Details for: APO-LEFLUNOMIDE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02256495 | APO-LEFLUNOMIDE | LEFLUNOMIDE | 10 MG | TABLET | ORAL |
| 02256509 | APO-LEFLUNOMIDE | LEFLUNOMIDE | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-LEFLUNOMIDE is used to treat adult patients who have active rheumatoid arthritis.
What it does
In rheumatoid arthritis, the immune system (body’s defenses against infection and foreign substances) turns against a patient’s own joint tissue. This causes inflammation and the patient can have pain, stiffness, and swelling, which over many months can lead to deformities of the joints.
APO-LEFLUNOMIDE works in rheumatoid arthritis by reducing or suppressing to a certain extent the abnormal activation and multiplication of cells responsible for the inflammation.
From the results of studies in patients with rheumatoid arthritis you can expect APO-LEFLUNOMIDE to reduce your arthritis signs and symptoms. It may take about 4 weeks until you start to feel an improvement in your symptoms.
When it should not be used
Tell your doctor and do not start treatment with APO- LEFLUNOMIDE:
- if you suspect that you may be pregnant, you must inform your doctor and you must not start taking APO-LEFLUNOMIDE. APO-LEFLUNOMIDE may increase the risk of having a baby with a birth defect.
- if you are of childbearing age, it must be confirmed with a pregnancy test that you are not pregnant just before you begin treatment with APO-LEFLUNOMIDE. There is also a risk that male patients taking APO-LEFLUNOMIDE might father a deformed baby. Both male and female patients should read below in the WARNINGS AND PRECAUTIONS section “What are the risks of birth defects with APO-LEFLUNOMIDE?”
- if you have a disease of the liver. Otherwise, your disease may get worse;
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, for example red rash, skin peeling, blisters), to teriflunomide or to any of the other ingredients (see below “What the nonmedicinal ingredients are:”);
- if you suffer from a disease (for example, AIDS) which decreases the strength of your body’s defenses against infection. Otherwise the weakening of your body’s defenses against infection worsen;
- if your bone marrow does not work well or if the number of red cells, white cells, or platelets in your blood is very much decreased. Again APO-LEFLUNOMIDE could worsen this problem;
- if you are suffering from a serious infection, as your infection may be more difficult to treat;
- if you have a disease of the kidney, because the kidney plays a role in the elimination of APO-LEFLUNOMIDE.
- if you are nursing your baby, as APO-LEFLUNOMIDE passes into breast milk and its effect on the nursing infant are not known;
- if you are younger than 18 years of age, it is not recommended that you take APO-LEFLUNOMIDE. This is because there is not enough experience of its use in children and adolescents.
What the medicinal ingredient is
The tablets contain the active drug, leflunomide.
What the non-medicinal ingredients are
The non-medicinal ingredients in APO-LEFLUNOMIDE are: anhydrous lactose, crospovidone, magnesium stearate and colloidal silicon dioxide.
What dosage form it comes in
APO-LEFLUNOMIDE is available as: 10 mg and 20 mg tablets.
Warnings and precautions
The medication can stay in your body for a long period of time. Therefore some precautions and side effects may follow from this characteristic of the drug.
WHAT ARE THE RISKS OF BIRTH DEFECTS WITH APO-LEFLUNOMIDE?
For female patients:
You may be at high risk of having a deformed baby if
you do not follow the following instructions:
If you are pregnant, or suspect that you may be, you must tell your doctor and you must not start taking APO-LEFLUNOMIDE.
If you are of childbearing age (women who might get pregnant), it must be confirmed with a pregnancy test that you are not pregnant just before beginning your treatment.
Women must use reliable birth control methods when taking APO-LEFLUNOMIDE. If you are of childbearing age, discuss methods to avoid becoming pregnant with your doctor.
