Deferiprone Interactions

Brand names: Deferiprone

Iron Chelator · Iron Chelating Activity

Route: Oral

FDA Black Box Warning

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA Deferiprone can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions (5.1) ] Measure the absolute neutrophil count (ANC) before starting deferiprone therapy and monitor regularly while on therapy. Interrupt deferiprone therapy if neutropenia develops. [see Warnings and Precautions (5.1) ] Interrupt deferiprone if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions (5.1) ] Advise patients taking deferiprone to report immediately any symptoms indicative of infection. [see Warnings and Precautions (5.1) ] WARNING: AGRANULOCYTOSIS AND NEUTROPENIA See full prescribing information for complete boxed warning. Deferiprone can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. ( 5.1 ) Measure the absolute neutrophil count (ANC) before starting deferiprone and monitor regularly while on therapy. ( 5.1 ) Interrupt deferiprone therapy if neutropenia develops. ( 5.1 ) Interrupt deferiprone if infection develops and monitor the ANC more frequently. ( 5.1 ) Advise patients taking deferiprone to report immediately any symptoms indicative of infection. ( 5.1 )

Contraindications

4 CONTRAINDICATIONS Deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash [see Adverse Reactions (6.2) ]. Hypersensitivity to deferiprone or to any of the excipients in the formulations. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary In animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (MRHD) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see Data ) . The limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Based on evidence and developmental toxicity in animal studies, deferiprone can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage is 2 to 4% and 15 to 20%, respectively. Data Human Data Post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: Of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. Of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. Animal Data During organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. The daily dose was administered as two equal divided doses approximately

3 interactions on record

UGT1A6 inhibitor (milk thistle); avoid co-administration with FERRIPROX.

Source: NLP:deferiprone