Exjade

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• unusual bruising or bleeding
• lack of energy
• loss of appetite
• flu-like symptoms
• diarrhea
• vomiting

Deferasirox binds to iron and removes it from the blood stream.

Deferasirox is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

Deferasirox is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.

Deferasirox may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.

Deferasirox can harm your liver or kidneys. Stop using deferasirox and call your doctor at once if you have swelling, rapid weight gain, shortness of breath, pain in your upper stomach, loss of appetite, pain in your side or lower back, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Deferasirox may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

You should not use this medication if you are allergic to it, or if you have:

• severe liver or kidney disease;
• advanced cancer;
• a bone marrow disorder; or
• low levels of platelets in your blood.

To make sure deferasirox is safe for you, tell your doctor if you have:

• kidney disease;
• liver disease;
• anemia (low red blood cells);
• cancer (especially blood cell cancer such as leukemia);
• a stomach ulcer;
• a history of stomach or intestinal bleeding;
• vision or hearing problems; or
• a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Deferasirox can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

It is not known whether deferasirox passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking deferasirox.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using deferasirox and call your doctor at once if you have:

• problems with vision or hearing;

• kidney problems--urinating more or less than usual; painful or difficult urination; swelling in your feet or ankles; weakness, bone pain; feeling tired or short of breath;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Serious side effects may be more likely in older adults.

Common side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea; or

• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General

Determine baseline serum ferritin and iron concentrations prior to initiation of therapy.1 Risk of toxicity may be increased when deferasirox is administered to patients with low iron burden or only slightly elevated serum ferritin concentrations.1

Restricted Distribution Program

• Patients must obtain deferasirox through the Exjade Patient Assistance and Support Services (EPASS) program.21 The clinician and patient must jointly complete a prescription and reimbursement application.21 Following verification of prescription information and review of healthcare benefits, an authorized specialty pharmacy ships deferasirox directly to the patient or the clinician’s office.21 To enroll in this program, call 888-903-7277 or visit .21

Administration

Oral Administration

Administer orally once daily on an empty stomach (≥30 minutes before eating), preferably at the same time each day.1 4 17

Deferasirox tablets for oral suspension should not be chewed or swallowed whole.1 4 5

Completely disperse tablets for oral suspension by stirring in water, orange juice, or apple juice.1 4 17

Disperse doses of <1 g in 3.5 oz and doses of ≥1 g in 7 oz of liquid.1 4 5

Use the suspension immediately following preparation.4 5

Following administration, resuspend any residue in a small volume of liquid and swallow.1 17

Dosage

Pediatric Patients

Children ≥2 years of age: Initially, 20 mg/kg daily, rounded to the nearest whole-tablet dosage strength.1 4 5 17

Adjust dosage every 3–6 months as needed based on trends in serum ferritin concentrations (monitor monthly).1 4 17

Adjust dosage in increments of 5 or 10 mg/kg daily according to the patient’s clinical response and therapeutic goals.1 4 17

In pediatric patients not adequately controlled with dosages of 30 mg/kg daily (e.g., serum ferritin concentrations consistently >2500 mcg/L and not showing a downward trend over time), consider dosages up to 40 mg/kg daily.1 Dosages >40 mg/kg daily not recommended.1

Consider temporarily interrupting therapy if serum ferritin concentrations are consistently <500 mcg/L.1 4 17

Interrupt therapy if a progressive increase in Scr beyond the age-appropriate ULN occurs.1 (See Renal Effects under Cautions.) Once Scr returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical benefit is expected to outweigh potential risks.1

Reduce dosage by 10 mg/kg daily if Scr at 2 consecutive visits increases to a level exceeding the age-appropriate ULN.1

Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.1 19 27 (See Hepatic Effects under Cautions.)

