Details for: APO-DEFERASIROX
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02461544 | APO-DEFERASIROX | DEFERASIROX | 125 MG | TABLET FOR SUSPENSION | ORAL |
| 02461552 | APO-DEFERASIROX | DEFERASIROX | 250 MG | TABLET FOR SUSPENSION | ORAL |
| 02461560 | APO-DEFERASIROX | DEFERASIROX | 500 MG | TABLET FOR SUSPENSION | 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-DEFERASIROX is used to treat chronic iron overload in:
- adult patients and children aged 6 years and older who receive blood transfusions for the treatment of anemias;
- children aged 2 to 5 years who receive blood transfusions for the treatment of anemias, and who cannot be adequately treated with deferoxamine;
- adult patients and children aged 10 years and older with thalassemia syndromes who do not require regular blood transfusions for the treatment of anemia.
What it does
APO-DEFERASIROX is an iron chelating agent which removes the excess iron from the body (also called iron overload), thereby reducing the risk of organ damage caused by iron overload.
When it should not be used
When it should not be used:
- If you are allergic (hypersensitive) to deferasirox or any of the other ingredients of APO-DEFERASIROX listed in the section What the nonmedicinal ingredients are.
- If you have severe kidney disease.
- If you have an advanced stage of myelodysplastic syndrome (MDS) or advanced cancer.
- If you have low platelet count (<50 x 109 /L).
What the medicinal ingredient is
The active substance is deferasirox.
What the non-medicinal ingredients are
Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.
What dosage form it comes in
APO-DEFERASIROX is supplied as tablets for oral suspension. Each tablet contains 125 mg, 250 mg or 500 mg deferasirox.
Each blister package contains 30 dispersible tablets.
Warnings and precautions
Serious Warnings and Precautions
APO-DEFERASIROX should be prescribed by doctors experienced in the treatment of chronic iron overload due to blood transfusions.
APO-DEFERASIROX has not been studied in patients with severe kidney and liver problems (impairment).
Serious adverse events with the use of APO- DEFERASIROX include:
- acute kidney failure
- liver failure
- ulcer or bleeding in the stomach or intestines
BEFORE you use APO-DEFERASIROX talk to your doctor or pharmacist if you have:
- severe heart problems (acute cardiac failure).
- ulcer or bleeding in the stomach or intestines.
- liver or kidney problems.
- visual (eye) problems.
- hearing problems.
- blood disorders (a low level of platelets or white blood cell count).
- skin problem.
During treatment with APO-DEFERASIROX, talk to your doctor or pharmacist immediately if you have:
- Rash, red skin, pain, swelling or blistering of the lips, eyes or mouth, skin peeling, high fever and flu-like symptoms and swollen lymph glands. If you get these symptoms, your doctor may stop your treatment.
- Vision and hearing problems.
Older people (65 years of age and above):
Elderly patients may experience more side effects than younger patients. They should be monitored closely by their doctor for side effects that may require a dose adjustment.
Children and adolescents (age 2 years to 16 years): Their growth and development need to be monitored during treatment with APO- DEFERASIROX.
Pregnancy and breast-feeding:
APO-DEFERASIROX is not recommended during pregnancy unless clearly necessary. If you are pregnant or think that you may be, tell your doctor. APO-DEFERASIROX may decrease the effect of hormonal contraceptives, and you may be at risk of getting pregnant if you are taking a hormonal contraceptive. You should use an additional or different type of contraception.
Breast-feeding is not recommended during treatment with APO-DEFERASIROX.
Driving and using machines:
If you feel dizzy after taking APO-DEFERASIROX, do not drive or operate any tools or machines until you are feeling normal again.
You should receive regular blood and urine tests before and during treatment with APO- DEFERASIROX. You may also be assessed by Magnetic Resonance Imaging (MRI). These will monitor the amount of iron in your body (level of ferritin) to see how well APO-DEFERASIROX is working. The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases, bilirubin and alkaline phosphatase). Your doctor will take these tests into consideration when deciding on the dose of APO-DEFERASIROX most suitable for you and will also use these tests to decide when you should stop taking APO- DEFERASIROX.
Your eyesight and hearing will also be tested before and periodically during treatment as a precautionary measure.
The safety of deferasirox when administered with other iron chelation therapy has not been established.
Interactions with this medication
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription drugs (obtained without a prescription), vitamins and natural products. Some medicines may interact with APO-DEFERASIROX:
- Antacids (medicines used to treat heartburn) containing aluminum should not be taken at the same time of day as APO-DEFERASIROX.
