Sandoz Deferasirox (Type J): Uses, Side Effects and Dosage

What is Sandoz Deferasirox (Type J) used for?

Sandoz Deferasirox (Type J) 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.

How does Sandoz Deferasirox (Type J) work?

Sandoz Deferasirox (Type J) contains the medicinal ingredient deferasirox which is an iron chelating agent. It removes the excess iron from the body (also called iron overload). This reduces the risk of organ damage caused by iron overload.

Serious Warnings and Precautions

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

What are the ingredients in Sandoz Deferasirox (Type J)?

Medicinal ingredient: deferasirox.

Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, FD&C blue #2/Indigo carminine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer (188), polyethylene glycol (4000), povidone (K30), talc, titanium dioxide.

Sandoz Deferasirox (Type J) comes in the following dosage forms:

Film-coated tablets: 90 mg, 180 mg, 360 mg

Do not use Sandoz Deferasirox (Type J) if:

• you are allergic (hypersensitive) to deferasirox or any of the other ingredients of Sandoz Deferasirox (Type J) (see What are the ingredients in Sandoz Deferasirox (Type J)?)
• you have severe kidney disease.
• you have an advanced stage of myelodysplastic syndrome (MDS) or advanced cancer.
• you have low levels of platelets in your blood.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Deferasirox (Type J). Talk about any health conditions or problems you may have, including if you:

• have severe heart problems (acute cardiac failure).
• have ulcers or bleeding in the stomach or intestines.

• are taking any medicines that can cause ulcers, such as:

  • non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids used to treat pain and inflammation
  • medicines used to treat osteoporosis
  • medicines used to prevent or treat blood clots
• have liver or kidney problems.
• have eye or vision problems.
• have hearing problems.
• have blood disorders (low level of platelets or white blood cells).
• have skin problems.
• are using any other iron chelation therapy to treat your iron overload.
• are 65 years of age or older. You may be more at risk of side effects.

Other warnings you should know about:

Serious Skin Reactions:

• Sandoz Deferasirox (Type J) can cause serious skin reactions, called severe cutaneous adverse reactions (SCARs), that can be fatal. These include:

  • Steven’s Johnson syndrome (SJS)
  • toxic epidermal necrolysis (TEN)
  • hypersensitivity vasculitis
  • drug reaction with eosinophilia and systemic symptoms (DRESS)
  • erythema multiforme
• Symptoms can include rash, red skin, pain, swelling or blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms and swollen lymph glands. If you notice any of these symptoms while you are taking Sandoz Deferasirox (Type J), tell your healthcare professional immediately.

Children and Adolescents (age 2 years to 16 years):

• Your healthcare professional will monitor your child’s growth and development during treatment with Sandoz Deferasirox (Type J).
• Talk to your healthcare professional right away if your child becomes sick (vomiting, diarrhea or trouble drinking fluids) while taking Sandoz Deferasirox (Type J). Your child may be dehydrated. If this happens, Sandoz Deferasirox (Type J) treatment may need to be interrupted. Your child will be treated for dehydration to prevent kidney problems.
• Treatment with Sandoz Deferasirox (Type J) can cause liver problems including liver failure that might lead to death in children. Liver failure has also happened with kidney problems in some children. Your healthcare professional will monitor how well your child’s liver and kidneys are working.

Pregnancy and Breastfeeding:

• You should not take Sandoz Deferasirox (Type J) if you are pregnant unless clearly necessary.
• If you are pregnant, or think that you may be pregnant, talk to your healthcare professional.
• Sandoz Deferasirox (Type J) may make hormonal birth control less effective. This may put you at risk of getting pregnant. While you are taking Sandoz Deferasirox (Type J) you should use another form of birth control or use an additional barrier method, such as condoms. Talk to your healthcare professional about the birth control options that are right for you.
• You should not breastfeed during treatment with Sandoz Deferasirox (Type J).

Driving and Using Machines:

• Sandoz Deferasirox (Type J) can cause dizziness. Give yourself time after taking Sandoz Deferasirox (Type J) to see how you feel before driving or operating any tools or machinery.

Blood Tests and Monitoring:

• You will have regular blood and urine tests before and during treatment with Sandoz Deferasirox (Type J). You may also be assessed by Magnetic Resonance Imaging (MRI). These tests will monitor the amount of iron in your body (level of ferritin) to see how well Sandoz Deferasirox (Type J) is working. The tests will also monitor the health of your kidneys and liver.
• Your healthcare professional will decide when to perform these tests and will interpret the results. This will help to decide on the dose of Sandoz Deferasirox (Type J) that is right for you. They will also use these tests to decide when you should stop taking Sandoz Deferasirox (Type J).
• Your eyesight and hearing will also be tested before you start taking Sandoz Deferasirox (Type J) and periodically during treatment.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Sandoz Deferasirox (Type J):

• Antacids (medicines used to treat heartburn) containing aluminum should not be taken at the same time of day as Sandoz Deferasirox (Type J).
• cyclosporine (used to help prevent organ rejection)
• simvastatin, cholestyramine (used to lower cholesterol)
• hormonal birth control
• medicines used to treat pain and inflammation (e.g. acetylsalicylic acid, ibuprofen, corticosteroids)
• oral bisphosphonates (used to treat osteoporosis)
• anticoagulant medicines (used to prevent or treat blood clots)
• 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)
• theophylline (used to treat breathing problems such as asthma)
• busulfan (used as treatment prior to bone marrow transplant)

How to take Sandoz Deferasirox (Type J):

• Always take Sandoz Deferasirox (Type J) exactly as your healthcare professional has told you. You should check with your healthcare professional if you are not sure.
• Take Sandoz Deferasirox (Type J) once a day, every day, at about the same time each day.

• Sandoz Deferasirox (Type J) should be taken on an empty stomach or with a light meal. Examples of light meals include: 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) or a turkey sandwich (2 oz. turkey on whole wheat bread with lettuce, tomato, and 1 packet mustard).

• Swallow the tablets whole with water or other liquids.
• If you have difficulty swallowing, Sandoz Deferasirox (Type J) tablets may be crushed and the full amount of medicine sprinkled in a soft food such as yogurt or applesauce. The food with the medicine should be immediately and completely consumed. Do not store it for future use.

Usual dose:

Your healthcare professional will decide on the dose that is right for you based on your body weight and the condition that is be treated.

The daily dose of Sandoz Deferasirox (Type J) may be adjusted or interrupted. This will depend on how you respond to the treatment and if you experience certain side effects.

Overdose:

If you take too much Sandoz Deferasirox (Type J) you may have abdominal pain, diarrhea, nausea or vomiting. You may also have serious liver or kidney problems.

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.

What are possible side effects from using Sandoz Deferasirox (Type J)?

These are not all the possible side effects you may have when taking Sandoz Deferasirox (Type J). If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Gastrointestinal problems such as nausea, vomiting, diarrhea, pain in the abdomen, bloating, constipation, indigestion
• Skin rash
• Headache
• Dizziness
• Fever
• Sore throat
• Swelling of arms or legs
• Change in the colour of the skin
• Anxiety
• Sleep disorder
• Tiredness
• Hair loss

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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 healthcare professional.

Reporting Side Effects

Storage:

• Keep out of the reach and sight of children and of pets.
• Do not use Sandoz Deferasirox (Type J) 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.

If you want more information about Sandoz Deferasirox (Type J):

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare 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 the manufacturer, Sandoz Canada Inc., at 1-800-361-3062.

Last Revised: February 15, 2023