The risk of giving birth to a deformed baby can best be estimated by the amount of APO-LEFLUNOMIDE remaining in your body when you become pregnant. If you plan to become pregnant after stopping APO-LEFLUNOMIDE, it is important to inform your doctor beforehand. Once you stop taking APO-LEFLUNOMIDE, you must wait a period of 2 years before trying to get pregnant. However, this waiting period may be shortened to a few weeks by taking a certain medicine that will speed up the elimination of APO- LEFLUNOMIDE from your body. If this option is chosen, inform your doctor if you are taking an oral contraceptive pill. The medicine that speeds up the elimination of APO-LEFLUNOMIDE may lower the effect of your contraceptive pill and you may need another contraceptive method during this period. In either case it should be confirmed by two blood tests two weeks apart that APO-LEFLUNOMIDE has been sufficiently eliminated from your body before you try to become pregnant. Your doctor can give you more information about the options available to reach low blood levels of APO-LEFLUNOMIDE. For information regarding blood levels measurements, please also contact your doctor.
If you are currently taking APO-LEFLUNOMIDE, or if you have taken it within the last 2 years and you believe that you may be pregnant, it is VERY IMPORTANT that you contact your doctor immediately. You must have a pregnancy test at the first delay of your period, and if the test confirms that you are pregnant, discuss with your doctor the risk of the treatment to your baby. Your doctor may propose at the first delay of your period to rapidly start the treatment which speeds up elimination of APO-LEFLUNOMIDE from the body, as this may decrease the risk to your baby.
For male patients:
You may be at high risk of fathering a deformed baby if you do not follow the following instructions:
Once you start taking APO-LEFLUNOMIDE, you should take every precaution to avoid getting your partner pregnant. You should use a reliable birth control as recommended by your doctor, during APO-LEFLUNOMIDE therapy. If you have any questions about reliable birth control methods, consult your doctor.
If you wish to father a child after having stopped APO-LEFLUNOMIDE, it is important to inform your doctor beforehand. Once you stop taking APO-LEFLUNOMIDE, you must wait a period of 2 years before trying to father a child. However, this waiting period may be shortened to a few weeks by taking a certain medicine that will speed up the elimination of APO-LEFLUNOMIDE from your body. In either case it should be confirmed by two blood tests that APO-LEFLUNOMIDE has been sufficiently eliminated from your body and you should then wait for another 3 months before you try to get your partner pregnant. Your doctor can give you more information about the options available to reach low blood levels of APO-LEFLUNOMIDE. For information regarding blood level measurements, please also contact your doctor.
If you are currently taking APO-LEFLUNOMIDE, or if you have taken it within the last 2 years and your partner suspects that she may be pregnant you must both immediately contact your doctors. Your partner must have a pregnancy test at the first delay of her period, and if the test confirms that she is pregnant, you should discuss with your doctors the risk of the treatment to the baby.
WHAT ARE OTHER PRECAUTIONS WITH APO- LEFLUNOMIDE?
All patients:
Before you start to take APO-LEFLUNOMIDE, and also while you are taking APO-LEFLUNOMIDE, your doctor will carry out blood tests to monitor your blood cells and your liver at regular intervals. Similarly, your blood pressure will need to be checked regularly. It is important to keep your medical appointments.
Tell your doctor if you have ever suffered from tuberculosis. If you have ever had tuberculosis, your doctor will carefully monitor you, in order to be able to treat you without delay in case it becomes active again.
Tell your doctor if you have, or if you have had heart disease or lung disorders.
Tell your doctor if you have unexplained chronic diarrhea or weight loss.
In certain circumstances (serious side effects, changing antirheumatic treatment or in case of a desired pregnancy) your doctor will decide that you should take a certain medicine which speeds up the elimination of APO-LEFLUNOMIDE from your body.
Tell your doctor if you experience symptoms that can cause numbness, tingling or burning in the hands and feet, muscle weakness or other altered sensations while taking APO-LEFLUNOMIDE. Your doctor will give you a medication which can speed up the elimination of APO-LEFLUNOMIDE from your body.
Interactions with this medication
Drinking alcohol with APO-LEFLUNOMIDE:
It is not recommended to drink alcohol during treatment with APO-LEFLUNOMIDE. Drinking alcohol while taking APO- LEFLUNOMIDE may result in harm to your liver more than you would usually expect.
Taking other medicines together with APO-LEFLUNOMIDE:
Medication to relieve pain and inflammation such as nonsteroidal anti-inflammatory drugs (NSAIDs) or cortisone can be taken together with APO-LEFLUNOMIDE. However, your doctor will give you specific instructions about these medicines.
