ISI

Glossary

 
A

Anemia
A blood disorder where you don't have enough healthy red blood cells.

B

β-thalassemia
A blood disorder that you may be born with where your red blood cells are missing some important proteins. Without the proteins, your red blood cells can't carry enough oxygen to the rest of your body.

Biopsy
A tissue sample from an organ or part of the body that your doctor may take to help with diagnosis.

Blood transfusion
Blood from a donor that is given to a person for treatment of an injury or other condition such as an anemia.

Blood test
A test using a blood sample that doctors use to find out whether someone may have a disease.

C

Cell
The smallest living unit in the human body.

Chelation
Chelation is a process that removes excess metal from the body. Iron chelation gets rid of the extra iron that has built up in your body due to blood transfusions.

Chelator
A drug that removes excess metal from the body. Iron chelators, like EXJADE, get rid of the extra iron that has built up over time due to blood transfusions.

Chronic
Ongoing for a long time.

Chronic iron overload
A condition of having too much iron in your body that can arise after having 10 or more blood transfusions in your lifetime.

Complication
Development of a disease or condition while having another disease or condition.

Condition
A disease.

D

Deferoxamine (DFO)
An iron chelator that may help your body get rid of extra iron you have due to blood transfusions. If you are prescribed DFO you may use an infusion pump to get your iron chelation medicine.

Diagnosis
Finding out whether a person has a disease, which includes separating one disease from another.

Disease
Any change from or interruption in the normal way a part, organ, or system of the body works. A patient's signs and symptoms often help medical professionals know what disease they have.

Disorder
Abnormal function of a part, organ, or system of the body.

E

Excess iron
More than what is considered a healthy amount of iron stored in the body; may be caused by receiving blood transfusions.

F

Ferritin
A compound that stores iron in the body, including the liver or spleen.

I

Infusion pump
A device that can be used to administer medication. The pump is connected to your body, and the medicine flows from the machine into your blood.

Iron
A metallic element that is an important component in how the body works.

Iron levels
The amount of iron present in the blood.

Iron overload
The build-up of excess iron in the body. Iron overload can be a genetic condition or can occur as a result of blood transfusions to treat blood-related disorders, including anemia and chronic hepatitis. Although it is uncommon, some people can have iron overload from eating foods that are rich in iron.

L

Liver biopsy
Removal of a tiny portion of the liver to help a physician diagnose a patient's health problem.

M

Medication
A drug or medicine.

Micrograms
A very small unit of measurement.

Myelodysplastic syndrome (MDS)
A disorder that involves abnormal cell production in the bone marrow. People with myelodysplastic syndrome often have anemia.

O

Oral medicine
A drug that you take by mouth by eating, drinking, or swallowing the medicine.

Oxygen
A gas that plants and animals breathe and is needed to live.

P

Procedure
A series of steps for doing something. Medical procedures find out, measure, or diagnose a patient's condition and treat, cure, or restore function or structure through surgery and rehabilitation.

R

Red blood cells
Cells that carry oxygen and nutrients to different parts of the body.

Results
The outcome of a laboratory test or treatment.

Risk
The probability of an unwanted result.

S

Screening
Testing a group of individuals to separate those who are well from those who are sick or at risk.

Serum ferritin
A compound that stores iron in the body. Serum ferritin can be found in the blood throughout your body.

Serum ferritin test
A blood test to measure how much iron is in your blood.

Sickle cell disease (SCD)
A blood disorder that you can be born with where your red blood cells form differently.

Symptoms
Physical or behavioral signs of a disease or condition.

T

Transfusion history
A record of all the blood transfusions a person has received.

Treatment
Care that is given to cure or manage a disease.

 

EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years and older. In these patients, EXJADE has been shown to reduce liver iron concentration and serum ferritin levels. Clinical trials to demonstrate increased survival or to confirm clinical benefit have not been completed.
Talk to your doctor to determine if EXJADE therapy is right for you. The expected benefit and risks of the therapy, as well as factors such as life expectancy and other illnesses should be considered.
The safety and efficacy of EXJADE when taken with other iron chelation therapy have not been proven.
Further studies are being performed to determine the long-term benefits and risks of EXJADE.
EXJADE is available by prescription only.

