Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 23–24

23 Glecaprevir/pibrentasvir Serum concentrations may be Concomitant administration of increased due to P-glycoprotein, glecaprevir/pibrentasvir and BCRP and OATP1B inhibition by Kaletra is not recommended due lopinavir/ritonavir. to an increased risk of ALT elevations associated with increased glecaprevir exposure. Sofosbuvir/velpatasvir/ Serum concentrations of It is not recommended to voxilaprevir sofosbuvir, velpatasvir and coadminister Kaletra and voxilaprevir may be increased due sofosbuvir/velpatasvir/ to P-glycoprotein, BCRP and voxilaprevir. OATP1B1/3 inhibition by lopinavir/ritonavir. However, only the increase in voxilaprevir exposure is considered clinically relevant. HCV protease inhibitors Simeprevir 200 mg daily Simeprevir: It is not recommended to (ritonavir 100 mg BID) AUC: ↑ 7.2-fold co-administer Kaletra and Cmax: ↑ 4.7-fold simeprevir. Cmin: ↑ 14.4-fold Herbal products St John’s wort (Hypericum Lopinavir: Herbal preparations containing St perforatum) Concentrations may be reduced John’s wort must not be combined due to induction of CYP3A by the with lopinavir and ritonavir. If a herbal preparation St John’s wort. patient is already taking St John’s wort, stop St John’s wort and if possible check viral levels. Lopinavir and ritonavir levels may increase on stopping St John’s wort. The dose of Kaletra may need adjusting. The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’s wort (see section 4.3). Therefore, Kaletra can be started safely 2 weeks after cessation of St John's wort. Immunosuppressants Cyclosporin, Sirolimus Cyclosporin, Sirolimus More frequent therapeutic (rapamycin), and (rapamycin), Tacrolimus: concentration monitoring is Tacrolimus Concentrations may be increased recommended until plasma levels due to CYP3A inhibition by of these products have been lopinavir/ritonavir. stabilised. Lipid lowering agents Lovastatin and Simvastatin Lovastatin, Simvastatin: Since increased concentrations of Markedly increased plasma HMG-CoA reductase inhibitors concentrations due to CYP3A may cause myopathy, including inhibition by lopinavir/ritonavir. rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3). Lipid-modifying agents Lomitapide CYP3A4 inhibitors increase the Concomitant use of Kaletra with exposure of lomitapide, with lomitapide is contraindicated (see strong inhibitors increasing prescribing information for exposure approximately 27-fold. lomitapide) (see section 4.3). Due to CYP3A inhibition by lopinavir/ritonavir, concentrations

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) protease (HOS-085623) lovastatin (HOS-086157) pibrentasvir (HOS-086298) lomitapide (HOS-086160) simvastatin (HOS-086158) glecaprevir (HOS-086297) voxilaprevir (HOS-108930) tacrolimus (HOS-085202) velpatasvir (HOS-108929) simeprevir (HOS-086302) sirolimus (HOS-085172)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage d661859df9e7416124e84f058321f8363c31c96c6c3cbfadb04946272feb4ff7 · Zeichen 52766–57555 im Abschnitt

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 59

HOS-109021 · Präparat HOS-093083

Lopinavir: ↔ Glecaprevir/pibrentasvir Serum concentrations may be Concomitant administration of increased due to P-glycoprotein, glecaprevir/pibrentasvir and Kaletra BCRP and OATP1B inhibition by is not recommended due to an lopinavir/ritonavir. increased risk of ALT elevations associated with increased glecaprevir exposure. Sofosbuvir/velpatasvir/ Serum concentrations of It is not recommended to voxilaprevir sofosbuvir, velpatasvir and coadminister Kaletra and voxilaprevir may be increased due sofosbuvir/velpatasvir/ voxilaprevir. to P-glycoprotein, BCRP and OATP1B1/3 inhibition by lopinavir/ritonavir. However, only the increase in voxilaprevir exposure is considered clinically relevant. HCV protease inhibitors Simeprevir 200 mg Simeprevir: It is not recommended to daily (ritonavir 100 mg AUC: ↑ 7.2-fold co-administer Kaletra and simeprevir. BID) Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) protease (HOS-085623) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) voxilaprevir (HOS-108930) velpatasvir (HOS-108929) simeprevir (HOS-086302)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage a7ffd699710dfcc905a1f28162df38c655a626dd6695d2536a15fef3b5c330fb · Zeichen 50777–52256 im Abschnitt

