Deferasirox 90mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication on an empty stomach or with a light meal. Swallow the tablet whole with water or another liquid. If you have difficulty swallowing tablets, you can crush the tablet and mix it with a small amount of soft food. However, be sure to take the mixture immediately and do not store it for later use.
Important Note: If you need to crush the 90 mg tablet, consult with your doctor or pharmacist first, as certain types of tablet crushers should not be used.
Take your medication at the same time every day, as directed by your doctor or healthcare provider. Continue taking the medication even if you feel well, unless your doctor instructs you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take the tablet whole, do not chew or crush it. It can be taken with or without a light meal.
- Stay well-hydrated while taking this medication.
- Avoid taking aluminum-containing antacids (like Maalox, Mylanta) with deferasirox, as they can interfere with its absorption.
- Report any new or worsening side effects to your doctor immediately.
- Attend all scheduled blood tests and eye/ear exams, as these are crucial for monitoring your treatment and detecting potential side effects early.
Available Forms & Alternatives
Available Strengths:
- Deferasirox 90mg Tablets
- Deferasirox 360mg Tablets
- Deferasirox 125mg Tablets For Susp
- Deferasirox 500mg Tablets For Susp
- Deferasirox 250mg Tablets For Susp
- Deferasirox 180mg Tablets
- Deferasirox 90mg Oral Granules
- Deferasirox 180mg Granules
- Deferasirox 360mg Granules
- Deferasirox 180mg Granules
- Deferasirox 360mg Granules
- Deferasirox 90mg Oral Granules
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of bowel problems: black, tarry, or bloody stools, fever, mucus in the stools, vomiting blood or coffee ground-like material, severe stomach pain, constipation, or diarrhea.
Changes in hearing or vision.
Chest pain or pressure, rapid heartbeat, or fainting.
Flu-like symptoms.
Rashes, which may require discontinuation of the medication. If you develop a rash, contact your doctor promptly to determine the best course of action.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, which can be life-threatening. Seek immediate medical attention if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Blood cell disorders, which can increase the risk of severe bleeding or infections. Contact your doctor right away if you experience signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal; bruising or bleeding; or excessive fatigue or weakness.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or persist, contact your doctor:
* Diarrhea, stomach pain, upset stomach, or vomiting.
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain, black or bloody stools, vomiting blood (signs of GI bleeding)
- Significant decrease in urine output, swelling in legs/ankles (signs of kidney problems)
- Yellowing of skin or eyes, dark urine, severe nausea/vomiting (signs of liver problems)
- Sudden decrease in hearing or vision changes (blurred vision, difficulty seeing)
- Severe skin rash, blistering, or peeling skin
- Unexplained fever, sore throat, or unusual bruising/bleeding (signs of blood problems)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Cancer
+ Blood or bone marrow disorders, such as low platelet count or high-risk myelodysplastic syndrome (MDS)
+ Kidney disease
+ Liver disease
Any instances of dehydration, which can be caused by:
+ Inability to eat or drink normally
+ Diarrhea
+ Vomiting
+ Other illnesses that may lead to dehydration
Use of similar medications. If you are unsure, consult your doctor or pharmacist.
Concurrent use of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding. Note that you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Regular monitoring is crucial; therefore, follow your doctor's instructions for scheduled blood work, lab tests, eye exams, and hearing tests.
To avoid potential interactions, do not take antacids containing aluminum while using this medication.
If you are 55 years or older, exercise caution when taking this drug, as you may be more susceptible to side effects. Similarly, when administering this medication to children, use it with caution, as they may have a higher risk of experiencing certain side effects. If your child's weight changes while taking this medication, consult your doctor, as their dose may need to be adjusted.
When using this medication, be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize this risk, consider using an additional form of birth control, such as a condom, while taking this drug.
If you are pregnant or planning to become pregnant, inform your doctor, as it is necessary to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Abdominal pain
- Diarrhea
- Nausea
- Vomiting
- Headache
- Dizziness
- Elevated liver transaminases
- Renal impairment
What to Do:
In case of suspected overdose, contact a poison control center or emergency room immediately. Call 1-800-222-1222 for the Poison Control Center. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Aluminum-containing antacids (e.g., aluminum hydroxide, aluminum carbonate) - due to potential for increased deferasirox exposure and aluminum toxicity.
Major Interactions
- UGT inducers (e.g., rifampin, phenytoin, phenobarbital, ritonavir) - may decrease deferasirox exposure, requiring dose increase.
- UGT inhibitors (e.g., fluconazole) - may increase deferasirox exposure, requiring dose reduction.
