MEDICATION GUIDE

DEFERASIROX

 (de FER a sir ox)

tablets

for oral suspension

What is the most important information I should know about deferasirox?

Deferasirox can cause serious side effects, including:

Kidney problems. Deferasirox can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with deferasirox may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with deferasirox. Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with deferasirox. Call your or your child’s healthcare provider right away if:

• your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with deferasirox. Your child may be dehydrated. Your child’s healthcare provider may need to temporarily stop treatment with deferasirox and treat your child for dehydration to help prevent kidney problems. Your child’s healthcare provider may monitor your child’s kidney function more closely.
• you notice that you or your child are passing less urine than usual during treatment with deferasirox.

Liver problems. Deferasirox can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated. See “Kidney problems” above.

Your healthcare provider should do blood tests to check your liver function before you start and regularly during treatment with deferasirox. Call your healthcare provider right away, if you develop any of the following signs and symptoms:

• drowsiness                                                                  
• upper right stomach-area (abdomen) pain
• yellowing or increased yellowing of your skin or eyes,
• dark urine

Bleeding, ulcers, and tears of the stomach or intestine. Severe stomach and intestine bleeding (hemorrhage) that have caused death have happened in some people treated with deferasirox, especially in elderly people who have advanced blood cancers or low platelet counts. Some people have also had ulcers of the stomach or intestine, sometimes with tears (perforation) that have caused death. In some people who have taken deferasirox, including children and adolescents, irritation of the upper gastrointestinal tract, ulcers, and bleeding have happened, but did not cause death.

Your risk of severe bleeding (hemorrhage) may be increased if you take deferasirox along with other medicines that can cause ulcers or bleeding, such as:

• nonsteroidal anti-inflammatory drugs (NSAIDs)                          
• certain osteoporosis medicines called oral bisphosphonates    
•  corticosteroids
• blood thinner medicines

Before you start taking deferasirox, tell your healthcare provider if you are taking one of these medicines. Ask your healthcare provider if you are not sure. If you develop an ulcer of the stomach or intestine, or severe bleeding, your healthcare provider may stop deferasirox. Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with deferasirox. Your healthcare provider may need to monitor you more closely during treatment with deferasirox.

• Tell your healthcare provider if you get heartburn during treatment with deferasirox.
• Get emergency medical help right away if you vomit blood or pass black or bloody stools, or if you have severe stomach-area (abdomen) pain during treatment with deferasirox.

See "What are the possible side effects of deferasirox?" for more information about side effects.

What is deferasirox?

Deferasirox is a prescription medicine that is used to treat:

• people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions

• certain people 10 years of age or older with thalassemia who have an increased amount of iron in their blood but who are not receiving regular blood transfusions

It is not known if deferasirox is safe and effective when used with other medicines to treat an increased amount of iron in the blood.

It is not known if deferasirox is safe and effective for treating children under 2 years of age who have an increased amount of iron in their blood for a long period of time (chronic) caused by repeated blood transfusions.

It is not known if deferasirox is safe and effective for treating children under 10 years of age with thalassemia who have an increased amount of iron in their blood, but who are not receiving regular blood transfusions.

  

Do not take deferasirox if you:

• have certain kidney problems
• have high-risk myelodysplastic syndrome (MDS)
• have advanced cancer
• have a low platelet count
• are allergic to deferasirox or any of the ingredients in deferasirox. See the end of this Medication Guide for a list of the ingredients in deferasirox.

Ask your healthcare provider if you are not sure if you have any of the medical conditions listed above.

Before taking deferasirox, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• have liver problems
• have advanced cancer. See “Do not take deferasirox if you”
• have a blood disorder that may increase your risk for bleeding
• are pregnant or plan to become pregnant. It is not known if deferasirox can harm your unborn baby. Hormonal forms of birth control may not be as effective if used during treatment with deferasirox. You could become pregnant. Talk to your healthcare provider about other birth control options that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment with deferasirox.
• are breastfeeding or plan to breastfeed. It is not known if deferasirox passes into your breast milk and can harm your baby. You and your healthcare provider should decide if you will take deferasirox or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how deferasirox works, and deferasirox may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take deferasirox with certain medicines. See "What is the most important information I should know about deferasirox?”

• Avoid taking the following medicines during treatment with deferasirox:
  • antacid products (medicines used to treat heartburn) that contain aluminum
  • theophylline
  • certain medicines to lower your cholesterol, called bile acid sequestrants.

Ask your healthcare provider if you are not sure if you take one of these medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take deferasirox?

