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Rx Item-REBLOZYL REBLOZYL (luspatercept-aamt) 75MG/VIAL for injection by Celgen

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Rx Item-REBLOZYL REBLOZYL (luspatercept-aamt) 75MG/VIAL for injection by Celgen

$12762.67$12154.93

REBLOZYL REBLOZYL (luspatercept-aamt) 75MG/VIAL for injection by Celgene USA NDC No. 59572-0775-01 59572-775-01 5957277501 59572077501 UPC/GTIN No.3-59572-77501-5 359572775015 359572-775015 MPN No. 77501 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. Other Name: for: for: Bet

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REBLOZYL (luspatercept-aamt) for injection is a white to off-white lyophilized powder supplied in a single-dose vial. Each carton contains one vial. HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use REBLOZYL safely and effectively. See full prescribing information for REBLOZYL.REBLOZYL� (luspatercept-aamt) for injection, for subcutaneous useInitial U.S. Approval:20 19-------------------------- INDICATIONS AND USAGE--------------------------REBLOZYL is an erythroid maturation agent indicated for the treatment ofanemia in: �Adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions (1.1). -----------------------DOSAGE AND ADMINISTRATION-----------------------�The recommended starting dose is 1 mg/kg once every 3 weeks by subcutaneous injection (2.1). �Review hemoglobin (Hgb) results prior to each administration (2. 1).�See full prescribing information for preparation and administration instructions (2.4). --------------------- DOSAGE FORMS AND STRENGTHS -------------------- �For injection: 25 mg lyophilized powder in a single-dose vial for reconstitution (3).�For injection: 75 mg lyophilized powder in a single-dose vial for reconstitution (3).-------------------------------CONTRAINDICATIONS--------------------------None (4).-----------------------WARNINGS AND PRECAUTIONS--------------------�Thrombosis/Thromboembolism: Increased risk in patients with beta thalassemia. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly (5.1). �Hypertension: Monitor blood pressure (BP) during treatment. Initiate anti-hypertensive treatment if necessary (5.2). �Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception (5.3, 8.1, 8.3). ------------------------------ ADVERSE REACTIONS ------------------------------ The most common adverse reactions (>10%) in patients with beta thalassemia were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea, and dizziness (6. 1). To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.--------------------------USE IN SPECIFIC POPULATIONS---------------------Lactation: Advise not to breastfeed (8.2). See 17 for PATIENT COUNSELING INFORMATION Revised: 11 /2019

Rx Item-REBLOZYL REBLOZYL (luspatercept-
RX59572-0775-01

Rx Item-REBLOZYL REBLOZYL (luspatercept-
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