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Deferasirox 500 mg Tablet, For Suspension, 30-count — NDC 62332-0326-30 package photo

Deferasirox 500 mg Tablet, For Suspension, 30-count

by Alembic Pharmaceuticals Inc. · 30 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-326-30)
NDC 62332-0326-30
🏷️ FDA NDC (as labeled) 62332-326-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Deferasirox (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 20, 2023 — Failed Dissolution Specifications (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0095-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62332-326-30
Product NDC 62332-326
11-digit billing NDC 62332032630
NCPDP billing unit EA — each (per item)
RxCUI 597768, 597770, 597772
UNII V8G4MOF2V9
UPC 0362332326303
Application # ANDA210060
SPL Set ID 1f9f1a69-bf71-4e6a-88b0-90f08c4da79f
Established class (EPC) Iron Chelator
Mechanism of action Iron Chelating Activity; Cytochrome P450 3A4 Inducers; Cytochrome P450 2C8 Inhibitors; Cytochrome P450 1A2 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-21
Route ORAL
Dosage form TABLET, FOR SUSPENSION
Substance DEFERASIROX
GPI-14 93100025007340
GPI class Deferasirox
GCN Seq No 060048
GCN 26044
HICL code 033337
Ingredient (HICL) Deferasirox
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C8
Therapeutic class — intermediate (HIC2) Antidotes To Poisons
HIC3 code C8A
Therapeutic class — specific (HIC3) Metallic Poison,Agents To Treat
AHFS code 64:00.00.00
AHFS class Heavy Metal Antagonists
FDB label name DEFERASIROX 500 MG TB FOR SUSP
FDB brand name Deferasirox
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62332-326-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62332-0326-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Iron Chelator class.

Pharmacologic class Iron Chelator
Drug family (ATC) Iron chelating agents
How it works Iron Chelating Activity, Cytochrome P450 1A2 Inhibitors, Cytochrome P450 3A4 Inducers, Cytochrome P450 2C8 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA210060 (ANDA)
Labeler code62332
First marketedNov 2019
Product typeHuman Prescription Drug
Portfolio491 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DEFERASIROX 500 MG TB FOR SUSP Ingredient Deferasirox
📗 Our plain-language guide HelloPharmacist
  • When you get a lot of blood transfusions, or when your body absorbs too much iron due to a condition like thalassemia, iron can pile up in organs like the liver and heart and cause...
  • What exactly is deferasirox doing in my body — and why do I need it?
  • It depends on which formulation you have. If you're taking Exjade (the tablet you dissolve in juice or water), take it on an empty stomach, at least 30 minutes before eating. If yo...
  • How should I take this — does it matter whether I eat first?
📖 Read our full Deferasirox guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintL463
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $22.97 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Exjade 500 mg 00078-0470-15 Novartis 30 tablets — AB FDA listed —
Deferasirox 500 mg 00480-7013-56 Teva 30 tablets — AB FDA listed —
Deferasirox 500 mg 43598-0854-05 Dr. 500 tablets — AB FDA listed —
Deferasirox 500 mg 45963-0456-30 Actavis 30 tablets — AB FDA listed —
Deferasirox 500 mg 46708-0326-30 Alembic 30 tablets — AB FDA listed —
Deferasirox 500 mgthis 62332-0326-30 Alembic 30 tablets — AB FDA listed —
deferasirox 500 mg 62756-0570-83 Sun 30 tablets — AB FDA listed —
Deferasirox 500 mg 67877-0551-30 Ascend 30 tablets — AB FDA listed —
deferasirox 500 mg 68462-0496-30 Glenmark 30 tablets — AB Discontinued —
Deferasirox 500 mg 69452-0161-13 Bionpharma 30 tablets — AB FDA listed —
Deferasirox 500 mg 69539-0023-05 MSN 500 tablets — AB FDA listed —
Deferasirox 500 mg 72205-0391-01 Novadoz 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Deferasirox — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Deferasirox. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.56M
Claims incl. refills
4.9K
Beneficiaries
2.4K
Spend / beneficiary
$2,732.57
Spend / claim
$1,327.82
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Deferasirox — the ingredient across all brands.

