Anagrelide Hydrochloride

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Overview

What is Anagrelide Hydrochloride?

Anagrelide hydrochloride, USP is a platelet-reducing agent. Its chemical name is 6,7-dichloro-1,5-dihydroimidazo[2,1-b] quinazolin-2(3H)-one monohydrochloride monohydrate and it has the following structural formula:

CHClNO·HCl·HO M.W. 310.56

Anagrelide hydrochloride, USP is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide.

Each Anagrelide Capsule USP, for oral administration, contains either 0.5 mg or 1 mg of anagrelide base (as anagrelide hydrochloride, USP) and has the following inactive ingredients: black iron oxide, crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Blue #1/Brilliant Blue Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red Aluminum Lake, gelatin, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze and titanium dioxide.

What does Anagrelide Hydrochloride look like?

What are the available doses of Anagrelide Hydrochloride?

Capsules: 0.5 mg, 1 mg ()

What should I talk to my health care provider before I take Anagrelide Hydrochloride?

How should I use Anagrelide Hydrochloride?

Anagrelide capsules are indicated 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 .

Adults: The recommended starting dosage of anagrelide capsules is 0.5 mg four times daily or 1 mg twice daily.

Pediatric Patients: The recommended starting dosage of anagrelide capsules is 0.5 mg daily.

What interacts with Anagrelide Hydrochloride?

Sorry No Records found

What are the warnings of Anagrelide Hydrochloride?

Sorry No Records found

What are the precautions of Anagrelide Hydrochloride?

Sorry No Records found

What are the side effects of Anagrelide Hydrochloride?

Sorry No records found

What should I look out for while using Anagrelide Hydrochloride?

None.

What might happen if I take too much Anagrelide Hydrochloride?

At higher than recommended doses, this medicine has been shown to cause hypotension. There have been postmarketing case reports of intentional overdose with anagrelide hydrochloride. Reported symptoms include sinus tachycardia and vomiting. Symptoms resolved with supportive management. Platelet reduction from anagrelide therapy is dose-related; therefore, thrombocytopenia, which can potentially cause bleeding, is expected from overdosage.

In case of overdosage, close clinical supervision of the patient is required; this especially includes monitoring of the platelet count for thrombocytopenia. Dosage should be stopped, as appropriate, until the platelet count returns to within the normal range.

How should I store and handle Anagrelide Hydrochloride?

HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5241” on the cap and “0.5 mg” on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP). Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5240” on the cap and “1 mg” on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5241” on the cap and “0.5 mg” on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP). Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5240” on the cap and “1 mg” on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5241” on the cap and “0.5 mg” on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP). Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5240” on the cap and “1 mg” on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5241” on the cap and “0.5 mg” on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP). Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5240” on the cap and “1 mg” on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5241” on the cap and “0.5 mg” on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP). Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5240” on the cap and “1 mg” on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

The precise mechanism by which anagrelide reduces blood platelet count is unknown. In cell culture studies, anagrelide suppressed expression of transcription factors including GATA-1 and FOG-1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.

Non-Clinical Toxicology

None.

Concomitant use of isosorbide mononitrate with phosphodiesterase inhibitors in any form is contraindicated (see ).

Concomitant use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).

The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

Torsades de pointes and ventricular tachycardia have been reported with anagrelide. Obtain a pre-treatment cardiovascular examination including an ECG in all patients. During treatment with anagrelide monitor patients for cardiovascular effects and evaluate as necessary.

Anagrelide increases the QTc interval of the electrocardiogram and increases the heart rate in healthy volunteers .

Do not use anagrelide 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 .

Hepatic impairment increases anagrelide exposure and could increase the risk of QTc prolongation. Monitor patients with hepatic impairment for QTc prolongation and other cardiovascular adverse reactions. The potential risks and benefits of anagrelide therapy in a patient with mild and moderate hepatic impairment should be assessed before treatment is commenced. Reduce anagrelide dose in patients with moderate hepatic impairment. Use of anagrelide in patients with severe hepatic impairment has not been studied .

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

Anagrelide is a phosphodiesterase 3 (PDE3) inhibitor and may cause vasodilation, tachycardia, palpitations, and congestive heart failure. Other drugs that inhibit PDE3 have caused decreased survival when compared with placebo in patients with Class III-IV congestive heart failure see .

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

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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