Ferriprox Oral Solution

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  • Miscellaneous hematological agents

Ferriprox Oral Solution Generic Name & Formulations

General Description

Deferiprone 80mg/mL (bubble gum flavor), 100mg/mL (cherry flavor).

Pharmacological Class

Iron chelating agent.

How Supplied

Tabs 500mg—100; 1000mg (three times a day)—50; 1000mg (twice a day)—50, 500; Oral soln 80mg/mL—250mL, 500mL; 100mg/mL—500mL

Manufacturer

Generic Availability

NO

Ferriprox Oral Solution Indications

Indications

Transfusional iron overload due to thalassemia syndromes, sickle cell disease or other anemias.

Limitations of Use

The safety and efficacy for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or with Diamond Blackfan anemia have not been established.

Ferriprox Oral Solution Dosage and Administration

Adults and Children

<3yrs: not established. Individualize. Round dose to the nearest 2.5mL soln. ≥3yrs: Initially 25mg/kg 3 times daily (total of 75mg/kg/day). Adjust dose to individual response and therapeutic goals; max 33mg/kg 3 times daily (total of 99mg/kg/day). Consider temporary dose interruption if serum ferritin falls consistently <500mcg/L.

Ferriprox Oral Solution Contraindications

Not Applicable

Ferriprox Oral Solution Boxed Warnings

Boxed Warning

Agranulocytosis and neutropenia.

Ferriprox Oral Solution Warnings/Precautions

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).

Ferriprox Oral Solution Pharmacokinetics

See Literature

Ferriprox Oral Solution Interactions

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).

Ferriprox Oral Solution Adverse Reactions

Adverse Reactions

Nausea, vomiting, abdominal pain, increased ALT/AST, arthralgia, neutropenia, chromaturia, pyrexia, bone pain, headache, pain in extremity, sickle cell anemia with crisis, back pain, oropharyngeal pain, nasopharyngitis, cough; agranulocytosis (manage appropriately if occurs; do not resume).

Ferriprox Oral Solution Clinical Trials

See Literature

Ferriprox Oral Solution Note

Not Applicable

Ferriprox Oral Solution Patient Counseling

See Literature