Top reported reactions

Death4,704
Diarrhoea2,343
Sickle Cell Anaemia With Crisis1,813
Pyrexia1,474
Nausea1,443
Haemoglobin Decreased1,410
Pneumonia1,251

Age at onset

Neonate9
Infant6
Child85
Adolescent29
Adult370
Elderly446

Reporter sex

26,369 reports
Male · 51%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization10,066
Death7,720
Life-threatening851
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 884 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62332-0326-30 You're viewing this 30 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-326-30) 2019-11-21 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 62332-326-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62332-0326-30, written without dashes as 62332032630. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62332-0326-30, the first segment (62332) is the labeler code FDA assigned to Alembic Pharmaceuticals Inc.; the middle segment (0326) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alembic Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure • Deferasirox tablets for oral suspension can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. • Evaluate baseline renal function prior to starting or increasing deferasirox tablets for oral suspension dosing in all patients. Deferasirox tablets for oral suspension are contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 .

Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly.

Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1, 2.4, 2.5), Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2)]. Hepatic Failure • Deferasirox tablets for oral suspension can cause hepatic injury including hepatic failure and death. • Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. • Avoid use of deferasirox tablets for oral suspension in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)].

Gastrointestinal Hemorrhage • Deferasirox tablets for oral suspension can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts. • Monitor patients and discontinue deferasirox tablets for oral suspension for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)]. WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE See full prescribing information for complete boxed warning.

Deferasirox tablets for oral suspension may cause: • acute kidney injury, including acute renal failure requiring dialysis and renal tubular toxicity including Fanconi syndrome (5.1) • hepatic toxicity, including failure (5.2) • gastrointestinal hemorrhage (5.3) Deferasirox tablets for oral suspension therapy requires close patient monitoring, including laboratory tests of renal and hepatic function. (5)

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1) Deferasirox tablets for oral suspension is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

(1.2) Limitations of Use: The safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. (1.3)

1.1Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

1.2Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.

1.3Limitations of Use The safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Transfusional Iron Overload: Initial dose for patients with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m 2 is 20 mg per kg body weight once daily, as oral suspension. Calculate dose to the nearest whole tablet. (2.1) NTDT Syndromes: Initial dose for patients with eGFR greater than 60 mL/min/1.73 m 2 is 10 mg per kg body weight once daily, as oral suspension.

Calculate dose to the nearest whole tablet. (2.2)

2.1Transfusional Iron Overload Deferasirox tablets for oral suspension therapy should only be considered when a patient has evidence of chronic transfusional iron overload. The evidence should include the transfusion of at least 100 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40 kg person or more in individuals weighing more than 40 kg), and a serum ferritin consistently greater than 1,000 mcg/L. Prior to starting therapy or increasing dose, evaluate: • Serum ferritin level • Baseline renal function: o Obtain serum creatinine in duplicate (due to variations in measurements) to establish accurate baseline o Calculate the estimated glomerular filtration rate (eGFR).

Use a prediction equation appropriate for adult patients (e.g., CKD-EPI, MDRD method) and in pediatric patients (e.g., Schwartz equations). o Obtain urinalyses and serum electrolytes to evaluate renal tubular function [see Dosage and Administration (2.4), Warnings and Precautions (5.1)]. • Serum transaminases and bilirubin [see Dosage and Administration (2.4), Warnings and Precautions (5.2)] • Baseline auditory and ophthalmic examinations [see Warnings and Precautions (5.10)] Initiating Therapy: The recommended initial dose of deferasirox tablets for oral suspension for patients 2 years of age and older with eGFR greater than 60 mL/min/1.73 m 2 is 20 mg per kg body weight orally, once daily.

Calculate doses (mg per kg per day) to the nearest whole tablet. During therapy: • Monitor serum ferritin monthly and adjust the dose of deferasirox tablets for oral suspension, if necessary, every 3 to 6 months based on serum ferritin trends. • Use the minimum effective dose to achieve a trend of decreasing ferritin. • Make dose adjustments in steps of 5 or 10 mg per kg and tailor adjustments to the individual patient’s response and therapeutic goals. • In patients not adequately controlled with doses of 30 mg per kg (e.g., serum ferritin levels persistently above 2,500 mcg/L and not showing a decreasing trend over time), doses of up to 40 mg per kg may be considered.

Doses above 40 mg per kg are not recommended [see Warnings and Precautions (5.6)]. • Adjust dose based on serum ferritin levels o If the serum ferritin falls below 1,000 mcg/L at 2 consecutive visits, consider dose reduction, especially if the dose is greater than 25 mg/kg/day [see Adverse Reactions (6.1)]. o If the serum ferritin falls below 500 mcg/L, interrupt deferasirox tablets for oral suspension to minimize the risk of overchelation, and continue monthly monitoring [see Warnings and Precautions (5.6)] . o Evaluate the need for ongoing chelation therapy for patients whose conditions no longer require regular blood transfusions. o Use the minimum effective dose to maintain iron burden in the target range [see Warnings and Precautions (5.6)]. • Monitor blood counts, liver function, renal function and ferritin monthly [see Warnings and Precautions (5.1, 5.2, 5.4)]. • Interrupt deferasirox tablets for oral suspension for pediatric patients who have acute illnesses, which can cause volume depletion, such as vomiting, diarrhea, or prolonged decreased oral intake, and monitor more frequently.

