DEFERASIROX - ORAL

DEFERASIROX - ORAL

PHONETIC PRONUNCIATION: (dee-FER-a-sir-ox)

COMMON BRAND NAME(S): Jadenu

GENERIC NAME(S): deferasirox

Uses

USES: This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents. Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.


How to use DEFERASIROX - ORAL

HOW TO USE: Take this medication by mouth on an empty stomach or with a light meal (such as a whole-wheat english muffin with jelly and nonfat milk) as directed by your doctor, usually once daily. Avoid taking this medication with a meal high in calories (greater than 250 calories) and fat since it may increase your risk of side effects. Ask your doctor or pharmacist for more details. Take the tablets with water or other beverages. If you have trouble swallowing the tablets, you may crush the tablets and mix it with soft foods (such as applesauce, yogurt). Swallow all of the drug/food mixture right away. Do not prepare a supply in advance. If you are using the sprinkle granules, sprinkle the dose on soft food (such as applesauce, yogurt) and take all of it right away. Antacids that contain aluminum can bind with deferasirox which may affect how deferasirox works. Avoid taking this medication with antacids that contain aluminum. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. The dosage is based on your medical condition, weight, laboratory tests, and response to treatment. Your dosage may need to be lowered or your treatment may need to be stopped if you get certain side effects. Follow your doctor's instructions carefully.

Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: hearing loss, vision changes (such as blurred vision). This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can worsen anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding. This drug may rarely cause serious stomach/intestinal problems (such as stomach/intestinal bleeding and ulcers). If you notice any of the following unlikely but serious side effects, stop taking deferasirox and consult your doctor or pharmacist right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain. Deferasirox may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark urine. Deferasirox has rarely caused very serious (possibly fatal) kidney problems. Tell your doctor right away if you develop signs of kidney problems, such as: change in the amount of urine, frothy urine. Deferasirox can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes). This drug may make you dizzy or blur your vision. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell the doctor right away if you develop any illness that may cause a serious loss of body water (including fever, diarrhea, or vomiting) or if you are unable to drink fluids. The doctor may need to stop or adjust deferasirox treatment, especially in children. Children may be more sensitive to the side effects of this drug, especially kidney problems and hearing loss. Older adults may be more sensitive to the side effects of this drug, especially liver problems, stomach/intestinal bleeding, and ulcers. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin). Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for DEFERASIROX - ORAL

Deferasirox is an oral medication used for the treatment of chronic iron overload caused by blood transfusions in patients with certain conditions such as thalassemia, sickle cell disease, and myelodysplastic syndrome.

Deferasirox works by binding to excessive iron in the body and promoting its elimination through the urine and feces. It helps to reduce the iron overload and prevent complications associated with excessive iron accumulation, such as organ damage.

The recommended dosage of Deferasirox depends on factors such as the patient's weight and the amount of iron in their body. The usual starting dose is 20 mg/kg once daily and may be adjusted based on the individual patient's response and tolerance.

Common side effects of Deferasirox may include nausea, abdominal pain, diarrhea, headache, rash, increased liver enzymes, and changes in kidney function. It is important to report any severe or persistent side effects to your healthcare provider.

The duration of Deferasirox treatment depends on the individual patient's response and the underlying condition causing iron overload. It is typically a long-term treatment that may be continued for several years as long as it is deemed necessary by the healthcare provider.

Deferasirox should be used with caution in patients with liver or kidney problems, hearing or vision disturbances, and in pregnant or breastfeeding women. It should not be used in patients with severe renal impairment or advanced gastrointestinal bleeding.

Deferasirox may interact with certain medications, such as antacids, iron supplements, and certain antibiotics. It is important to inform your healthcare provider about all the medications you are taking to avoid any potential drug interactions.

Deferasirox should be taken once daily on an empty stomach, at least 30 minutes before food. The tablets should be swallowed whole with water and not crushed, chewed, or dissolved. It is important to follow the instructions provided by your healthcare provider.

Yes, Deferasirox can be used in children aged 2 years and older who require iron chelation therapy for chronic iron overload caused by blood transfusions.


Warning

WARNING: Deferasirox may rarely cause serious (possibly fatal) kidney disease, liver disease, and stomach/intestinal bleeding (see also Side Effects section). Kidney disease may be more likely to occur in people with kidney problems and in people with serious blood diseases. Liver disease may be more likely to occur in people with liver problems (such as cirrhosis) and in older adults. Stomach/intestinal bleeding may be more likely to occur in older adults with serious blood diseases (including blood cancers). Consult your doctor for more details. Your doctor will monitor you closely while you are taking this medication. Keep all regular medical and laboratory appointments.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.