Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Gegenanzeigen · Norvir
Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 5
HOS-086159 · Präparat HOS-083284
Microsomal Lomitapide Increased plasma concentrations of lomitapide
triglyceride transfer (see section 4.5).
protein (MTTP)
inhibitor
PDE5 inhibitors Avanafil Increased plasma concentrations of avanafil
(see section 4.4. and 4.5).
Sildenafil Contraindicated when used for the treatment of
pulmonary arterial hypertension (PAH) only.
Increased plasma concentrations of sildenafil.
Thereby, increasing the potential for sildenafil-
associated adverse events (which include
hypotension and syncope). See section 4.4 and
section 4.5 for co-administration of sildenafil in
patients with erectile dysfunction.
Vardenafil Increased plasma concentrations of vardenafil
(see section 4.4. and 4.5).
Sedatives/hypnotics Clorazepate, diazepam, Increased plasma concentrations of clorazepate,
estazolam, flurazepam, diazepam, estazolam, flurazepam, oral
oral midazolam and midazolam and triazolam. Thereby, increasing
triazolam the risk of extreme sedation and respiratory
depression from these agents. (For caution on
parenterally administered midazolam, 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): estazolam (HOS-086165) lomitapide (HOS-086160) clorazepate (HOS-086164) diazepam (HOS-085904) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) flurazepam (HOS-086166) midazolam (HOS-086167) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 08cb4669d26fd4170f47a5f99fcf18bde7e922c35f378d07e3e1c1cab8b82945 · Zeichen 6375–8447 im Abschnitt
Gegenanzeigen · Norvir
Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 37
HOS-086390 · Präparat HOS-083284
Microsomal Lomitapide Increased plasma concentrations of lomitapide
triglyceride transfer (see section 4.5).
protein (MTTP)
inhibitor
PDE5 inhibitor Avanafil Increased plasma concentrations of avanafil
(see section 4.4. and 4.5).
Sildenafil Contraindicated when used for the treatment of
pulmonary arterial hypertension (PAH) only.
Increased plasma concentrations of sildenafil.
Thereby, increasing the potential for sildenafil-
associated adverse events (which include
hypotension and syncope). See section 4.4 and
section 4.5 for co-administration of sildenafil in
patients with erectile dysfunction.
Vardenafil Increased plasma concentrations of vardenafil
(see section 4.4. and 4.5).
Sedatives/hypnotics Clorazepate, diazepam, Increased plasma concentrations of clorazepate,
estazolam, flurazepam, diazepam, estazolam, flurazepam, oral
oral midazolam and midazolam and triazolam. Thereby, increasing
triazolam the risk of extreme sedation and respiratory
depression from these agents. (For caution on
parenterally administered midazolam, see
section 4.5.).
Ritonavir medicinal product level decreased
Herbal Preparation St. John’s Wort Herbal preparations containing St John’s wort
(Hypericum perforatum) due to the risk of
decreased plasma concentrations and reduced
clinical effects of ritonavir (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): estazolam (HOS-086165) lomitapide (HOS-086160) clorazepate (HOS-086164) diazepam (HOS-085904) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) flurazepam (HOS-086166) midazolam (HOS-086167) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 235db82cd2afd722d3066659d7d625c3a96a3162e89ca0b2b4a6f83e7ca9d95d · Zeichen 6173–8675 im Abschnitt
Wechselwirkungen · Norvir
Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 20
HOS-086311 · Präparat HOS-083284
Lipid-modifying agents
Lomitapide CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors
increasing exposure approximately 27-fold. Due to CYP3A inhibition by ritonavir,
concentrations of lomitapide are expected to increase. Concomitant use of ritonavir
with lomitapide is contraindicated (see the SmPC for lomitapide) (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): lomitapide (HOS-086160)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage f499610fd87544644f60d87d18abe1419829300cbabfb1131b094526c8d8c566 · Zeichen 46286–46799 im Abschnitt
Wechselwirkungen · Norvir
Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 53
HOS-086476 · Präparat HOS-083284
Lipid-modifying agents
Lomitapide CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing
exposure approximately 27-fold. Due to CYP3A inhibition by ritonavir, concentrations
of lomitapide are expected to increase. Concomitant use of ritonavir with lomitapide is
contraindicated (see the SmPC for lomitapide) (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): lomitapide (HOS-086160)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 17f47396b5cf4f031ceee77ddd7dfae79f711a44eb102aa315b24f3c0012f53e · Zeichen 48230–48735 im Abschnitt
Gegenanzeigen · Kaletra
Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 6
HOS-108817 · Präparat HOS-093083
HMG Co-A Reductase Lovastatin, simvastatin Increased plasma concentrations of
Inhibitors lovastatin and simvastatin; thereby,
increasing the risk of myopathy
including rhabdomyolysis (see section
4.5).
