Jadenu

Brand Name

Jadenu

Common Name

deferasirox

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Deferasirox belongs to the class of medications known as iron chelators. It is used to treat the iron overload that occurs when anemia is treated with frequent blood transfusions. It is used in adults and children 6 years and older. It is also used in children 2 to 5 years old for whom deferoxamine is not providing an adequate response. It works by binding to excess iron in the blood and removing it from the body (mainly through the stools), thereby relieving the iron overload caused by blood transfusions. It can also be used to treat chronic iron overload in people 10 years of age and older who have thalassemia and do not require regular blood transfusions.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For the regular or film-coated tablets, the usual recommended starting dose of deferasirox film-coated tablets is 7 mg to 21 mg per kilogram of body weight per day, depending on the individual. Your doctor will determine the exact dosage that is appropriate for your circumstances.

Deferasirox regular and film-coated tablets should be taken once daily at about the same time each day, on an empty stomach or with a light meal. If you cannot swallow whole tablets, the film-coated tablets may be crushed and administered by sprinkling the full dose on a soft food (e.g., yogurt or applesauce). Immediately eat the food that the medication is sprinkled on, and follow the medication with a glass of water. The dose should not be stored for future use.

For the dispersible tablets or tablets for suspension, the usual recommended starting dose of deferasirox is 10 mg to 30 mg per kilogram of body weight per day, depending on the individual. Your doctor will determine the exact dosage that is appropriate for your circumstances.

Deferasirox dispersible tablets and tablets for suspension should be taken once daily at about the same time each day, on an empty stomach and at least 30 minutes before the first meal of the day. The tablets must be mixed with water, apple, or orange juice (100 mL of liquid for doses of less than 1 g, and 200 mL for doses of 1 g or more). Drop the tablet into the liquid and stir until the tablet dissolves completely. Drink all the liquid, then add a little water or juice to what is left in the glass and drink that as well. Do not chew or crush the tablets, or swallow them whole.

Do not use milk or carbonated beverages such as soda pop to dissolve the tablets. Milk slows down dissolution and carbonated beverages will foam up.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Leave the medication in its original package until it is time to take a dose.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

90 mg
Each light blue, unscored, ovaloid, film-coated tablet with bevelled edges, debossed with "NVR" on one side and "90" on a slight upward slope in between two debossed curved lines on the other side, contains 90 mg of deferasirox. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer (188), and povidone (K30); film-coating material: FD&C Blue No. 2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol (4000), talc, and titanium dioxide.

180 mg
Each medium blue, unscored, ovaloid, film-coated tablet with bevelled edges debossed with "NVR" on one side and "180" on a slight upward slope in between two debossed curved lines on the other side, contains 180 mg of deferasirox. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer (188), and povidone (K30); film-coating material: FD&C Blue No. 2/Indigo carminine aluminum lake, hypromellose, polyethylene glycol (4000), talc, and titanium dioxide.

360 mg
Each dark blue, unscored, ovaloid, film-coated tablet with bevelled edges, debossed with "NVR" on one side and "360" on a slight upward slope in between two debossed curved lines on the other side, contains 360 mg of deferasirox. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer (188), and povidone (K30); film-coating material: FD&C Blue No. 2/Indigo carminine aluminum lake, hypromellose, polyethylene glycol (4000), talc, and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to deferasirox or any ingredients of this medication
• have a low platelet count (less than 50×109/L)
• have myelodysplastic syndrome (MDS)
• have rapidly worsening disease and are not likely to be helped with chelation therapy
• have severe kidney impairment (creatinine clearance less than 60 mL per minute or creatinine levels in the blood that are more than double the upper limit of normal)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bloating
• constipation
• diarrhea
• dizziness
• fever
• hair loss
• headache
• heartburn
• nausea
• skin colour changes
• skin rash
• sore throat
• stomach pain
• tiredness
• trouble sleeping
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety
• blurred or cloudy eyesight
• reduced hearing
• heartburn or abdominal pain (ulcers) particularly after eating or taking the drug
• partial vision loss
• increased frequency of flu-like symptoms or infections
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling of the arms or legs

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of gastrointestinal (stomach or intestines) bleeding, such as vomiting blood and/or black stools
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of a gastrointestinal perforation (e.g., severe abdominal pain or tenderness, nausea, vomiting, chills, or fever)
• symptoms of a severe allergic reaction (hives; skin rash; itchy skin; trouble breathing; swelling of the face, lips, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot).

