DEFERASIROX (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Deferasirox tablets 90 mg are light blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S102’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-768-83).

Deferasirox tablets 180 mg are medium blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S103’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-769-83).

Deferasirox tablets 360 mg are dark blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S104’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-770-83).

Store deferasirox tablets at 20°C-25°C (68°F-77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Dosing Instructions

Advise patients to take deferasirox tablets with water or other liquids. Advise patients to swallow deferasirox tablets once daily with water or other liquids, preferably at the same time each day. Advise patients to take deferasirox tablets on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories). Examples of light meals include 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) or a turkey sandwich (2 oz. turkey on whole wheat bread w/lettuce, tomato, and 1 packet mustard). For patients who have difficulty swallowing whole tablets, deferasirox tablets may be crushed and mixed with soft foods (e.g., yogurt or applesauce) immediately prior to use and administered orally. Advise against the use of commercial crushers with serrated surfaces for crushing a single 90 mg tablet. Advise patients to immediately and completely consume the dose and not store it for future use [see Dosage and Administration (2.3)].

Blood Testing

Advise patients that blood tests will be performed frequently to check for damage to kidneys, liver, or blood cells [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5)].

Acute Kidney Injury, Including Acute Renal Failure

Caution patients about the potential for kidney toxicity when taking deferasirox tablets. Inform patients of the signs and symptoms of kidney injury. Advise patients to contact their healthcare provider immediately if they experience any of these symptoms [see Warnings and Precautions (5.1)].

Hepatic Toxicity and Failure

Caution patients about the potential for hepatic toxicity when taking deferasirox tablets. Inform patients of the signs and symptoms of hepatic toxicity. Advise patients to contact their healthcare provider immediately if they experience any of these symptoms [see Warnings and Precautions (5.2)].

Gastrointestinal Ulceration and Hemorrhage

Caution patients about the potential for the development of GI ulcers or bleeding when taking deferasirox tablets in combination with drugs that have ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, or anticoagulants. Inform patients of the signs and symptoms of GI ulcers or bleeding. Advise patients to contact their healthcare provider for symptoms of heartburn but to seek immediate medical attention for symptoms of gastrointestinal hemorrhage [see Warnings and Precautions (5.3)].

Allergic Reactions

Serious allergic reactions (which include swelling of the throat) have been reported in patients taking deferasirox tablets, usually within the first month of treatment. If reactions are severe, advise patients to stop taking deferasirox tablets immediately and seek immediate medical attention [see Warnings and Precautions (5.7)].

Severe Skin Reactions

Severe skin reactions have been reported in patients taking deferasirox tablets. Inform patients of the signs and symptoms of severe skin reactions. If reactions are severe, advise patients to stop taking deferasirox tablets immediately and seek immediate medical attention [see Warnings and Precautions (5.8)].

Skin Rash

Skin rashes may occur during deferasirox tablets treatment. If the skin rash is severe, advise patients to stop taking deferasirox tablets and seek medical attention [see Warnings and Precautions (5.9)]

Pediatric Patients with Acute Illness

Instruct pediatric patients and their caregivers to contact their healthcare provider during episodes of acute illness, especially if the patient has not been drinking fluids or the patient has volume depletion due to fever, vomiting, or diarrhea [see Warnings and Precautions (5.1)].

Auditory and Ocular Testing

Because auditory and ocular disturbances have been reported with deferasirox, conduct auditory testing and ophthalmic testing before starting deferasirox tablets treatment and thereafter at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment [see Warnings and Precautions (5.10)].

Drug Interactions

Caution patients not to take aluminum containing antacids and deferasirox tablets simultaneously [see Drug Interactions (7.1)].

Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when deferasirox tablets are administered with these drugs [see Drug Interactions (7.2)].

Caution patients about potential loss of effectiveness of deferasirox tablets when administered with drugs that are potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of deferasirox tablets when concomitantly used with potent UGT inducers [see Drug Interactions (7.5)].

Caution patients about potential loss of effectiveness of deferasirox tablets when administered with drugs that are bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol). Based on serum ferritin levels and clinical response, consider increases in the dose of deferasirox tablets when concomitantly used with bile acid sequestrants [see Drug Interactions (7.6)].

Caution patients with diabetes to monitor their glucose levels more frequently when repaglinide is used concomitantly with deferasirox tablets [see Drug Interactions (7.3)].

Handling Instructions

Advise patients to store deferasirox tablets in a dry, room-temperature environment [see How Supplied/Storage and Handling (16)].

Driving and Using Machines

Caution patients experiencing dizziness to avoid driving or operating machinery [see Adverse Reactions (6.1)].

All trademarks are the property of their respective owners.

Manufactured by:

ALKALOIDA Chemical Company Zrt.

4440 Tiszavasvári,

Kabay János u. 29.

