Patient Medication Information: uses, side effects, how to take - Sandoz Teriflunomide
Serious Warnings and Precautions
Liver Disorder Sandoz Teriflunomide may cause liver disorders. Severe liver injury including fatal liver failure occurred rarely in patients treated with teriflunomide. The risk for severe liver disorder may be increased if you take Sandoz Teriflunomide when you already have liver disease or if you are taking other drugs that affect the liver. Your health care professional should do blood tests to check your liver function:
Call your health care professional right away if you experience any symptoms of liver disorder (see the Serious side effects and what to do about them table below for a list of symptoms). Birth Control, Pregnancy and Risk of Birth Defects Do not take Sandoz Teriflunomide if you are pregnant. If used during pregnancy, Sandoz Teriflunomide may cause major birth defects and even death to your baby. Pregnancy must be avoided by using effective birth control when a man or woman is on Sandoz Teriflunomide. Continue birth control for two years after you stop taking Sandoz Teriflunomide to make sure your blood levels of teriflunomide are low enough. Your health care professional can prescribe a medicine to help lower your blood levels of teriflunomide more quickly. Your health care professional can inform you when it is safe to get pregnant or to father a child. If you are a woman of childbearing age, you should have a pregnancy test before you start taking Sandoz Teriflunomide. If you become pregnant, are late starting your period or have any reason to suspect pregnancy while taking Sandoz Teriflunomide or within 2 years after stopping it, tell your health care professional right away. |
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What is Sandoz Teriflunomide used for?
Sandoz Teriflunomide is used to treat adult patients with relapsing remitting multiple sclerosis (RRMS).
How does Sandoz Teriflunomide work?
Sandoz Teriflunomide can alter the way the body’s immune system works. Sandoz Teriflunomide does not cure RRMS, but it can help decrease the number of attacks (relapses) that occur. Sandoz Teriflunomide can help slow the build-up of physical problems (disability progression) that RRMS causes.
What are the ingredients in Sandoz Teriflunomide?
Medicinal ingredients: teriflunomide
Non-medicinal ingredients: allura red AC aluminum lake, anhydrous colloidal silica, brilliant blue FCF aluminum lake, lactose monohydrate, corn starch, glycerol, hydroxypropylcellulose, hypromellose, indigo carmine aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, and titanium dioxide.
Sandoz Teriflunomide comes in the following dosage forms:
Tablet; 14 mg
Do not use Sandoz Teriflunomide if:
- you are allergic to teriflunomide, leflunomide or to any of the other ingredients in the formulation
- you are taking a drug for rheumatoid arthritis with the medicinal ingredient leflunomide
- you have severe liver problems
- you are suffering from a serious infection
- you are pregnant, suspect you may be pregnant or plan to get pregnant
- you are a woman of childbearing potential not using reliable methods of birth control.
- you are of childbearing age, until it is confirmed with a pregnancy test that you are not pregnant.
you have low platelets, or low white blood cell counts, or uncontrolled infection. Low white blood cell counts may be caused by other things that affect the immune system such as:
- immunodeficiency syndrome or AIDS
- weakened bone marrow function or transplantation
treatments that can suppress the immune system such as
- drugs used to treat cancer
- other drugs used to treat MS
To help avoid side effects and ensure proper use, talk to your health care professional before you take Sandoz Teriflunomide. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- have high blood pressure
- have a fever or infection, or you are unable to fight infections
- have low protein levels in your blood
- have or have ever had blood or bone marrow problems
- have kidney problems
- have or have ever had tuberculosis
- have diabetes
- are older than 60 years
- are breastfeeding or plan to breastfeed. You and your health care professional should decide if you will take Sandoz Teriflunomide or breastfeed. You should not do both at the same time.
- have a condition that affects the skin or nails called psoriasis
- have an allergy to lactose or a rare hereditary problem of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption. Sandoz Teriflunomide contains lactose.
- are going to receive a vaccine. You should not receive a “live attenuated vaccine” during treatment with Sandoz Teriflunomide. Talk to your health care professional before receiving any vaccinations during or after treatment
Other warnings you should know about:
Pregnancy: Sandoz Teriflunomide may harm your unborn baby. Before you start treatment with Sandoz Teriflunomide, your health care professional may require you to do a pregnancy test to make sure you are not pregnant. You must use a reliable form of birth control while taking Sandoz Teriflunomide. Do not become pregnant during treatment.
Teriflunomide Enhanced Pharmacovigilance Pregnancy Active Surveillance Program: If you become pregnant or suspect you may be pregnant while taking SANDOZ TERIFLUNOMIDE or become pregnant within two years after you stop taking SANDOZ TERIFLUNOMIDE, contact your health care professional right away. A Teriflunomide Enhanced Pharmacovigilance Pregnancy Active Surveillance Program has been established to collect information about the effect of teriflunomide exposure during pregnancy. Your health care professional can enroll you in the Enhanced Pharmacovigilance Pregnancy Active Surveillance Program, or you may enroll yourself in the Enhanced Pharmacovigilance Pregnancy Active Surveillance Program by calling 1-800-343-8839, ext. 4636. Program details and educational materials can be found at the following website https://www.sandoz.ca.
Use in Males: If your partner can get pregnant, make sure to use a reliable form of birth control when you are taking Sandoz Teriflunomide. If you wish to father a child or donate sperm, talk to your health care professional about stopping your treatment.