In particular tell your doctor if you are taking any of the following:
- cyclosporine (used in transplantation to prevent graft rejection or for any other condition)
- simvastatin (used to lower cholesterol)
- hormonal contraceptive agents (birth control medicines)
- certain painkillers or anti-inflammatory medicines (e.g. acetylsalicylic acid, ibuprofen, corticosteroids)
- oral bisphosphonates (used to treat osteoporosis)
- anticoagulant medicines (used to prevent or treat blood clotting)
- repaglinide (used to treat diabetes)
- rifampicin (used to treat tuberculosis)
- paclitaxel (used in cancer treatment)
- phenytoin, phenobarbital (used to treat epilepsy)
- ritonavir (used in the treatment of HIV infection)
- cholestyramine (used mainly to lower cholesterol)
- theophylline (used to treat respiratory diseases such as asthma)
- busulfan (used as treatment prior to bone marrow transplant)
Proper use of this medication
Always take APO-DEFERASIROX exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual Dose
For patients receiving regular blood transfusion:
- Initial dose: 10 mg, or 20 mg, or 30 mg per kg body weight daily.
- Maximum dose: 30 mg per kg body weight daily.
For patients with thalassemia syndromes who do not require regular blood transfusions:
- Initial dose: 10 mg per kg body weight daily.
- Maximum dose: 20 mg per kg body weight daily.
The daily dose will be adjusted depending on how you respond to the treatment.
When to take APO-DEFERASIROX
- Take APO-DEFERASIROX once a day, every day, at about the same time each day;
- Must be taken on an empty stomach;
- Then wait at least 30 minutes before eating the first meal of the day.
How to take APO-DEFERASIROX:
- Drop the tablet(s) into a glass of water, orange or apple juice (100 mL for doses of less than 1 g, and 200 mL for doses of 1 g or more).
- Stir until the tablet(s) dissolve completely. The liquid in the glass will look cloudy.
- Drink everything in the glass. Then add a little water or juice to what is left in the glass and drink that too.
Do not dissolve the tablets in fizzy drinks or milk.
Do not chew, break or crush the tablets. Do not swallow the tablets whole.
Overdose
If you think you have taken too much APO- DEFERASIROX, or if someone else accidentally takes your tablets, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. Show the doctor the blister package of tablets. Urgent medical treatment may be necessary. You may experience effects such as abdominal pain, diarrhea, nausea and vomiting, and kidney or liver problems that can be serious.
Missed Dose
If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do not take a double dose on the next day to make up for the forgotten dose. Do not take more than one dose on the same day.
Side effects and what to do about them
Like all medicines, APO-DEFERASIROX can cause side effects.
Common: these side effects may affect between 1 and 10 in every 100 patients.
- Gastrointestinal disorders, such as nausea, vomiting, diarrhea, pain in the abdomen, bloating, constipation, indigestion
- Skin rash
- Headache
Uncommon: these side effects may affect less than 1 in every 100 patients.
- Dizziness
- Fever
- Sore throat
- Swelling of arms or legs
- Change in the colour of the skin
- Anxiety
- Sleep disorder
- Tiredness
- Hearing loss
- Vision change (early cataracts)
- Ulcer and/or bleeding in the stomach or intestine
- Liver disorders
- Traces of blood and/or protein in the urine
- Hair loss
- A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), and in the number of white blood cells (neutropenia)
You will have some blood tests while taking APO- DEFERASIROX. Your doctor will look for any changes in kidney function, liver function, or in blood cell counts.
Your doctor may also want to test your eyesight and hearing while you are taking APO-DEFERASIROX.
You may notice other side effects not listed in this leaflet. If you are concerned with any side effect, or if any side effect makes you feel unwell, please tell you doctor or pharmacist.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Blurred or cloudy eyesight | ✔ | ||
| Reduced hearing | ✔ | ||
| Severe upper stomach pain (sign of pancreatitis) | ✔ | ||
| Vomiting blood and/or have black stools | ✔ | ||
| Frequent heartburn or abdominal pain (signs of ulcers) particularly after eating or taking the drug | ✔ | ||
| Rare | |||
| Acute renal failure (severe kidney problems), decreased urine output (sign of kidney problem) | ✔ | ||
| Difficulty breathing, dizziness, rash or swelling of the face and throat (signs of allergic reaction) | ✔ | ||
| Frequent heartburn | ✔ | ||
| Partial loss of vision | ✔ | ||
| Rash, red skin, pain, blistering of the lips, eyes or mouth, skin peeling, high fever flu- like symptoms and swollen lymph glands (signs of serious skin reaction) | ✔ | ||
| Very Rare | |||
| Drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems) | ✔ | ||
| Unknown frequency | |||
| Tear in stomach or intestine wall that can be painful and cause nausea | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO- DEFERASIROX contact your doctor or pharmacist.
How to store
- Keep out of the reach and sight of children and of pets.
- Do not use APO-DEFERASIROX after the expiry date which is stated on the package/carton after EXP. The expiry date refers to the last day of that month.
- Store at room temperature (15oC to 30oC). Protect from moisture.
- Store in the original package.
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 for information on how to report online, by mail or by fax; or
- Calling 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
If you want more information about APO- DEFERASIROX:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website. Find the Consumer Information on the manufacturer’s website, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: May 4, 2020