Important Safety Information

EXJADE is available by prescription only.

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.

These problems occurred more often in elderly patients, patients with high-risk myelodysplastic syndromes, pre-existing kidney or liver problems, or low blood counts.

EXJADE may also cause serious liver problems. In some cases, these problems were fatal. These problems occurred more often in patients greater than 55 years of age.

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 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

Please see additional Important Safety Information, including Boxed WARNING.

Please see accompanying Full Prescribing Information.

getting exjade
Print

EPASS™ Complete Care

EPASS™ Complete Care Helps You Reach Your Treatment Goals with EXJADE

EPASS™ Complete Care is the special distribution system for EXJADE. As a patient enrolled in EPASS™ Complete Care, you can expect the support you need to succeed on EXJADE. And this valuable program helps you get the medicine you need for your chronic iron overload due to blood transfusions, as recommended by your doctor. It helps to make sure you stay on track with your EXJADE treatment plan. Here are some of the ways EPASS™ can help you:

  • Reimbursement Assistance and Counseling to guide you through the reimbursement process
    • Assists you with prior authorization appeals
    • Provides access to co-pay assistance through the HealthWell Foundation
    • Gives you access to Novartis Patient Assistance Programs

  • EXJADE ScriptAssist to help make treatment more accessible and more affordable
    • Provides savings of up to $100 toward each co-pay or out-of-pocket expense.*
    • In addition to co-pay assistance provided to eligible patients by the HealthWell Foundation or the Chronic Disease Fund

  • Personal prescription delivery ensures you get your EXJADE prescription delivered to your home on time, or at the location of your choice (for example, your doctor's office)
    • Distributes EXJADE prescriptions through a specialty pharmacy partner
    • Calls to confirm you have received your initial prescription for EXJADE and answers any questions you may have
    • Reminds you to refill your prescription for EXJADE

  • A dedicated Nurse Case Manager from one of the specialty pharmacies helps you stay on track with your treatment with EXJADE
    • Calls you regularly to discuss how you are doing on EXJADE
    • Counsels you on the importance of taking your EXJADE
    • Gives you ongoing educational support to encourage you to stay on your treatment with EXJADE
    • Answers any questions about EXJADE or about your anemia

Getting Your EXJADE Prescription Through EPASS™ Complete Care

With EPASS™ Complete Care, it takes approximately two to three weeks from initial enrollment to delivery of your prescription (fulfillment can take longer if there are reimbursement issues). To get EXJADE, follow these four steps:

Step 1: Enroll in EPASS™
If you are prescribed EXJADE, work with your doctor's office to completely fill out the EPASS™ Complete Care application form.

EPASS Complete Care Application Form
> Download EPASS™ Complete Care
  Application Form
Adobe Reader
You will need Adobe® Reader®.

Step 2: Talk With Your Specialty Pharmacy
You will receive a phone call from one of the three EPASS™ pharmacies (Accredo Health Group, BioScrip, or U.S. Bioservices). It is important that you promptly return any phone calls from the pharmacy, as your confirmation is needed to fill the prescription. The pharmacy will:

  • Review your prescription drug coverage
  • Collect or arrange for copayment
  • Discuss your medication with you
  • Confirm the delivery address and schedule the delivery date of your medication

Step 3: Get Your Prescription
Your prescription will be shipped to your home or location of choice via overnight delivery.

Step 4: Refill Your Prescription
You will be contacted by your EPASS™ pharmacy before your prescription runs out to coordinate and schedule your next prescription.


Getting In Touch With Us Is Easy

If you have any questions about how to get EXJADE or about your specific EPASS™ application, please call the EPASS™ hotline at 1-888-90-EPASS (1-888-903-7277).

Once you have been assigned a specialty pharmacy, you can also contact that pharmacy directly with any questions about getting your EXJADE.


Ask Questions - Increase Your EXJADE IQ

The more you know about your treatment with EXJADE, the better. Your doctor and your EPASS™ Nurse Case Manager have many of the answers. Here's a list of questions you may want to ask your Nurse Case Manager:

  • How will treatment with EXJADE help me?
  • How will I know if EXJADE is working?
  • How long should I continue taking EXJADE?
  • Does my insurance plan cover EXJADE?
  • If my insurance plan does not cover EXJADE, how can I obtain financial assistance for my treatment?
  • If I have a question or need assistance, how do I contact you?

A Nurse Case Manager will reach out to you when you begin taking EXJADE, as well as thereafter for continued support. If you have any questions, you also may contact your EPASS™ Nurse Case Manager by calling your specialty pharmacy during normal business hours. If you call outside of these hours, please leave a message with your name, telephone number, and reason for your call and your Nurse Case Manager will return your call.


Specialty Pharmacies That Carry EXJADE:

Accredo Health Group: 1-866-352-4042
U.S. Bioservices: 1-877-263-7089
BioScrip: 1-866-807-0516

Use the Risk Assessment
Tool to find out if you are
at risk.
Click here
 


 

EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Further studies are being performed to determine the long-term benefits and risks of EXJADE.

The safety and efficacy of EXJADE when taken with other iron chelation medication has not been proven.

EXJADE is available by prescription only.

Important Safety Information About EXJADE

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.

These problems occurred more often in elderly patients, patients with high-risk myelodysplastic syndromes, pre-existing kidney or liver problems, or low blood counts.

EXJADE may also cause serious liver problems. In some cases, these problems were fatal. These problems occurred more often in patients greater than 55 years of age.

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 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
  • 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: 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. 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.

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

Full Prescribing Information

The prescribing information includes detailed information on how EXJADE works, clinical studies, risks/side effects, drug interactions, and dosing for patients.

Read the full prescribing information for EXJADE® (deferasirox) Tablets for Oral Suspension.