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ASPARLAS- calaspargase pegol injection, solution


  1. Advise Patients/caregivers Of The Following Risks Of Asparlas:
  2. Manufactured By:

Advise Patients/caregivers Of The Following Risks Of Asparlas: 

Hypersensitivity

Inform patients on the possibility of serious allergic reactions, including anaphylaxis. Instruct the patient on the symptoms of allergic reactions and to seek medical advice immediately if they experience such symptoms[seeWarnings and Precautions (5.1)].

Pancreatitis

Instruct patients on the signs and symptoms of pancreatitis and to seek immediate medical attention if they experience severe abdominal pain[seeWarnings and Precautions (5.2)].

Instruct patients on the risk of hyperglycemia and glucose intolerance. Advise patients to seek medical advice if they experience excessive thirst or any increase in the volume or frequency of urination[seeDosage and Administration (2.2)].

Thombosis

Instruct patients on the risk of thrombosis and to seek medical advice immediately if they experience severe headache, arm or leg swelling, shortness of breath, or chest pain[seeWarnings and Precautions (5.3)].

Hemorrhage

Advise patients to report any unusual bleeding or bruising to their physician[seeWarnings and Precautions (5.4)].

Hepatotoxicity

Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding[seeWarnings and Precautions (5.5)].

Pregnancy and Lactation

Advise female patients of reproductive potential to use effective contraceptive methods while receiving ASPARLAS and for at least 3 months after the last dose. Advise patients to notify their healthcare provider immediately in the event of a pregnancy or if pregnancy is suspected during ASPARLAS treatment. Since there is a potential for an indirect interaction between ASPARLAS and oral contraceptives, the concomitant use of ASPARLAS and oral contraceptives is not recommended[seeUse in Specific Populations (8.3)].

Advise lactating women not to breastfeed during treatment with ASPARLAS and for at least 3 months after the last dose[seeUse in Specific Populations (8.2)].

Manufactured By: 

Servier Pharmaceuticals LLC
Boston, MA 02210
U.S. License No. 2125

Copyright 2018
All rights reserved.

ASPARLASTM is a registered trademark of Servier IP UK Ltd, a wholly owned indirect subsidiary of Les
Laboratoires Servier. Servier Pharmaceuticals LLC is a wholly own subsidiary of Les Laboratoires Servier.



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