Rx Item-Campath Am 10Mg/ml 12X3ml Dshp

These highlights do not include all the information needed to use CAMPATH safely and effectively. See full prescribing information for CAMPATH. CAMPATH � (alemtuzumab) Injection for intravenous use Initial U.S. Approval: 2001 WARNING: CYTOPENIAS, INFUSION REACTIONS, AND INFECTIONS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Serious, including fatal, cytopenias, infusion reactions, and infections can occur (5.1� 5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. (2.1) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion reactions. (5.2) Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections. (2.2, 5.3) INDICATIONS AND USAGE CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). (1) DOSAGE AND ADMINISTRATION Administer as an IV infusion over 2 hours. (2.1) Escalate to recommended dose of 30 mg/day three times per week for 12 weeks. (2.1) Premedicate with oral antihistamine and acetaminophen prior to dosing. (2.2) DOSAGE FORMS AND STRENGTHS 30 mg/1 mL single use vial (3). CONTRAINDICATIONS None (4). WARNINGS AND PRECAUTIONS Cytopenias: Obtain complete blood counts (CBC) and platelet counts at weekly intervals during therapy and CD4 counts after therapy until recovery to ?200 cells/�L. (5.4) Discontinue for autoimmune or severe hematologic adverse reactions. (5.1) Infections: CAMPATH induces severe and prolonged lymphopenia and increases risk of infection. If a serious infection occurs, withhold treatment until infection resolves. (5.3) Do not administer live viral vaccines to patients who have recently received CAMPATH. (5.5) ADVERSE REACTIONS Most common adverse reactions (?10%): cytopenias, infusion reactions, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4-CAMPATH (1-877-422-6728) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 10/2017

Rx Item-Campath Am 10Mg/ml 12X3ml Dshp
Item No.: RX50419-0355-12 NDC No.RX50419035512 UPC No.:350419355124 Item No.: RX50419-0355-12 Generic Name:
Alemtuzumab
Description:
Campath Am 10Mg/ml 12X3ml Dshp
Alt Item #:
32607

Genzyme Corporation
BRAND: CAMPATH NDC: RX50419-0355-12 ,RX50419035512 UPC: 350419-355124,350419355124 Generic Name: ALEMTUZUMAB Description: CAMPATH AM 10MG/ML 12X3ML DSHP Alt Item #: 3260734 NDC: 50419-0355-1

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