適用於與Cabotegravir注射劑併用,治療在穩定抗反轉錄病毒療法下已達病毒學抑制效果(HIV-1 RNA < 50 copies/mL),且對Cabotegravir及Rilpivirine不具已知或疑似抗藥性之成人的HIV-1感染症。
Indicated for use in combination with Cabotegravir injection to treat HIV-1 infection in adults who have achieved viral suppression (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to Cabotegravir and Rilpivirine.
Rilpivirine 是一種非核核反轉錄錄抑制劑 (NNRTI),藉由非競爭性地抑制 HIV-1 反轉錄錄,阻止病毒 RNA 轉換為 DNA。
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that non-competitively inhibits HIV-1 reverse transcriptase, preventing viral RNA from converting into DNA.
吸收:肌肉注射後緩慢吸收,於 3-10 天達到血漿峰值濃度。
分布:與血漿蛋白高度結合 (99%)。
代謝:主要經由 CYP3A 酵素代謝。
排除:主要經由糞便排出,少量由尿液排除。
Absorption: Slowly absorbed after intramuscular injection, reaching peak plasma concentration in 3-10 days.
Distribution: Highly bound to plasma proteins (99%).
Metabolism: Primarily metabolized by CYP3A enzyme.
Excretion: Mainly excreted in feces, with a small amount in urine.
對Rilpivirine或賦形劑過敏者禁用。不得與CYP3A酵素誘導劑(如Rifampin、Carbamazepine、Phenobarbital等)合併使用。
Contraindicated in patients with hypersensitivity to Rilpivirine or excipients. Do not use with CYP3A inducers such as Rifampin, Carbamazepine, or Phenobarbital.
懷孕期間不建議使用 Rilpivirine,除非潛在效益超越風險,需嚴密監測病毒載量。
Rilpivirine is not recommended during pregnancy unless the potential benefits outweigh the risks, and viral load should be closely monitored.
Rilpivirine 預期可分泌至乳汁,HIV 感染婦女應避免哺乳以預防病毒傳染。
Rilpivirine is expected to be excreted in human milk. HIV-infected women should avoid breastfeeding to prevent viral transmission.
極常見:注射部位反應、頭痛、發燒。
常見:噁心、失眠、皮疹、肌痛。
少見:肝毒性、過敏反應、血管迷走神經反應。
Very Common: Injection site reactions, headache, fever.
Common: Nausea, insomnia, rash, myalgia.
Rare: Hepatotoxicity, hypersensitivity reactions, vasovagal reactions.
起始劑量:每月一次,肌肉注射 900 mg。
維持劑量:每月一次 600 mg 或每兩個月一次 900 mg。
Initial Dose: 900 mg IM once monthly.
Maintenance Dose: 600 mg IM monthly or 900 mg IM every two months.
18 歲以下兒童與青少年的安全性與療效尚未確立。
Safety and efficacy in children and adolescents under 18 years of age have not been established.
輕度至中度腎功能不全者無需調整劑量,對於重度腎功能不全者應謹慎使用。
No dose adjustment is required for mild to moderate renal impairment. Use cautiously in severe renal impairment.
輕度至中度肝功能不全者無需調整劑量,但不建議用於重度肝功能不全患者。
No dose adjustment is required for mild to moderate hepatic impairment. Not recommended for severe hepatic impairment.