NESP

NESP Adverse Reactions

darbepoetin alfa

Manufacturer:

Kyowa Kirin

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Adverse Reactions
Adverse reactions were reported in 471 (32.3 %) of 1,462 patients treated with NESP. The major adverse reactions were increased blood pressure in 248 cases (17.0 %), shunt thrombosis/occlusion in 44 cases (3.0 %), headache in 28 cases (1.9 %) and malaise in 20 cases (1.4 %). [Data at the time of approval of NESP Injection].
Clinically significant adverse reactions: Cerebral infarction (0.9 %): Since cerebral infarction may occur, patients should be closely monitored. If any abnormalities are observed, appropriate measures such as discontinuation of NESP should be taken.
Cerebral hemorrhage (0.1 %): Since cerebral hemorrhage may occur, patients should be closely monitored. If any abnormalities are observed, appropriate measures such as discontinuation of NESP should be taken.
Hepatic function disorder, jaundice (0.1 %): Since hepatic function disorder and/or jaundice accompanied by increased ALT (GPT), γ-GTP, etc. may occur, patients should be closely monitored. If any abnormalities are observed, appropriate measures such as discontinuation of NESP should be taken.
Hypertensive encephalopathy (incidence unknown): Since hypertensive encephalopathy may occur, patients should be closely monitored for changes in the blood pressure, etc. during the treatment.
Shock and anaphylactoid reactions (incidence unknown): Since shock and/or anaphylactoid reactions (urticaria, dyspnea, lip edema, pharyngeal edema, etc.) may occur, patients should be closely monitored. If any abnormalities are observed, NESP should be discontinued and appropriate measures should be taken.
Pure red cell aplasia (incidence unknown): Pure red cell aplasia accompanied by production of anti-erythropoietin antibodies may occur. If such a problem is observed, NESP should be discontinued and appropriate measures should be taken.
Myocardial infarction, pulmonary infarction (incidence unknown): Since myocardial infarction and/or pulmonary infarction may occur, patients should be closely monitored. If any abnormalities are observed, appropriate measures such as discontinuation of NESP should be taken.
Other adverse reactions: See Table 7.

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