Microsomal Lomitapide Increased plasma concentrations of
triglyceride transfer lomitapide (see section 4.5).
protein (MTTP)
inhibitor
Phosphodiesterase Avanafil Increased plasma concentrations of
(PDE5) inhibitors avanafil (see sections 4.4 and 4.5).
Sildenafil Contraindicated when used for the
treatment of pulmonary arterial
hypertension (PAH) only. Increased
plasma concentrations of sildenafil.
Thereby, increasing the potential for
sildenafil-associated adverse events
(which include hypotension and
syncope). See section 4.4 and section
4.5 for co-administration of sildenafil in
patients with erectile dysfunction.
Vardenafil Increased plasma concentrations of
vardenafil (see sections 4.4 and 4.5)
Sedatives/hypnotics Oral midazolam, triazolam Increased plasma concentrations of oral
midazolam and triazolam. Thereby,
increasing the risk of extreme sedation
and respiratory depression from these
agents.
For caution on parenterally administered
midazolam, see section 4.5.
Lopinavir/ritonavir medicinal product level decreased
Herbal products St. John’s wort Herbal preparations containing St John’s
wort (Hypericum perforatum) due to the
risk of decreased plasma concentrations
and reduced clinical effects of lopinavir
and ritonavir (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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) midazolam (HOS-086167) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage c938be9b188cbabde88400ddb49de67c2831b955f638dc8fa5306b13f1652968 · Zeichen 6187–9289 im Abschnitt
Gegenanzeigen · Kaletra
Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 43
HOS-108989 · Präparat HOS-093083
HMG Co-A Lovastatin, simvastatin Increased plasma concentrations of
Reductase Inhibitors lovastatin and simvastatin; thereby,
increasing the risk of myopathy
including rhabdomyolysis (see section
4.5).
Microsomal Lomitapide Increased plasma concentrations of
triglyceride transfer lomitapide (see section 4.5).
protein (MTTP)
inhibitor
Phosphodiesterase Avanafil Increased plasma concentrations of
(PDE5) inhibitors avanafil (see sections 4.4 and 4.5)
Sildenafil Contraindicated when used for the
treatment of pulmonary arterial
hypertension (PAH) only. Increased
plasma concentrations of sildenafil.
Thereby, increasing the potential for
sildenafil-associated adverse events
(which include hypotension and
syncope). See section 4.4 and section
4.5 for co-administration of sildenafil
in patients with erectile dysfunction.
Vardenafil Increased plasma concentrations of
vardenafil (see sections 4.4 and 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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) avanafil (HOS-086161) sildenafil (HOS-086162) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage f8543c2c8cda6c1a0fcb441c8b738d361d39474d709f5eb46342c2fd917ec3a5 · Zeichen 6637–8576 im Abschnitt
Gegenanzeigen · Kaletra
Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 78
HOS-109063 · Präparat HOS-093083
HMG Co-A Reductase Lovastatin, simvastatin Increased plasma concentrations of
Inhibitors lovastatin and simvastatin; thereby,
increasing the risk of myopathy including
rhabdomyolysis (see section 4.5).
Microsomal triglyceride Lomitapide Increased plasma concentrations of
transfer protein (MTTP) lomitapide (see section 4.5).