You must not receive any type of live vaccinations while treated with APO-LEFLUNOMIDE or within 6 months after stopping APO-LEFLUNOMIDE. Check ahead with the clinic if you have to be vaccinated.
Before you start taking APO-LEFLUNOMIDE, be sure to tell your doctor about all medicines you are taking or have taken recently including any that you bought without a prescription or any natural products. This is because the effects of APO-LEFLUNOMIDE or the other medicines may be changed or you might get side effects. Furthermore, do not start any new medicine, whether prescription, non-prescription or natural products without first checking with your doctor.
Examples of drugs that may interact with APO-LEFLUNOMIDE are:
- activated charcoal
- azathioprine
- cholestyramine
- cimetidine (stomach acid medicine)
- D penicillamine
- duloxetine (anti-depressant)
- gold
- methotrexate
- phenytoin
- teriflunomide
- theophylline (asthma medicine)
- tizanidine (muscle relaxant medicine)
- warfarin
- medicines used to treat diabetes, such as: repaglinide, pioglitazone, rosiglitazone, nateglinide or tolbutamide
- oral contraceptives
- some medicines used to treat infections such as: antimalarial drugs, cefaclor, ciprofloxacin, penicillin G, rifampin, rifampicin, 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, topotecan, daunorubicin, doxorubicin
APO-LEFLUNOMIDE can stay in your body for a long period of time after you stop taking it. Therefore, when APO-LEFLUNOMIDE is stopped and another drug (for example methotrexate) is started to treat your rheumatoid arthritis, there is a possibility of increased risks of adverse events. Your doctor may give you a certain medicine that will speed up the elimination of APO-LEFLUNOMIDE from your body before starting the other drug.
Proper use of this medication
Usual Dose
APO-LEFLUNOMIDE has been prescribed for you alone. Do not share it with anyone else, even if their symptoms are the same as yours, as it may bring more harm than good.
APO-LEFLUNOMIDE is supplied as tablets of 10 and 20 mg strengths. Your doctor will usually want you to build up the amount of APO-LEFLUNOMIDE in your body. For doing so, you will usually start the treatment by taking a dose of 100 mg once daily for the first 3 days. Thereafter, your doctor will usually reduce the dose to a tablet of 20 mg to be taken once daily. For some people, their doctor will instead prescribe a tablet of 10 mg once daily.
You should always follow your doctor’s instructions. Do not take any more or any less tablets than what your doctor says. You will normally take APO-LEFLUNOMIDE over long periods of time. However, your doctor will advise you if and when you need to stop taking APO-LEFLUNOMIDE.
You can take APO-LEFLUNOMIDE during meals or at any time between meals. However, it works best if you take it at the same time every day. Swallow the tablet whole with a glass of water or another fluid.
Overdose
If you accidentally take more than one tablet, nothing is likely to happen. If possible, take your tablets or the box with you to show the doctor.
In general, an overdose may lead to increased symptoms as described under “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”. Should this happen, it is possible that medicine may be administered by your doctor in order to speed up the elimination of APO- LEFLUNOMIDE from your body.
Missed Dose
If you forget to take a tablet of APO-LEFLUNOMIDE take it as soon as you remember, unless it is nearly time for your next dose. Do not double-up on the next dose to make up for the one missed.
Side effects and what to do about them
As with any medication, APO-LEFLUNOMIDE can cause some side effects. It may, however, affect different people in different ways. Just because side effects have occurred in other people does not mean you will get them. In studies of patients with rheumatoid arthritis, common side effects included: diarrhea, loss of appetite, nausea (queasiness), vomiting, abdominal pain, weight loss (usually mild), headache, dizziness, weakness, abnormal skin sensations like tingling, inflammation of a tendon sheath, increased hair loss, eczema, and dry skin. Should these side effects occur and be bothersome, please consult your doctor. Your doctor may decide to decrease the dose of APO-LEFLUNOMIDE or may want you to stop the medication.
APO-LEFLUNOMIDE can also increase blood pressure (usually mildly) and your blood pressure will need to be checked regularly.
Ulceration or inflammation of the mouth and skin rash are common with APO-LEFLUNOMIDE. However, tell your doctor without any delay if you develop skin rash or mucous membrane lesions (e.g. lesions in the mouth). This is because, in cases, such reactions may develop into severe, sometimes life-threatening skin reactions such as painful blister, red rash spreading and skin peeling. They may, therefore, require discontinuation of APO-LEFLUNOMIDE and immediate action by your doctor.