If concomitant use of cholestyramine or potent UGT inducers (e.g., phenobarbital, phenytoin, rifampin, ritonavir) cannot be avoided (see Interactions), consider increasing initial deferasirox dosage to 30 mg/kg daily.1 Make further dosage adjustments according to patient’s clinical response and serum ferritin concentrations.1

Adults

Initially, 20 mg/kg daily, rounded to the nearest whole-tablet dosage strength.1 4 5 17

Adjust dosage every 3–6 months as needed based on trends in serum ferritin concentrations (monitor monthly).1 4 17

Adjust dosage in increments of 5 or 10 mg/kg daily according to the patient’s clinical response and therapeutic goals.1 4 17

In adults not adequately controlled with dosages of 30 mg/kg daily (e.g., serum ferritin concentrations consistently >2500 mcg/L and not showing a downward trend over time), consider dosages up to 40 mg/kg daily.1 Dosages >40 mg/kg daily not recommended.1

Consider temporarily interrupting therapy if serum ferritin concentrations are consistently <500 mcg/L.1 4 17

Interrupt therapy if a progressive increase in Scr beyond the ULN occurs.1 (See Renal Effects under Cautions.) Once Scr returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical benefit is expected to outweigh potential risks.1

Reduce dosage by 10 mg/kg daily if Scr at 2 consecutive visits increases to a level >33% above the average pretreatment value and the increase cannot be attributed to other causes.1

Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.1 19 27 (See Hepatic Effects under Cautions.)

If concomitant use of cholestyramine or potent UGT inducers (e.g., phenobarbital, phenytoin, rifampin, ritonavir) cannot be avoided (see Interactions), consider increasing initial deferasirox dosage to 30 mg/kg daily.1 Make further dosage adjustments according to patient’s clinical response and serum ferritin concentrations.1

Prescribing Limits

Pediatric Patients

Children ≥2 years of age: Maximum 40 mg/kg daily.1

Adults

Maximum 40 mg/kg daily.1

Special Populations

Hepatic Impairment

Not studied in patients with preexisting hepatic impairment.1 4 No specific dosage recommendations for these patients.1 Has been initiated at usual recommended dosages in patients with baseline transaminase concentrations up to 5 times the ULN.1 23 (See Hepatic Effects under Cautions.)

Renal Impairment

Not studied in patients with preexisting renal impairment.1 (See Contraindications and also Renal Effects under Cautions.)

Geriatric Patients

No specific dosage recommendations at this time.1 (See Geriatric Use under Cautions.)

Storage

Oral

25°C (may be exposed to 15–30°C).1

Protect from moisture.1

• It is used to get rid of iron when too much is in the body.

Use Exjade as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach. Take 30 minutes before a meal.
• Mix the tablet with fruit juice (orange, apple) or water until melted and drink right away. Do not chew or swallow it whole.
• After drinking, rinse the rest of the drug in the glass with more juice or water and drink.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep taking Exjade as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Feeling very tired or weak.
• Change in hearing.
• Hearing loss.
• Change in eyesight.
• Very bad belly pain.
• Rashes may happen with this medicine. This medicine may need to be stopped for some types of rashes. If you get a rash while taking Exjade, call your doctor right away to find out what to do.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

     Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. This indication is based on a reduction of liver iron concentrations and serum ferritin levels [see Clinical Studies (14)]. An improvement in survival or disease-related symptoms has not been established [see Indications and Usage (1.3)].

     Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is based on achievement of an LIC less than 5 mg Fe/g dw [see Clinical Studies (14)]. An improvement in survival or disease-related symptoms has not been established.

     Limitation of Use

Controlled clinical trials of Exjade with myelodysplastic syndromes (MDS) and chronic iron overload due to blood transfusions have not been performed [see Clinical Studies (14)].

The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established.

The following adverse reactions are also discussed in other sections of the labeling:

• Renal Toxicity, Renal Failure, and Proteinuria [see Warnings and Precautions (5.1)]
• Hepatic Toxicity and Failure [see Warnings and Precautions (5.2)]
• Gastrointestinal (GI) Hemorrhage [see Warnings and Precautions (5.3)]
• Bone Marrow Suppression [see Warnings and Precautions (5.4)]
• Hypersensitivity [see Warnings and Precautions (5.6)]
• Severe Skin Reactions [see Warnings and Precautions (5.7)]
• Skin Rash [see Warnings and Precautions (5.8)]
• Auditory and Ocular Abnormalities [see Warnings and Precautions (5.9)]

     Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Transfusional Iron Overload

A total of 700 adult and pediatric patients were treated with Exjade (deferasirox) for 48 weeks in premarketing studies. These included 469 patients with beta-thalassemia, 99 with rare anemias, and 132 with sickle cell disease. Of these patients, 45% were male, 70% were Caucasian and 292 patients were less than 16 years of age. In the sickle cell disease population, 89% of patients were black. Median treatment duration among the sickle cell patients was 51 weeks. Of the 700 patients treated, 469 (403 beta-thalassemia and 66 rare anemias) were entered into extensions of the original clinical protocols. In ongoing extension studies, median durations of treatment were 88-205 weeks.

Six hundred twenty-seven (627) patients with MDS were enrolled across 5 uncontrolled trials. These studies varied in duration from 1 to 5 years. The discontinuation rate across studies in the first year was 46% (AEs 20%, withdrawal of consent 10%, death 8%, other 4%, lab abnormalities 3%, and lack of efficacy 1%). Among 47 patients enrolled in the study of 5-year duration, 10 remained on Exjade at the completion of the study.

Table 1 displays adverse reactions occurring in greater than 5% of Exjade-treated beta-thalassemia patients (Study 1), sickle cell disease patients (Study 3), and patients with MDS (MDS pool). Abdominal pain, nausea, vomiting, diarrhea, skin rashes, and increases in serum creatinine were the most frequent adverse reactions reported with a suspected relationship to Exjade. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related.

In Study 1, a total of 113 (38%) patients treated with Exjade had increases in serum creatinine greater than 33% above baseline on 2 separate occasions (Table 2) and 25 (8%) patients required dose reductions. Increases in serum creatinine appeared to be dose related [see Warnings and Precautions (5.1)]. In this study, 17 (6%) patients treated with Exjade developed elevations in SGPT/ALT levels greater than 5 times the ULN at 2 consecutive visits. Of these, 2 patients had liver biopsy proven drug-induced hepatitis and both discontinued Exjade therapy [see Warnings and Precautions (5.2)]. An additional 2 patients, who did not have elevations in SGPT/ALT greater than 5 times the ULN, discontinued Exjade because of increased SGPT/ALT. Increases in transaminases did not appear to be dose related. Adverse reactions that led to discontinuations included abnormal liver function tests (2 patients) and drug-induced hepatitis (2 patients), skin rash, glycosuria/proteinuria, Henoch Schönlein purpura, hyperactivity/insomnia, drug fever, and cataract (1 patient each).

In Study 3, a total of 48 (36%) patients treated with Exjade had increases in serum creatinine greater than 33% above baseline on 2 separate occasions (Table 2) [see Warnings and Precautions (5.1)]. Of the patients who experienced creatinine increases in Study 3, 8 Exjade-treated patients required dose reductions. In this study, 5 patients in the Exjade group developed elevations in SGPT/ALT levels greater than 5 times the ULN at 2 consecutive visits and 1 patient subsequently had Exjade permanently discontinued. Four additional patients discontinued Exjade due to adverse reactions with a suspected relationship to study drug, including diarrhea, pancreatitis associated with gallstones, atypical tuberculosis, and skin rash.

In the MDS pool, in the first year, a total of 229 (37%) patients treated with Exjade had increases in serum creatinine greater than 33% above baseline on 2 consecutive occasions (Table 2) and 8 (3.5%) patients permanently discontinued [see Warnings and Precautions (5.1)]. A total of 5 (0.8%) patients developed SGPT/ALT levels greater than 5 times the ULN at 2 consecutive visits. The most frequent adverse reactions that led to discontinuation included increases in serum creatinine, diarrhea, nausea, rash, and vomiting. Death was reported in the first year in 52 (8%) of patients [see Clinical Studies (14)].

Non-Transfusion-Dependent Thalassemia Syndromes

In Study 4, 110 patients with NTDT received 1 year of treatment with Exjade 5 or 10 mg/kg/day and 56 patients received placebo in a double-blind, randomized trial. In Study 5, 130 of the patients who completed Study 4 were treated with open-label Exjade at 5, 10, or 20 mg/kg/day (depending on the baseline LIC) for 1 year [see Clinical Studies (14)]. Table 3 displays adverse reactions occurring in greater than 5% in any group. The most frequent adverse reactions with a suspected relationship to study drug were nausea, rash, and diarrhea.

