よむ、つかう、まなぶ。
資料１－２ 調査結果報告書 (16 ページ)
出典
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会安全対策調査会（令和4年度第10回） |
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別添 3
表 1：リオシグアトの海外添付文書における抗 HIV 薬との併用についての関連記載
国・地域
米国
製品名
（添付文書の版）
ADEMPAS
（2021 年 9 月）
記載状況
4 CONTRAINDICATIONS
（関連記載なし）
2 DOSAGE AND ADMINISTRATION
2.5 Strong CYP and P-gp/BCRP Inhibitors
Consider a starting dose of 0.5 mg, three times a day when initiating Adempas in patients receiving strong cytochrome P450 (CYP) and
P-glycoprotein/breast cancer resistance protein (P-gp/BCRP) inhibitors such as azole antimycotics (for example, ketoconazole,
itraconazole) or HIV protease inhibitors (for example, ritonavir). Monitor for signs and symptoms of hypotension on initiation and on
treatment with strong CYP and P-gp/BCRP inhibitors [see Warnings and Precautions (5.3), Drug Interactions (7.2) and Clinical
Pharmacology (12.3)].
5 WARNINGS AND PRECAUTIONS
5.3 Hypotension
Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe
left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or
strong CYP and P-gp/BCRP inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Consider a dose reduction if
patient develops signs or symptoms of hypotension.
7 DRUG INTERACTIONS
7.2 Pharmacokinetic Interactions with Adempas
Strong CYP and P-gp/BCRP inhibitors: Concomitant use of riociguat with strong cytochrome CYP inhibitors and Pgp/BCRP inhibitors
such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat
exposure and may result in hypotension. Consider a starting dose of 0.5 mg 3 times a day when initiating Adempas in patients receiving
strong CYP and P-gp/BCRP inhibitors. Monitor for signs and symptoms of hypotension on initiation and on treatment with strong CYP
and P-gp/BCRP inhibitors. A dose reduction should be considered in patients who may not tolerate the hypotensive effect of riociguat
[see Dosage and Administration (2.5), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
12 CLINICAL PHARMACOLOGY
12.3 Pharmacokinetics
Drug interactions: The effect of extrinsic factors on riociguat and M1 were studied in healthy subjects and are shown in Figure 2.
16
表 1：リオシグアトの海外添付文書における抗 HIV 薬との併用についての関連記載
国・地域
米国
製品名
（添付文書の版）
ADEMPAS
（2021 年 9 月）
記載状況
4 CONTRAINDICATIONS
（関連記載なし）
2 DOSAGE AND ADMINISTRATION
2.5 Strong CYP and P-gp/BCRP Inhibitors
Consider a starting dose of 0.5 mg, three times a day when initiating Adempas in patients receiving strong cytochrome P450 (CYP) and
P-glycoprotein/breast cancer resistance protein (P-gp/BCRP) inhibitors such as azole antimycotics (for example, ketoconazole,
itraconazole) or HIV protease inhibitors (for example, ritonavir). Monitor for signs and symptoms of hypotension on initiation and on
treatment with strong CYP and P-gp/BCRP inhibitors [see Warnings and Precautions (5.3), Drug Interactions (7.2) and Clinical
Pharmacology (12.3)].
5 WARNINGS AND PRECAUTIONS
5.3 Hypotension
Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe
left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or
strong CYP and P-gp/BCRP inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Consider a dose reduction if
patient develops signs or symptoms of hypotension.
7 DRUG INTERACTIONS
7.2 Pharmacokinetic Interactions with Adempas
Strong CYP and P-gp/BCRP inhibitors: Concomitant use of riociguat with strong cytochrome CYP inhibitors and Pgp/BCRP inhibitors
such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat
exposure and may result in hypotension. Consider a starting dose of 0.5 mg 3 times a day when initiating Adempas in patients receiving
strong CYP and P-gp/BCRP inhibitors. Monitor for signs and symptoms of hypotension on initiation and on treatment with strong CYP
and P-gp/BCRP inhibitors. A dose reduction should be considered in patients who may not tolerate the hypotensive effect of riociguat
[see Dosage and Administration (2.5), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
12 CLINICAL PHARMACOLOGY
12.3 Pharmacokinetics
Drug interactions: The effect of extrinsic factors on riociguat and M1 were studied in healthy subjects and are shown in Figure 2.
16