NESP Adverse Reactions

General: In the post-marketing experience, severe cutaneous reactions including blistering, skin exfoliation, Erythema multiforme and SJS/TEN, which can be life-threatening or fatal, have been reported in patients treated with darbepoetin alfa.
Renal Anemia: Adverse reactions were reported in 472 (32.3%) of 1462 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 29 cases (2.0%) and malaise in 20 cases (1.4%). [Data at the time of approval of NESP Injection].
Anemia with myelodysplastic syndrome: Adverse reactions including laboratory data abnormalities were reported in 18 (34.6%) of 52 patients including 31 Japanese patients in the safety analysis set of international joint study (phase 2 study). The major adverse reactions were diarrhea in 2 cases (3.8%), blood alkaline phosphatase increased in 2 cases (3.8%), hyperuricaemia in 2 cases (3.8%), folate deficiency in 2 cases (3.8%), headache in 2 cases (3.8%) and hypertension in 2 cases (3.8%). [Data at the time of approval of additional indication].
Clinically significant adverse reactions: Cerebral infarction (0.8%): 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 anaphylaxis (incidence unknown): Since shock and/or anaphylaxis (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 8.

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