Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 20

HMG Co-A Reductase Inhibitors Atorvastatin, Fluvastatin, Lovastatin, HMG-CoA reductase inhibitors which are highly dependent on CYP3A metabolism, Pravastatin, Rosuvastatin, Simvastatin such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer. Since increased concentrations of lovastatin and simvastatin may predispose patients to myopathies, including rhabdomyolysis, the combination of these medicinal products with ritonavir is contraindicated (see section 4.3). Atorvastatin is less dependent on CYP3A for metabolism. While rosuvastatin elimination is not dependent on CYP3A, an elevation of rosuvastatin exposure has been reported with ritonavir co-administration. The mechanism of this interaction is not clear, but may be the result of transporter inhibition. When used with ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent, the lowest possible doses of atorvastatin or rosuvastatin should be administered. The metabolism of pravastatin and fluvastatin is not dependent on CYP3A, and interactions are not expected with ritonavir. If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is 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): lovastatin (HOS-086157) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 9aca472a9605d2ce92f2e3c73c3d58774cec61e0cad5a2ae7e9aa807365f0d07 · Zeichen 43147–44996 im Abschnitt

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 52

HOS-086472 · Präparat HOS-083284

HMG Co-A Reductase Inhibitors Atorvastatin, Fluvastatin, Lovastatin, HMG-CoA reductase inhibitors which are highly dependent on CYP3A metabolism, such Pravstatin, Rosuvastatin, Simvastatin as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer. Since increased concentrations of lovastatin and simvastatin may predispose patients to myopathies, including rhabdomyolysis, the combination of these medicinal products with ritonavir is contraindicated (see section 4.3). Atorvastatin is less dependent on CYP3A for metabolism. While rosuvastatin elimination is not dependent on CYP3A, an elevation of rosuvastatin exposure has been reported with ritonavir co-administration. The mechanism of this interaction is not clear, but may be the result of transporter inhibition. When used with ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent, the lowest possible doses of atorvastatin or rosuvastatin should be administered. The metabolism of pravastatin and fluvastatin is not dependent on CYP3A, and interactions are not expected with ritonavir. If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is 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): lovastatin (HOS-086157) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage aecf6db95f104726bea3f53130826841fcecb464a1fff5ff24afdad33e090079 · Zeichen 44359–46167 im Abschnitt

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 24–25

HOS-108934 · Präparat HOS-093083

24 of lomitapide are expected to increase. Atorvastatin Atorvastatin: The combination of Kaletra with AUC: ↑ 5.9-fold atorvastatin is not recommended. Cmax: ↑ 4.7-fold If the use of atorvastatin is Due to CYP3A inhibition by considered strictly necessary, the lopinavir/ritonavir. lowest possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Rosuvastatin, 20 mg QD Rosuvastatin: Caution should be exercised and AUC: ↑ 2-fold reduced doses should be Cmax: ↑ 5-fold considered when Kaletra is While rosuvastatin is poorly co-administered with rosuvastatin metabolised by CYP3A4, an (see section 4.4). increase of its plasma concentrations was observed. The mechanism of this interaction may result from inhibition of transport proteins. Fluvastatin or Pravastatin Fluvastatin, Pravastatin: If treatment with an HMG-CoA No clinical relevant interaction reductase inhibitor is indicated, expected. fluvastatin or pravastatin is Pravastatin is not metabolised by recommended. CYP450. Fluvastatin is partially metabolised by CYP2C9. Opioids Buprenorphine, 16 mg QD Buprenorphine: ↔ No dose adjustment necessary.

