Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), Thrombocytopenia (11%), and stomatitis (11%). Infection/influenza/ nasopharyngitis/ bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract The last dose of LYNPARZA and to not donate sperm during this time.ĪDVERSE REACTIONS -First-Line Maintenance BRCAm Advanced Ovarian Potential or who are pregnant to use effective contraception during treatment and for 3 months following Males Advise male patients with female partners of reproductive Risk to a fetus and to use effective contraception during treatment and for 6 months following the last Verify pregnancy status in females of reproductiveįemales Advise females of reproductive potential of the potential Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.Įmbryo-Fetal Toxicity: Based on its mechanism of action and findings inĪnimals, LYNPARZA can cause fetal harm. In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. Venous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE) occurred in patients treated with LYNPARZA. Discontinue LYNPARZA if pneumonitis is confirmed LYNPARZA treatment and initiate prompt investigation. Respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt If patients present with new or worsening Pneumonitis: Occurred in 0.8% of patientsĮxposed to LYNPARZA monotherapy, and some cases were fatal. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologistįor further investigations, including bone marrow analysis and blood sample for cytogenetics.ĭiscontinue LYNPARZA if MDS/AML is confirmed. LYNPARZA and monitor blood count weekly until recovery. For prolonged hematological toxicities, interrupt Monitor complete blood count for cytopenia at baseline and monthly thereafterįor clinically significant changes during treatment. Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previousĬhemotherapy (≤Grade 1).
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