Teva-Deferasirox: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-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:

TEVA-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:

• If you are allergic (hypersensitive) to deferasirox or any of the other ingredients (in particular, lactose) of TEVA-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 nonmedicinal ingredients are:

Colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

What dosage forms it comes in:

TEVA-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

TEVA-DEFERASIROX should be prescribed by doctors experienced in the treatment of chronic iron overload due to blood transfusions.

TEVA-DEFERASIROX has not been studied in patients with severe kidney and liver problems (impairment).

Serious adverse events with the use of TEVA-DEFERASIROX include:

• acute kidney failure
• liver failure
• ulcer or bleeding in the stomach or intestines

BEFORE you use TEVA-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.
• severe intolerance to lactose (milk sugars). TEVA-DEFERASIROX tablets contain lactose
• visual (eye) problems..
• hearing problems.
• blood disorders (a low level of platelets or white blood cell count).
• skin problem.

During treatment with TEVA-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.

Older people (age 65 years and over):

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 TEVA-DEFERASIROX.

Pregnancy and breast-feeding:

TEVA-DEFERASIROX is not recommended during pregnancy unless clearly necessary. If you are pregnant or think that you may be, tell your doctor. TEVA-DEFERASIROX may decrease the effect of hormonal contraceptives, and you may be at risk of getting pregnant if you are taking a hormonal contraceptive.

Breast-feeding is not recommended during treatment with TEVA-DEFERASIROX.

Driving and using machines:

If you feel dizzy after taking TEVA-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 TEVA-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 TEVA-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 TEVA-DEFERASIROX most suitable for you and will also use these tests to decide when you should stop taking TEVA-DEFERASIROX.

Your eyesight and hearing will also be tested before and periodically during treatment as a precautionary measure.

The safety of TEVA-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 TEVA-DEFERASIROX:

• Antacids (medicines used to treat heartburn) containing aluminum should not be taken at the same time of day as TEVA-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)

PROPER USE OF THIS MEDICATION

Always take TEVA-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 TEVA-DEFERASIROX

• Take TEVA-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 TEVA-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 have taken too much TEVA-DEFERASIROX, or if someone else accidentally takes your tablets, contact your doctor or go to the hospital or contact your local poison control centre. Show them the blister package of tablets. Medical treatment may be necessary.

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, TEVA-DEFERASIROX can cause side effects.

Some side effects are 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

Other side effects are 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

You will have some blood tests while taking TEVA-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 TEVA-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.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-DEFERASIROX contact your doctor or pharmacist.

HOW TO STORE IT

• Keep out of the reach and sight of children and of pets.
• Do not use TEVA-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 (15-30ºC).
• Store in the original package in order to protect from moisture.

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

  (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

www.tevacanada.com

Last revised: January 9, 2018