In Study 4, 1 patient in the placebo 10 mg/kg/day group experienced an ALT increase to greater than 5 times ULN and greater than 2 times baseline (Table 4). Three Exjade-treated patients (all in the 10 mg/kg/day group) had 2 consecutive serum creatinine level increases greater than 33% from baseline and greater than ULN. Serum creatinine returned to normal in all 3 patients (in 1 spontaneously and in the other 2 after drug interruption). Two additional cases of ALT increase and 2 additional cases of serum creatinine increase were observed in the 1-year extension of Study 4.

Proteinuria

In clinical studies, urine protein was measured monthly. Intermittent proteinuria (urine protein/creatinine ratio greater than 0.6 mg/mg) occurred in 18.6% of Exjade-treated patients compared to 7.2% of deferoxamine-treated patients in Study 1 [see Warnings and Precautions (5.1)].

Other Adverse Reactions

In the population of more than 5,000 patients with transfusional iron overload who have been treated with Exjade during clinical trials, adverse reactions occurring in 0.1% to 1% of patients included gastritis, edema, sleep disorder, pigmentation disorder, dizziness, anxiety, maculopathy, cholelithiasis, pyrexia, fatigue, laryngeal pain, cataract, hearing loss, gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, renal tubular disorder (Fanconi’s Syndrome), and acute pancreatitis (with and without underlying biliary conditions). Adverse reactions occurring in 0.01% to 0.1% of patients included optic neuritis, esophagitis, and erythema multiforme. Adverse reactions which most frequently led to dose interruption or dose adjustment during clinical trials were rash, gastrointestinal disorders, infections, increased serum creatinine, and increased serum transaminases.

     Postmarketing Experience

The following adverse reactions have been spontaneously reported during postapproval use of Exjade in the transfusional iron overload setting. Because these reactions are reported voluntarily from a population of uncertain size, in which patients may have received concomitant medication, it is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS), hypersensitivity vasculitis, urticaria, alopecia, toxic epidermal necrolysis (TEN)

Immune system disorders: hypersensitivity reactions (including anaphylactic reaction and angioedema)

Renal and urinary disorders: acute renal failure, tubulointerstitial nephritis

Hepatobiliary disorders: hepatic failure

Gastrointestinal disorders: gastrointestinal perforation

Blood and lymphatic system disorders: worsening anemia

Exjade (deferasirox) is an iron chelating agent. Exjade tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is:

Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4.

Inactive Ingredients: Lactose monohydrate (NF), crospovidone (NF), povidone (K30) (NF), sodium lauryl sulphate (NF), microcrystalline cellulose (NF), silicon dioxide (NF), and magnesium stearate (NF).

Do not use other iron-chelating medicines such as deferoxamine (Desferal), unless your doctor has told you to.

While you are taking Exjade, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Exjade may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Exjade is used to treat chronic iron overload.

Exjade comes as a tablet for oral suspension. This is a tablet that you dissolve fully in water, orange juice, or apple juice and drink right away. This drug is also available as an oral tablet.

Exjade is a brand name for the deferasirox tablet for oral suspension. It’s not available as a generic drug.

• FDA warning See Details

• Low blood cell counts See Details

• Vision and hearing problems See Details

What is Exjade?

This drug is a prescription drug. It comes in as a tablet for oral suspension and an oral tablet. The tablet for oral suspension is only available as the brand-name drug Exjade. It’s not available as a generic drug.

Why it's used

This drug is used to treat chronic iron overload in people with certain health conditions. It’s used to treat iron overload that’s caused by blood transfusions. It’s also used to treat chronic iron overload in people with non-transfusion dependent thalassemia. This is a blood disorder that isn’t related to a blood transfusion. It happens when you don’t have enough of a protein called hemoglobin, which carries oxygen in your blood.

How it works

This drug belongs to a class of drugs called chelating agents. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

This drug works by attaching to iron in your blood. It then removes the iron from your body. This decreases your iron levels.