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): atorvastatin (HOS-086304) lomitapide (HOS-086160) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) buprenorphine (HOS-086193) pravastatin (HOS-086306)

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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 2a27011337575de5ab6a9cbb05a4ed667b9b72fba13fff3beebbce86283b037b · Zeichen 57600–59815 im Abschnitt

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 59–60

HOS-109022 · Präparat HOS-093083

59 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. Immunosuppressants Cyclosporin, Sirolimus Cyclosporin, Sirolimus More frequent therapeutic (rapamycin), and (rapamycin), Tacrolimus: concentration monitoring is Tacrolimus Concentrations may be increased recommended until plasma levels of due to CYP3A inhibition by these products have been stabilised. lopinavir/ritonavir. Lipid lowering agents Lovastatin and Lovastatin, Simvastatin: Since increased concentrations of Simvastatin Markedly increased plasma HMG-CoA reductase inhibitors may concentrations due to CYP3A 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 of lomitapide are expected to increase. Atorvastatin Atorvastatin: The combination of Kaletra with AUC: ↑ 5.9-fold atorvastatin is not recommended. If Cmax: ↑ 4.7-fold the use of atorvastatin is considered Due to CYP3A inhibition by strictly necessary, the lowest possible lopinavir/ritonavir. dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Rosuvastatin, 20 mg QD Rosuvastatin: Caution should be exercised and AUC: ↑ 2-fold reduced doses should be considered Cmax: ↑ 5-fold when Kaletra is co-administered with While rosuvastatin is poorly rosuvastatin (see section 4.4). metabolised by CYP3A4, an increase of its plasma concentrations was observed. The mechanism of this interaction may result from inhibition of transport proteins. Fluvastatin or Fluvastatin, Pravastatin: If treatment with an HMG-CoA Pravastatin reductase inhibitor is indicated,

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): lovastatin (HOS-086157) atorvastatin (HOS-086304) lomitapide (HOS-086160) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) tacrolimus (HOS-085202) sirolimus (HOS-085172) pravastatin (HOS-086306)

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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 828eb1430737116e7e38afe94ac9495cef2e1489ddb625df82544aac21c48455 · Zeichen 52305–56991 im Abschnitt

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 60–61

HOS-109023 · Präparat HOS-093083

60 No clinical relevant interaction fluvastatin or pravastatin is expected. recommended. Pravastatin is not metabolised by CYP450. Fluvastatin is partially metabolised by CYP2C9. Opioids Buprenorphine, 16 mg Buprenorphine: ↔ No dose adjustment necessary. QD Methadone Methadone: ↓ Monitoring plasma concentrations of methadone is recommended. Oral contraceptives Ethinyl Oestradiol Ethinyl Oestradiol: ↓ In case of co-administration of Kaletra with contraceptives containing ethinyl oestradiol (whatever the contraceptive formulation e.g. oral or patch), additional methods of contraception must be used. Smoking cessation aids Bupropion Buproprion and its active If the co-administration of Kaletra metabolite, hydroxybupropion: with bupropion is judged AUC and Cmax ↓ ~50% unavoidable, this should be done under close clinical monitoring for This effect may be due to bupropion efficacy, without induction of bupropion exceeding the recommended dosage, metabolism. despite the observed induction.

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): bupropion (HOS-086329) methadone (HOS-086198) fluvastatin (HOS-086305) buprenorphine (HOS-086193) pravastatin (HOS-086306)

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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 66795734d42d6453cc3ecae53ffe464f62e190070894ffc9d2f185474a98d737 · Zeichen 57035–59066 im Abschnitt

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 95–96

HOS-109101 · Präparat HOS-093083

95 Immunosuppressants Cyclosporin, Sirolimus Cyclosporin, Sirolimus More frequent therapeutic (rapamycin), and (rapamycin), Tacrolimus: concentration monitoring is Tacrolimus Concentrations may be increased recommended until plasma levels of due to CYP3A inhibition by these products have been stabilised. lopinavir/ritonavir. Lipid lowering agents Lovastatin and Lovastatin, Simvastatin: Since increased concentrations of Simvastatin 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 of lomitapide are expected to increase. Atorvastatin Atorvastatin: The combination of Kaletra with AUC: ↑ 5.9-fold atorvastatin is not recommended. If Cmax: ↑ 4.7-fold the use of atorvastatin is considered Due to CYP3A inhibition by strictly necessary, the lowest lopinavir/ritonavir. possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Rosuvastatin, 20 mg QD Rosuvastatin: Caution should be exercised and AUC: ↑ 2-fold reduced doses should be considered Cmax: ↑ 5-fold when Kaletra is co-administered While rosuvastatin is poorly with rosuvastatin (see section 4.4). metabolised by CYP3A4, an increase of its plasma concentrations was observed. The mechanism of this interaction may result from inhibition of transport proteins. Fluvastatin or Fluvastatin, Pravastatin: If treatment with an HMG-CoA Pravastatin No clinical relevant interaction reductase inhibitor is indicated, expected. fluvastatin or pravastatin is Pravastatin is not metabolised by recommended. CYP450. Fluvastatin is partially metabolised by CYP2C9. Opioids Buprenorphine, 16 mg Buprenorphine: ↔ No dose adjustment necessary. QD Methadone Methadone: ↓ Monitoring plasma concentrations of methadone is 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): methadone (HOS-086198) lovastatin (HOS-086157) atorvastatin (HOS-086304) lomitapide (HOS-086160) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) buprenorphine (HOS-086193) tacrolimus (HOS-085202) sirolimus (HOS-085172) pravastatin (HOS-086306)