Also common are mild allergic reactions and itching, whereas occurrence of hives is uncommon. Severe and potentially serious allergic reactions are very rare. Symptoms of severe allergic reactions to any medications include weakness, drop in blood pressure and difficult breathing. If such symptoms do occur, do not take any more APO-LEFLUNOMIDE tablets and consult your doctor immediately.
Blood tests may often show a decrease in the number of white blood cells. However, a pronounced decrease in the number of white cells or of all blood cells may occur rarely in some patients. Tell your doctor without any delay if you have symptoms such as paleness, tiredness, if you bruise or bleed easily or if you have symptoms of infection such as fever, chills or sore throat. Such symptoms may be due to disorders of your blood cells. They may require discontinuation of APO-LEFLUNOMIDE and other medications, and further action by your doctor.
Blood tests may also show an increase in some liver function test results. In very rare cases this may indicate an abnormality, which may develop into serious conditions such as hepatitis and liver failure, which may be fatal. Therefore, if you develop symptoms such as unusual tiredness, nausea, vomiting, abdominal pain, or jaundice (yellow discoloration of the eyes or skin) inform your doctor at once.
Like other antirheumatic medicines that to some extent reduce the immune defense, APO-LEFLUNOMIDE may increase the susceptibility to infections. Tell your doctor without any delay if you have any symptoms of an infection (such as fever, sore throat, or cough). This is because some infections might become more severe and, therefore, they need to be treated early.
Cases of lung inflammation causing difficulty breathing have occurred rarely in patients receiving APO-LEFLUNOMIDE. Tell your doctor without delay if you experience new or worsening of shortness of breath and/or cough, with or without associated fever, at any time while you are taking APO-LEFLUNOMIDE.
Your doctor will assess your condition and will decide on appropriate course of action. This may require additional tests, for example, blood analysis. In some cases your doctor may recommend to stop taking APO-LEFLUNOMIDE. However, simply stopping APO-LEFLUNOMIDE may not be enough to prevent further progression of the side effect. You may be required to take certain medicines, which speeds up the elimination of APO-LEFLUNOMIDE from your body. Additional follow-up visits to the doctor and diagnostic tests may be needed to monitor your condition.
Please consult your doctor or pharmacist if you notice any of the side effects listed in this leaflet or any other undesired effects or unexpected changes. If sudden or severe reactions do occur, do not take any more APO-LEFLUNOMIDE tablets and consult your doctor immediately.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Hypertension (high blood pressure) | ✔ | ||
| Pain and swelling of the tendon | ✔ | ||
| Loss of appetite | ✔ | ||
| Skin rash | ✔ | ||
| HMouth sores | ✔ | ||
| Uncommon | |||
| Bruise or bleed easily | ✔ | ||
| Heart disorders (for example: chest pain, palpitation, fast heart beat) | ✔ | ||
| Eye disorders (for example: dimness of vision, eye infection, cataract) | ✔ | ||
| Infection or symptoms of infection such as fever (see text) | ✔ | ||
| Liver problem, if symptoms such as jaundice or other related symptoms (see text) | ✔ | ||
| Lung inflammation, if symptoms such as new or worsening of shortness of breath or other related symptoms (see text) | ✔ | ||
| Severe allergic reactions | ✔ | ||
| Unknown frequency | |||
| Colitis: abdominal pain, bloody stools, diarrhea, fever, rectal pain, bloating, weight loss | ✔ | ||
| Shortness of breath, fatigue, dizziness, chest pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-LEFLUNOMIDE, contact your doctor or pharmacist.
How to store
Do not expose APO-LEFLUNOMIDE tablets to light. Store this medicine at temperatures between 15°C and 30°C, in a dry place. As with all medicines, you should keep APO-LEFLUNOMIDE tablets out of the reach of children. Do not use the tablets in this package after the expiry date shown on the container label.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator: 0701E
Ottawa, ON
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
IMPORTANT INFORMATION AND WARNING: APO- LEFLUNOMIDE may cause severe birth defects
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last Revised: February 09, 2016