Resume therapy as appropriate, based on assessments of renal function, when oral intake and volume status are normal [see Dosage and Administration (2.4, 2.5), Warnings and Precautions (5.1), Use in Specific Populations (8.4), Clinical Pharmacology (12.3)].

2.2 Iron Overload in Non-Transfusion-Dependent Thalassemia Syndrome…

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS 125 mg tablets White to off-white, round, flat tablets debossed with “L461” on one side and plain on the other side. 250 mg tablets White to off-white, round, flat tablets debossed with “L462” on one side and plain on the other side. 500 mg tablets White to off-white, round, flat tablets debossed with “L463” on one side and plain on the other side. Tablets for oral suspension: 125 mg, 250 mg, 500 mg. (3)

⛔ Contraindications 161 words ▾

4 CONTRAINDICATIONS Deferasirox tablets for oral suspension are contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m 2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)]; Poor performance status; [see Warnings and Precautions (5.1, 5.3)] High-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelation therapy) Advanced malignancies. [see Warnings and Precautions (5.1, 5.3)] Platelet counts less than 50 x 10 9 /L [see Warnings and Precautions (5.3, 5.4)] Known hypersensitivity to deferasirox or any component of deferasirox tablets for oral suspension [see Warnings and Precautions (5.7), Adverse Reactions (6.2)] . • Estimated GFR less than 40 mL/min/1.73 m 2 .

(4) • Patients with poor performance status. (4) • Patients with high-risk myelodysplastic syndrome (MDS). (4) • Patients with advanced malignancies.

(4) • Patients with platelet counts less than 50 x 10 9 /L. (4) • Known hypersensitivity to deferasirox or any component of deferasirox tablets for oral suspension. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy. Monitor renal function during deferasirox tablets for oral suspension therapy and reduce dose or interrupt therapy for toxicity. (2.1, 2.4, 5.1) Hepatic Toxicity: Monitor hepatic function.

Reduce dose or interrupt therapy for toxicity. (5.2) Fatal and Nonfatal Gastrointestinal Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking deferasirox tablets for oral suspension in combination with drugs that have known ulcerogenic or hemorrhagic potential. (5.3) Bone Marrow Suppression: Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events; monitor blood counts during deferasirox tablets for oral suspension therapy.

Interrupt therapy for toxicity. (5.4) Age-related Risk of Toxicity: Monitor elderly and pediatric patients closely for toxicity. (5.5) Hypersensitivity Reactions: Discontinue deferasirox tablets for oral suspension for severe reactions and institute medical intervention.

(5.7) Severe Skin Reactions, including Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue deferasirox tablets for oral suspension. (5.8)

5.1Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome Deferasirox tablets for oral suspension are contraindicated in patients with eGFR less than 40 mL/min/1.73 m 2 . Exercise caution in pediatric patients with eGFR between 40 and 60 mL/minute/1.73 m 2 . If treatment is needed, use the minimum effective dose and monitor renal function frequently.

Individualize dose titration based on improvement in renal injury [see Use in Specific Populations (8.6)] . For patients with renal impairment (eGFR 40 to 60 mL/min/1.73 m 2 ) reduce the starting dose by 50% [see Dosage and Administration (2.4, 2.5), Use in Specific Populations (8.6)] . Deferasirox tablets for oral suspension can cause acute kidney injury including renal failure requiring dialysis that has resulted in fatal outcomes.

Based on postmarketing experience, most fatalities have occurred in patients with multiple comorbidities and who were in advanced stages of their hematological disorders. In the clinical trials, adult and pediatric deferasirox tablets for oral suspension-treated patients with no preexisting renal disease experienced dose-dependent mild, non-progressive increases in serum creatinine and proteinuria. Preexisting renal disease and concomitant use of other nephrotoxic drugs may increase the risk of acute kidney injury in adult and pediatric patients.

