Deferasirox Tablets

What is this medication?

DEFERASIROX (de FER a sir ox) treats high iron levels in your body. It works by binding to iron so your body can remove it through the stool.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Jadenu

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Eye disease, vision problems
• Hearing problems
• History of blood diseases
• Kidney disease
• Liver disease
• Low blood counts, such as low white cells, platelets, or red cell counts
• An unusual or allergic reaction to deferasirox, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it on an empty stomach or with a light meal (less than 250 calories). Swallow the tablets whole. You may crush the tablet and mix it with applesauce or yogurt. Swallow the mixture right away. Keep taking it unless your care team tells you to stop.

Take antacids with aluminum in them at a different time of day than this medication. Talk to your care team if you have questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Dasabuvir; ombitasvir, paritaprevir; ritonavir
• Iron supplements
• Ombitasvir; paritaprevir; ritonavir

This medication may also interact with the following:

• Antacids
• Certain medications for cholesterol, such as cholestyramine, colesevelam, colestipol, simvastatin
• Certain medications for osteoporosis, such as alendronate, risedronate
• Certain medications for seizures, such as phenobarbital, phenytoin
• Certain medications that prevent or treat blood clots, such as warfarin
• Conivaptan
• Cyclosporine
• Estrogen and progestin hormones
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Paclitaxel
• Repaglinide
• Rifampin
• Ritonavir
• Steroid medications, such as prednisone or cortisone
• Theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work and urine tests done while you are taking this medication.

Your vision and hearing may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight or hearing.

Make sure you stay hydrated while taking this medication. Drink water often. Eat fruits and veggies with lots of water. Drink more water when it is hot or you are active. Talk to your care team right away if you have severe diarrhea, nausea or vomiting, or if you sweat a lot. The loss of too much body fluid increases the risk of kidney and liver injury.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Peptic ulcer—burning stomach pain, loss of appetite, bloating, burping, heartburn, nausea, vomiting
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Stomach pain that is severe, does not go away, or gets worse
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer wanted or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.