Deferasirox Side Effects

Some side effects of deferasirox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to deferasirox: oral tablet dispersible

Get emergency medical help if you have any of these signs of an allergic reaction while taking deferasirox: 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 of deferasirox 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.

For Healthcare Professionals

Applies to deferasirox: oral tablet dispersible

General

General side effects including pyrexia (18.9%), headache (15.9%), abdominal pain (13.9%), influenza (10.8%), upper abdominal pain (7.8%), and fatigue (6.1%) have been reported.

Respiratory

Respiratory side effects including cough (13.9%), nasopharyngitis (13.2%), pharyngolaryngeal pain (10.5%), respiratory tract infection (9.5%), bronchitis (9.1%), pharyngitis (7.8%), and rhinitis (6.1%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (11.8%), nausea (10.5%), vomiting (10.1%), and upper gastrointestinal ulceration and hemorrhage have been reported.

Renal

Nonprogressive increases in serum creatinine have been noted in 38% of deferasirox-treated patients and appear to be dose related. These increases were within the normal range in 94% of patients. Deferasirox dosages had been adjusted once serum creatinine elevations were detected during the study. Dose reduction, interruption, or discontinuation should be considered for elevations in serum creatinine. If there is a progressive increase in serum creatinine beyond the age-appropriate upper limit of normal, deferasirox should be interrupted. Once the creatinine has returned to within the normal range, therapy with deferasirox may be reinitiated at a lower dose followed by gradual dose escalation, if the clinical benefit is expected to outweigh potential risks.

Intermittent proteinuria (urine protein/creatinine ratio greater than 0.6 mg/mg) has been reported in 18.6% of deferasirox treated patients. Monthly monitoring is recommended.

Renal side effects including increased creatinine, intermittent proteinuria, and renal tubulopathy have been reported. There have also been postmarketing reports of acute renal failure and tubulointerstitial nephritis.

Dermatologic

Dermatologic side effects including rash (8.4%), urticaria (3.7%), and postmarketing reports of leukocytoclastic vasculitis, urticaria, and alopecia have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (7.4%) and back pain (5.7%) have been reported.

Immunologic

Immunologic side effects including acute tonsillitis (6.4%) have been reported.

Other

Other side effects including ear infection (5.4%), high-frequency hearing loss, and decreased hearing have been reported.

Hepatic

Hepatic side effects have included two patients with drug-induced hepatitis and two patients with increased serum transaminases who discontinued use of deferasirox because of these hepatic abnormalities. There have been postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with deferasirox. Most of these events occurred in patients greater than 55 years of age. Seventeen of the patients in the clinical trials developed elevations in SGPT/ALT levels greater than five times the upper limit of normal at two consecutive visits.

Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multiorgan failure.

Increases in transaminases were not dose related.

Hematologic

Although most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure, a contributory role for deferasirox could not be excluded.

Hematologic side effects have included cytopenias such as agranulocytosis, neutropenia, thrombocytopenia and postmarketing reports of worsening anemia.

Hypersensitivity

If reactions are severe, deferasirox should be discontinued and appropriate medical intervention instituted.

Hypersensitivity side effects including postmarketing reports of anaphylaxis and angioedema have been reported.

Ocular

Ocular side effects including lens opacities, cataracts, elevations in intraocular pressure, and retinal disorders have been reported with deferasirox therapy in less than 1% of patients in clinical trials.

Ophthalmic testing (including slit lamp examinations and dilated fundoscopy) are recommended before the start of deferasirox treatment and thereafter every 12 months.

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