Acute illnesses associated with volume depletion and overchelation may increase the risk of acute kidney injury in pediatric patients. In pediatric patients, small decreases in eGFR can result in increases in deferasirox tablets for oral suspension exposure, particularly in younger patients with body surface area typical of patients less than age 7 years. This can lead to a cycle of worsening renal function and further increases in deferasirox tablets for oral suspension exposure, unless the dose is reduced or interrupted.

Renal tubular toxicity, including acquired Fanconi syndrome, has been reported in patients treated with deferasirox tablets for oral suspension, most commonly in pediatric patients with beta-thalassemia and serum ferritin levels less than 1,500 mcg/L [see Warnings and Precautions (5.6), Adverse Reactions (6.1, 6.2), Use in Specific Populations (8.4 ), Clinical Pharmacology (12.3) ]. Evaluate renal glomerular and tubular function before initiating therapy or increasing the dose. Use prediction equations validated for use in adult and pediatric patients to estimate GFR.

Obtain serum electrolytes and urinalysis in all patients to evaluate renal tubular function [see Dosage and Administration (2.1, 2.2)]. Monitor all patients for changes in eGFR and f…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [see Warnings and Precautions (5.1, 5.6)] Hepatic Toxicity and Failure [see Warnings and Precautions (5.2, 5.6)] GI Hemorrhage [see Warnings and Precautions (5.3)] Bone Marrow Suppression [see Warnings and Precautions (5.4)] Hypersensitivity [see Warnings and Precautions (5.7)] Severe Skin Reactions [see Warnings and Precautions (5.8)] Skin Rash [see Warnings and Precautions (5.9)] Auditory and Ocular Abnormalities [see Warnings and Precautions (5.10)] In patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine.

In deferasirox tablets for oral suspension-treated patients with NTDT syndromes, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, rash, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Transfusional Iron Overload A total of 700 adult and pediatric patients were treated with deferasirox tablets for oral suspension (deferasirox) for 48 weeks in premarketing studies. These included 469 patients with beta-thalassemia, 99 with rare anemias, and 132 with sickle cell disease.

Of these patients, 45% were male, 70% were Caucasian, and 292 patients were less than 16 years of age. In the sickle cell disease population, 89% of patients were black. Median treatment duration among the sickle cell patients was 51 weeks.

Of the 700 patients treated, 469 (403 beta-thalassemia and 66 rare anemias) were entered into extensions of the original clinical protocols. In ongoing extension studies, median durations of treatment were 88 to 205 weeks. Six hundred twenty-seven (627) patients with myelodysplastic syndrome (MDS) were enrolled across 5 uncontrolled trials.

These studies varied in duration from 1 to 5 years. The discontinuation rate across studies in the first year was 46% (adverse events 20%, withdrawal of consent 10%, death 8%, other 4%, lab abnormalities 3%, and lack of efficacy 1%). Among 47 patients enrolled in the study of 5-year duration, 10 remained on deferasirox tablets for oral suspension at the completion of the study.

Table 1 displays adverse reactions occurring in greater than 5% of deferasirox tablets for oral suspension-treated beta-thalassemia patients (Study 1), sickle cell disease patients (Study 3), and patients with MDS (MDS pool). Abdominal pain, nausea, vomiting, diarrhea, skin rashes, and increases in serum creatinine were the most frequent adverse reactions reported with a suspected relationship to deferasirox tablets for oral suspension. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related.

Table 1. Adverse Reactions a Occurring in Greater Than 5% of Deferasirox Tablets for Oral Suspension-treated Patients in Study 1, Study 3, and MDS Pool Study 1 (Beta-thalassemia) Study 3 (Sickle Cell Disease) MDS Pool Adverse Reactions Deferasirox Tablets for Oral Suspension N=296 n (%) Deferoxamine N=290 n (%) Deferasirox Tablets for Oral Suspension N=132 n (%) Deferoxamine N=63 n (%) Deferasirox Tablets for Oral Suspension N=627 n (%) Abdominal Pain b 63 (21) 41 (14) 37 (28) 9 (14) 145 (23) Diarrhea 35 (12) 21 (7) 26 (20) 3 (5) 297 (47) Creatinine Increased c 33 (11) 0 (0) 9 (7) 0 89 (14) Nausea 31 (11) 14 (5) 30 (23) 7 (11) 161 (26) Vomiting 30 (10) 28 (10…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Do not take deferasirox tablets for oral suspension with aluminum-containing antacid preparations. (7.1) Deferasirox tablets for oral suspension increases the exposure of the CYP2C8 substrate repaglinide. Consider repaglinide dose reduction and monitor blood glucose levels.