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 94–95

HOS-109100 · Präparat HOS-093083

94 Sofosbuvir/velpatasvir/ Serum concentrations of It is not recommended to voxilaprevir sofosbuvir, velpatasvir and coadminister Kaletra and voxilaprevir may be increased due sofosbuvir/velpatasvir/ to P-glycoprotein, BCRP and voxilaprevir. OATP1B1/3 inhibition by lopinavir/ritonavir. However, only the increase in voxilaprevir exposure is considered clinically relevant. HCV protease inhibitors Simeprevir 200 mg Simeprevir: It is not recommended to daily (ritonavir 100 mg AUC: ↑ 7.2-fold co-administer Kaletra and BID) Cmax: ↑ 4.7-fold simeprevir. Cmin: ↑ 14.4-fold Herbal products St John’s wort Lopinavir: Herbal preparations containing St (Hypericum perforatum) Concentrations may be reduced John’s wort must not be combined due to induction of CYP3A by the with lopinavir and ritonavir. If a herbal preparation St John’s wort. patient is already taking St John’s wort, stop St John’s wort and if possible check viral levels. Lopinavir and ritonavir levels may increase on stopping St John’s wort. The dose of Kaletra may need adjusting. The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’s wort (see section 4.3). Therefore, Kaletra can be started safely 2 weeks after cessation of St John's wort.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) protease (HOS-085623) voxilaprevir (HOS-108930) velpatasvir (HOS-108929) simeprevir (HOS-086302)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage ee23650cbabf756b8993f6c87d5c69ed1f0fde54c3889133693585c6c3314a93 · Zeichen 52603–55069 im Abschnitt

Gegenanzeigen · Evra

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch · Abschnitt 4.3 · PDF-Seite 5–6

HOS-110299 · Präparat HOS-093363

5 • Presence or risk of arterial thromboembolism (ATE) • Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris); • Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA); • Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant); • History of migraine with focal neurological symptoms; • A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms - severe hypertension - severe dyslipoproteinaemia • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • Known or suspected carcinoma of the breast • Carcinoma of the endometrium or other known or suspected oestrogen-dependent neoplasia • Abnormal liver function related to acute or chronic hepatocellular disease • Hepatic adenomas or carcinomas • Undiagnosed abnormal genital bleeding • Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, medicinal products containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 4.5).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dasabuvir (HOS-110302) voxilaprevir (HOS-108930) ombitasvir (HOS-110300) velpatasvir (HOS-108929) ritonavir (HOS-084521) paritaprevir (HOS-110301)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2025-04-22T17:22:00Z · SHA-256 08ee5b4a9562d12725bc2847cb5a881102ab4ddbaaf7c1a2e28b65b78fd2ab5d · Passage 0b84b4ce379340aec479b3699d0b67d6f02d4b453bb9a5e3d40b02692d6515fc · Zeichen 895–2550 im Abschnitt

Wechselwirkungen · Evra

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch · Abschnitt 4.5 · PDF-Seite 11