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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 8615aceaaf9aeead58e7d8428a116c5869ad8f9e57e471dff2f6359133eeb12b · Zeichen 55116–58920 im Abschnitt

Wechselwirkungen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 23

HOS-112115 · Präparat HOS-093615

The increase in progestin exposure may lead to related side effects (e.g., insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance. LIPID-MODIFYING AGENTS HMG-CoA reductase inhibitors Simvastatin Simvastatin and lovastatin are highly Co-administration of simvastatin or Lovastatin dependent on CYP3A4 for their lovastatin with REYATAZ is metabolism and co-administration with contraindicated due to an increased REYATAZ may result in increased risk of myopathy including concentrations. rhabdomyolysis (see section 4.3). Atorvastatin The risk of myopathy including Co-administration of atorvastatin rhabdomyolysis may also be increased with REYATAZ is not with atorvastatin, which is also recommended. If the use of metabolised by CYP3A4. atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Pravastatin Although not studied, there is a potential Caution should be exercised. Fluvastatin for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors. Pravastatin is not metabolised by CYP3A4. Fluvastatin is partially metabolised by CYP2C9. Other lipid-modifying agents Lomitapide Lomitapide is highly dependent on Co-administration of lomitapide CYP3A4 for metabolism and co- and REYATAZ with ritonavir is administration with REYATAZ with contraindicated due to a potential ritonavir may result in increased risk of markedly increased concentrations. transaminase levels and hepatotoxicity (see section 4.3). INHALED BETA AGONISTS Salmeterol Co-administration with REYATAZ may Co-administration of salmeterol result in increased concentrations of with REYATAZ is not salmeterol and an increase in salmeterol- recommended (see section 4.4). associated adverse events.

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): protease (HOS-085623) lovastatin (HOS-086157) atorvastatin (HOS-086304) lomitapide (HOS-086160) simvastatin (HOS-086158) fluvastatin (HOS-086305) salmeterol (HOS-086285) lead (HOS-085592) ritonavir (HOS-084521) pravastatin (HOS-086306)

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Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 8b78bbc3e02ae5f0c1ee3136e8833b5a4db25ba5d80192d381b81c04949c1b1f · Zeichen 66846–70225 im Abschnitt

Wechselwirkungen · Reyataz

REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 59

HOS-112201 · Präparat HOS-093615

The increase in progestin exposure may lead to related side effects (e.g., insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance. LIPID-MODIFYING AGENTS HMG-CoA reductase inhibitors Simvastatin Simvastatin and lovastatin are highly Co-administration of Lovastatin dependent on CYP3A4 for their simvastatin or lovastatin with metabolism and co-administration with REYATAZ is contraindicated REYATAZ may result in increased due to an increased risk of concentrations. myopathy including rhabdomyolysis (see section 4.3). Atorvastatin The risk of myopathy including Co-administration of rhabdomyolysis may also be increased with atorvastatin with REYATAZ is atorvastatin, which is also metabolised by not recommended. If the use of CYP3A4. atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Pravastatin Although not studied, there is a potential Caution should be exercised. Fluvastatin for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors. Pravastatin is not metabolised by CYP3A4. Fluvastatin is partially metabolised by CYP2C9. Other lipid-modifying agents Lomitapide Lomitapide is highly dependent on Co-administration of CYP3A4 for metabolism and co- lomitapide and REYATAZ administration with REYATAZ with with ritonavir is ritonavir may result in increased contraindicated due to a concentrations. potential risk of markedly increased transaminase levels and hepatotoxicity (see section 4.3).