(7.3) Avoid the use of deferasirox tablets for oral suspension with CYP1A2 substrate theophylline. (7.4) Deferasirox increases exposure of busulfan. Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow dose adjustment of busulfan as needed.

(7.7)

7.1Aluminum-Containing Antacid Preparations The concomitant administration of deferasirox tablets for oral suspension and aluminum-containing antacid preparations has not been formally studied. Although deferasirox has a lower affinity for aluminum than for iron, do not take deferasirox tablets for oral suspension with aluminum-containing antacid preparations due to the mechanism of action of deferasirox tablets for oral suspension.

7.2Agents Metabolized by CYP3A4 Deferasirox may induce CYP3A4 resulting in a decrease in CYP3A4 substrate concentration when these drugs are coadministered. Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)] .

7.3Agents Metabolized by CYP2C8 Deferasirox inhibits CYP2C8 resulting in an increase in CYP2C8 substrate (e.g., repaglinide and paclitaxel) concentration when these drugs are coadministered. If deferasirox tablets for oral suspension and repaglinide are used concomitantly, consider decreasing the dose of repaglinide and perform careful monitoring of blood glucose levels. Closely monitor patients for signs of exposure related toxicity when deferasirox tablets for oral suspension are coadministered with other CYP2C8 substrates [see Clinical Pharmacology (12.3)].

7.4Agents Metabolized by CYP1A2 Deferasirox inhibits CYP1A2 resulting in an increase in CYP1A2 substrate (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) concentration when these drugs are coadministered. An increase in theophylline plasma concentrations could lead to clinically significant theophylline-induced CNS or other adverse reactions. Avoid the concomitant use of theophylline or other CYP1A2 substrates with a narrow therapeutic index (e.g., tizanidine) with deferasirox tablets for oral suspension.

Monitor theophylline concentrations and consider theophylline dose modification if you must coadminister theophylline with deferasirox tablets for oral suspension. Closely monitor patients for signs of exposure related toxicity when deferasirox tablets for oral suspension are coadministered with other drugs metabolized by CYP1A2 [see Clinical Pharmacology (12.3)] .

7.5Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism Deferasirox is a substrate of UGT1A1 and to a lesser extent UGT1A3. The concomitant use of deferasirox tablets for oral suspension with potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) may result in a decrease in deferasirox tablets for oral suspension efficacy due to a possible decrease in deferasirox concentration. Avoid the concomitant use of potent UGT inducers with deferasirox tablets for oral suspension.

Consider increasing the initial dose of deferasirox tablets for oral suspension if you must coadminister these agents together [see Dosage and Administration (2.5),…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. (8.2)

8.1Pregnancy Risk Summary There are no studies with deferasirox tablets for oral suspension in pregnant women to inform drug-associated risks. Administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than the recommended human dose on an mg/m 2 basis. No fetal effects were noted in pregnant rabbits at doses equivalent to the human recommended dose on an mg/m 2 basis.

Deferasirox tablets for oral suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes .

However, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In embryo-fetal developmental studies, pregnant rats and rabbits received oral deferasirox during the period of organogenesis at doses up to 100 mg/kg/day in rats and 50 mg/kg/day in rabbits (1.2 times the maximum recommended human dose (MRHD) on an mg/m 2 basis). These doses resulted in maternal toxicity but no fetal harm was observed.

In a prenatal and postnatal developmental study, pregnant rats received oral deferasirox daily from organogenesis through lactation day 20 at doses of 10, 30, and 90 mg/kg/day (0.1, 0.3, and 1 times the MRHD on an mg/m 2 basis). Maternal toxicity, loss of litters, and decreased offspring viability occurred at 90 mg/kg/day (1 times the MRHD on a mg/m 2 basis) and increases in renal anomalies in male offspring occurred at 30 mg/kg/day (0.3 times the MRHD on a mg/m 2 basis).

8.2Lactation Risk Summary No data are available regarding the presence of deferasirox or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Deferasirox and its metabolites were excreted in rat milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in a breastfeeding child from deferasirox and its metabolites, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

8.3Females and Males of Reproductive Potential Contraception Counsel patients to use non-hormonal method(s) of contraception since deferasirox tablets for oral suspension can render hormonal contraceptives ineffective [see Drug Interactions (7.2)] .