- CYP2C8 inhibitors (e.g., gemfibrozil) - may increase deferasirox exposure, requiring dose reduction.
- Bile acid sequestrants (e.g., cholestyramine) - may decrease deferasirox exposure.
Moderate Interactions
- CYP3A4 substrates (e.g., midazolam, cyclosporine, simvastatin) - deferasirox is a weak CYP3A4 inducer, may decrease exposure of co-administered drugs.
- CYP2C8 substrates (e.g., repaglinide) - deferasirox is a weak CYP2C8 inhibitor, may increase exposure of co-administered drugs.
- Oral contraceptives (hormonal) - deferasirox may decrease efficacy, consider alternative or additional contraception.
- Vitamin K antagonists (e.g., warfarin) - increased risk of bleeding, monitor INR closely.
Minor Interactions
- Not specifically listed as minor interactions with clinical significance requiring dose adjustment.
Monitoring
Baseline Monitoring
Rationale: To establish baseline iron burden and guide initial dosing.
Timing: Prior to initiation of therapy.
Rationale: To assess renal function, guide dosing, and identify patients at risk for renal impairment.
Timing: Prior to initiation of therapy.
Rationale: To assess hepatic function and identify patients at risk for hepatic impairment.
Timing: Prior to initiation of therapy.
Rationale: To assess hematological status and monitor for cytopenias.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline hearing function.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline vision and monitor for ocular toxicity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Monthly
Target: Goal is typically <1000 mcg/L, but individualized based on clinical response.
Action Threshold: Increase dose if ferritin >2500 mcg/L and well-tolerated; consider dose reduction if ferritin <500 mcg/L.
Frequency: Weekly for the first month, then monthly thereafter.
Target: Within normal limits or stable baseline.
Action Threshold: If increase >33% above baseline on 2 consecutive measurements, or if CrCl falls below 20 mL/min, interrupt or discontinue therapy. Consider dose reduction if increase >33% above baseline and within normal range.
Frequency: Weekly for the first month, then monthly thereafter.
Target: Within normal limits or stable baseline.
Action Threshold: If transaminases increase >5 times ULN, interrupt therapy. If increase >2 times ULN and persistent, consider dose reduction or interruption.
Frequency: Monthly
Target: Within normal limits.
Action Threshold: Monitor for neutropenia, thrombocytopenia, or worsening anemia. Consider dose interruption if severe cytopenias develop.
Frequency: Annually
Target: Stable hearing.
Action Threshold: If hearing impairment develops, consider dose reduction or interruption.
Frequency: Annually
Target: Stable vision.
Action Threshold: If visual disturbances develop, consider dose reduction or interruption.
Symptom Monitoring
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain)
- Skin rash
- Changes in urine output or color
- Yellowing of skin or eyes (jaundice)
- Unusual bleeding or bruising
- Vision changes (blurred vision, decreased acuity)
- Hearing changes (decreased hearing, tinnitus)
- Fatigue, weakness, or malaise (signs of organ dysfunction)
Special Patient Groups
Pregnancy
Based on animal data, deferasirox may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
Lactation
It is not known whether deferasirox is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with deferasirox.
Pediatric Use
Approved for patients 2 years of age and older. Dosing is weight-based. Monitor growth and development, as iron overload and chelation therapy can impact these. Renal and hepatic function should be monitored closely, as children may be more susceptible to adverse effects.
Geriatric Use
Increased incidence of adverse reactions, including renal failure, hepatic failure, and GI hemorrhage, has been reported in elderly patients (âĨ65 years). Use with caution and monitor closely, especially for renal, hepatic, and GI toxicities.
Clinical Information
Clinical Pearls
- Jadenu film-coated tablets offer improved patient convenience compared to Exjade dispersible tablets, as they can be swallowed whole and taken with or without a light meal.
- Strict adherence to monitoring schedules (renal, hepatic, ferritin, vision, hearing) is critical due to the potential for serious adverse effects.
- Patients should be educated on the importance of hydration to minimize the risk of renal toxicity.
- Dose adjustments are frequently required based on serum ferritin trends, renal function, and tolerability.
- For patients with significant GI irritation, taking the dose with a light meal may improve tolerability, but avoid high-fat meals.
- Deferasirox is not indicated for iron overload in patients with myelodysplastic syndromes (MDS) who are not transfusion-dependent.
Alternative Therapies
- Deferoxamine (Desferal) - parenteral iron chelator
- Deferiprone (Ferriprox) - oral iron chelator
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention by calling your local poison control center or visiting the emergency room. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will enable healthcare professionals to provide you with the most appropriate and timely care.