"An expert panel has recommended expanded adoption of the drug hydroxyurea for the care of people with sickle cell disease, according to a report issued today. The report also suggests that clinicians give periodic blood transfusions to children w"...
Exjade Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Exjade (deferasirox) is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old. It is an iron-chelating agent, which binds to iron and removes it from the blood stream. Common side effects include nausea, vomiting, diarrhea, dizziness, headache, fever, and stomach/abdominal pain.
The recommended initial daily dose of Exjade is 20 mg/kg body weight, taken once daily on an empty stomach at least 30 minutes before food, at the same time each day. Exjade may interact with antacids that contain aluminum, other iron chelating medicines, alendronate, etidronate, ibandronate, pamidronate, risedronate, tiludronate, zoledronic acid, antibiotics, birth control pills, blood thinners, cholesterol-lowering drugs, heart or blood pressure medications, heart rhythm medications, HIV medicines, medicines used to prevent organ transplant rejection, NSAIDs (non-steroidal anti-inflammatory drugs, sedatives, or steroids. Many other drugs may interact with Exjade. Tell your doctor all prescription and over-the-counter medications and supplements you use. Exjade should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Exjade (deferasirox) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Exjade in Detail - Patient Information: Side Effects
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 a serious side effect such as:
- kidney problems - drowsiness, confusion, mood changes, swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;
- liver problems - nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- increased thirst and urination, loss of appetite, weakness, constipation;
- problems with vision or hearing;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
- severe blistering, peeling, and red skin rash.
Less serious side effects may include:
- mild nausea, stomach pain, diarrhea, vomiting;
- dizziness, anxiety, tired feeling;
- sleep problems (insomnia);
- mild rash, discolored skin; or
- headache, cough, sinus pain, runny or stuffy nose.
Read the entire detailed patient monograph for Exjade (Deferasirox) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Exjade Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: trouble sleeping, hearing loss, unusual feelings of restlessness/high energy (hyperactivity), vision changes.
This drug may rarely cause serious (even fatal) liver disease. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing of eyes/skin.
This drug may rarely cause serious (even fatal) stomach/intestinal bleeding and ulcers. Tell your doctor immediately if you have any of the following rare but serious symptoms: severe stomach/abdominal pain, black/tarry/bloody stools, vomit that looks like coffee grounds.
This drug may rarely cause serious (even fatal) kidney or blood problems. Tell your doctor immediately if you notice any of the following symptoms: change in amount of urine, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), unusual tiredness.
Deferasirox can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Exjade (Deferasirox)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Exjade FDA Prescribing Information: Side Effects
Clinical Trials Experience
The following adverse reactions are also discussed in other sections of the labeling:
- Renal Toxicity, Renal Failure, and Proteinuria [see WARNINGS AND PRECAUTIONS]
- Hepatic Toxicity and Failure [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal (GI) Hemorrhage [see WARNINGS AND PRECAUTIONS]
- Bone Marrow Suppression [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity [see WARNINGS AND PRECAUTIONS]
- Severe Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Skin Rash [see WARNINGS AND PRECAUTIONS]
- Auditory and Ocular Abnormalities [see WARNINGS AND PRECAUTIONS]
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 < 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 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 > 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.
Table 1: Adverse Reactions* Occurring in > 5% of
Exjade-treated Patients in Study 1, Study 3, and MDS Pool
|Study 1 (Beta-thalassemia)||Study 3 (Sickle Cell Disease)||MDS Pool|
|Preferred Term||n (%)||n (%)||n (%)||n (%)||n (%)|
|Abdominal Pain**||63 (21)||41 (14)||37 (28)||9 (14)||145 (23)|
|Diarrhea||35 (12)||21 (7)||26 (20)||3 (5)||297 (47)|
|Increased***||33 (11)||0 (0)||9 (7)||0||89 (14)|
|Nausea||31 (11)||14 (5)||30 (23)||7 (11)||161 (26)|
|Vomiting||30 (10)||28 (10)||28 (21)||10 (16)||83 (13)|
|Rash||25 (8)||9 (3)||14 (11)||3 (5)||83 (13)|
|*Adverse reaction frequencies
are based on adverse events reported regardless of relationship to study drug.