8.4Pediatric Use Transfusional Iron Overload The safety and effectiveness of deferasirox tablets for oral suspension have been established in pediatric patients 2 years of age and older for the treatment of transfusional iron overload [ see Dosage and Administration (2.1)]. Safety and effectiveness have not been established in pediatric patients less than 2 years of age for the treatment of transfusional iron overload. Pediatric approval for treatment of transfusional iron overload was based on clinical studies of 292 pediatric patients 2 years to less than 16 years of age with various congenital and acquired anemias.

Seventy percent of these patients had beta-thalassemia [see Indications and Usage (1), Dosage and Administration (2.1), Clinical Studies (14)] . In those clinical studies, 173 children (ages 2 to < 12 years) and 119 adolescents (ages 12 to < 17 years) were exposed to deferasirox. A trial conducted in treatment-naïve pediatric patients, 2 to < 18 years of age with transfusional iron overload (NCT02435212) did not provide additional relevant information about the safety or effectiveness of the deferasirox granules dosage form (Jadenu Sprinkle) compared to the deferasirox oral tablets for suspension dosage form…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no studies with deferasirox tablets for oral suspension in pregnant women to inform drug-associated risks. Administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than the recommended human dose on an mg/m 2 basis. No fetal effects were noted in pregnant rabbits at doses equivalent to the human recommended dose on an mg/m 2 basis.

Deferasirox tablets for oral suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes .

However, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In embryo-fetal developmental studies, pregnant rats and rabbits received oral deferasirox during the period of organogenesis at doses up to 100 mg/kg/day in rats and 50 mg/kg/day in rabbits (1.2 times the maximum recommended human dose (MRHD) on an mg/m 2 basis). These doses resulted in maternal toxicity but no fetal harm was observed.

In a prenatal and postnatal developmental study, pregnant rats received oral deferasirox daily from organogenesis through lactation day 20 at doses of 10, 30, and 90 mg/kg/day (0.1, 0.3, and 1 times the MRHD on an mg/m 2 basis). Maternal toxicity, loss of litters, and decreased offspring viability occurred at 90 mg/kg/day (1 times the MRHD on a mg/m 2 basis) and increases in renal anomalies in male offspring occurred at 30 mg/kg/day (0.3 times the MRHD on a mg/m 2 basis).

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Transfusional Iron Overload The safety and effectiveness of deferasirox tablets for oral suspension have been established in pediatric patients 2 years of age and older for the treatment of transfusional iron overload [ see Dosage and Administration (2.1)]. Safety and effectiveness have not been established in pediatric patients less than 2 years of age for the treatment of transfusional iron overload. Pediatric approval for treatment of transfusional iron overload was based on clinical studies of 292 pediatric patients 2 years to less than 16 years of age with various congenital and acquired anemias.

Seventy percent of these patients had beta-thalassemia [see Indications and Usage (1), Dosage and Administration (2.1), Clinical Studies (14)] . In those clinical studies, 173 children (ages 2 to < 12 years) and 119 adolescents (ages 12 to < 17 years) were exposed to deferasirox. A trial conducted in treatment-naïve pediatric patients, 2 to < 18 years of age with transfusional iron overload (NCT02435212) did not provide additional relevant information about the safety or effectiveness of the deferasirox granules dosage form (Jadenu Sprinkle) compared to the deferasirox oral tablets for suspension dosage form (Exjade).

Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes The safety and effectiveness of deferasirox tablets for oral suspension have been established in patients 10 years of age and older for the treatment of chronic iron overload with non-transfusion-dependent thalassemia (NTDT) syndromes [see Dosage and Administration (2.2)] . Safety and effectiveness have not been established in patients less than 10 years of age with chronic iron overload in NTDT syndromes. Pediatric approval for treatment of NTDT syndromes with liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L was based on 16 pediatric patients treated with deferasirox tablets for oral suspension therapy (10 years to less than 16 years of age) with chronic iron overload and NTDT.

Use of deferasirox tablets for oral suspension in these age groups is supported by evidence from adequate and well-controlled studies of deferasirox tablets for oral suspension in adult and pediatric patients [see Indications and Usage (1.2), Dosage and Administration (2.2), Clinical Studies (14)]. In general, risk factors for deferasirox-associated kidney injury include preexisting renal disease, volume depletion, overchelation, and concomitant use of other nephrotoxic drugs. Acute kidney injury, and acute liver injury and failure has occurred in pediatric patients.

In a pooled safety analysis, pediatric patients with higher deferasirox tablets for oral suspension exposures had a greater probability of renal toxicity and decreased renal function, resulting in increased deferasirox exposure and progressive renal toxicity/kidney injury. Higher rates of renal adverse reactions have been identified among pediatric patients receiving deferasirox tablets for oral suspension doses greater than 25 mg/kg/day when their serum ferritin values were less than 1,000 mcg/L [see Dosage and Administration (2.5), Warnings and Precautions (5.1, 5.6), Adverse Reactions (6.1, 6.2)] .