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): protease (HOS-085623) lovastatin (HOS-086157) atorvastatin (HOS-086304) lomitapide (HOS-086160) simvastatin (HOS-086158) fluvastatin (HOS-086305) lead (HOS-085592) ritonavir (HOS-084521) pravastatin (HOS-086306)

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Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 44aa56d8a668b485784b1f653b51695f82980278276d44827d822987d189c2df · Zeichen 69471–72847 im Abschnitt

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 15–16

HOS-114832 · Präparat HOS-094169

15 Inhibition of CYP 3A4 by tipranavir/r HMG CoA reductase inhibitors Atorvastatin 10 mg QD Atorvastatin Cmax ↑ 8.6 fold Co-administration of atorvastatin Atorvastatin AUC ↑ 9.4 fold and Aptivus, co-administered Atorvastatin Cmin ↑ 5.2 fold with low dose ritonavir, is not recommended. Other HMG-CoA Tipranavir ↔ reductase inhibitors should be considered such as pravastatin, Inhibition of CYP 3A4 by fluvastatin or rosuvastatin (See tipranavir/r also section 4.4 and rosuvastatin and pravastatin recommendations). In cases where co-administration is necessary, the dose of 10 mg atorvastatin daily should not be exceeded. It is recommended to start with the lowest dose and careful clinical monitoring is necessary (see section 4.4). Rosuvastatin 10 mg QD Rosuvastatin Cmax ↑ 123% Co-administration of Aptivus, co- Rosuvastatin AUC ↑ 37% administered with low dose Rosuvastatin Cmin ↑ 6% ritonavir, and rosuvastatin should be initiated with the lowest dose Tipranavir ↔ (5 mg/day) of rosuvastatin, titrated to treatment response, and Mechanism unknown. accompanied with careful clinical monitoring for rosuvastatin associated symptoms as described in the label of rosuvastatin. Pravastatin Based on similarities in the Co-administration of Aptivus, co- No interaction study elimination between pravastatin administered with low dose performed and rosuvastatin, TPV/r could ritonavir, and pravastatin should increase the plasma levels of be initiated with the lowest dose pravastatin. (10 mg/day) of pravastatin, titrated to treatment response, and Mechanism unknown. accompanied with careful clinical monitoring for pravastatin associated symptoms as described in the label of pravastatin.

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): atorvastatin (HOS-086304) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) ritonavir (HOS-084521) pravastatin (HOS-086306)

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Version 2026-04-23T09:35:00Z · SHA-256 1c396190f98e89933229f2261b0e436bd43dac9c1de8e2dacaa36a755dc06dce · Passage 74f0f6a876d317957363e31e1c33f99584b8a000435d6c65678be0fe9ff9b411 · Zeichen 30010–33650 im Abschnitt

Wechselwirkungen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.5 · PDF-Seite 12–13

