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Rx Item-Agrylin 0.5mg Cap 100 By Takeda Pharma

NDC No.54092-0063-01 UPC/GTIN No.3-54092-06301-7 MPN No. 6301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Agrylin 0.5mg Cap 100 By Takeda Pharma

$992.31$989.00

RX9154678 915678 NDC No.54092-0063-01 54092-063-01 54092006301 5409206301 UPC/GTIN No. 3-54092-06301-7 354092-063017 354092063017 MPN No. 6301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item. Rx Item No.Rx915678 Agrylin 0.5mg Cap 100 By Shire Pharma Item No.3915678 NDC No.54092006301 UPC N

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Clinical Information
Gen. Code and Des.
30949 anagrelide HCl ORAL CAPSULE 0.5 MG
GCN and Des.
22391 anagrelide HCl ORAL CAPSULE 0.5 MG
Strength
0.5MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
20121400 PLATELET-REDUCING AGENTS
Active Ingredients
6436 anagrelide HCl 58579514
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398
2549 gelatin 9000708

These highlights do not include all the information needed to use AGRYLIN safely and effectively. See full prescribing information for AGRYLIN.

AGRYLIN® (anagrelide) capsules, for oral use
Initial U.S. Approval: 1997
INDICATIONS AND USAGE

AGRYLIN 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. (1)
DOSAGE AND ADMINISTRATION

The starting dose for adults is 0.5 mg four times a day or 1 mg twice a day. (2.1)
The starting dose for pediatric patients is 0.5 mg per day. (2.1)
Maintain the starting dose for at least one week and then titrate to maintain target platelet counts. (2.2)
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. (2.2)
Moderate hepatic impairment: Start with 0.5 mg per day. (2.3)

DOSAGE FORMS AND STRENGTHS

Capsules: 0.5 mg. (3)
CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

Cardiovascular Toxicity: 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. (5.1)
Pulmonary Hypertension: Assess underlying cardiopulmonary disease prior to initiating therapy. (5.2)
Bleeding Risk: Monitor patients for bleeding, including those receiving concomitant therapy with other drugs known to cause bleeding. (5.3)

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 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, and dyspepsia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Other PDE3 inhibitors: Exacerbation of inotropic effects. (7.2)
Aspirin and Drugs that Increase Bleeding Risk: Increased risk of bleeding with concomitant use. (7.3)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2021

NDC No.54092-0063-01 UPC/GTIN No.3-54092-06301-7 MPN No. 6301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,
Rx Item-Agrylin 0.5mg Cap 100 By Shire P
NDC No.54092-0063-01 UPC/GTIN No.3-54092-06301-7 MPN No. 6301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ANAGRELIDE HCL ORAL CAPSU
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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