Exjade can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how Exjade might interact with something else you’re taking, talk to your doctor or pharmacist.

Food interactions

This drug can cause more side effects from caffeine. Drinking or eating foods that contain caffeine during treatment can cause a faster heart rate, restlessness, and nervousness.

Medications that might interact with Exjade

Do not take these drugs with Exjade. Doing so can cause dangerous effects in your body. Examples of these drugs include:

• Antacids that contain aluminum
  • These drugs may make Exjade less effective.
• Theophylline and tiaznidine
  • Exjade can prevent these drugs from breaking down. This can increase your risk of side effects.
• Dasabuvir, ombitasvir, paritaprevir, and ritonavir
  • These drugs can decrease the levels of Exjade in your body. This can make it less effective.

Increased side effects from other drugs: Taking Exjade with certain medications raises your risk of side effects from these drugs. Examples of these drugs include:

• Alosetron, duloxetine, melatonin, ramelteon, and tacrine
• Repaglinide and paclitaxel
  • Exjade may prevent your body from breaking these drugs down well. Your doctor may decrease your dosage of either of these medications. 

When other drugs are less effective: When certain drugs are used with Exjade, they may not work as well. This is because the amount of these drugs in your body may be decreased. Your doctor may adjust your dosage of any of these drugs or give you a new medication. Examples of these drugs include:

• Pain drugs such as alfentanil and fentanyl
• Anti-nausea drugs such as aprepitant
• Asthma drugs such as budesonide and fluticasone
• Anxiety drugs such as buspirone
• Diuretics such as conivaptan, eplerenone, and tolvaptan
• Immunosuppressant drugs such as cyclosporine, sirolimus, and tacrolimus
• Overactive bladder drugs such as darifenacin
• HIV drugs such as darunavir, indinavir, lopinavir, maraviroc, saquinavir, and tipranivir
• Cancer drugs such as dasatinib and everolimus
• Migraine drugs such as dihydroergotamine, eletriptan, and ergotamine
• Heart problems drugs such as dronedarone and ticagrelor
• High blood pressure drugs such as felodipine and nisoldipine
• High cholesterol drugs such as lovastatin and simvastatin
• Hormonal forms of birth control
• Schizophrenia drugs such as lurasidone
• Sedatives such as midazolam and triazolam
• Antipsychotics such as pimozide and quetiapine
• Erectile dysfunction drugs such as sildenafil and vardenafil
• Quinidine, a drug used to treat heart rhythm problems and malaria

When Exjade is less effective: When you take Exjade with certain drugs, it may not work as well to treat your condition. This is because the amount of Exjade in your body may be decreased. Examples of these drugs include:

• Phenytoin and phenobarbital
  • If you have to take either of these medications with Exjade, your doctor may increase your dosage of Exjade.
• Cholestyramine, colesevalam, and colestipol
  • If you have to take any of these medications with Exjade, your doctor may increase your dosage of Exjade.

People with kidney problems

If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of this drug in your body and cause more side effects. You should not take this drug if you have severe kidney disease. If you have mild or moderate kidney disease, ask your doctor if this drug is safe for you. This medication may also decrease your kidney function. This can make your kidney disease worse.

People with liver problems

If you have liver disease, you may not be able to process this drug well. This may increase the levels of this drug in your body and cause more side effects. If you have mild to moderate liver disease, ask your doctor if this drug is safe for you. If you have severe liver disease, you should not take this drug.

People with low platelet counts

This drug can cause low levels of white blood cells, red blood cells, and platelets in your body. If you already have low platelets, this drug may make them worse. You shouldn’t use this drug if you have very low platelet counts.

Pregnant women

This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the pregnancy when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the pregnancy.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the pregnancy.

Women who are breast-feeding

It isn’t known if this drug passes into breast milk. If it does, it may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors

The kidneys, liver, and heart of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. Older adults may also have other conditions that can affect the way this drug works. Both of these raise your risk of side effects.

Your doctor will watch you for signs of side effects. They may also start you on a lowered dosage or a different treatment schedule.

