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Anagrelide Hydrochloride (Anagrelide Hydrochloride)

Trade Name : Anagrelide Hydrochloride

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 1 mg/1

ANAGRELIDE HYDROCHLORIDE Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Anagrelide Hydrochloride (Anagrelide Hydrochloride) which is also known as Anagrelide Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1 mg/1 per ml. Read more

Anagrelide Hydrochloride (Anagrelide Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 .
  • Anagrelide is a platelet reducing agent indicated for the treatment of 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. ()
  • No data
  • The starting dose for adults is 0.5 mg four times a day or 1 mg twice a day ()
  • The starting dose for pediatric patients is 0.5 mg per day ()
  • 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 ()
  • Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink u201cIvax hourglass logou201d u201c5241u201d on the cap and u201c0.5 mgu201d on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride).
  • Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink u201cIvax hourglass logou201d u201c5240u201d on the cap and u201c1 mgu201d on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride).
  • Capsules: 0.5 mg, 1 mg ()
  • None.
  • None ()
  • No data
  • Cardiovascular Toxicity: QT prolongation and ventricular tachycardia have been reported with anagrelide. Obtain a pre-treatment cardiovascular examination including an ECG in all patients. Monitor patients for cardiovascular effects. ()
  • Bleeding Risk: Monitor patients for bleeding, including those receiving concomitant therapy with other drugs known to cause bleeding ()
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most common adverse reactions (incidence u2265 5%) are 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 ()
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or
  • No data
  • Other PDE 3 inhibitors:
  • Aspirin and Drugs that Increase Bleeding Risk
  • No data
  • Nursing Mothers:
  • 8.3
  • 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.
  • 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:
  • CHClNOu00b7HClu00b7HO 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.
  • No data
  • No data
  • Clinical Studies in Adult Patients:
  • A total of 942 patients with myeloproliferative neoplasms including 551 patients with Essential Thrombocythemia (ET), 117 patients with Polycythemia Vera (PV), 178 patients with Chronic Myelogenous Leukemia (CML), and 96 patients with other myeloproliferative neoplasms (OMPN), were treated with anagrelide in three clinical trials. Patients with OMPN included 87 patients who had Myeloid Metaplasia with Myelofibrosis (MMM), and 9 patients who had unclassified myeloproliferative neoplasms.
  • Patients were enrolled in clinical trials if their platelet count was u2265 900,000/u03bcL on two occasions or u2265 650,000/u03bcL on two occasions with documentation of symptoms associated with thrombocythemia. The mean duration of anagrelide therapy for ET, PV, CML, and OMPN patients was 65, 67, 40, and 44 weeks, respectively; 23% of patients received treatment for 2 years. Patients were treated with anagrelide starting at doses of 0.5 to 2 mg every 6 hours. The dose was increased if the platelet count was still high, but to no more than 12 mg each day. Efficacy was defined as reduction of platelet count to or near physiologic levels (150,000 to 400,000/u03bcL). The criteria for defining subjects as u201crespondersu201d were reduction in platelets for at least 4 weeks to u2264600,000/u03bcL, or by at least 50% from baseline value. Subjects treated for less than 4 weeks were not considered evaluable. The results are depicted graphically below:
  • *x 10/u03bcL
  • u2020Nine hundred and forty-two subjects with myeloproliferative neoplasms were enrolled in three research studies. Of these, 923 had platelet counts measured over the duration of the studies.
  • Anagrelide was effective in phlebotomized patients as well as in patients treated with other concomitant therapies including hydroxyurea, aspirin, interferon, radioactive phosphorus, and alkylating agents.
  • Clinical Study in Pediatric Patients:
  • An open label safety and PK/PD study was conducted in 18 pediatric patients 7 to 16 years of age (8 patients 7 to 11 years of age and 10 patients 12 to 16 years of age, mean age of 12 years; 8 males and 10 females) with thrombocythemia secondary to ET as compared to 17 adult patients (mean age of 66 years, 9 males and 8 females). Prior to entry on to the study, 17 of 18 pediatric patients and 12 of 17 adult patients had received anagrelide treatment for an average of 2 years. The median starting total daily dose, determined by retrospective chart review, for pediatric and adult patients with ET who had received anagrelide prior to study entry was 1 mg for each of the three age groups (7 to 11 and 12 to 16 year old patients and adults). The starting dose for 6 anagrelide-naive patients at study entry was 0.5 mg once daily. At study completion, the median total daily maintenance doses were similar across age groups, median of 1.75 mg for patients of 7 to 11 years of age, 2.25 mg in patients 12 to 16 years of age, and 1.5 mg for adults.
  • Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink u201cIvax hourglass logou201d u201c5241u201d on the cap and u201c0.5 mgu201d on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP).
  • NDC 0172--60t0.5 mg packaged in bottles of 100 capsules
  • Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink u201cIvax hourglass logou201d u201c5240u201d on the cap and u201c1 mgu201d on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP).
  • NDC 0172--60t1 mg packaged in bottles of 100 capsules
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [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.
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. J 3/2016
  • No data
  • No data

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