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deferiprone (Rx)Brand and Other Names:Ferriprox

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 500mg
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Transfusional Iron Overload

Iron chelator indicated for treatment of transfusional iron overload caused by thalassemia syndromes when current chelation therapy is inadequate

Approval based on serum ferritin level reduction; no controlled trials demonstrating a direct treatment benefit (eg, improvement in disease-related symptoms, functioning, or increased survival)

25-33 mg/kg PO TID (ie, total daily dosage range 75-99 mg/kg/day)  

Round dose to nearest 250 mg (half-tablet)

Monitoring and dose adjustments

  • Monitor serum ferritin concentration every 2-3 months to assess the effects on body iron stores
  • Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden)
  • If the serum ferritin falls consistently <500 mcg/L, consider temporarily interrupting therapy

Siderosis (Orphan)

Orphan designation for treatment of superficial siderosis

Orphan sponsor

  • ApoPharma, Inc; 200 Barmac Drive; Canada

Safety and efficacy not established

Safety and effectiveness in elderly individuals have not been established

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

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Interactions

Interaction Checker

deferiprone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Chromaturia (14.6%)

            Nausea (12.6%)

            Abdominal pain/discomfort (10.4%)

            1-10%

            Arthralgia (9.8%)

            Vomiting (9.8%)

            Increased ALT (7.5%)

            Decreased neutrophil count (7.3%)

            Neutropenia (6.2%)

            Increased appetite (4%)

            Diarrhea (3%)

            Headache (2.5%)

            Dyspepsia (2%)

            Back pain (2%)

            Extremity pain (1.9%)

            Increased weight (1.9%)

            Agranulocytosis (1.7%)

            Arthropathy (1.4%)

            Increased AST (1.2%)

            Decreased appetite (1.1%)

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            Warnings

            Black Box Warnings

            Can cause agranulocytosis that can lead to serious infections and death; neutropenia may precede agranulocytosis

            Measure absolute neutrophil count (ANC) before initiating and monitor weekly while on therapy

            Interrupt treatment if infection develops and monitor ANC more frequently

            Advise patients taking to report immediately any symptoms indicative of infection

            Contraindications

            Hypersensitivity; Henoch-Schönlein purpura, urticaria, and periorbital edema with skin rash have been reported

            Cautions

            Fatal agranulocytosis can occur; interrupt therapy if neutropenia develops (ANC <1.5 x 10^9/L)

            If infection occurs, interrupt therapy and monitor the ANC more frequently

            Pregnancy; can cause fetal harm; women should be advised of the potential hazard to the fetus and to avoid pregnancy while on this drug

            Monitor serum ferritin concentration every 2-3 months to assess the effects on body iron stores

            Avoid coadministration with other drugs known to cause neutropenia or agranulocytosis; however, if this is not possible, closely monitor the absolute neutrophil count

            Allow at least a 4-hour interval between deferiprone and mineral supplements, and antacids that contain polyvalent cations (eg, iron, aluminum, zinc) to avoid binding and malabsorption of supplements

            Caution is administered with UGT 1A6 inhibitor (eg, silymarin [milk thistle])

            Thorough QT interval studies have not been conducted

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            Pregnancy & Lactation

            Pregnancy Category: D; can cause fetal harm when administered to pregnant women

            In animal studies, administration during organogenesis resulted in embryofetal death and malformations at doses lower than equivalent human clinical doses

            There are no studies in pregnant women, and available human data are limited

            Lactation: Unknown whether distributed in breast milk; because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Chelating agent with an affinity for ferric ion (iron III); binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable over a wide range of pH values

            Has a lower binding affinity for other metals (eg, copper, aluminum, zinc) than for iron

            Metabolism

            Primarily eliminated via metabolism to the 3-O-glucuronide (lacks iron binding capability)

            UGT 1A6 is primarily responsible for glucuronidation

            Elimination

            Half-life: 1.9 hr

            Excretion: 75-90% excreted within 24 hr in urine as metabolite

            Absorption

            Absorption: Rapidly absorbed from upper GI within 5-10 minutes of PO administration

            Peak Plasma Time: 1 hr (fasting); 2 hr (with food)

            Peak Plasma Concentration: 20 mcg/mL

            AUC: 53 mcg•hr/mL

            Food decreases Cmax by 38% and AUC by 10%, but magnitude of exposure change does not warrant dose adjustment

            Distribution

            Protein Bound: <10%

            Vd: 1.6 L/kg (in patients with thalassemia); 1 L/kg (in healthy subjects)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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