Important Safety Information

What is the most important safety information to know about EXJADE?

EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems and bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years. All of these were more common in patients with high-risk myelodysplastic syndromes, pre-existing kidney problems, or low, blood counts (low platelets).

Your doctor should check your kidneys with a blood test called serum creatinine and/or creatinine clearance:
  • Before taking EXJADE
  • Monthly during treatment
If you already have a history of kidney problems or are at risk for kidney problems your doctor should check your kidneys:
  • Every week for the first month
  • Monthly during treatment
Your doctor should check your liver with blood tests called serum transaminases and bilirubin:
  • Before taking EXJADE
  • Every other week for the first month after starting EXJADE
  • Monthly during treatment
Certain people should not take EXJADE, including:
  • People with certain kinds of kidney problems
  • People with high-risk myelodysplastic syndromes or cancers
  • People with low blood counts (low platelets)
  • People who are allergic to EXJADE or any ingredient of EXJADE

Kidneys: If you are at increased risk of complications because you have a pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, your doctor will give you a blood test every week for the first month you are taking EXJADE or if your dose has changed, and then every month after that. Your doctor may also collect urine samples monthly.

Some patients developed severe kidney problems while on EXJADE, 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. There may be increased risk of complications for patients who already have a kidney condition, are elderly, have multiple medical conditions, or take medicine that affects kidney function.

Liver: People with pre-existing severe liver problems should not use EXJADE. A lower starting dose of 10 mg/kg/day is recommended for people with moderate liver problems. Anyone using EXJADE who has mild or moderate liver problems should be closely monitored. They may need their dose adjusted based on efficacy or safety.

Some patients developed severe liver problems, in some cases fatal, while on EXJADE. Many of these patients were greater than 55 years of age and/or had multiple medical conditions already affecting their liver. Your doctor will give you blood tests called serum transaminases and bilirubin before starting treatment, every 2 weeks during the first month of treatment, and then monthly.

Stomach: Some patients developed stomach irritation or bleeds while on EXJADE. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had pre-existing blood cancers and/or low blood counts (low platelets). Talk to your doctor if you are taking other drugs which can also irritate your stomach or cause a stomach bleed (e.g., NSAIDs, corticosteroids, oral bisphosphonates, blood thinners).

Blood Disorders: Some patients developed blood disorders, in some cases fatal, while on EXJADE therapy, but it is not known whether this was a result of EXJADE therapy or other causes, as most of these patients already had diseases affecting their blood.

Allergic Reactions: Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment. If reactions are severe, stop taking EXJADE and contact your doctor immediately.

Serious Reactions: Should you develop swelling of the throat, a severe rash, or any hearing problems or vision disturbances, please contact your doctor immediately.

Rash: A skin disorder that results in a very serious rash, called erythema multiforme, has been reported during treatment with EXJADE.

Comorbidities: Since EXJADE has been on the market, there have been reports of some serious reactions, sometimes leading to death. These serious reactions happened most often when EXJADE was taken by elderly patients, those with multiple medical conditions, or those with advanced diseases. Most of these deaths happened within 6 months of starting EXJADE, and the original disease usually got worse. The reports do not rule out the possibility that EXJADE may have contributed to the deaths.

How to Take EXJADE: EXJADE should be taken once daily on an empty stomach, at least 30 minutes prior to food, preferably at the same time every day.

EXJADE should not be chewed or swallowed whole, and should not be taken at the same time as aluminum-containing antacids (for example, Maalox®).

Other Medicines and EXJADE: If you are taking other medicines, such as birth control pills, diabetes drugs, seizure drugs, cholesterol-lowering drugs, or medicine for serious illnesses, talk to your doctor. EXJADE may affect how these drugs work.

Hearing and Vision Tests: You may also receive a hearing or vision test prior to receiving EXJADE and yearly thereafter. Your dose of EXJADE may be changed if needed based on the results of these tests.

Common Side Effects: The most commonly reported side effects related to EXJADE in clinical trials were mainly nausea, vomiting, diarrhea, stomach pain, increases in kidney lab values, and skin rash. These side effects were mild to moderate in severity. If you experience diarrhea or vomiting you should ensure that you continue to drink fluids.