Monitoring Recommendations for pediatric patients with Transfusional Iron Overload and NTDT It is recommended that serum ferritin be monitored every month to assess the patient’s response to therapy and to minimize the risk of overchelation [see Warnings and Precautions (5.6)]. Monitor renal function by estimating GFR using an eGFR prediction equation appropriate for pediatric patients and evaluate renal tubular function. Monitor renal function more frequently in pediatric patients in the presence of renal toxicity risk factors, including episodes of dehydration, fever and acute illness that may result in volume depletion or decreased renal perfusion.

Use the minimum effective dose [see Warnings and Precautions (5.1)] . Interru…

🧓 Geriatric Use 182 words ▾

8.5Geriatric Use Four hundred thirty-one (431) patients greater than or equal to 65 years of age were studied in clinical trials of deferasirox tablets for oral suspension in the transfusional iron overload setting. Two hundred twenty-five (225) of these patients were between 65 and 75 years of age while 206 were greater than or equal to 75 years of age. The majority of these patients had myelodysplastic syndrome (MDS) (n=393).

In these trials, elderly patients experienced a higher frequency of adverse reactions than younger patients. Monitor elderly patients for early signs or symptoms of adverse reactions that may require a dose adjustment. Elderly patients are at increased risk for toxicity due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. In elderly patients, including those with MDS, individualize the decision to remove accumulated iron based on clinical circumstances and the anticipated clinical benefit and risks of deferasirox tablets for oral suspension therapy.

🆘 Overdosage 189 words ▾

10 OVERDOSAGE Cases of overdose (2 to 3 times the prescribed dose for several weeks) have been reported. In one case, this resulted in hepatitis, which resolved without long-term consequences after a dose interruption. In one pediatric case, a dose of 2 to 3 times the prescribed dose for 6 days, resulted in acute renal failure requiring hemofiltration and acute liver injury/failure, which were reversible with intensive care support.Single doses up to 80 mg per kg per day in iron overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted.

In healthy volunteers, single doses of up to 40 mg per kg per day were tolerated. Early signs of acute overdose are digestive effects such as abdominal pain, diarrhea, nausea, and vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine increased with recovery after treatment discontinuation.

An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment. There is no specific antidote for deferasirox tablets for oral suspension. In case of overdose, it may be treated with induction of vomiting or gastric lavage, and by symptomatic treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Deferasirox tablets for oral suspension are an orally active chelator that is selective for iron (as Fe 3+ ). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

12.2Pharmacodynamics Pharmacodynamic effects tested in an iron balance metabolic study showed that deferasirox (10, 20, and 40 mg per kg per day) was able to induce a mean net iron excretion (0.119, 0.329, and 0.445 mg Fe/kg body weight per day, respectively) within the clinically relevant range (0.1 to 0.5 mg per kg per day). Iron excretion was predominantly fecal. An analysis of pooled pediatric clinical trial data found a statistically significant relationship between exposure and the probability of renal toxicity (increase in serum creatinine and urinary protein), resulting in a decrease in renal function.

Decreases in renal function resulted in an increase in deferasirox exposure, which may increase the probability of renal toxicity. Cardiac Electrophysiology At the maximum approved recommended dose, deferasirox does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Absorption Deferasirox tablets for oral suspension are absorbed following oral administration with median times to maximum plasma concentration (T max ) of about 1.5 to 4 hours. The C max and area under the curve (AUC) of deferasirox increase approximately linearly with dose after both single administration and under steady-state conditions. Exposure to deferasirox increased by an accumulation factor of 1.3 to 2.3 after multiple doses.

The absolute bioavailability (AUC) of deferasirox tablets for oral suspension is 70% compared to an intravenous dose. The bioavailability (AUC) of deferasirox was variably increased when taken with a meal. Distribution Deferasirox is highly (~99%) protein bound almost exclusively to serum albumin.

The percentage of deferasirox confined to the blood cells was 5% in humans. The volume of distribution at steady state (V ss ) of deferasirox is 14.37 ±

2.69L in adults. Metabolism Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion. Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur.

Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3. CYP450-catalyzed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). Deconjugation of glucuronide metabolites in the intestine and subsequent reabsorption (enterohepatic recycling) was confirmed in a healthy volunteer study in which the administration of cholestyramine 12 g twice daily (strongly binds to deferasirox and its conjugates) 4 and 10 hours after a single dose of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC) by interfering with the enterohepatic recycling of deferasirox.

