Anagrelide

What is Anagrelide?

• Anagrelide (Agrylin) is a platelet reducing agent used to decrease the number of platelets in the blood of patients who have a bone marrow disorder, in which the body makes too many of one or more types of blood cells, such as essential thrombocythemia or polycythemia vera.

Anagrelide

Anagrelide2DACS

What are the uses of this medicine?

• Anagrelide (Agrylin) used for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

How does this medicine work?

• Anagrelide (an ag' re lide) is platelet reducing agent that is used to treat thrombocytosis due to myeloproliferative diseases.
• Its mechanism of action is not well defined, but it appears to inhibit the maturation and differentiation of megakaryocytes, and both synthesis and release of platelets as well as subsequent platelet aggregation.
• In addition, anagrelide inhibits phosphodiesterase-3 which causes vasodilation and may account for many of its side effects.
• In several open label trials, anagrelide was shown to reduce platelet counts in patients with thrombocythemia due to essential thrombocytosis and other myeloproliferative diseases.
• Severe thrombocythemia is associated with an increased risk of arterial and venous thromboses including transient ischemic attacks, stroke, myocardial infarction and other thrombotic ischemic conditions.
• Less commonly, thrombocytosis is associated with venous thromboses including deep vein thrombosis, pulmonary embolus and portal or splanchnic vein thrombosis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• atazanavir (Reyataz)
• cilostazol (Pletal)
• cimetidine (Tagamet)
• clozapine (Clozaril)
• cyclobenzaprine (Flexeril)
• fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin)
• fluvoxamine (Luvox)
• imipramine (Tofranil)
• inamrinone
• mexiletine (Mexitil)
• milrinone (Primacor)
• naproxen (Aleve, Naprosyn, in Prevacid NapraPAC)
• riluzole (Rilutek)
• sucralfate (Carafate)
• tacrine (Cognex)
• theophylline (Elixophyllin, Theo-24, Theolair, others)
• ticlopidine (Ticlid)

Is this medicine FDA approved?

• Anagrelide was approved for use in thrombocythemia due to myeloproliferative diseases in 1997, but is considered a second line agent, appearing to be less effective and less well tolerated than hydroxyurea.

How should this medicine be used?

Recommended dosage: Adults:

• The recommended starting dosage of Agrylin is 0.5 mg four times daily or 1 mg twice daily.

Pediatric Patients:

• The recommended starting dosage of Agrylin is 0.5 mg daily.

• Maintain the starting dose for at least one week and then titrate to maintain target platelet counts.
• Do not exceed a dose increment of 0.5 mg/day in any one week. Do not exceed 10 mg/day or 2.5 mg in a single dose.

Moderate hepatic impairment:

• Start with 0.5 mg per day.

Administration:

• Anagrelide comes as a capsule to take by mouth.
• It is usually taken with or without food two to four times a day.
• Take anagrelide at around the same times every day.
• Your doctor will probably start you on a low dose of anagrelide and gradually increase your dose, not more often than once a week.
• Your doctor may change your dose during your treatment based upon your body's response to the medication.
• Anagrelide may help control your condition but will not cure it.
• Continue to take anagrelide even if you feel well.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 0.5 mg.

This medicine is available in fallowing brand namesː

• Agrylin

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• palpitations
• diarrhea
• asthenia
• edema
• nausea
• abdominal pain
• dizziness
• pain
• dyspnea
• cough
• flatulence
• vomiting
• fever
• peripheral edema
• rash
• chest pain
• anorexia
• tachycardia
• malaise
• paresthesia
• back pain
• pruritus
• dyspepsia

• Rare, but potentially severe adverse reactions include arrhythmias, prolongation of the QTc interval, excessive bleeding and interstitial nephritis.

What special precautions should I follow?

• Torsades de pointes and ventricular tachycardia have been reported with Agrylin. QT prolongation and ventricular tachycardia have been reported with Agrylin. Obtain a pre-treatment cardiovascular examination including an ECG in all patients. Monitor patients for cardiovascular effects.
• Cases of pulmonary hypertension have been reported in patients treated with Agrylin. Assess underlying cardiopulmonary disease prior to initiating therapy.
• Warn the patient that concomitant aspirin (or other medicines that affect blood clotting) may increase the risk of bleeding. Tell the patient to contact a doctor immediately if they experience signs or symptoms of bleeding (e.g., vomit blood, pass bloody or black stools) or experience unexplained bruising/bruise more easily than usual.
• Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported to be associated with the use of Agrylin. If suspected, discontinue Agrylin and evaluate. Symptoms may improve after discontinuation.
• Anagrelide has had limited clinical use, but has not been linked to significant serum enzyme elevations during therapy or to instances of clinically apparent acute liver injury.
• Tell the patient that their dose will be adjusted on a weekly basis until they are on a dose that lowers their platelets to an appropriate level. This will also help the patient to adjust to common side effects. Tell the patient to contact their doctor if they experience tolerability issues, so the dose or dosing frequency can be adjusted.
• Advise patients not to breastfeed during treatment with Agrylin, and for one week following the last dose.
• Advise females of reproductive potential treatment with Agrylin may impair fertility.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• sinus tachycardia
• vomiting
• thrombocytopenia

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In case of overdosage, stop Agrylin dosing and monitor platelet counts for thrombocytopenia and observe for possible complications such as bleeding.
• Consider resumption of Agrylin dosing once the platelet count returns to the normal range.

Can this medicine be used in pregnancy?

• Available data from case reports with Agrylin use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Agrylin have been established in pediatric patients 7 years of age and older.
• There are no data for pediatric patients less than 7 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• ANAGRELIDE HYDROCHLORIDE ANHYDROUS

Inactive Ingredients:

• ANHYDROUS LACTOSE
• CROSPOVIDONE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POVIDONE K30

Who manufactures and distributes this medicine?

Distributed by:

• Takeda Pharmaceuticals America, Inc.
• Lexington, MA

• Agrylin® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F).
• Store in a light resistant container.

• Dailymed label info on Anagrelide
• FDA Anagrelide

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