HOS-110304 · Präparat HOS-093363

Pharmacodynamic interactions During clinical trials with patients treated for hepatitis C virus infections (HCV) with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequently in women using ethinyl estradiol-containing medications such as combined hormonal contraceptives (CHCs). Additionally, also in patients treated with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, ALT elevations were observed in women using ethinyl estradiol-containing medications such as CHCs (see section 4.3). Therefore, EVRA-users must switch to an alternative method of contraception (e.g., progestagen-only contraception or non-hormonal methods) prior to starting therapy with these combination drug regimens. EVRA can be restarted 2 weeks following completion of treatment with these combination drug regimens.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) hepatitis C virus (HOS-108813) ribavirin (HOS-088127) dasabuvir (HOS-110302) voxilaprevir (HOS-108930) ombitasvir (HOS-110300) velpatasvir (HOS-108929) ritonavir (HOS-084521) paritaprevir (HOS-110301)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2025-04-22T17:22:00Z · SHA-256 08ee5b4a9562d12725bc2847cb5a881102ab4ddbaaf7c1a2e28b65b78fd2ab5d · Passage a2c9d2476ababdf6aa70cd37d7f709e3b0de8b4455edc5193e41c8ca51311e4e · Zeichen 125–1104 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9–10

HOS-110492 · Präparat HOS-093385

9 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Adefovir dipivoxil AUC: ↔ Tenofovir disoproxil should not be Cmax: ↔ administered concurrently with adefovir dipivoxil (see section 4.4). Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma concentrations (90 mg/400 mg q.d.) + AUC: ↑ 96% of tenofovir resulting from Atazanavir/Ritonavir Cmax: ↑ 68% co-administration of tenofovir (300 mg q.d./100 mg q.d.) + Cmin: ↑ 118% disoproxil, ledipasvir/sofosbuvir Emtricitabine/Tenofovir disoproxil and atazanavir/ritonavir may (200 mg/245 mg q.d.)1 Sofosbuvir: increase adverse reactions related AUC: ↔ to tenofovir disoproxil, including Cmax: ↔ renal disorders. The safety of tenofovir disoproxil when used GS-3310072: with ledipasvir/sofosbuvir and a AUC: ↔ pharmacokinetic enhancer (e.g. Cmax: ↔ ritonavir or cobicistat) has not Cmin: ↑ 42% been established.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) adefovir dipivoxil (HOS-110478) atazanavir (HOS-086180) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) cobicistat (HOS-088111) hepatitis C virus (HOS-108813) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 824f9677703ef0bd8736160366b3629ad69b12899569fa4edf1bdab9fd603c0c · Zeichen 7039–9028 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10–11

HOS-110500 · Präparat HOS-093385

10 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Ledipasvir/Sofosbuvir Ledipasvir: Increased plasma concentrations (90 mg/400 mg q.d.) + AUC: ↔ of tenofovir resulting from Darunavir/Ritonavir Cmax: ↔ co-administration of tenofovir (800 mg q.d./100 mg q.d.) + Cmin: ↔ disoproxil, ledipasvir/sofosbuvir Emtricitabine/Tenofovir disoproxil and darunavir/ritonavir may (200 mg/245 mg q.d.)1 Sofosbuvir: increase adverse reactions related AUC: ↓ 27% to tenofovir disoproxil, including Cmax: ↓ 37% renal disorders. The safety of tenofovir disoproxil when used GS-3310072: with ledipasvir/sofosbuvir and a AUC: ↔ pharmacokinetic enhancer (e.g. Cmax: ↔ ritonavir or cobicistat) has not Cmin: ↔ been established.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) cobicistat (HOS-088111) darunavir (HOS-086181) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 087a97d32c6196144fac42069c01c95f98b657dbaf4644b79b530f187480c3be · Zeichen 10060–11640 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-110504 · Präparat HOS-093385

11 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Ledipasvir/Sofosbuvir Ledipasvir: No dose adjustment is (90 mg/400 mg q.d.) + AUC: ↓ 34% recommended. The increased Efavirenz/Emtricitabine/Tenofovir Cmax: ↓ 34% exposure of tenofovir could disoproxil Cmin: ↓ 34% potentiate adverse reactions (600 mg/200 mg/245 mg q.d.) associated with tenofovir Sofosbuvir: disoproxil, including renal AUC: ↔ disorders. Renal function should Cmax: ↔ be closely monitored (see section 4.4). GS-3310072: AUC: ↔ Cmax: ↔ Cmin: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) efavirenz (HOS-087947) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 4cf73b681106fe290bbd0ab4e8211c8302f9d1035d30b719be486f7cd517bb4c · Zeichen 12676–14014 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-110507 · Präparat HOS-093385

