"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reaction information for Ferriprox represents the pooled data collected from 642 patients who participated in single arm or active-controlled clinical studies.
The most serious adverse reaction reported in clinical trials with Ferriprox was agranulocytosis [see WARNINGS AND PRECAUTIONS].
The table below lists the adverse drug reactions that occurred in at least 1% of patients treated with Ferriprox in clinical trials.
Table 2: Adverse drug reactions occurring in ≥
1% of 642 Ferriprox-treated patients
|Body System Preferred Term||% Subjects|
|BLOOD AND LYMPHATIC SYSTEM DISORDERS|
|Alanine Aminotransferase increased||7.5|
|Neutrophil count decreased||7.3|
|Aspartate Aminotransferase increased||1.2|
|METABOLISM AND NUTRITION DISORDERS|
|MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS|
|Pain in extremity||1.9|
|NERVOUS SYSTEM DISORDERS|
Gastrointestinal symptoms such as nausea, vomiting, and abdominal pain were the most frequent adverse reactions reported by patients participating in clinical trials and led to the discontinuation of Ferriprox therapy in 1.6% of patients.
Chromaturia (reddish/brown discoloration of the urine) is a result of the excretion of the iron in the urine.
The following additional adverse reactions have been reported in patients receiving Ferriprox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Cardiac disorders: atrial fibrillation, cardiac failure.
Congenital, familial and genetic disorders: hypospadias.
General disorders and administration site conditions: chills, pyrexia, edema peripheral, multi-organ failure.
Immune system disorders: anaphylactic shock, hypersensitivity.
Investigations: blood bilirubin increased, blood creatinine phosphokinase increased.
Metabolism and nutrition disorders: metabolic acidosis, dehydration.
Renal disorders: glycosuria, hemoglobinuria.
Read the Ferriprox (deferiprone) Side Effects Center for a complete guide to possible side effects
Drugs Associated With Neutropenia Or Agranulocytosis
Avoid concomitant use of Ferriprox with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is not possible, closely monitor the absolute neutrophil count [see WARNINGS AND PRECAUTIONS].
Deferiprone is primarily eliminated via metabolism to the 3-O-glucuronide. In vitro studies suggest that UDP glucuronosyltransferase (UGT) 1A6 is primarily responsible for the glucuronidation of deferiprone which can be reduced up to 78% in the presence of the UGT1A6 inhibitor phenylbutazone. However, the clinical significance of coadministration of Ferriprox with a UGT1A6 inhibitor (e.g. diclofenac, probenecid, or silymarin (milk thistle)) on the systemic exposure of deferiprone has not been determined. Closely monitor patients for adverse reactions that may require downward dose titration or interruption when Ferriprox is concomitantly administered with a UGT1A6 inhibitor.
Concurrent use of Ferriprox with foods, mineral supplements, and antacids that contain polyvalent cations has not been studied. However, since deferiprone has the potential to bind polyvalent cations (e.g., iron, aluminum, and zinc), allow at least a 4-hour interval between Ferriprox and other medications (e.g., antacids), or supplements containing these polyvalent cations [see DOSAGE AND ADMINISTRATION].
Read the Ferriprox Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/24/2016
Additional Ferriprox Information
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