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Jadenu
Overview
What is Jadenu?
JADENU (deferasirox) is an iron chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula:
Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4. It is insoluble in water with a pH of suspension of 4.1.
JADENU tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone, povidone (K-30), magnesium stearate, colloidal silicon dioxide, and poloxamer (188). The film coating contains opadry blue.
JADENU Sprinkle granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone; povidone (K-30), magnesium stearate, colloidal silicon dioxide, poloxamer (188).
What does Jadenu look like?
What are the available doses of Jadenu?
Tablets: 90 mg, 180 mg, 360 mg. ()
Granules: 90 mg, 180 mg, 360 mg. ()
What should I talk to my health care provider before I take Jadenu?
How should I use Jadenu?
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. This indication is approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
JADENU 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 1000 mcg/L.
Prior to starting therapy, obtain:
The recommended initial dose of JADENU for patients 2 years of age and older is 14 mg per kg body weight orally, once daily. Calculate doses (mg per kg per day) to the nearest whole tablet or nearest whole sachet content for granules. Changes in weight of pediatric patients over time must be taken into account when calculating the dose.
After commencing therapy, monitor serum ferritin monthly and adjust the dose of JADENU, if necessary, every 3 to 6 months based on serum ferritin trends. Make dose adjustments in steps of 3.5 or 7 mg per kg and tailor adjustments to the individual patient’s response and therapeutic goals. In patients not adequately controlled with doses of 21 mg per kg (e.g., serum ferritin levels persistently above 2500 mcg/L and not showing a decreasing trend over time), doses of up to 28 mg per kg may be considered. Doses above 28 mg per kg are not recommended.
If the serum ferritin falls consistently below 500 mcg/L, consider temporarily interrupting therapy with JADENU .
What interacts with Jadenu?
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What are the warnings of Jadenu?
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What are the precautions of Jadenu?
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What are the side effects of Jadenu?
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What should I look out for while using Jadenu?
JADENU is contraindicated in patients with:
Renal Failure
Hepatic Failure
Gastrointestinal Hemorrhage
What might happen if I take too much Jadenu?
Cases of overdose (2 to 3 times the prescribed dose for several weeks) have been reported. In 1 case, this resulted in hepatitis which resolved without long-term consequences after a dose interruption. Single doses of deferasirox up to 80 mg per kg per day with the tablet for oral suspension formulation in iron overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy subjects, single doses of up to 40 mg per kg per day with the tablet for oral suspension formulation were tolerated. There is no specific antidote for JADENU. In case of overdose, induce vomiting and employ gastric lavage.
How should I store and handle Jadenu?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0654-15).JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0655-15).JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tablets (NDC 0078-0656-15).Store JADENU tablets 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.JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0727-15).JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0713-15).JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachets. (NDC 0078-0720-15).Store JADENU Sprinkle granules 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
JADENU(deferasirox) is an orally active chelator that is selective for iron (as Fe). 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.
Non-Clinical Toxicology
JADENU is contraindicated in patients with:Renal Failure
Hepatic Failure
Gastrointestinal Hemorrhage
Inhibitors of CYP3A4 and CYP2D6
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone and Acetaminophen Tablets.
If concomitant use is necessary, consider dosage reduction of Oxycodone and Acetaminophen Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone and Acetaminophen Tablets dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other CNS Depressants
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergic Drugs
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone and Acetaminophen Tablets if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The use of Oxycodone and Acetaminophen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Oxycodone and Acetaminophen Tablets and/or the muscle relaxant as necessary.
Diuretics
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone and Acetaminophen Tablets are used concomitantly with anticholinergic drugs.
Alcohol, ethyl
Oral Contraceptives
Charcoal (activated)
Beta Blockers (Propranolol)
Loop Diuretics
Lamotrigine
Probenecid
Zidovudine
JADENU can cause acute renal failure, fatal in some patients and requiring dialysis in others. Postmarketing experience showed that most fatalities occurred in patients with multiple comorbidities and who were in advanced stages of their hematological disorders. In the clinical trials, deferasirox-treated patients experienced dose-dependent increases in serum creatinine. In patients with transfusional iron overload, these increases in creatinine occurred at a greater frequency compared to deferoxamine-treated patients (38% versus 14%, respectively, in Study 1 and 36% versus 22%, respectively, in Study 3) .
Measure serum creatinine in duplicate (due to variations in measurements) and determine the CLCr (estimated by the Cockcroft-Gault method) before initiating therapy in all patients in order to establish a reliable pretreatment baseline. Monitor serum creatinine weekly during the first month after initiation or modification of therapy and at least monthly thereafter. Monitor serum creatinine and/or CLCr more frequently if creatinine levels are increasing. Dose reduction, interruption, or discontinuation based on increases in serum creatinine may be necessary .
JADENU is contraindicated in patients with CLCr less than 40 mL/minute or serum creatinine greater than 2 times the age appropriate ULN.
Renal tubular damage, including Fanconi’s Syndrome, has been reported in patients treated with deferasirox, most commonly in children and adolescents with beta-thalassemia and serum ferritin levels less than 1500 mcg/L.
Intermittent proteinuria (urine protein/creatinine ratio greater than 0.6 mg/mg) occurred in 18.6% of deferasirox-treated patients compared to 7.2% of deferoxamine-treated patients in Study 1. In clinical trials in patients with transfusional iron overload, deferasirox was temporarily withheld until the urine protein/creatinine ratio fell below 0.6 mg/mg. Monthly monitoring for proteinuria is recommended. The mechanism and clinical significance of the proteinuria are uncertain .
The following adverse reactions are also discussed in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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