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ALIQOPA(copanlisib)for injection, for intravenous use(六)
2018-06-22 02:21:27 来源: 作者: 【 】 浏览:10915次 评论:0
tively. The mean BP started decreasing approximately 2 hours post-infusion; BP remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hypertension [see Dosage and Administration (2.5)].
 
5.4 Non-Infectious Pneumonitis 
 
Non-infectious pneumonitis occurred in 5% of 317 patients treated with ALIQOPA monotherapy [see Adverse Reactions (6.1)]. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of non-infectious pneumonitis [see Dosage and Administration (2.5)].
 
5.5 Neutropenia 
 
Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA monotherapy. Serious neutropenic events occurred in 1.3% [see Adverse Reactions (6.1)]. Monitor blood counts at least weekly during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of neutropenia [see Dosage and Administration (2.5)].
 
5.6 Severe Cutaneous Reactions 
 
Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with ALIQOPA monotherapy, respectively [see Adverse Reactions (6.1)]. Serious cutaneous reaction events were reported in 0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of severe cutaneous reactions [see Dosage and Administration (2.5)].
 
5.7 Embryo-Fetal Toxicity 
 
Based on findings in animals and its mechanism of action, ALIQOPA can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1)].
 
6 ADVERSE REACTIONS 
 
The following serious adverse reactions are described elsewhere in the labeling. 
• Infections [see Warnings and Precautions (5.1)] • Hyperglycemia  [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Non-infectious pneumonitis [see Warnings and Precautions (5.4)] • Neutropenia [see Warnings and Precautions (5.5)] • Severe cutaneous reactions [see Warnings and Precautions (5.6)] 
 
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