For children

This drug has not been studied in children younger than 2 years with chronic iron overload due to blood transfusions. It should not be used in people younger than 2 years for this condition.

This drug has not been studied in children younger than 10 years with chronic iron overload due to non-transfusion dependent thalassemia. It should not be used in people younger than 10 years for this condition.

When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

Allergies

This drug can cause a severe allergic reaction. Symptoms include:

• swelling of your throat
• trouble breathing

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

The dosage information below is for the conditions that Exjade is most often prescribed to treat. This list may not contain all conditions that your doctor can prescribe this drug for. If you have questions about your prescription, talk with your doctor.

What are you taking this medication for?

Brand: Exjade

• Typical starting dosage: 20 mg/kg of body weight once per day. Your doctor will round your dosage to the nearest whole tablet.
• Dosage changes: Your doctor will adjust your dosage every 3–6 months if needed. They’ll increase it or decrease it by 5 mg/kg or 10 mg/kg depending on how you respond to the drug. Your doctor may temporarily stop your treatment with Exjade or change your dosage if you have certain side effects.
• Maximum dosage: 40 mg/kg per day

It has not been confirmed that Exjade is safe and effective for use in people younger than 2 years for this condition.

• Typical starting dosage: 20 mg/kg of body weight once per day. The doctor will round your child’s dosage to the nearest whole tablet.
• Dosage increases: The doctor will adjust your child’s dosage every 3–6 months if needed. They’ll increase it or decrease it by 5mg/kg or 10 mg/kg depending on how your child responds to the drug. Your child’s doctor may temporarily stop treatment with Exjade or change your child’s dosage if they have certain side effects.
• Maximum dosage: 40 mg/kg per day

The kidneys, liver, and heart of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different treatment schedule. This can help keep levels of Exjade from building up too much in your body.

People with kidney disease: If you have mild to moderate kidney disease, your doctor may give you half of the typical starting dosage. If you have severe kidney disease, you should not take Exjade.

People with liver disease: If you have moderate liver disease, your doctor may give you half of the typical starting dosage. If you have severe liver disease, you should not take Exjade.

People who are taking UGT inducers: Your doctor may give you half of the typical starting dosage.

People who are taking bile acid sequestrants: Your doctor may give you half of the typical starting dosage.

People who are taking deferasirox oral tablets (Jadenu): If you’re taking the other form of this drug, ask your doctor about your dosage. The dosage between the two forms is not the same.

Brand: Exjade

• Typical starting dosage: 10 mg/kg of body weight once per day. Your doctor will round your dosage to the nearest whole tablet.
• Dosage changes: Your doctor may adjust your dosage to 20 mg/kg after 1 week. This depends on how you respond to the drug.
• Maximum dosage: 20 mg/kg per day

It has not been confirmed that Exjade is safe and effective for use in people younger than 10 years of age for this condition.

• Typical starting dosage: 10 mg/ kg body weight once per day. Your doctor will round your child’s dosage to the nearest whole tablet.
• Dosage increases: Your doctor may adjust your child’s dosage to 20 mg/kg after 1 week. This depends on how your child responds to the drug.
• Maximum dosage: 20 mg/kg per day

The kidneys, liver, and heart of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different treatment schedule. This can help keep levels of Exjade from building up too much in your body.

People with kidney disease: If you have mild to moderate kidney disease, your doctor may give you half of the typical starting dosage. If you have severe kidney disease, you should not take Exjade.

People with liver disease: If you have moderate liver disease, your doctor may give you half of the typical starting dosage. If you have severe liver disease, you should not take Exjade.

People who are taking UGT inducers: Your doctor may give you half of the typical starting dosage.

People who are taking bile acid sequestrants: Your doctor may give you half of the typical starting dosage.

People who are taking deferasirox oral tablets (Jadenu): If you’re taking the other form of this drug, ask your doctor about your dosage. The dosage between the two forms is not the same.

Do not take this drug with food

Take this drug at the same time every day

Do not chew the tablets or swallow them whole

Store this drug carefully

A prescription for this medication is refillable

Travel

Self-management

Clinical monitoring

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Insurance

Are there any alternatives?