JADENU SPRINKLE Rx

Indications for JADENU SPRINKLE:

Chronic iron overload due to blood transfusions in patients ≥2yrs of age. Chronic iron overload in patients ≥10yrs of age with non-transfusion dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5mg Fe per gram of dry weight and a serum ferritin >300mcg/L.

Limitations Of use:

Safety and efficacy with concomitant other iron chelation therapy not established.

Adults and Children:

Calculate dose to nearest whole tab or sachet (for granules). May be taken on an empty stomach or with a light meal (<7% fat content). Tabs: swallow whole with water at same time each day. If unable to swallow whole, tabs may be crushed and mixed with soft foods (eg, yogurt or apple sauce) immediately prior to administration. Oral granules: sprinkle full dose on soft foods immediately prior to administration. Transfusional iron overload: <2yrs: not established. ≥2yrs: initially 14mg/kg once daily; may adjust dose by 3.5mg/kg or 7mg/kg every 3–6 months based on serum ferritin levels or response. If inadequate control at 21mg/kg, may consider increasing up to max 28mg/kg. Adjust dose if severe skin rashes occur; consider suspending therapy if serum ferritin <500mcg/L. NTDT syndromes: <10yrs: not established. ≥10yrs: initially 7mg/kg once daily; if baseline LIC>15mg Fe/g dw, consider increasing dose to 14mg/kg/day after 4 weeks. Suspend therapy if serum ferritin <300mcg/L and obtain LIC to determine whether it has fallen to <3mg Fe/g dw. After 6 months, if LIC remains >7mg Fe/g dw, increase dose to max 14mg/kg/day. If after 6 months, LIC is 3–7mg Fe/g dw, continue with max 7mg/kg/day. When LIC is <3mg Fe/g dw, interrupt treatment and continue to monitor LIC. Restart when LIC rises again to >5mg Fe/g dw. Moderate hepatic impairment or renal impairment (CrCl 40–60mL/min): reduce dose by 50%. Severe hepatic impairment: avoid. Conversion from Exjade, dose modifications: see full labeling.

Contraindications:

eGFR <40mL/min/1.73m². Poor performance status. High risk myelodysplastic syndromes. Advanced malignancies. Platelets <50x10⁹/L.

Boxed Warning:

Renal failure. Hepatic failure. GI hemorrhage.

Warnings/Precautions:

Risk of renal or hepatic injury/failure, GI hemorrhage; may be fatal (monitor). Advanced disease or co-morbid conditions. Increased risk of acute kidney injury or liver failure in pediatrics from acute illnesses associated with volume depletion or overchelation; monitor frequently. Renal tubular toxicity including Fanconi Syndrome. Obtain baseline serum ferritin level, monitor monthly and adjust dose accordingly. Measure serum creatinine in duplicate before starting therapy; monitor for eGFR changes, renal toxicity weekly during 1^st month then at least monthly thereafter; more frequently if pre-existing renal disease or decreased function. Obtain urinalyses, serum electrolytes to evaluate renal tubular function. Measure serum transaminases, bilirubin before initiating therapy then every 2 weeks during 1^st month, then monthly. Monitor blood counts; interrupt therapy if cytopenias develop. For NTDT syndromes: obtain LIC by liver biopsy prior to starting therapy, monitor LIC every 6 months. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, erythema multiforme); discontinue if suspected and do not restart. Do baseline auditory and ocular exams, then every 12 months; if disturbances occur, adjust dose or suspend therapy. Elderly: monitor. Pregnancy. Nursing mothers: not recommended.

See Also:

JADENU

Pharmacological Class:

Iron chelating agent.

Interactions:

Avoid aluminum-containing antacids, bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol), or strong UGT inducers (eg, rifampicin, phenytoin, phenobarbital, ritonavir); if co-administration necessary consider increasing initial Jadenu dose by 50% and monitor serum ferritin levels and clinical responses. Caution with drugs that have ulcerogenic or hemorrhagic potential (eg, NSAIDs, corticosteroids, oral bisphosphonates, anticoagulants) or drugs metabolized by CYP3A4 (eg, alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, others). Potentiates repaglinide (consider reducing repaglinide dose); monitor blood glucose levels. Caution with other CYP2C8 substrates (eg, paclitaxel). Avoid concomitant theophylline or other CYP1A2 substrates with narrow therapeutic index (eg, tizanidine); if concomitant theophylline necessary, consider adjusting theophylline dose and monitor.

Adverse Reactions:

Diarrhea, vomiting, nausea, abdominal pain, elevated serum creatinine, rash or skin reactions (may be severe); renal or hepatic injury/failure, GI hemorrhage, cytopenias (eg, agranulocytosis, neutropenia, thrombocytopenia, anemia), auditory and ocular abnormalities, hypersensitivity reactions.

Generic Availability:

NO

How Supplied:

Tabs—30; Sachets—30