Tenofovir: AUC: ↑ 98% Cmax: ↑ 79% Cmin: ↑ 163% Ledipasvir/Sofosbuvir Ledipasvir: No dose adjustment is (90 mg/400 mg q.d.) + AUC: ↔ recommended. The increased Emtricitabine/Rilpivirine/Tenofovir Cmax: ↔ exposure of tenofovir could disoproxil Cmin: ↔ potentiate adverse reactions (200 mg/25 mg/245 mg q.d.) associated with tenofovir Sofosbuvir: disoproxil, including renal AUC: ↔ disorders. Renal function should Cmax: ↔ be closely monitored (see section 4.4). GS-3310072: AUC: ↔ Cmax: ↔ Cmin: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) rilpivirine (HOS-088090) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage b8c6be031ebe3d6d0741cb7dde7b82035f6c6602a837599f77b7eba5a4a24e4f · Zeichen 14432–15633 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12–13

HOS-110510 · Präparat HOS-093385

12 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Ledipasvir/Sofosbuvir Sofosbuvir: No dose adjustment is (90 mg/400 mg q.d.) + AUC: ↔ recommended. The increased Dolutegravir (50 mg q.d.) + Cmax: ↔ exposure of tenofovir could Emtricitabine/Tenofovir disoproxil potentiate adverse reactions (200 mg/245 mg q.d.) GS-3310072 associated with tenofovir AUC: ↔ disoproxil, including renal Cmax: ↔ disorders. Renal function should Cmin: ↔ be closely monitored (see section 4.4). Ledipasvir: AUC: ↔ Cmax: ↔ Cmin: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) ledipasvir (HOS-110493) dolutegravir (HOS-089992) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage c762d44730be45d39da66d9757f0cf67b6db354582132f9f4f0bb4d12a22578c · Zeichen 16268–17590 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 13–14

HOS-110514 · Präparat HOS-093385

13 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma concentrations (400 mg/100 mg q.d.) + AUC: ↔ of tenofovir resulting from Atazanavir/Ritonavir Cmax: ↔ co-administration of tenofovir (300 mg q.d./100 mg q.d.) + disoproxil, sofosbuvir/velpatasvir Emtricitabine/Tenofovir disoproxil GS-3310072: and atazanavir/ritonavir may (200 mg/245 mg q.d.) AUC: ↔ increase adverse reactions related Cmax: ↔ to tenofovir disoproxil, including Cmin: ↑ 42% renal disorders. The safety of tenofovir disoproxil when used Velpatasvir: with sofosbuvir/velpatasvir and a AUC: ↑ 142% pharmacokinetic enhancer (e.g. Cmax: ↑ 55% ritonavir or cobicistat) has not Cmin: ↑ 301% been established.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) atazanavir (HOS-086180) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage a352840ea53b0c7aa2c2c1477faa3502b999395202d25ef8a0192525e4dfa26d · Zeichen 18217–19800 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 14–15

HOS-110518 · Präparat HOS-093385

14 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma concentrations (400 mg/100 mg q.d.) + AUC: ↓28% of tenofovir resulting from Darunavir/Ritonavir Cmax: ↓ 38% co-administration of tenofovir (800 mg q.d./100 mg q.d.) + disoproxil, sofosbuvir/velpatasvir Emtricitabine/Tenofovir disoproxil GS-3310072: and darunavir/ritonavir may (200 mg/245 mg q.d.) AUC: ↔ increase adverse reactions related Cmax: ↔ to tenofovir disoproxil, including Cmin: ↔ renal disorders. The safety of tenofovir disoproxil when used Velpatasvir: with sofosbuvir/velpatasvir and a AUC: ↔ pharmacokinetic enhancer (e.g. Cmax: ↓ 24% ritonavir or cobicistat) has not Cmin: ↔ been established.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) darunavir (HOS-086181) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 737e46afeb9439dde410899a01dd79d8a2f0e067b384f6b1c089de70a2e4dede · Zeichen 20772–22354 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 15–16