• Take deferasirox exactly as your healthcare provider tells you to.
• Do not change your dose of deferasirox or stop taking it unless your healthcare provider tells you to.
• Take deferasirox 1 time every day, preferably at the same time every day.
• Take deferasirox on an empty stomach at least 30 minutes before eating food.
• Do not chew deferasirox tablets or swallow them whole.
• Place the prescribed number of deferasirox tablets in a cup with water, orange juice, or apple juice. Stir to disperse the tablets in the liquid.
  •  If your prescribed dose of deferasirox is less than 1 gram, use 3.5 ounces of liquid to disperse the tablets.
  •  If your prescribed dose of deferasirox is 1 gram or more, use 7 ounces of liquid to disperse the tablets.
  
  
• Completely disperse the tablets until it becomes a fine suspension. Then drink the suspension right away.
• Do not disperse deferasirox tablets in carbonated drinks or milk.
• After drinking the suspension, add a small amount of water, orange juice, or apple juice to the cup to disperse any remaining medicine, and then drink it.
• Do not take deferasirox with aluminum-containing antacid products. See “Before taking deferasirox.”
• Tell your healthcare provider if you or your child gain or lose any weight. Your or your child’s dose of deferasirox may need to be adjusted.
• If you take the diabetes medicine repaglinide during treatment with deferasirox, you may need to test your blood sugar (glucose) levels more often. Follow your healthcare provider’s instructions about how often to test your blood sugar during this time.
• Your healthcare provider should do blood and urine tests before, and during treatment to check how you respond to deferasirox, and to monitor you for side effects. Your healthcare provider may change your dose, or temporarily or permanently stop deferasirox if you have certain side effects.
• In people who have thalassemia, your healthcare provider will check the amount of iron in your liver before and during treatment with deferasirox.
• If you or your child take too much deferasirox, call your healthcare provider right away or go to the nearest hospital emergency room. Symptoms that can happen if you take too much deferasirox include: stomach-area (abdominal) pain, diarrhea, nausea, and vomiting.

What should I avoid while taking deferasirox?

• Deferasirox may cause dizziness. Avoid driving or operating machinery until you know how deferasirox affects you. Do not drive or operate machinery if deferasirox makes you dizzy.

What are the possible side effects of deferasirox?

Deferasirox can cause serious side effects, including:

• See "What is the most important information I should know about deferasirox?"
• Effects on your bone marrow. Deferasirox can affect your bone marrow and cause you to have a low white blood cell count which can be serious, decreased platelets, or worsening of your anemia, and may lead to death. Your risk for effects on your bone marrow may be increased if you already have other blood disorders. Your healthcare provider will do blood tests to monitor your blood cell counts for these problems.
• Serious allergic reactions. Deferasirox may cause serious allergic reactions, which usually start within the first month of treatment. Get medical help right away if you develop any of the following symptoms of a serious allergic reaction including:
  • difficulty in breathing or swallowing          
  • swelling of the face, lips, mouth, tongue or throat
  • chest pain                                                 
  • severe itching of the skin with a red rash or raised bumps
  • rapid heartbeat                                          
  • hives
  • feeling faint

• Skin rash and severe skin reactions. Skin rashes are common with deferasirox. If you get a more severe rash, your healthcare provider may temporarily stop deferasirox.

Severe skin reactions can also happen with deferasirox and can be life-threatening or lead to death. Get medical help right away if you develop any one or more of the following signs and symptoms of a severe skin reaction, including:

• rash or red skin
• skin peeling
• blisters on your lips, or around your mouth or eyes
• high fever or flu-like symptoms
• mouth sores
• enlarged lymph nodes

 

• Hearing and vision problems. Deferasirox can cause decreased hearing and changes in your vision, including cataracts, increased pressure in your eye, and problems with your retinas. Your healthcare provider should do hearing and vision tests before you start and then regularly during treatment. Your healthcare provider may decrease your dose or stop deferasirox if you develop hearing or vision problems.

Tell your healthcare provider if you develop any changes in your vision or hearing during treatment with deferasirox.

The most common side effects in anyone who takes deferasirox include: diarrhea and nausea. Other common side effects in people with too much iron in their blood due to repeated blood transfusions include: vomiting, stomach-area (abdomen) pain, and an abnormal kidney function blood test. These are not all the possible side effects of deferasirox.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store deferasirox?

• Store deferasirox at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the bottle closed tightly and away from moisture.

Keep deferasirox and all medicines out of the reach of children.

General information about the safe and effective use of deferasirox. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use deferasirox for a condition for which it was not prescribed. Do not give deferasirox to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about deferasirox that is written for health professionals.

What are the ingredients in deferasirox tablets for oral suspension?

Active ingredient: deferasirox

Inactive ingredients: colloidal silicon dioxide, crospovidone, dibasic sodium phosphate anhydrous, hydrogenated castor oil, hypromellose, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate.

 

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

For more information, you can call on Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901).
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: May, 2022

PT 2836-06