Deferasirox

[ for deferasirox dispersible tablets/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 should be taken once daily at about the same time each day. It should be taken 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 Deferasirox 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 Deferasirox 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.

[for deferasirox tablets 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 should be taken once daily at about the same time each day. Take it 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.

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 Deferasirox 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 Deferasirox 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause stomach ache; it may cause a fever; it may cause nausea or, rarely, vomiting; it may cause a cough. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

125 mg
Each off-white, round, uncoated tablet, flat with bevelled edge, debossed with "568" on one side and plain on other side, contains 125 mg of deferasirox. Nonmedicinal ingredients: lactose monohydrate, crospovidone, povidone (K29/32), sodium lauryl sulphate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.

250 mg
Each off-white, round, uncoated tablet, flat with bevelled edge, debossed with "569" on one side and plain on other side, contains 250 mg of deferasirox. Nonmedicinal ingredients: lactose monohydrate, crospovidone, povidone (K29/32), sodium lauryl sulphate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.

500 mg
Each off-white, round, uncoated tablets, flat with bevelled edge, debossed with "570" on one side and plain on other side, contains 500 mg of deferasirox. Nonmedicinal ingredients: lactose monohydrate, crospovidone, povidone (K29/32), sodium lauryl sulphate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.

Do not take Deferasirox if you:

• are allergic to deferasirox or any ingredients of Deferasirox
• 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)

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

• Abiraterone
• acetylsalicylic acid (Aspirin)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• antacids containing aluminum (e.g., aluminum hydroxide)
• anti-cancer medications (e.g., Doxorubicin, Paclitaxel, Vincristine, Vinorelbine)
• anticoagulant medications (e.g., Apixaban, dabigatran, Edoxaban, Rivaroxaban, Warfarin)
• anti-psychotics (e.g., Aripiprazole, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Amiodarone
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Clonazepam, Diazepam, Lorazepam)
• Bisoprolol
• birth control pills
• bisphosphonates (e.g., Alendronate, etidronate, Risedronate)
• Buprenorphine
• Buspirone
• caffeine
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Celecoxib
• Cholestyramine
• chloroquine
• clozapine
• Cobicistat
• Colesevelam
• Colestipol
• conivaptan
• corticosteroids (e.g., Hydrocortisone, Prednisone)
• Cyclosporine
• Dabrafenib
• Dapsone
• Darifenacin
• dasabuvir
• Dasatinib
• Desloratadine
• Disopyramide
• Duloxetine
• Eliglustat
• Enzalutamide
• Eplerenone
• estrogens
• Everolimus
• Flibanserin
• Flutamide
• "gliptin" Diabetes medications (DPP-IV inhibitors; e.g., Linagliptin, Saxagliptin, Sitagliptin)
• Heparin and low-molecular weight heparins (e.g., Dalteparin, Tinzaparin)
• Hepatitis C antivirals (e.g., asunaprevir, daclatasvir, dasabuvir, grazoprevir, ombitasvir, paritaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lomitapide
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• melatonin
• Methadone
• mifepristone
• mefloquine
• methadone
• Mirtazapine
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Diclofenac, ibuprofen, Naproxen)
• Ondansetron
• other iron chelators
• Pentoxifylline
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• Phenytoin
• Pioglitazone
• Primaquine
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• Propranolol
• protein kinase inhibitors (e.g., Bosutinib, Ibrutinib, imatinib, Lapatinib, Nilotinib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• Pseudoephedrine
• quinidine
• quinine
• Rasagiline
• Repaglinide
• rifabutin
• rifampin
• Riociguat
• rivaroxaban
• Roflumilast
• Romidepsin
• Ropinirole
• seizure medications (e.g., Carbamazepine, Phenobarbital, phenytoin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sildenafil
• Sirolimus
• Solifenacin
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• suvorexant
• Tacrolimus
• Tamoxifen
• Tetracycline
• Theophylline
• Ticagrelor
• Ticlopidine
• Tizanidine
• Tofacitinib
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• Ulipristal
• Zolpidem
• Zopiclone

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 Deferasirox. 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.

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 Deferasirox.

Blood counts: Deferasirox 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 Deferasirox 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: Deferasirox 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 Deferasirox may affect your medical condition, how your medical condition or medications may affect the dosing and effectiveness of Deferasirox, 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 Deferasirox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Deferasirox, 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: Deferasirox 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 Deferasirox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Deferasirox, 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 Deferasirox, the effect the medication has on your liver and kidney, and to monitor your blood cell levels.

Lactose intolerance: Deferasirox 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 Deferasirox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Deferasirox, and whether any special monitoring is needed.

Skin rash: Deferasirox 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 Deferasirox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Deferasirox, 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: Deferasirox should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Deferasirox, contact your doctor immediately.

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

Children: The safety and effectiveness of Deferasirox have not been established for children less than 2 years of age. There is limited data on the use of Deferasirox 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.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication must be taken on an empty stomach or with a light meal. To ensure effectiveness, avoid taking an aluminum-based antacid at the same time.