HOS-110522 · Präparat HOS-093385

15 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: Increased plasma concentrations (400 mg/100 mg q.d.) + AUC: ↓ 29% of tenofovir resulting from Lopinavir/Ritonavir Cmax: ↓ 41% co-administration of tenofovir (800 mg/200 mg q.d.) + disoproxil, sofosbuvir/velpatasvir Emtricitabine/Tenofovir disoproxil GS-3310072: and lopinavir/ritonavir may (200 mg/245 mg q.d.) AUC: ↔ increase adverse reactions related Cmax: ↔ to tenofovir disoproxil, including Cmin: ↔ renal disorders. The safety of tenofovir disoproxil when used Velpatasvir: with sofosbuvir/velpatasvir and a AUC: ↔ pharmacokinetic enhancer (e.g. Cmax: ↓ 30% ritonavir or cobicistat) has not Cmin: ↑ 63% been established.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) lopinavir (HOS-086269) sofosbuvir (HOS-108928) cobicistat (HOS-088111) velpatasvir (HOS-108929) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 26c0232f6e9aca312defaa3abb7db0177d9af751e67aef58f622af58ce0b6a51 · Zeichen 23322–24904 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-110525 · Präparat HOS-093385

16 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: No dose adjustment is (400 mg/100 mg q.d.) + AUC: ↔ recommended. The increased Raltegravir Cmax: ↔ exposure of tenofovir could (400 mg b.i.d) + potentiate adverse reactions Emtricitabine/Tenofovir disoproxil GS-3310072: associated with tenofovir (200 mg/245 mg q.d.) AUC: ↔ disoproxil, including renal Cmax: ↔ disorders. Renal function should Cmin: ↔ be closely monitored (see section 4.4). Velpatasvir: AUC: ↔ Cmax: ↔ Cmin: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) velpatasvir (HOS-108929) raltegravir (HOS-086187) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 966a3427a78d47bcc95eb523705319fb15c2f308fe708ed9b5a99fd363633252 · Zeichen 25864–27187 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 17

HOS-110527 · Präparat HOS-093385

Tenofovir: AUC: ↑ 40% Cmax: ↑ 46% Cmin: ↑ 70% Sofosbuvir/Velpatasvir Sofosbuvir: Concomitant administration of (400 mg/100 mg q.d.) + AUC: ↔ sofosbuvir/velpatasvir and Efavirenz/Emtricitabine/Tenofovir Cmax: ↑ 38% efavirenz is expected to decrease disoproxil plasma concentrations of (600 mg/200 mg/245 mg q.d.) GS-3310072: velpatasvir. Co-administration of AUC: ↔ sofosbuvir/velpatasvir with Cmax: ↔ efavirenz-containing regimens is Cmin: ↔ not recommended.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) velpatasvir (HOS-108929) efavirenz (HOS-087947) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 19af9fb82c372f5c469cbedf4451efbe959c7dc1bb44317e7ac3acbbd33aaeea · Zeichen 27602–28530 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 17–18

HOS-110531 · Präparat HOS-093385

17 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir Sofosbuvir: No dose adjustment is (400 mg/100 mg q.d.) + AUC: ↔ recommended. The increased Emtricitabine/Rilpivirine/Tenofovir Cmax: ↔ exposure of tenofovir could disoproxil potentiate adverse reactions (200 mg/25 mg/245 mg q.d.) GS-3310072: associated with tenofovir AUC: ↔ disoproxil, including renal Cmax: ↔ disorders. Renal function should Cmin: ↔ be closely monitored (see section 4.4). Velpatasvir: AUC: ↔ Cmax: ↔ Cmin: ↔

