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详细处方信息以本药内容附件PDF文件（201951522274830.pdf）的“原文Priscribing Information”为准
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部分中文ODEFSEY处方资料（仅供参考）

【英文名称】ODEFSEY

【适用证】

ODEFSEY是恩曲他滨（FTC）和替诺福韦艾拉酚胺（TAF）的三种药物组合，HIV核苷类似物逆转录酶抑制剂（NRTIs）和rilpivirine（RPV），一种非核苷类逆转录酶抑制剂（NNRTI），在没有抗逆转录病毒治疗史且HIV-1 RNA小于或等于100,000拷贝/ mL的患者中，对于体重至少为35kg的患者进行HIV-1感染治疗的完整方案被指出;或者在病毒学抑制的患者（HIV-1 RNA低于50拷贝/ mL）中替代稳定的抗逆转录病毒治疗方案至少6个月，没有治疗失败史且没有与ODEFSEY的个体成分抗性相关的已知替代。 （1）

使用限制：

治疗开始时HIV-1 RNA大于100,000拷贝/ mL的更多rilpivirine治疗患者出现病毒学失败（HIV-1RNA≥50拷贝/ mL），而rilpivirine治疗的HIV-1 RNA低于或等于100,000拷贝/ mL。 （14.2,14.3）

【用法用量】

测试：在启动ODEFSEY之前或之时，测试乙型肝炎病毒感染。 在开始ODEFSEY之前或之时，以及在临床上适当的时间表治疗期间，评估所有患者的血清肌酸酐，估计的肌酸酐清除率，尿糖和尿蛋白。 在慢性肾病患者中，还要评估血清磷（2.1）

推荐剂量：每日一次口服一片，一餐。（2.2）

对于怀孕前已服用ODEFSEY并且病毒学抑制（HIV-1 RNA低于50拷贝/ mL）的怀孕患者，可以继续每天服用一片。 在怀孕期间观察到较低的利司韦林暴露，因此应密切监测病毒载量。（2.3）

肾功能损害：估计肌酐清除率低于每分钟30 mL的患者不建议使用ODEFSEY。（2.4）

【禁忌】

当与药物共同给药时，ODEFSEY是禁忌的，其中可能发生RPV血浆浓度的显着降低，这可能导致病毒学应答的丧失以及可能的抗性和交叉抗性。（4）

【使用注意】

皮肤和超敏反应：在含有RPV的方案的上市后体验中已经报道了严重的皮肤和过敏反应，包括与嗜酸粒细胞增多症和系统症状（DRESS）的药物反应的病例。如果过敏或出现全身症状或肝脏血清生化指标升高的皮疹，则立即停止治疗，并密切监测临床状态，包括肝血清生化。 （5.2）

肝毒性：接受含RPV方案的患者报告了肝脏不良事件。在患有潜在肝病或肝脏相关检查显着升高的患者中，在ODEFSEY治疗前和治疗期间监测肝脏相关检查。还要考虑在没有风险因素的患者中监测肝脏相关检查。 （5.3）

抑郁症：已报道严重抑郁症。建议对严重抑郁症进行即时医学评估。 （5.4）

新发病或恶化的肾功能损害：在开始ODEFSEY时和在所有患者的临床适当时间表治疗期间评估血清肌酐，估计的肌酐清除率，尿糖和尿蛋白。还评估慢性肾病患者的血清磷。 （5.5）

同时使用ODEFSEY与已知风险的药物延长心电图的QTc间期可能会增加Torsade de Pointes的风险。 （5.6）

乳酸性酸中毒/严重肝肿大伴脂肪变性：对出现症状或实验室检查结果提示乳酸性酸中毒或明显肝毒性的患者，停止治疗。 （5.7）

免疫重建综合征：可能需要进一步评估和治疗。 （5.8）

【INDICATIONS AND USAGE】

ODEFSEY is a three-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), and is indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY. (1)

Limitations of Use:

More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥ 50 copies/mL) compared to rilpivirine treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. (14.2,14.3)

【CONTRAINDICATIONS】

ODEFSEY is contraindicated when coadministered with drugs where significant decreases in RPV plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance. (4)

【WARNINGS AND PRECAUTIONS】

Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during postmarketing experience with RPV-containing regimens, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Immediately discontinue treatment if hypersensitivity or rash with systemic symptoms or elevations in hepatic serum biochemistries develops and closely monitor clinicalstatus, including hepatic serum biochemistries. (5.2)

Hepatotoxicity: Hepatic adverse events have been reported in patients receiving an RPV containing regimen. Monitor liver-associated tests before and during treatment with ODEFSEY in patients with underlying hepatic disease or marked elevations in liver-associated tests. Also consider monitoring liver-associated tests in patients without risk factors. (5.3)

Depressive disorders: Severe depressive disorders have been reported. Immediate medical evaluation is recommended for severe depressive disorders. (5.4)

New onset or worsening renal impairment: Assessment of serum creatinine, estimated creatinine clearance, urine glucose, and urine protein when initiating ODEFSEY and during therapy on a clinically appropriate schedule in all patients. Also assess serum phosphorus in patients with chronic kidney disease. (5.5)

Concomitant use of ODEFSEY with drugs with a known risk to prolong the QTc interval of the electrocardiogram may increase the risk of Torsade de Pointes. (5.6)

Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.7)

Immune reconstitution syndrome: May necessitate further evaluation and treatment. (5.8)

【DOSAGE AND ADMINISTRATION】

Testing: Prior to or when initiating ODEFSEY, test for hepatitis B virus infection. Prior to or when initiating ODEFSEY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus (2.1)

Recommended dosage: one tablet taken orally once daily with a meal. (2.2)

For pregnant patients who are already on ODEFSEY prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely. (2.3)

Renal impairment: ODEFSEY is not recommended in patients with estimated creatinine clearance below 30 mL per minute. (2.4)

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详细处方信息以本药内容附件PDF文件（201951522274830.pdf）的“原文Priscribing Information”为准
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