EXJADE Has an Established Safety Profile in Children and Adults1
| Blood and lymphatic system disorders |
| Not known: |
Pancytopenia*, thrombocytopenia* |
| Immune system disorders |
| Not known: |
Hypersensitivity reactions (including anaphylaxis and angioedema)* |
| Psychiatric disorders |
| Uncommon: |
Anxiety, sleep disorder |
| Nervous system disorders |
| Common: |
Headache |
| Uncommon: |
Dizziness |
| Eye disorders |
| Uncommon: |
Early cataract, maculopathy |
| Ear and labyrinth disorders |
| Uncommon: |
Hearing loss |
| Respiratory, thoracic and mediastinal disorders |
| Uncommon: |
Pharyngolaryngeal pain |
| Gastrointestinal disorders |
| Common: |
Diarrhea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia |
| Uncommon: |
Gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis |
| Rare: |
Esophagitis |
| Hepatobiliary disorders |
| Common: |
Transaminases increased |
| Uncommon: |
Hepatitis, cholelithiasis |
| Not known: |
Hepatic failure* |
| Skin and subcutaneous tissue disorders |
| Common: |
Rash, pruritus |
| Uncommon: |
Pigmentation disorder |
| Not known: |
Leukocytoclastic vasculitis*, urticaria*, erythema multiforme*, alopecia* |
| Renal and urinary disorders |
| Very common: |
Blood creatinine increased |
| Common: |
Proteinuria |
| Uncommon: |
Renal tubulopathy (acquired Fanconi’s syndrome), glycosuria |
| Not known: |
Acute renal failure* |
| General disorders and administration site conditions |
| Uncommon: |
Pyrexia, edema, fatigue |
| * |
Adverse reactions reported during postmarketing experience. These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product. |
|
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Gallstones and related biliary disorders were reported in about 2% of patients. Elevations of liver transaminases were reported as an adverse reaction in 2% of patients. Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%). During postmarketing experience, hepatic failure, sometimes fatal, has been reported with EXJADE, especially in patients with pre-existing liver cirrhosis. As with other iron chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been uncommonly observed in patients treated with EXJADE.
Pediatric population
- Diarrhea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients.
- Renal tubulopathy has been mainly reported in children and adolescents with β-thalassemia treated with EXJADE.
Managing the most common adverse events
Gastrointestinal event management from published
key thought-leaders2,3 |
|---|
| ADVERSE EVENT | Management Strategy |
| Abdominal pain |
- Patient should sip water and avoid solid food for several hours
- Patient should avoid narcotic pain and nonsteroidal anti-inflammatory medications
- Consider altering time of day of EXJADE administration
|
| Mild-moderate diarrhea, nausea/vomiting |
- Ensure patient is adequately hydrated and avoid dairy products
- Avoid solid foods until vomiting has stopped for at least 6 hours
- If necessary, consider reducing dose to 10 mg/kg/day and titrate in weekly 5-mg/kg/day increments after resolution to return to previous dose
- Transient, generally resolve without treatment discontinuation
|
Adverse event management from the
Summary of Product Characteristics1 |
|---|
| ADVERSE EVENT | Management Strategy |
| Skin rash |
- The rashes resolve spontaneously in most cases
- When interruption of treatment may be necessary, treatment may be reintroduced after resolution of the rash, at a lower dose followed by gradual dose escalation
- In severe cases this reintroduction could be conducted in combination with a short period of oral steroid administration
|
| Serum creatinine increases |
- For adult patients, the daily dose may be reduced by 10 mg/kg if a rise in serum creatinine by >33% above the average of the pre-treatment measurements and estimated creatinine clearance decreases below the lower limit of the normal range (<90 mL/min) are seen at two consecutive visits, and cannot be attributed to other causes
- For pediatric patients, the dose may be reduced by 10 mg/kg if estimated creatinine clearance decreases below the lower limit of the normal range (<90 mL/min) and/or serum creatinine levels rise above the age-appropriate upper limit of normal at two consecutive visits.
|
U.S. Residents