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) velpatasvir (HOS-108929) rilpivirine (HOS-088090) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 7b3ecba6da2d284d03b65e52edaa2021f453243f80887fa3055792f01dde485f · Zeichen 29352–30691 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18–19

HOS-110533 · Präparat HOS-093385

18 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir/Velpatasvir/ Sofosbuvir: Increased plasma concentrations Voxilaprevir (400 mg/100 mg/ AUC: ↔ of tenofovir resulting from co- 100 mg+100 mg q.d.)3 + Darunavir Cmax: ↓ 30% administration of tenofovir (800 mg q.d.) + Ritonavir (100 mg Cmin: N/A disoproxil, q.d.) + Emtricitabine/Tenofovir sofosbuvir/velpatasvir/voxilaprevir disoproxil (200 mg/245 mg q.d.) GS-3310072: and darunavir/ritonavir may AUC: ↔ increase adverse reactions related Cmax:↔ to tenofovir disoproxil, including Cmin: N/A renal disorders. The safety of tenofovir disoproxil Velpatasvir: when used with AUC: ↔ sofosbuvir/velpatasvir/voxilaprevir Cmax: ↔ and a pharmacokinetic enhancer Cmin: ↔ (e.g. ritonavir or cobicistat) has not been established. Voxilaprevir: AUC: ↑ 143% The combination should be used Cmax:↑ 72% with caution with frequent renal Cmin: ↑ 300% monitoring (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) cobicistat (HOS-088111) voxilaprevir (HOS-108930) velpatasvir (HOS-108929) darunavir (HOS-086181) ritonavir (HOS-084521) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage d550c8d9097fb86a9733da7c544c1bce662495bf9924cb0e60e96c3044614d33 · Zeichen 31330–33402 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19–20

HOS-110538 · Präparat HOS-093385

19 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with 245 mg (dose in mg) Cmax, Cmin tenofovir disoproxil Sofosbuvir Sofosbuvir: No dose adjustment is required. (400 mg q.d.) + AUC: ↔ Efavirenz/Emtricitabine/Tenofovir Cmax: ↓ 19% disoproxil (600 mg/200 mg/245 mg q.d.) GS-3310072: AUC: ↔ Cmax: ↓ 23%

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) efavirenz (HOS-087947) emtricitabine (HOS-085840)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage 6da7a806d5e3759d4cc6cf4f003f85ea7f61ed10ba85ea30fee0d83f0cdd72dc · Zeichen 34204–34934 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 20

HOS-110541 · Präparat HOS-093385

Tenofovir: AUC: ↔ Cmax: ↑ 25% Cmin: ↔ 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir. Staggered administration (12 hours apart) provided

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) sofosbuvir (HOS-108928) ledipasvir (HOS-110493)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage a519d772db011d14d65a2faf3e47e7155eefa24f5d0f280320ee89f6472888d9 · Zeichen 35397–35684 im Abschnitt

Wechselwirkungen · Viread

Viread 123 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 20

HOS-110542 · Präparat HOS-093385

similar results. 2 The predominant circulating metabolite of sofosbuvir. 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sofosbuvir (HOS-108928) voxilaprevir (HOS-108930)

Vollständigen Kontext in der EMA-Fachinformation lesen →

Quellennachweis

Version 2024-02-29T16:34:00Z · SHA-256 ab427f9266bbb81991653ebf14729e0d885f7cb9014fd47e3b3ee4fc69589ee0 · Passage d12af83f9069de56e0a7f05c9cbb7d21da74a5bc6a869f0604451e99818a4a4d · Zeichen 35686–35881 im Abschnitt

Quellenpassagen (612)

Wechselwirkungen · Kaletra

Wechselwirkungen · Kaletra

Wechselwirkungen · Kaletra

Gegenanzeigen · Evra

Wechselwirkungen · Evra

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread

Wechselwirkungen · Viread