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資料１－２ 調査結果報告書 (21 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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inhibited by HIV protease inhibitors (ritonavir,
atazanavir > indinavir, IC50 values of 5.3 to 11.7
μM).
Ritonavir and saquinavir showed inhibitory
potency on P-gp/BCRP mediated efflux of
riociguat in vitro ([I1]/IC50 >0.1 or [I2]/IC50>10).
The impact of HAART (including different
combinations of abacavir, atazanavir, cobicistat,
darunavir, dolutegravir, efavirenz, elvitegravir,
emtricitabine, lamivudine, rilpivirine, ritonavir,
and tenofovir) on riociguat exposure was
investigated in a pharmacokinetic drug-drug
interaction study with HIV non-PAH patients.
Concomitant administration of a stable regimen of
varying HAART combinations with a single 0.5
mg dose of ADEMPAS led to an increase in
ADEMPAS mean AUC and Cmax of up to about
160% and 29%, respectively in HIV non-PAH
patients compared to a healthy historical control
group. No new safety findings were observed in
this single dose study.
オーストラ
リア
ADEMPAS
therapy, consider a starting dose of 0.5
mg riociguat, three times a day to
mitigate the risk of hypotension.
Monitor for signs and symptoms of
hypotension on initiation and on
treatment. Consider a dose reduction for
patients on ADEMPAS doses higher
than or equal to 1.0 mg if the patient
develops signs or symptoms of
hypotension (see WARNINGS AND
PRECAUTIONS, Concomitant Use
with CYP or P-gp/BCRP Inhibitors).
In patients on stable doses of
ADEMPAS, the initiation of strong
multi pathway CYP and P-gp/BCRP
inhibitors is not recommended as no
dosage recommendation can be given
due to limited data. Alternative
treatments should be considered.
DOSAGE AND ADMINISTRATION
Strong CYP and P-gp/BCRP Inhibitors
Coadministration of ADEMPAS with strong multipathway CYP and P-gp/BCRP inhibitors such as azole antimycotics (e.g. ketoconazole,
itraconazole) or HIV protease inhibitors (e.g. ritonavir) increases exposure to ADEMPAS (see DRUG INTERACTIONS, Drug-Drug
Interactions). Consider a starting dose of 0.5 mg, three times a day when initiating ADEMPAS in patients on stable doses of strong
multipathway CYP and P-gp/BCRP inhibitors to mitigate risk of hypotension. Monitor for signs and symptoms of hypotension on
initiation and on treatment with strong multipathway CYP and P-gp/BCRP inhibitors. Consider a dose reduction for patients on
ADEMPAS doses higher than or equal to 1.0 mg if the patient develops signs or symptoms of hypotension (see WARNINGS AND
PRECAUTIONS, Concomitant Use with CYP or P-gp/BCRP Inhibitors and DRUG INTERACTIONS, Drug-Drug Interactions).
4.3 CONTRAINDICATIONS
(関連記載なし)
4.2 DOSE AND METHOD OF ADMINISTRATION
21
atazanavir > indinavir, IC50 values of 5.3 to 11.7
μM).
Ritonavir and saquinavir showed inhibitory
potency on P-gp/BCRP mediated efflux of
riociguat in vitro ([I1]/IC50 >0.1 or [I2]/IC50>10).
The impact of HAART (including different
combinations of abacavir, atazanavir, cobicistat,
darunavir, dolutegravir, efavirenz, elvitegravir,
emtricitabine, lamivudine, rilpivirine, ritonavir,
and tenofovir) on riociguat exposure was
investigated in a pharmacokinetic drug-drug
interaction study with HIV non-PAH patients.
Concomitant administration of a stable regimen of
varying HAART combinations with a single 0.5
mg dose of ADEMPAS led to an increase in
ADEMPAS mean AUC and Cmax of up to about
160% and 29%, respectively in HIV non-PAH
patients compared to a healthy historical control
group. No new safety findings were observed in
this single dose study.
オーストラ
リア
ADEMPAS
therapy, consider a starting dose of 0.5
mg riociguat, three times a day to
mitigate the risk of hypotension.
Monitor for signs and symptoms of
hypotension on initiation and on
treatment. Consider a dose reduction for
patients on ADEMPAS doses higher
than or equal to 1.0 mg if the patient
develops signs or symptoms of
hypotension (see WARNINGS AND
PRECAUTIONS, Concomitant Use
with CYP or P-gp/BCRP Inhibitors).
In patients on stable doses of
ADEMPAS, the initiation of strong
multi pathway CYP and P-gp/BCRP
inhibitors is not recommended as no
dosage recommendation can be given
due to limited data. Alternative
treatments should be considered.
DOSAGE AND ADMINISTRATION
Strong CYP and P-gp/BCRP Inhibitors
Coadministration of ADEMPAS with strong multipathway CYP and P-gp/BCRP inhibitors such as azole antimycotics (e.g. ketoconazole,
itraconazole) or HIV protease inhibitors (e.g. ritonavir) increases exposure to ADEMPAS (see DRUG INTERACTIONS, Drug-Drug
Interactions). Consider a starting dose of 0.5 mg, three times a day when initiating ADEMPAS in patients on stable doses of strong
multipathway CYP and P-gp/BCRP inhibitors to mitigate risk of hypotension. Monitor for signs and symptoms of hypotension on
initiation and on treatment with strong multipathway CYP and P-gp/BCRP inhibitors. Consider a dose reduction for patients on
ADEMPAS doses higher than or equal to 1.0 mg if the patient develops signs or symptoms of hypotension (see WARNINGS AND
PRECAUTIONS, Concomitant Use with CYP or P-gp/BCRP Inhibitors and DRUG INTERACTIONS, Drug-Drug Interactions).
4.3 CONTRAINDICATIONS
(関連記載なし)
4.2 DOSE AND METHOD OF ADMINISTRATION
21