HOS-119741 · Präparat HOS-095005

12 OESTROGEN-BASED CONTRACEPTIVES Ethinylestradiol ethinylestradiol The combination of 0.035 mg once daily AUC ↑ 1.22 (1.13-1.31) oestrogen- and/or Norethindrone Cmin ↔ 1.09 (1.01-1.18) progesterone-based 1 mg once daily Cmax ↑ 1.33 (1.21-1.46) contraceptives and norethindrone INTELENCE can be used AUC ↔ 0.95 (0.90-0.99) without dose adjustment. Cmin ↓ 0.78 (0.68-0.90) Cmax ↔ 1.05 (0.98-1.12) etravirine AUC ↔a Cmin ↔a Cmax ↔a HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS Ribavirin Not studied, but no interaction expected based The combination of on the renal elimination pathway of ribavirin. INTELENCE and ribavirin can be used without dose adjustments. Daclatasvir Not studied. Co-administration of etravirine Co-administration of with daclatasvir may decrease daclatasvir INTELENCE and daclatasvir concentrations. is not recommended. Elbasvir/grazoprevir Not studied. Co-administration of etravirine Co-administration is with elbasvir/grazoprevir may decrease elbasvir contraindicated (see and grazoprevir concentrations, leading to section 4.3). reduced therapeutic effect of elbasvir/grazoprevir. HERBAL PRODUCTS St John’s wort Not studied. St John’s wort is expected to Combination not (Hypericum perforatum) decrease the plasma concentrations of recommended. etravirine. HMG CO-A REDUCTASE INHIBITORS Atorvastatin atorvastatin The combination of 40 mg once daily AUC ↓ 0.63 (0.58-0.68) INTELENCE and Cmin ND atorvastatin can be given Cmax ↑ 1.04 (0.84-1.30) without any dose 2-OH-atorvastatin adjustments, however, the AUC ↑ 1.27 (1.19-1.36) dose of atorvastatin may Cmin ND need to be altered based on Cmax ↑ 1.76 (1.60-1.94) clinical response. etravirine AUC ↔ 1.02 (0.97-1.07) Cmin ↔ 1.10 (1.02-1.19) Cmax ↔ 0.97 (0.93-1.02) Fluvastatin Not studied. No interaction between pravastatin Dose adjustments for these Lovastatin and etravirine is expected. HMG Co-A reductase Pravastatin Lovastatin, rosuvastatin and simvastatin are inhibitors may be necessary. Rosuvastatin CYP3A4 substrates and co-administration with Simvastatin etravirine may result in lower plasma concentrations of the HMG Co-A reductase inhibitor. Fluvastatin, and rosuvastatin are metabolised by CYP2C9 and co-administration with etravirine may result in higher plasma concentrations of the HMG Co-A reductase inhibitor. H2-RECEPTOR ANTAGONISTS Ranitidine etravirine INTELENCE can be 150 mg twice daily AUC ↓ 0.86 (0.76-0.97) co-administered with Cmin ND H2-receptor antagonists Cmax ↓ 0.94 (0.75-1.17) without dose adjustments.

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): elbasvir (HOS-108814) daclatasvir (HOS-119742) lovastatin (HOS-086157) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) hepatitis C virus (HOS-108813) ribavirin (HOS-088127) grazoprevir (HOS-108815) ranitidine (HOS-085660) norethindrone (HOS-088136) pravastatin (HOS-086306)

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Quellennachweis

Version 2024-08-13T16:37:00Z · SHA-256 b6b2c3fd3d600c0f1fd17ddc8f6c1da50bcb8b2181089113d0397c5ec46864c4 · Passage b4ae62f3b56de12cf8406dcb55d38bc3538cd806a08b537965c6bb7ead0cc339 · Zeichen 24913–29265 im Abschnitt

Wechselwirkungen · Revolade

Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-122059 · Präparat HOS-095473

Administration of eltrombopag 75 mg once daily for 5 days with a single 10 mg dose of the OATP1B1 and BCRP substrate rosuvastatin to 39 healthy adult subjects increased plasma rosuvastatin Cmax 103% (90% confidence interval [CI]: 82%, 126%) and AUC0- 55% (90% CI: 42%, 69%). Interactions are also expected with other HMG-CoA reductase inhibitors, including atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin. When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

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): lovastatin (HOS-086157) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Quellennachweis

Version 2026-02-26T10:21:00Z · SHA-256 3912609780c75b6cf657bad81a36f25e9a4985d64364fb3ab11f095445db8751 · Passage 0cc6386bb923481f82383194897ccaa3e68fec9b77243bccf999c6446b94ecd2 · Zeichen 82–685 im Abschnitt

Wechselwirkungen · Revolade

Revolade 25 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 52

HOS-122155 · Präparat HOS-095473

Administration of eltrombopag 75 mg once daily for 5 days with a single 10 mg dose of the OATP1B1 and BCRP substrate rosuvastatin to 39 healthy adult subjects increased plasma rosuvastatin Cmax 103% (90% confidence interval [CI]: 82%, 126%) and AUC0- 55% (90% CI: 42%, 69%). Interactions are also expected with other HMG-CoA reductase inhibitors, including atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin. When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

