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Jadenu Dosage

Generic name: DEFERASIROX 90mg
Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1     Transfusional Iron Overload

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:

  • serum ferritin level
  • baseline serum creatinine in duplicate (due to variations in measurements) and determine the ClCr (Cockcroft-Gault method) [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 (5.9)]

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. 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 [see Warnings and Precautions (5.10)].

2.2     Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

JADENU therapy should only be considered when a patient with NTDT syndrome has an LIC of at least 5 mg Fe/g dw and a serum ferritin greater than 300 mcg/L.

Prior to starting therapy, obtain:

  • LIC by liver biopsy or by an FDA-cleared or approved method for identifying patients for treatment with deferasirox therapy
  • Serum ferritin level on at least 2 measurements 1 month apart [see Clinical Studies (14)]
  • Baseline serum creatinine in duplicate (due to variations in measurements) and determine the ClCr (Cockcroft-Gault method) [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 (5.9)]

Initiating therapy:

  • The recommended initial dose of JADENU is 7 mg per kg body weight orally once daily. Calculate doses (mg per kg per day) to the nearest whole tablet.
  • If the baseline LIC is greater than 15 mg Fe/g dw, consider increasing the dose to 14 mg/kg/day after 4 weeks.

During therapy:

  • Monitor serum ferritin monthly. Interrupt treatment when serum ferritin is less than 300 mcg/L and obtain an LIC to determine whether the LIC has fallen to less than 3 mg Fe/g dw.
  • Monitor LIC every 6 months.
  • After 6 months of therapy, if the LIC remains greater than 7 mg Fe/g dw, increase the dose of deferasirox to a maximum of 14 mg/kg/day. Do not exceed a maximum of 14 mg/kg/day.
  • If after 6 months of therapy, the LIC is 3 to 7 mg Fe/g dw, continue treatment with deferasirox at no more than 7 mg/kg/day.
  • When the LIC is less than 3 mg Fe/g dw, interrupt treatment with deferasirox and continue to monitor the LIC.
  • Monitor blood counts, hepatic function, and renal function [see Warnings and Precautions (5.1, 5.2, 5.4)].

Restart treatment when the LIC rises again to more than 5 mg Fe/g dw.

2.3     Administration

JADENU tablets should be swallowed once daily with water or other liquids, preferably at the same time each day. JADENU tablets may be taken on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories). Examples of light meals include 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) or a turkey sandwich (2 oz. turkey on whole wheat bread w/ lettuce, tomato, and 1 packet mustard). Do not take JADENU with aluminum-containing antacid products [see Drug Interactions (7.1)].

For patients who are currently on chelation therapy with EXJADE tablets for oral suspension and converting to JADENU tablets, the dose of JADENU should be about 30% lower, rounded to the nearest whole tablet. The table below provides additional information on dosing conversion to JADENU tablets.

EXJADE
Tablets for oral suspension
(white round tablet)
JADENU
Tablets
(film coated blue oval tablet)
Transfusion-Dependent Iron Overload
Starting Dose 20 mg/kg/day 14 mg/kg/day
Titration Increments 5–10 mg/kg 3.5–7 mg/kg
Maximum Dose 20 mg/kg/day 14 mg/kg/day
Non-Transfusion-Dependent Thalassemia Syndromes
Starting Dose 10 mg/kg/day 7 mg/kg/day
Titration Increments 5–10 mg/kg 3.5–7 mg/kg
Maximum Dose 40 mg/kg/day 28 mg/kg/day

‚ÄčFor patients who have difficulty swallowing whole tablets, JADENU tablets may be crushed and mixed with soft foods (e.g., yogurt or apple sauce) immediately prior to use and administered orally. Commercial crushers with serrated surfaces should be avoided for crushing a single 90 mg tablet. The dose should be immediately and completely consumed and not stored for future use.

2.4     Use in Patients with Baseline Hepatic or Renal Impairment

Patients with Baseline Hepatic Impairment

Mild (Child-Pugh A) hepatic impairment: No dose adjustment is necessary.

Moderate (Child-Pugh B) hepatic impairment: Reduce the starting dose by 50%.

Severe (Child-Pugh C) hepatic impairment: Avoid JADENU [see Warnings and Precautions (5.2), Use in Specific Populations (8.7)].

Patients with Baseline Renal Impairment

For patients with renal impairment (ClCr 40 to 60 mL/min), reduce the starting dose by 50% [see Use in Specific Populations (8.6)]. Do not use JADENU in patients with serum creatinine greater than 2 times the upper limit of normal (ULN) or ClCr less than 40 mL/min [see Contraindications (4)].

2.5     Dose Modifications for Increases in Serum Creatinine

For serum creatinine increases while receiving JADENU [see Warnings and Precautions (5.1)] modify the dose as follows:

Transfusional Iron Overload

Adults and Adolescents (ages 16 years and older):

  • If the serum creatinine increases by 33% or more above the average baseline measurement, repeat the serum creatinine within 1 week, and if still elevated by 33% or more, reduce the dose by 7 mg per kg.

Pediatric Patients (ages 2 to 15 years):

  • Reduce the dose by 7 mg per kg if serum creatinine increases to greater than 33% above the average baseline measurement and greater than the age appropriate ULN.

All Patients (regardless of age):

  • Discontinue therapy for serum creatinine greater than 2 times the age-appropriate ULN or for creatinine clearance less than 40 mL/min. [see Contraindications (4)]

Non-Transfusion-Dependent Thalassemia Syndromes

Adults and Adolescents (ages 16 years and older):

  • If the serum creatinine increases by 33% or more above the average baseline measurement, repeat the serum creatinine within 1 week, and if still elevated by 33% or more, interrupt therapy if the dose is 3.5 mg per kg, or reduce by 50% if the dose is 7 or 14 mg per kg.

Pediatric Patients (ages 10 to 15 years):

  • Reduce the dose by 3.5 mg per kg if serum creatinine increases to greater than 33% above the average baseline measurement and greater than the age appropriate ULN.

All Patients (regardless of age):

  • Discontinue therapy for serum creatinine greater than 2 times the age-appropriate ULN or for creatinine clearance less than 40 mL/min [see Contraindications (4)].

2.6     Dose Modifications Based on Concomitant Medications

UDP-glucuronosyltransferases (UGT) Inducers

Concomitant use of UGT inducers decreases JADENU systemic exposure. Avoid the concomitant use of potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) with JADENU. If you must administer JADENU with 1 of these agents, consider increasing the initial dose of JADENU by 50%, and monitor serum ferritin levels and clinical responses for further dose modification [see Dosage and Administration (2.1, 2.2), Drug Interactions (7.5)].

Bile Acid Sequestrants

Concomitant use of bile acid sequestrants decreases JADENU systemic exposure. Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with JADENU. If you must administer JADENU with 1 of these agents, consider increasing the initial dose of JADENU by 50%, and monitor serum ferritin levels and clinical responses for further dose modification [see Dosage and Administration (2.1, 2.2), Drug Interactions (7.6)].

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