Miscellaneous hematological agents:

Indications for FERRIPROX TWICE-A-DAY:

Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Limitations of Use:

The safety and efficacy for the treatment of transfusional iron overload in other chronic anemias have not been established.

Adult:

Take with food. Individualize. Round dose to the nearest 500mg. Initially 75mg/kg/day in 2 divided doses (approx. 12hrs apart). Adjust dose to individual response and therapeutic goals; max 99mg/kg/day in 2 divided doses (approx. 12hrs apart). Consider temporary dose interruption if serum ferritin falls consistently <500mcg/L.

Children:

Not established.

Boxed Warning:

Agranulocytosis and neutropenia.

Warnings/Precautions:

Risk of neutropenia or fatal agranulocytosis. Measure ANC before starting therapy and monitor weekly during. Interrupt therapy if infection or neutropenia develops (ANC <1.5×109/L). If neutropenia occurs, obtain CBCs, WBCs, ANC, and platelets daily until recovery (ANC ≥1.5×109/L). Monitor serum ALT monthly; consider interruption if persistent increase in transaminase levels. Monitor serum ferritin every 2–3 months. Monitor plasma zinc and supplement if deficient. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).

Pharmacologic Class:

Iron chelating agent.

Interactions:

Avoid concomitant other drugs associated with neutropenia or agranulocytosis; if unavoidable, closely monitor ANC. Avoid concomitant UGT1A6 inhibitors (eg, diclofenac, probenecid, milk thistle). Allow ≥4-hour interval with antacids or mineral supplements containing polyvalent cations (eg, iron, aluminum, zinc).

Adverse Reactions:

Nausea, vomiting, abdominal pain, increased ALT, arthralgia, neutropenia, chromaturia; agranulocytosis (manage appropriately if occurs; do not resume).

Generic Availability:

NO

How Supplied:

Tabs 500mg—100; 1000mg (three times a day)—50; 1000mg (twice a day)—50, 500; Oral soln—500mL (w. measuring cup)