Blood Tests: Your health care professional should do blood tests before starting treatment with Sandoz Teriflunomide and while you are taking it. These tests will monitor:
- blood pressure
- complete blood cell count
- liver enzyme levels
Sandoz Teriflunomide may cause your test results to look abnormal. Your health care professional will interpret the results.
Interstitial Lung Disease (ILD): A condition called ILD has been reported with teriflunomide. If you have a history of ILD, you are at higher risk of developing ILD again. If you already have ILD, Sandoz Teriflunomide may worsen the symptoms. ILD can be a fatal disorder and can happen at any time during your treatment. Talk to your health care professional right away if you experience:
- persistent cough
- shortness of breath with or without fever
Sandoz Teriflunomide can cause serious side effects, including:
- Pancreatitis (inflammation of the pancreas)
- Peripheral Neuropathy (damage to nerves)
- Severe skin reactions such as Stevens - Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
See the Serious side effects and what to do about them table below for more information on these and other serious side effects.
Accelerated Elimination Procedure: It can take 8 months to 2 years to fully remove teriflunomide from your system. If you need to stop taking Sandoz Teriflunomide, your health care professional may talk to you about undergoing an accelerated elimination procedure to remove teriflunomide from your body faster.
Tell your health care professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sandoz Teriflunomide:
- leflunomide, a medication for rheumatoid arthritis
- medicines that could raise your chance of getting infections, such as medicines to treat cancer or to control your immune system. Ask your health care professional or pharmacist for a list of these medicines if you are not sure
- warfarin
- medicines used to treat diabetes, such as: repaglinide, pioglitazone, rosiglitazone, nateglinide
- oral contraceptives
- some medicines used to treat infections such as: cefaclor, penicillin G, ciprofloxacin, rifampin, zidovudine
- medicines used to lower blood cholesterol, such as: rosuvastatin, atorvastatin, simvastatin, pravastatin
- anti-inflammatory drugs, such as: indomethacin, ketoprofen, sulfasalazine
- diuretics (water losing pills), such as: furosemide
- some medicines to treat cancer such as: paclitaxel, methotrexate, mitoxantrone, topotecan, daunorubicin, doxorubicin
- duloxetine (anti-depressant); theophylline (asthma medicine); cimetidine (stomach acid medicine); tizanidine (muscle relaxant medicine)
- avoid drinking alcohol while taking Sandoz Teriflunomide as it may cause liver problems.
- other medicines that can potentially harm the liver
How to take Sandoz Teriflunomide
- Follow your health care professional’s instructions carefully. Do not take more than the recommended dose.
Take Sandoz Teriflunomide orally (by mouth) with or without food.
- Do not stop taking Sandoz Teriflunomide without talking with your health care professional first.
Usual dose:
1 tablet a day.
Overdose:
| If you think you, or a person you are caring for, have taken too much Sandoz Teriflunomide, contact a health care professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, just take your next dose as planned. Do not take a double dose to make up for a forgotten tablet.
What are possible side effects from using Sandoz Teriflunomide?
These are not all the possible side effects you may have when taking Sandoz Teriflunomide. If you experience any side effects not listed here, tell your health care professional.
- diarrhea, nausea, flu or sinus infection, upset stomach, abdominal pain
- rash
- abnormal liver tests
- hair thinning or loss
- cold sores
- toothache
- shortness of breath
- frequent urination
- having your period for longer than 7 days
- sore muscles
- weight loss
Serious side effects and what to do about them
| Symptom ⁄ effect | Talk to your health care professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains and flu-like symptoms | ✓ | ||
| Hypertension: (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | ✓ | ||
Liver Disorder: yellowing of the skin or eyes, dark urine and pale stools, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| UNCOMMON | |||
| Decreased Platelets: bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
Severe Heart Problems: pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat. Deaths due to heart-related issues have occurred in patients treated with teriflunomide. | ✓ | ||
| Peripheral Neuropathy/Carpal tunnel syndrome: numbness or tingling of hands or feet | ✓ | ||
| RARE | |||
| Interstitial Lung Disease (disease that inflames or scars lung tissue): | ✓ | ||
Serious side effects and what to do about them
| Symptom ⁄ effect | Talk to your health care professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| shortness of breath when resting that gets worse with exertion, trouble breathing, lasting cough | |||
| UNKNOWN | |||
| Allergic Reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat | ✓ | ||
| Colitis (chronic digestive disease): diarrhea with blood or pus, abdominal pain, cramping, rectal pain or bleeding, weight loss, fatigue | ✓ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, fast heart beat, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||
| Psoriasis (chronic skin disease on the skin or nails): red patches of skin covered with thick, silvery scales, dry cracked skin that may bleed, itching, burning or soreness, swollen and stiff joints | ✓ | ||
| Severe Skin Reactions: Fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes or genitals and spread to other areas of the body, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your health care professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Store Sandoz Teriflunomide between 15°C to 30°C.
For blister card wallet, remove tablet only when ready to use.
Keep out of sight and reach of children.
If you want more information about Sandoz Teriflunomide:
- Talk to your health care professional.
- Find the full product monograph that is prepared for health care professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sandoz.ca or by calling 1-800-361-3062.