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

Serious Warnings and Precautions

What is JAMP Deferasirox (Type J) used for?

JAMP 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 JAMP Deferasirox (Type J) work?

JAMP 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.

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

Medicinal ingredient: Deferasirox.

Non-medicinal ingredients: Crospovidone, FD&C blue no. 2 aluminum lake, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, polysorbate 80, talc and titanium dioxide.

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

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

Do not use JAMP Deferasirox (Type J) if:

• you are allergic (hypersensitive) to deferasirox or any of the other ingredients of JAMP Deferasirox (Type J) (see What are the ingredients in JAMP 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 JAMP 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 cell s).
• 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:

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

  • Stevens-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

  • peeling, high fever, flu-like symptoms and swollen lymph glands. If you notice any of these symptoms while you are taking JAMP 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 JAMP Deferasirox (Type J).
• Talk to your healthcare professional right away if your child becomes sick (vomiting, diarrhea or trouble drinking fluids) while taking JAMP Deferasirox (Type J). Your child may be dehydrated. If this happens, JAMP Deferasirox (Type J) treatment may need to be interrupted. Your child will be treated for dehydration to prevent kidney problems.
• Treatment with JAMP 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 JAMP 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.
• JAMP Deferasirox (Type J) may make hormonal birth control less effective. This may put you at risk of getting pregnant. While you are taking JAMP 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 JAMP Deferasirox (Type J).

Driving and Using Machines:

• JAMP Deferasirox (Type J) can cause dizziness. Give yourself time after taking JAMP 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 JAMP 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 JAMP 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 JAMP Deferasirox (Type J) that is right for you. They will also use these tests to decide when you should stop taking JAMP Deferasirox (Type J).
• Your eyesight and hearing will also be tested before you start taking JAMP 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 JAMP Deferasirox (Type J):

• Antacids (medicines used to treat heartburn) containing aluminum should not be taken at the same time of day as JAMP 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 JAMP Deferasirox (Type J):

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

• JAMP 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, JAMP 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 being treated.

The daily dose of JAMP 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 JAMP 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 JAMP Deferasirox (Type J)?

These are not all the possible side effects you may have when taking JAMP 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:

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

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Revised: JUL 15, 2024