anagrelide hydrochloride monohydrate: clinical use

Prescribing considerations

• Initiation and supervision should be by a clinician experienced in essential thrombocythaemia.
• Confirm the licensed at-risk context and periodically reassess the diagnosis and ongoing need for treatment.
• Assess renal and hepatic function and cardiovascular risk before treatment.
• Avoid abrupt withdrawal; if treatment is interrupted or stopped, monitor platelet counts frequently because rebound can occur rapidly.
• Use caution in children and adolescents because clinical experience is very limited.

Contraindications and cautions

• Hypersensitivity to anagrelide or an excipient
• Moderate or severe hepatic impairment
• Moderate or severe renal impairment, defined for this product as creatinine clearance below 50 mL/min
• This lactose-containing product is unsuitable for specified rare hereditary disorders of galactose metabolism or absorption

Monitoring

• Full blood count, including platelet, haemoglobin and white-cell counts
• Liver and renal function
• Potassium, magnesium and calcium
• Baseline cardiovascular assessment including ECG and echocardiography, with ongoing assessment for cardiovascular effects
• Symptoms or signs of pulmonary hypertension or other cardiopulmonary disease
• Frequent platelet counts after interruption or withdrawal

Clinical pharmacology

Anagrelide inhibits phosphodiesterase III and reduces platelet formation by disrupting megakaryocyte maturation, size and ploidy. It is primarily metabolised by CYP1A2 to the active metabolite 3-hydroxy-anagrelide and has a short plasma half-life.

Formulation and product differences

• The selected product is a hard gelatin capsule containing lactose monohydrate and is essentially sodium-free.
• The capsule must be swallowed whole and must not be crushed or dispersed in liquid.
• Bottle packaging includes a desiccant and should be kept tightly closed and protected from moisture.

Capsule

Route: Oral

Strengths: 0.5 mg