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): lovastatin (HOS-086157) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Quellennachweis

Version 2026-02-26T10:21:00Z · SHA-256 3912609780c75b6cf657bad81a36f25e9a4985d64364fb3ab11f095445db8751 · Passage 0cc6386bb923481f82383194897ccaa3e68fec9b77243bccf999c6446b94ecd2 · Zeichen 82–685 im Abschnitt

Wechselwirkungen · Votrient

Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-122580 · Präparat HOS-095539

Concomitant use of pazopanib and simvastatin increases the incidence of ALT elevations. Results from a meta-analysis using pooled data from clinical studies with pazopanib show that ALT >3x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of simvastatin (p = 0.038). If a patient receiving concomitant simvastatin develops ALT elevations, follow guidelines for pazopanib posology and discontinue simvastatin (see section 4.4). In addition, concomitant use of pazopanib and other statins should be undertaken with caution as there are insufficient data available to assess their impact on ALT levels. It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin).

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): atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Quellennachweis

Version 2025-10-28T11:24:00Z · SHA-256 38e00132fe316301c56a9c9a4f9247483c54b55dd743bedaab120a272380aaff · Passage 02417d93f64624bcba1d87ba2b7ee22b0a56a24fc0c60650a1bc7612e4cf2fbc · Zeichen 6113–6944 im Abschnitt

Wechselwirkungen · NexoBrid

NexoBrid 5 g powder and gel for gel · Abschnitt 4.5 · PDF-Seite 7

HOS-213871 · Präparat HOS-155226

The medicinal product, when absorbed, is an inhibitor of cytochrome P450 2C8 (CYP2C8) and P450 2C9 (CYP2C9). This should be taken into account if this medicinal product is used in patients receiving CYP2C8 substrates (including amiodarone, amodiaquine, chloroquine, fluvastatin, paclitaxel, pioglitazone, repaglinide, , and torasemide) and CYP2C9 substrates (including ibuprofen, tolbutamide, glipizide, losartan, celecoxib, warfarin, and phenytoin).

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): glipizide (HOS-109460) losartan (HOS-087482) ibuprofen (HOS-087884) celecoxib (HOS-113199) amodiaquine (HOS-146807) fluvastatin (HOS-086305) pioglitazone (HOS-089663) paclitaxel (HOS-087959) amiodarone (HOS-085596) phenytoin (HOS-084531) warfarin (HOS-085950) repaglinide (HOS-086935) tolbutamide (HOS-086568) chloroquine (HOS-109138)

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Version 2025-12-03T16:44:00Z · SHA-256 0e966e92cc19adf0ef382cd0ae4ca84db51705148a696b737819286b20db4bab · Passage 93865059fa8cabd6eff57948947ccf5e585dc227295712122812666b6c809ed5 · Zeichen 558–1008 im Abschnitt

Wechselwirkungen · Stivarga

Stivarga 40 mg film-coated tablets. · Abschnitt 4.5 · PDF-Seite 8

HOS-127094 · Präparat HOS-096369

This indicates that co-administration of regorafenib may increase the plasma concentrations of other concomitant BCRP substrates (e.g. methotrexate, fluvastatin, atorvastatin). Therefore, it is recommended to monitor patients closely for signs and symptoms of increased exposure to BCRP substrates.

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): atorvastatin (HOS-086304) fluvastatin (HOS-086305) methotrexate (HOS-087522)

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Version 2026-03-24T12:26:00Z · SHA-256 188477d5802aa3c29bbcc6435c9e581d56ccf3178a537b51e23d7bce8cf4f8be · Passage dcdcb98d4117118d8b1ac1ed87761d96e6b300a5481ab13f5e7d5ff3081a1126 · Zeichen 2742–3040 im Abschnitt

Wechselwirkungen · Ibrance

IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-132458 · Präparat HOS-097230

Based on in vitro data, palbociclib is predicted to inhibit intestinal P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) mediated transport. Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, fluvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions. Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic

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): sulfasalazine (HOS-089673) rosuvastatin (HOS-086307) digoxin (HOS-086172) dabigatran (HOS-112096) fluvastatin (HOS-086305) colchicine (HOS-086147) pravastatin (HOS-086306)