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, in your blood.

Dizziness: Deferasirox may cause dizziness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Hearing problems: Deferasirox may cause hearing problems such as decreased hearing or difficulty hearing high-pitched sounds. Your doctor may recommend you have hearing tests before and throughout treatment. If you notice changes in your hearing, contact your doctor as soon as possible.

Heart failure: This medication is not recommended for people with heart failure due to iron overload. If you have heart failure caused by iron overload, discuss with your doctor how this medication may affect your medical condition, how your medical condition or medications may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Deferasirox may cause serious kidney problems, including kidney failure. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor may recommend you have your kidney function tested regularly throughout treatment. This can be done with blood tests.

Liver function: This medication is not recommended for people with severe liver impairment. Deferasirox may cause serious liver problems, including liver failure. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor may recommend you have your liver function tested regularly throughout treatment. This can be done with blood tests.

Laboratory tests: Your doctor may recommend regular blood tests to monitor your response to this medication, the effect the medication has on your liver and kidney, and to monitor your blood cell levels.

Lactose intolerance: : The dispersible tablet form of this medication contains lactose. It is not recommended for people with hereditary galactose intolerance, glucose-galactose malabsorption, or severe lactase deficiency.

If you have poor lactose tolerance, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin rash: This medication may cause a skin rash. Mild-to-moderate rashes often resolve without treatment and do not require any changes in deferasirox therapy. Severe rashes may require a change in dose, or treatment may need to be stopped, as recommended by your doctor. If you notice symptoms including a rash, itching, blistering, or peeling skin, contact your doctor right away.

Stomach problems: Deferasirox can irritate the lining of the stomach and cause indigestion, or in more serious situations, bleeding in the stomach and digestive system. This is more likely to happen when you are also taking other medications that irritate the stomach, such as anti-inflammatory pain relievers (e.g., acetylsalicylic acid or ibuprofen).

If you have stomach problems, have a history of stomach problems, or are taking any medications that can irritate the stomach, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision problems: Changes to your vision or eyes, such as cloudy vision or cataracts, may occur with the use of deferasirox. Your doctor may recommend you have eye tests before and throughout treatment. If you notice changes in your vision, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if deferasirox passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 2 years of age. There is limited data on the use of this medication by children aged 2 to 5 years.

Seniors: Seniors are at an increased risk of experiencing side effects related to the kidneys, liver, and heart. If you are a senior, your doctor should closely monitor your condition while you are taking deferasirox.

What other drugs could interact with this medication?

There may be an interaction between deferasirox and any of the following:

• antacids containing aluminum (e.g., aluminum hydroxide)
• anti-cancer medications (e.g., busulfan, paclitaxel)
• anticoagulant medications (e.g., apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)
• bisoprolol
• birth control pills
• bisphosphonates (e.g., alendronate, etidronate, risedronate)
• bromazepam
• caffeine
• cholestyramine
• clomipramine
• clozapine
• cola-containing drinks
• colesevelam
• colestipol
• corticosteroids (e.g., hydrocortisone, prednisone)
• dabrafenib
• desloratadine
• duloxetine
• efavirenz
• enzalutamide
• estrogens
• heparin and low-molecular weight heparins (e.g., dalteparin, tinzaparin)
• melatonin
• nirmatrelvir and ritonavir
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., celecoxib, diclofenac, ibuprofen, naproxen)
• olanzapine
• other iron chelators
• ozanimod
• pentoxifylline
• pirfenidone
• pioglitazone
• pomalidomide
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• propranolol
• rasagiline
• repaglinide
• rifampin
• ritonavir
• ropinirole
• seizure medications (e.g., carbamazepine, phenobarbital, phenytoin)
• sirolimus
• "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
• theophylline
• tipranavir
• tizanidine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Jadenu