it.
• Swallow THALOMID® Ca psules whole with wa ter.
• Do not brea k, chew, or open your ca psules.
It is importa nt to remember tha t if you a re being a ssisted with your medica tion, fema les who could become pregna nt, or who pla n to become pregna nt ca n ha ndle THALOMID® ca psules if
they a re using la tex gloves.
Will I have to go for tests during treatment with THALOMID®?
You will ha ve regula r blood tests during your trea tment with THALOMID®. You should ha ve your blood tested a bout once a
month. Your hea lthca re provider ma y a djust your dose of THALOMID® or interrupt your trea tment ba sed on the results of
your blood tests a nd on your genera l condition.
Dose:
Ca psules should be ta ken once da ily with wa ter a t bedtime. • Patients older than 75 years of age: 100 mg once daily • Patients 75 years of age or younger: 200 mg once daily
Overdose:
If you think you ha ve ta ken too much THALOMID®, conta ct
your hea lthca re professiona l, hospita l emergency depa rtment or regiona l poison control centre immedia tely, even if there a re no symptoms.
Missed Dose:
There a re two options if you miss a dose:
1. If less tha n 12 hours ha ve pa ssed since missing a dose, ta ke the dose.
2. If more tha n 12 hours ha ve pa ssed since missing a dose a t the norma l time, do not ta ke the dose. Ta ke the next dose a t the norma l time on the following da y. Do not ta ke 2 doses a t the sa me time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, THALOMID® can have side effects. The most common side effects a re:
• Cha nges in your blood cell counts. Your doctor will monitor your blood cell counts during trea tment with THALOMID®
• Constipa tion
• Sleepiness or feeling tired
• Unusua l sensa tion of numbness, tingling, pins a nd needles, loss of sensa tion or pa in
• Dizziness • Feeling sha ky
• Swelling of your ha nds a nd feet • Na usea
• Ra sh
The less common side effects a re:
• Hea rt fa ilure, slow hea rt ra te which ca n be irregula r or regula r
• Being sick (vomiting), dry mouth, feeling sick (na usea ), dia rrhea , upper a bdomina l pa in
• Feeling wea k, fever, feeling genera lly unwell, swelling • Herpes zoster infection, chest infection (pneumonia ),
mouth infection (ora l funga l infection)
• Recurrence (to become a ctive a ga in) of a previous hepa titis B or C infection, which ca n be fa ta l in some ca ses
• Cha nges of pota ssium level in your blood • Ba ck pa in
• Abnorma l coordina tion, unstea dy, difficulty in wa lking, sta te of unconsciousness, memory a nd thinking a bility disorder
• Depression, confusion
• Kidney disea se (a cute rena l fa ilure)
• Problems rela ted to sexua l function (una ble to enga ge in sexua l intercourse)
• Shortness of brea th, sudden pa in in your chest or difficulty in brea thing (which ma y be a symptom of blood clots in the lungs ca lled pulmona ry embolism), lung disea se
• Ra sh, dryness of the skin
• Pa in or swelling in your legs which ma y be due to blood clots in the veins (thrombosis), low blood pressure
Peripheral Neuropathy
Tell your doctor if you notice a ny numbness, tingling, a bnormal co-ordina tion or pa in in your ha nds a nd feet. This ma y be due to nerve da ma ge (ca lled periphera l neuropa thy), which is a very common side effect. It ma y become very severe, pa inful a nd disa bling. If you experience such symptoms, spea k to your doctor, who ma y reduce the dose or stop your trea tment. This side effect usua lly ha ppens a fter you ha ve been ta king this medicine for severa l months but ca n ha ppen sooner tha n this. It ca n a lso ha ppen some time a fter trea tment ha s stopped. It ma y not go a wa y, or ma y go a wa y slowly.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist Only if severe In all cases Common • constipation • rash • numbness, tingling, or pa in or a burning sensa tion in the feet or ha nds • dizziness √ √ √ √ Un-common
• breathing problems, chest pa in, a rm or leg swelling • severe blood infection
(sepsis) a ccompanied by fever, chills a nd severe sha king, a nd possibly complica ted by low blood pressure a nd confusion (septic shock)
• Chest pain spreading to the a rms, neck, ja w, ba ck or stoma ch, feeling swea ty a nd brea thless, feeling sick or vomiting. This ma y be due to blood clots in the a rteries (which ma y be symptoms of a hea rt a tta ck/myocardia l infa rction).
• Having difficulty in seeing or spea king, which is tempora ry. This ma y be due to a clot in a n a rtery in the bra in.
• Bleeding or bruising in the a bsence of injury. √ √ √ √ √ Rare • Symptoms of severe a llergic rea ctions (a na phyla ctic rea ction a nd/or a ngioedema ) such a s sudden swelling of the fa ce, lips, tongue; throa t problems, brea thing or swa llowing; severe ra sh or itching; fa inting; very ra pid hea rtbea t • Bloody or black tarry
stools
√
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist Only if severe In all cases Very Rare • Symptoms of
infla mma tion of the liver (hepa titis /rea ctiva tion of hepa titis B a nd C virus) itchy skin, ja undice (yellowing of the skin or whites of eyes), fever, tiredness, joint/muscle pa in, loss of a ppetite, na usea a nd vomiting, pa in in the upper right
a bdomen, pa le stools a nd da rk urine
• Skin reactions (Stevens-Johnson Syndrome or Toxic Epiderma l
Necrolysis) red ra sh a cross fa ce a nd body, peeling skin or blistered skin, fla t red ra sh, fever, body a ches; (Drug rea ction with eosinophilia a nd systemic symptoms) flu-like symptoms a nd a ra sh on the fa ce then a n extended ra sh with a high
tempera ture a nd swollen gla nds Unknown • Symptoms of Progressive Multifoca l Leukoencepha lopathy: vision cha nges, difficulty spea king, wea kness in limbs, cha nge in the wa y you wa lk or ba la nce, persistent numbness, decrea sed or loss of sensa tion, memory loss or confusion
This is not a complete list of side effects. For any unexpected
effects while taking THALOMID®, contact your doctor or
pharmacist.
HOW TO STORE IT
Store THALOMID® a t 15-30°C. Keep out of the rea ch of
children.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
---
• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-
canada/services/drugs-health-products/medeffect-canada.html) for
information on how to report online, by mail or by fax; or
• Call toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
The informa tion in this document is current a s of the la st revision da te shown below. The most current informa tion ca n be found a t: www.reva id.ca or by conta cting the sponsor, Celgene Inc., a t 1-888-RevAid1 (1-888-738-2431) or visiting www.celgeneca na da .net.
This lea flet wa s prepa red by Celgene Inc.* * a Bristol Myers Squibb compa ny
© 2010-2021 Celgene Corpora tion.
® THALOMID is a registered tra dema rk of Celgene
Corpora tion.