Excretion Deferasirox and metabolites are primarily (84% of the dose) excreted in the feces. Renal excretion of deferasirox and metabolites is minimal (8% of the administered dose). The mean elimination half-life (t 1/2 ) ranged from 8 to 16 hours following oral administration.

Drug Interactions Midazolam : In healthy volunteers, the concomitant administration of deferasirox tablets for oral suspension and midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam peak concentration by 23% and exposure by 17%. In the clinical setting, this effect may be more pronounced. The study was not adequately designed to conclusively assess the potential induction of CYP3A4 by deferasirox [see Drug Interactions (7.2)] .

Repaglinide : In a healthy volunteer study, the concomitant administration of deferasirox tablets for oral suspe…

🧬 Mechanism of Action 73 words ▾

12.1Mechanism of Action Deferasirox tablets for oral suspension are an orally active chelator that is selective for iron (as Fe 3+ ). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

📦 How Supplied / Storage and Handling 125 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Deferasirox Tablets for Oral Suspension 125 mg White to off-white, round, flat tablets debossed with “L461” on one side and plain on the other side. NDC 62332-324-30 Bottle of 30 tablets Deferasirox Tablets for Oral Suspension 250 mg White to off-white, round, flat tablets debossed with “L462” on one side and plain on the other side. NDC 62332-325-30 Bottle of 30 tablets Deferasirox Tablets for Oral Suspension 500 mg White to off-white, round, flat tablets debossed with “L463” on one side and plain on the other side.

NDC 62332-326-30 Bottle of 30 tablets Store deferasirox tablets for oral suspension at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 92 words ▾

11 DESCRIPTION Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is: Deferasirox is a white to slightly yellow powder.

Its molecular formula is C 21 H 15 N 3 O 4 and its molecular weight is 373.36 g/mol. Inactive Ingredients: Crospovidone (NF), sodium starch glycolate (NF), croscarmellose sodium (NF), colloidal silicon dioxide (NF), sodium lauryl sulphate (NF), povidone (K-30) (USP), lactose monohydrate (NF), and magnesium stearate (NF). Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Dosing Instructions Advise patients to take deferasirox tablets for oral suspension once daily on an empty stomach at least 30 minutes prior to food, preferably at the same time every day. Instruct patients to completely disperse the tablets in water, orange juice, or apple juice, and drink the resulting suspension immediately.

After the suspension has been swallowed, resuspend any residue in a small volume of the liquid and swallow [see Dosage and Administration (2.3)] . Advise patients not to chew tablets or swallow them whole [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 for oral suspension. 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 for oral suspension. 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)].

GI Ulceration and Hemorrhage Caution patients about the potential for the development of GI ulcers or bleeding when taking deferasirox tablets for oral suspension 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 health care provider for symptoms of heartburn but to seek immediate medical attention for symptoms of GI 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 for oral suspension, usually within the first month of treatment. If reactions are severe, advise patients to stop taking deferasirox tablets for oral suspension 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 for oral suspension.

Inform patients of the signs and symptoms of severe skin reactions. If reactions are severe, advise patients to stop taking deferasirox tablets for oral suspension immediately and seek immediate medical attention [see Warnings and Precautions (5.8)]. Skin Rash Skin rashes may occur during deferasirox tablets for oral suspension treatment.

If the skin rash is severe, advise patients to stop taking deferasirox tablets for oral suspension 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 tablets for oral suspension, conduct auditory testing and ophthalmic testing before starting deferasirox tablets for oral suspension 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-cont…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Deferasirox ( dee-FER-a-sir-ox ) Tablets for Oral Suspension What is the most important information I should know about deferasirox tablets for oral suspension? Deferasirox tablets for oral suspension can cause serious side effects, including: Kidney problems. Deferasirox tablets for oral suspension 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 for oral suspension 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 for oral suspension.

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 for oral suspension. 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 tablets for oral suspension. Your child may be dehydrated.

Your child’s healthcare provider may need to temporarily stop treatment with deferasirox tablets for oral suspension 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 tablets for oral suspension. Liver problems.

Deferasirox tablets for oral suspension can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox tablets for oral suspension 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 for oral suspension.

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 for oral suspension, 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 for oral suspension, 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 for oral suspension 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 for oral suspension, 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 for oral suspension. Elderly people may be at a higher risk of d…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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