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Quellennachweis

Version 2025-03-07T16:43:00Z · SHA-256 73a98bcaed2e5b347266ff9f037099270b545348fdf729a2479eedc3e06fd319 · Passage d4ce4c1e4df94132e8b743593b697a4ce05c55ef8a18b79734c8a38cdc9c6d9d · Zeichen 4364–4872 im Abschnitt

Wechselwirkungen · Ibrance

IBRANCE 75 mg film-coated tablets IBRANCE 100 mg film-coated tablets IBRANCE 125 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 32

HOS-132511 · Präparat HOS-097230

Based on in vitro data, palbociclib is predicted to inhibit intestinal P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) mediated transport. Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, fluvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions. Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).

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): sulfasalazine (HOS-089673) rosuvastatin (HOS-086307) digoxin (HOS-086172) dabigatran (HOS-112096) fluvastatin (HOS-086305) colchicine (HOS-086147) metformin (HOS-091032) pravastatin (HOS-086306)

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Quellennachweis

Version 2025-03-07T16:43:00Z · SHA-256 73a98bcaed2e5b347266ff9f037099270b545348fdf729a2479eedc3e06fd319 · Passage edd9eba7a0c0c471b554ae39ea645ae60042cbb1cdeb1db12005e9643996c4c7 · Zeichen 3978–4607 im Abschnitt

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 14–15

HOS-132878 · Präparat HOS-097310

14 * Rosuvastatin is not a CYP 3A4 substrate. Ketoconazole did not produce any change in rosuvastatin pharmacokinetics, therefore, co-administration of ketoconazole and rosuvastatin is unlikely to increase the risk of toxicity of rosuvastatin. Other statins that are not CYP3A4 substrates (pravastatin and fluvastatin) can be co-administered with ketoconazole.

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): rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Quellennachweis

Version 2025-05-05T12:00:00Z · SHA-256 1463d2e081bcaa454cdfd6129ad3b8e03e3df9233f9d0704cfceba71c89c59b5 · Passage 8fe3df94962ad64d52e6bb7d53bb1aedb4d2d56c320976d8bc18fb8873f55741 · Zeichen 31802–32163 im Abschnitt

Wechselwirkungen · Genvoya

Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Genvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18–19

HOS-134021 · Präparat HOS-097520

18 Medicinal product by Effects on medicinal product Recommendation concerning therapeutic areas levels. co-administration with Genvoya Mean percent change in AUC, Cmax, Cmin1 Pravastatin Interaction not studied with any of Dose modifications are not Fluvastatin the components of Genvoya. necessary when administered in combination with Genvoya. Concentrations of these HMG Co-A reductase inhibitors are expected to transiently increase when administered with elvitegravir and cobicistat. Lovastatin Interaction not studied with any of Co-administration of Genvoya and Simvastatin the components of Genvoya. lovastatin and simvastatin is contraindicated (see section 4.3). LIPID-MODIFYING AGENTS Lomitapide Interaction not studied with any of Coadministration with lomitapide is the components of Genvoya. contraindicated (see section 4.3).

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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) fluvastatin (HOS-086305) pravastatin (HOS-086306)

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Quellennachweis

Version 2022-11-28T16:51:00Z · SHA-256 5b1a306ad5f7dd33700254558ee14691810f4eafdcf9d1256ccc229ad5e01997 · Passage 324f5a649d9a139c08caf58f8daef9e1c1f8b6a2ec71552eb5f5622353a4ddae · Zeichen 41462–43018 im Abschnitt

Wechselwirkungen · Symtuza

Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets Symtuza 675 mg/150 mg/200 mg/10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 14–15