**Includes 'abdominal pain', 'abdominal pain lower', and 'abdominal pain upper' which were reported as adverse events.
***Includes 'blood creatinine increased' and 'blood creatinine abnormal' which were reported as adverse events. Also see Table 2.
In Study 1, a total of 113 (38%) patients treated with Exjade had increases in serum creatinine > 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]. In this study, 17 (6%) patients treated with Exjade developed elevations in SGPT/ALT levels > 5 times the upper limit of normal at 2 consecutive visits. Of these, 2 patients had liver biopsy proven drug-induced hepatitis and both discontinued Exjade therapy [see WARNINGS AND PRECAUTIONS]. An additional 2 patients, who did not have elevations in SGPT/ALT > 5 times the upper limit of normal, 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 > 33% above baseline on 2 separate occasions (Table 2) [see WARNINGS AND PRECAUTIONS]. 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 > 5 times the upper limit of normal 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 > 33% above baseline on 2 consecutive occasions (Table 2) and 8 (3.5%) patients permanently discontinued [see WARNINGS AND PRECAUTIONS]. A total of 5 (0.8%) patients developed SGPT/ALT levels > 5 times the upper limit of normal 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].
Table 2: Number (%) of
Patients with Increases in Serum Creatinine or SGPT/ALT in Study 1, Study 3,
and MDS Pool
|Laboratory Parameter||Study 1 (Beta-thalassemia)||Study 3 (Sickle Cell Disease)||MDS Pool|
|Creatinine increase > 33% at 2 consecutive postbaseline visits||113 (38)||41 (14)||48 (36)||14 (22)||229 (37)|
|Creatinine increase > 33% and > ULN at 2 consecutive postbaseline visits||7 (2)||1 (0)||3 (2)||2 (3)||126 (20)|
|SGPT/ALT > 5 x ULN at 2 postbaseline visits||25 (8)||7 (2)||2 (2)||0||9 (1)|
|SGPT/ALT > 5 x ULN at 2 consecutive postbaseline visits||17 (6)||5 (2)||5 (4)||0||5 (1)|
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]. Table 3 displays adverse reactions occurring in > 5% in any group. The most frequent adverse reactions with a suspected relationship to study drug were nausea, rash, and diarrhea.
Table 3: Adverse Reactions
Occurring in > 5% in NTDT Patients
|Study 4||Study 5|
|Any adverse reaction||31 (28)||9 (16)||27 (21)|
|Nausea||7 (6)||4 (7)||2 (2)|
|Rash||7 (6)||1 (2)||2 (2)|
|Diarrhea||5 (5)||1 (2)||7 (5)|
In Study 4, 1 patient in the placebo 10 mg/kg/day group experienced an ALT increase to > 5 times ULN and > 2 times baseline (Table 4). Three Exjade-treated patients (all in the 10 mg/kg/day group) had 2 consecutive serum creatinine level increases > 33% from baseline and > 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.
Table 4: Number (%) of NTDT
Patients with Increases in Serum Creatinine or SGPT/ALT
|Study 4||Study 5|
|Laboratory Parameter||n (%)||n (%)||n (%)|
|Serum creatinine ( > 33% increase from baseline and > ULN at ≥ 2 consecutive postbaseline values)||3 (3%)||0||2 (2%)|
|SGPT/ALT ( > 5 x ULN and > 2 x baseline)||1 (1%)||1 (2%)||2 (2%)|
In clinical studies, urine protein was measured monthly. Intermittent proteinuria (urine protein/creatinine ratio > 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].
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, pharyngolaryngeal pain, early cataract, hearing loss, gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, and renal tubulopathy (Fanconi's Syndrome). 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.
The following adverse reactions have been spontaneously reported during post-approval 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.
Hepatobiliary disorders: hepatic failure
Gastrointestinal disorders: gastrointestinal hemorrhage
Blood and lymphatic system disorders: worsening anemia
Read the entire FDA prescribing information for Exjade (Deferasirox) »
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