anagrelide (Rx)

Brand and Other Names:Agrylin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 0.5mg
  • 1mg

Thrombocythemia

Indicated for essential thrombocythemia and for thrombocythemia secondary to myeloproliferative disorders to decrease risk thrombosis and thrombo-hemorrhagic event

0.5 PO q6hr or 1 mg q12hr; increase PRN not more frequently than 0.5 mg/day/week

Not to exceed 10 mg/day or 2.5 mg/dose

Platelet count responds typically in 7-14 days; time to complete response is 4 to 12 weeks

Polycythemia Vera (Orphan)

Orphan indication sponsor

  • Roberts Pharmaceutical Corp; Meridian Center II, 4 Industrial Way West; Eatontown, NJ 07724-2274

Hepatic Impairment

Moderate: Start with 0.5 mg/day for at least 1 week; increase PRN no more frequently than 0.5 mg/day/week

Severe: Contraindicated

Monitor

Platelet count

Dosage Forms & Strengths

capsule

  • 0.5mg
  • 1mg

Thrombocythemia

<7 years

  • Safety and efficacy not established

≥7 years

  • 0.5 mg/day to 0.5 mg PO q6hr; adjust dose PRN no more frequently than 0.5 mg/day/week
  • Platelet count responds typically in 7-14 days; time to complete response is 4 to 12 weeks
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Interactions

Interaction Checker

and anagrelide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (44%)

            Palpitations (26%)

            Diarrhea (26%)

            Asthenia (23%)

            Edema (21%)

            Nausea (17%)

            Abdominal pain (16%)

            Dizziness (15%)

            General pain (15%)

            Dyspnea (12%)

            1-10%

            Flatulence (10%)

            Vomiting (10%)

            Fever (9%)

            Edema (9%)

            Rash (8%)

            Chest pain (8%)

            Anorexia (8%)

            Tachycardia (8%)

            Pharyngitis (7%)

            Malaise (6%)

            Cough (6%)

            Paresthesia (6%)

            Back pain (6%)

            Pruritus (6%)

            Confusion (1-5%)

            Depression

            Migraine

            Myalgia

            Nervousness

            Photosensitivity

            Arthralgia

            Vision abnormalities

            Angina

            Arrhythmia

            Cardiovascular disease

            Heart failure

            Hemorrhage

            Hypertension

            Postural hypotension

            Syncope

            Thrombosis

            Vasodilation

            Bronchitis

            Rhinitis

            Sinusitis

            Constipation

            Dyspepsia

            Gastritis

            Anemia

            Elevated liver enzymes

            Flu symptoms

            Leg cramps

            Dehydration

            Postmarketing Reports

            Interstitial lung diseases, including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis

            Hepatotoxicity

            Tubulointerstitial nephritis

            Supraventricular tachycardia (SVT)

            Hypoesthesia

            Torsades de pointes

            Cardiovascular toxicity

            Pulmonary hypertension

            Bleeding risk

            Pulmonary toxicity

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            Warnings

            Contraindications

            Severe hepatic impairment

            Cautions

            Caution in heart disease, renal impairment, mild-moderate hepatic impairment

            Torsades de pointes and ventricular tachycardia reported; obtain pretreatment cardiovascular exam, including EKG, in all patients

            Hepatic impairment increases anagrelide exposure and could increase risk of QTc prolongation; monitor patients with hepatic impairment for QTc prolongation and other cardiovascular adverse reactions

            Increases QTc interval and heart rate in healthy volunteers; should not be used in patients with known risk factors for QT interval prolongation, such as congenital long QT syndrome, a known history of acquired QTc prolongation, medicinal products that can prolong QTc interval and hypokalemia

            In patients with cardiac disease, use only when benefits outweigh risks

            In patients with heart failure, bradyarrhythmias, or electrolyte abnormalities, consider periodic ECG monitoring

            Orthostatic hypotension reported with higher doses; minimal BP changes observed following 2 mg/dose

            Coadministration with aspirin increases risk for major hemorrhagic event

            Cases of pulmonary hypertension reported; evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during anagrelide therapy

            Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) reported to be associated with use of anagrelide in post-marketing reports; most cases presented with progressive dyspnea with lung infiltrations; time of onset ranged from 1 week to several years after initiating anagrelide; discontinue anagrelide if it occurs and evaluate; symptoms may improve after discontinuation

            Monitor platelets, Hgb, WBC, LFTs, Cr, BUN for at least first 2 weeks

            May induce highoutput heart failure by PDE4 inhibition (may be reversible upon discontinuation)

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            Pregnancy & Lactation

            Pregnancy

            Available data from case reports in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; in animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area; there are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy

            Thrombotic events, such as stroke, deep vein thrombosis, or myocardial infarction, can be complications of thrombocythemia; thrombocythemia in pregnancy is associated with an increased risk for miscarriage, stillbirth, and other maternal outcomes, such as preeclampsia

            Animal data

            • In a pre- and post-natal study conducted in female rats, anagrelide hydrochloride administered at oral doses of 60 mg/kg/day (58 times the maximum clinical dose based on body surface area) or higher during organogenesis through lactation produced delay or blockage of parturition, deaths of non-delivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born

            Infertility

            • Based on findings from animal studies, therapy may impair female fertility

            Lactation

            There is no information regarding presence of drug in human milk, effect on breastfed child, or on milk production; the drug or its metabolites have been detected in milk of lactating rats; because of potential for serious adverse reactions, including thrombocytopenia, in a breastfed child, advise patients that breastfeeding is not recommended during treatment, and for one week following last dose

            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

            Phosphodiesterase 3 (PDE3) inhibitor; inhibits nucleotide PDE and the release of arachidonic acid from phospholipase A2; reduces also platelet production by disrupting the maturation phase of megakaryocytes

            Pharmacokinetics

            Onset of action: Within 7-14 days (initial); 4-12 weeks (complete)

            Peak plasma time: 1 hr

            Duration: 6-24 hr

            Metabolism: Extensive; partially through CYP1A2

            Half-life: 1.3 hr

            Excretion: Urine (<1%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.