ed cancer
Low blood counts (low platelets)
An allergy to JADENU or any ingredient of JADENU
Additional Important Safety Information
Kidneys
If you have a preexisting kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will do blood tests (serum creatinine and/or creatinine clearance, estimated glomerular filtration rate (eGFR), and serum electrolytes) every week for the first month you are taking JADENU or if your dose has changed, and then every month after that. Your doctor may adjust your dose based on the results of these tests
Your doctor will also collect urine samples monthly
Some patients developed severe kidney problems while taking deferasirox, in some cases fatal, and in some cases requiring dialysis. Most of the fatalities occurred in patients who were very ill because of their disease
In younger patients, stop taking JADENU during serious illnesses that can cause dehydration such as vomiting, diarrhea, or prolonged decreased oral intake.
Liver
If you have a preexisting severe liver problem, you should not use JADENU
If you have mild or moderate liver problems, your doctor will do blood tests (serum transaminases and bilirubin) before starting treatment, every 2 weeks during the first month of treatment, and then monthly. Your doctor may adjust your dose based on the results of these tests
Some patients developed severe liver problems, in some cases fatal, while taking deferasirox. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver
Bleeding in the Stomach or Intestines
Some patients developed stomach irritation or bleeds while taking deferasirox. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had preexisting blood cancers and/or low blood counts (low platelets)
Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/anti-inflammatory drugs, corticosteroids, oral bisphosphonates, or blood thinners)
Blood Disorders
Some patients developed severe blood disorders, in some cases fatal, while on deferasirox therapy.
Having a preexisting blood disorder may increase the risk
Your doctor will do a blood test to check your blood counts
Increased Risks With Different Ages
Elderly Patients: Since deferasirox has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when deferasirox was taken by elderly patients
Pediatric Patients: Serious and fatal events have occurred in pediatric patients. These were associated with dehydration or when dosing is continued as the iron burden is in the range of normal
Allergic Reactions
Serious allergic reactions (which include swelling of the throat) have been reported in patients taking deferasirox, usually within the first month of treatment
If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking JADENU and contact your doctor immediately
Severe Skin Reactions
Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme have been reported during treatment with deferasirox. Other skin reactions including DRESS (drug reaction with eosino |
