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Exjade

Last reviewed on RxList: 5/1/2017
Exjade Side Effects Center

Last reviewed on RxList 02/22/2017

Exjade (deferasirox) is an iron-chelating agent, which binds to iron and removes it from the blood stream, used to treat iron overload caused by blood transfusions in adults and children at least 2 years old. Common side effects of Exjade include:

  • nausea,
  • vomiting,
  • stomach/abdominal pain,
  • diarrhea,
  • dizziness,
  • anxiety,
  • tired feeling,
  • sleep problems (insomnia),
  • rash,
  • discolored skin,
  • headache,
  • fever,
  • cough,
  • sinus pain, or
  • runny or stuffy nose.

Tell your doctor if you have serious side effects of Exjade including:

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 (nonsteroidal 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 breastfeeding.

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.

Exjade Consumer Information

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.

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.

Read the entire detailed patient monograph for Exjade (Deferasirox)

Exjade Professional Information

SIDE EFFECTS

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

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.

Table 1. Adverse Reactions * Occurring in Greater Than 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 Exjade
N=296
n (%)
Deferoxamine
N=290
n (%)
Exjade
N=132
n (%)
Deferoxamine
N=63
n (%)
Exjade
N=627
n (%)
Abdominal Pain** 63 (21) 41 (14) 37 (28) 9 (14) 145 (23)
Diarrhea 35 (12) 21 (7) 26 (20) 3 (5) 297 (47)
Creatinine
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 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]. 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]. 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]. 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]. 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].

Table 2. Number (%) of Patients with Increases in Serum Creatinine or SGPT/ALT in Study 1, Study 3, and MDS Pool

  Study 1 (Beta-thalassemia) Study 3 (Sickle Cell Disease) MDS Pool
Laboratory Parameter Exjade
N=296
n (%)
Deferoxamine
N=290
n (%)
Exjade
N=132
n (%)
Deferoxamine
N=63
n (%)
Exjade
N=627
n (%)
Serum Creatinine
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
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 greater than 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 Greater Than 5% in NTDT Patients

  Study 4 Study 5
Exjade
N=110
n (%)
Placebo
N=56
n (%)
Exjade
N=130
n (%)
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 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.

Table 4. Number (%) of NTDT Patients with Increases in Serum Creatinine or SGPT/ALT

  Study 4 Study 5
Exjade
N=110
n (%)
Placebo
N=56
n (%)
Exjade
N=130
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)

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].

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

Read the entire FDA prescribing information for Exjade (Deferasirox)

Related Resources for Exjade

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© Exjade Patient Information is supplied by Cerner Multum, Inc. and Exjade Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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