Hungary

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Iss. 03/2020

Medication Guide

Deferasirox Tablets

(def-era-si-rox)

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

Deferasirox tablets can cause serious side effects, including:

Kidney problems: Deferasirox tablets 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 tablets 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 tablets.

Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with deferasirox tablets. Call your healthcare provider right away if:

your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with deferasirox tablets. Your child may be dehydrated. Your healthcare provider may need to temporarily stop treatment with deferasirox tablets and treat your child for dehydration to help prevent kidney problems. Your 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 tablets.

Liver problems. Deferasirox tablets can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox tablets 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 tablets. Call your healthcare provider right away, if you develop any of the following signs and symptoms:

drowsiness
yellowing or increased yellowing of your skin or eyes
upper right stomach-area (abdomen) pain
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 tablets, 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 tablets, 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 tablets 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 tablets, 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 tablets.

Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with deferasirox tablets. Your healthcare provider may need to monitor you more closely during treatment with deferasirox tablets.

Tell your healthcare provider if you get heartburn during treatment with deferasirox tablets.
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 tablets.

See “What are possible side effects of deferasirox tablets?” for more information about side effects.

What are deferasirox tablets?

Deferasirox tablets are prescription medicines that are 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 tablets are safe and effective when used with other medicines to treat an increased amount of iron in the blood.

It is not known if deferasirox tablets are 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 tablets are 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 tablets 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 tablets. See the end of this leaflet for a list of the ingredients in deferasirox tablets.

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

Before taking deferasirox tablets 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 tablets 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 tablets can harm your unborn baby. Hormonal forms of birth control may not be as effective if used during treatment with deferasirox tablets. 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 tablets.
are breastfeeding or plan to breastfeed. It is not known if deferasirox tablets pass into your breast milk and can harm your baby. You and your healthcare provider should decide if you will take deferasirox tablets 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 tablets works, and deferasirox tablets may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take deferasirox tablets with certain medicines. See ‘What is the most important information I should know about deferasirox tablets?”

Avoid taking the following medicines during treatment with deferasirox tablets:
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 tablets?

Take deferasirox tablets exactly as your healthcare provider tells you.
Do not change your dose of deferasirox tablets or stop taking unless your healthcare provider tells you to.
Deferasirox tablets comes as tablets.
You may take deferasirox tablets on an empty stomach or with a light meal. Examples of a light meal include:
1 whole wheat English muffin, 1 packet of jelly (0.5 ounce), and skim milk (8 fluid ounces), or
A turkey sandwich (2 ounces of turkey on whole wheat bread with lettuce, tomato, and 1 packet of mustard)
Taking deferasirox tablets:
Take deferasirox tablets by mouth with water or other liquids 1 time every day, preferably at the same time every day.
If you have trouble swallowing the tablets whole, you may crush deferasirox tablets and mix them with soft foods such as yogurt or apple sauce right before taking your dose.
Take the dose right away. Do not save any of the deferasirox tablets and soft food mixture for later use.
Do not use store-bought pill crushers with serrated surfaces for crushing deferasirox tablets 90 mg tablets.
Do not take deferasirox tablets with aluminum-containing antacid products. See “Before taking deferasirox tablets”
Tell your healthcare provider if you or your child gain or lose any weight. Your or your child’s dose of deferasirox tablets may need to be adjusted.
If you take the diabetes medicine repaglinide during treatment with deferasirox tablets 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 tablets, and to monitor you for side effects. Your healthcare provider may change your dose, temporarily or permanently stop deferasirox tablets 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 tablets.
If you or your child take too much deferasirox tablets, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking deferasirox tablets?

Deferasirox tablets may cause dizziness. Avoid driving or operating machinery until you know how deferasirox tablets affect you. Do not drive or operate machinery if deferasirox tablets make you dizzy.

What are the possible side effects of deferasirox tablets?

Deferasirox tablets can cause serious side effects, including:

See “What is the most important information I should know about deferasirox tablets?”
Effects on your bone marrow. Deferasirox tablets can affect your bone marrow and cause you to have 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 tablets 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
rapid heartbeat
bumps
feeling faint
hives
Skin rash and severe skin reactions. Skin rashes are common with deferasirox tablets. If you get a more severe rash, your healthcare provider may temporarily stop deferasirox tablets. Severe skin reactions can also happen with deferasirox tablets 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 tablets 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 tablets if you develop hearing or vision problems.

The most common side effects in anyone who takes deferasirox tablets 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 tablets.

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 tablets?

Store deferasirox tablets 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 tablets and all medicines out of the reach of children.

General information about the safe and effective use of deferasirox tablets

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

What are the ingredients in deferasirox tablets?

Deferasirox tablets: Active ingredient: deferasirox

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer and povidone. The film coating contains hypromellose, FD&C Blue No. 2, polyethylene glycol, talc and titanium dioxide.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

For more information, call 1-800-818-4555.

All trademarks are the property of their respective owners.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Iss. 03/2020

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.