Jadenu

JADENU- deferasirox granule
Catalent Germany Schorndorf GmbH

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

  • JADENU can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
  • Measure serum creatinine and determine creatinine clearance (CLcr) in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine [see Dosage and Administration (2.4, 2.5), Warnings and Precautions (5.1)] .

Hepatic Failure

  • JADENU 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 JADENU 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

  • JADENU 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 JADENU for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)] .

1 INDICATIONS AND USAGE

1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

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 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

JADENU 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 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. This indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

1.3 Limitations of Use

Controlled clinical trials of JADENU with myelodysplastic syndromes (MDS) and chronic iron overload due to blood transfusions have not been performed [see Clinical Studies (14)].

The safety and efficacy of JADENU when administered with other iron chelation therapy have not been established.

2 DOSAGE AND ADMINISTRATION

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 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 [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 or nearest whole sachet content for granules.
  • 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

Swallow JADENU tablets once daily with water or other liquids, preferably at the same time each day. Take JADENU tablets 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 tablets with aluminum-containing antacid products [see Drug Interactions (7.1)]. For 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.

Take JADENU Sprinkle granules on an empty stomach or with a light meal [see Pharmacokinetics (12.3)]. Administer JADENU Sprinkle granules by sprinkling the full dose on soft food (e.g. yogurt or apple sauce) immediately prior to use and administered orally. JADENU Sprinkle granules should be taken once a day, preferably at the same time each day. Do not take JADENU Sprinkle granules 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, the dose should be about 30% lower, rounded to the nearest whole tablet or nearest whole sachet content for granules. The table below provides additional information on dosing conversion to JADENU.

EXJADE Tablets for oral suspension (white round tablet) JADENU Tablets (film coated blue oval tablet) JADENU Sprinkle Granules (white to almost white granules)
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 40 mg/kg/day 28 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 20 mg/kg/day 14 mg/kg/day
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