HOS-138493 · Präparat HOS-098200

14 ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Based on theoretical considerations Co-administration of Symtuza bosentan is expected to decrease and bosentan is not darunavir and/or cobicistat plasma recommended. concentrations. (CYP3A induction) Symtuza is expected to increase bosentan plasma concentrations. (CYP3A inhibition) ERGOT DERIVATIVES e.g. Based on theoretical considerations Co-administration of Symtuza Dihydroergotamine DRV/COBI may increase ergot and ergot derivatives is Ergometrine derivative exposure. contraindicated (see section 4.3). Ergotamine Methylergonovine HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A inhibitors Elbasvir/grazoprevir Based on theoretical considerations Concomitant use of Symtuza with Symtuza may increase the elbasvir/grazoprevir is exposure to grazoprevir. contraindicated (see section 4.3). (OATP1B and CYP3A inhibition) Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to DRV/COBI may increase the co-administer Symtuza with exposure to glecaprevir and glecaprevir/pibrentasvir. pibrentasvir. (P-gp, BCRP and/or OATP1B1/3 inhibition) Daclatasvir Based on theoretical Symtuza and sofosbuvir, Ledipasvir considerations, no clinically sofosbuvir/ledipasvir, or Sofosbuvir relevant interaction is expected. daclatasvir can be used concomitantly without dose adjustment Herbal products St. John’s Wort (Hypericum Based on theoretical consideration, The concomitant use of Symtuza perforatum) St. John’s Wort may substantially with these medicinal products is decrease DRV/COBI (CYP3A4 contraindicated (see section 4.3). induction) and TAF exposures. (P-gp induction) HMG CO-A REDUCTASE INHIBITORS Atorvastatin Atorvastatin (10 mg once daily): Concomitant use of a HMG CoA Fluvastatin atorvastatin AUC ↑ 290% reductase inhibitor and Symtuza Pitavastatin atorvastatin Cmax ↑ 319% may increase plasma Pravastatin atorvastatin Cmin ND concentrations of the lipid Rosuvastatin lowering agent, which may lead Rosuvastatin (10 mg once daily): to adverse reactions such as rosuvastatin AUC ↑ 93% myopathy. rosuvastatin Cmax ↑ 277% When administration of rosuvastatin Cmin ND HMG CoA reductase inhibitors and Symtuza is desired, it is Based on theoretical considerations recommended to start with the DRV/COBI is expected to increase lowest dose and titrate up to the the plasma concentrations of desired clinical effect while fluvastatin, pitavastatin, monitoring for safety. pravastatin, lovastatin and Lovastatin simvastatin. Concomitant use of Symtuza with Simvastatin (CYP3A inhibition and/or lovastatin and simvastatin is transport) contraindicated (see section 4.3).

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): elbasvir (HOS-108814) methylergonovine (HOS-086155) daclatasvir (HOS-119742) sofosbuvir (HOS-108928) lovastatin (HOS-086157) atorvastatin (HOS-086304) pibrentasvir (HOS-086298) ledipasvir (HOS-110493) simvastatin (HOS-086158) rosuvastatin (HOS-086307) glecaprevir (HOS-086297) fluvastatin (HOS-086305) hepatitis C virus (HOS-108813) lead (HOS-085592) grazoprevir (HOS-108815) ergotamine (HOS-086154) bosentan (HOS-086291) dihydroergotamine (HOS-086152) pravastatin (HOS-086306) pitavastatin (HOS-125743)

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Quellennachweis

Version 2026-09-16T11:21:00Z · SHA-256 542f840b29cc7afaff9940b20511550e8d35031b33d95efd774fd49f70f7819d · Passage 7dedc11142e46d7502bc7e251f11ffb3c178eac67ce8ce16fb9ccc902e5f3904 · Zeichen 28527–32949 im Abschnitt

Quellenpassagen (31)

Wechselwirkungen · Norvir

Wechselwirkungen · Norvir

Wechselwirkungen · Kaletra

Wechselwirkungen · Kaletra

Wechselwirkungen · Kaletra

Wechselwirkungen · Kaletra

Wechselwirkungen · Reyataz

Wechselwirkungen · Reyataz

Wechselwirkungen · Aptivus

Wechselwirkungen · Intelence

Wechselwirkungen · Revolade

Wechselwirkungen · Revolade

Wechselwirkungen · Votrient

Wechselwirkungen · NexoBrid

Wechselwirkungen · Stivarga

Wechselwirkungen · Ibrance

Wechselwirkungen · Ibrance

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Wechselwirkungen · Genvoya

Wechselwirkungen · Symtuza