inhibitor
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)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage c1f30e879c14eae663f4c58f72a72fc5a44b4e93e6280c2d524687cb97bb42ed · Zeichen 6506–7088 im Abschnitt
Wechselwirkungen · Kaletra
Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 23–24
HOS-108925 · Präparat HOS-093083
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 (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)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 828eb1430737116e7e38afe94ac9495cef2e1489ddb625df82544aac21c48455 · Zeichen 52305–56991 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)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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 44
HOS-112157 · Präparat HOS-093615
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ
with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a
narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride,
pimozide, quinidine, bepridil, triazolam, orally administered midazolam, lomitapide, and ergot
alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3). Co-administration of
REYATAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed-dose
combination is contraindicated because of the increase in grazoprevir and elbasvir plasma
concentrations and potential for the increase in risk of ALT elevations associated with increased
grazoprevir concentrations (see section 4.3). Co-administration of REYATAZ with
glecaprevir/pibrentasvir fixed-dose combination is contraindicated because of the potential increase in
the risk of ALT elevations due to a significant increase in glecapreir and pibrentasvir plasma
concentrations (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): quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) cisapride (HOS-085610) pibrentasvir (HOS-086298) lomitapide (HOS-086160) bepridil (HOS-085612) quinidine (HOS-085593) glecaprevir (HOS-086297) grazoprevir (HOS-108815) pimozide (HOS-085600) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) terfenadine (HOS-085607) lurasidone (HOS-086148) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 8c472f02d161fbf877b321685a02acd6721db094612098433562a9a244834b35 · Zeichen 315–1385 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)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 44aa56d8a668b485784b1f653b51695f82980278276d44827d822987d189c2df · Zeichen 69471–72847 im Abschnitt
Gegenanzeigen · Prezista
PREZISTA 100 mg/ml oral suspension · Abschnitt 4.3 · PDF-Seite 6
HOS-116288 · Präparat HOS-094447
Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that
are highly dependent on CYP3A for clearance, which results in increased exposure to the
co-administered medicinal product. Therefore, concomitant treatment with such medicinal products
for which elevated plasma concentrations are associated with serious and/or life-threatening events is
contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active
substances include e.g.:
- alfuzosin
- amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine
- astemizole, terfenadine
- colchicine when used in patients with renal and/or hepatic impairment (see section 4.5)
- ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine)
- elbasvir/grazoprevir
- cisapride
- dapoxetine
- domperidone
- naloxegol
- lurasidone, pimozide, quetiapine, sertindole (see section 4.5)
- triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
see section 4.5)
- sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil
- simvastatin, lovastatin, lomitapide (see section 4.5)
- ticagrelor (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): sertindole (HOS-085601) ticagrelor (HOS-112065) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) lovastatin (HOS-086157) lomitapide (HOS-086160) cobicistat (HOS-088111) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage e2536d703754b5f39bebb9603c70a8d8759f7198e0666cec1af181c80f42d82c · Zeichen 1442–2753 im Abschnitt
Gegenanzeigen · Prezista
PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 49
HOS-116497 · Präparat HOS-094447
Co-administration of PREZISTA with low dose ritonavir, with active substances that are highly
dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with
serious and/or life-threatening events. These active substances include e.g.:
- alfuzosin
- amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine
- astemizole, terfenadine
- colchicine when used in patients with renal and/or hepatic impairment (see section 4.5)
- ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine)
- elbasvir/grazoprevir
- cisapride
- dapoxetine
- domperidone
- naloxegol
- lurasidone, pimozide, quetiapine, sertindole (see section 4.5)
- triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
see section 4.5)
- sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil
- simvastatin, lovastatin and lomitapide (see section 4.5)
- ticagrelor (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): sertindole (HOS-085601) ticagrelor (HOS-112065) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) lovastatin (HOS-086157) lomitapide (HOS-086160) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 6a604bfa742092630f592a37246ad3ddd261ae7ceba904108fadd195ca4e43c8 · Zeichen 481–1534 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 21–22
HOS-116415 · Präparat HOS-094447
21
Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of
10 mg once daily rosuvastatin Cmax ↑ 144%║ rosuvastatin and boosted
║
based on published data with PREZISTA is required, it is
darunavir/ritonavir recommended to start with the
lowest possible dose of
rosuvastatin AUC ↑ 93%§ rosuvastatin and titrate up to the
rosuvastatin Cmax ↑ 277%§ desired clinical effect while
rosuvastatin Cmin ND§ monitoring for safety.
§
with darunavir/cobicistat 800/150 mg
OTHER LIPID MODIFYING AGENTS
Lomitapide Based on theoretical considerations Co-administration is
boosted PREZISTA is expected to contraindicated (see section 4.3).
increase the exposure of lomitapide when
co-administered.
(CYP3A inhibition)
H2-RECEPTOR ANTAGONISTS
Ranitidine # Boosted PREZISTA can be
darunavir AUC ↔
150 mg twice daily #
darunavir Cmin ↔ co-administered with H2-receptor
#
darunavir Cmax ↔ antagonists without dose
adjustments.
IMMUNOSUPPRESSANTS
Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the
Sirolimus immunosuppressants will be increased immunosuppressive agent must be
Tacrolimus when co-administered with boosted done when co-administration
PREZISTA. occurs.
(CYP3A inhibition)
Everolimus Concomitant use of everolimus
and boosted PREZISTA is not
recommended.
INHALED BETA AGONISTS
Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and
salmeterol and boosted darunavir may boosted PREZISTA is not
increase plasma concentrations of recommended. The combination
salmeterol. may result in increased risk of
cardiovascular adverse event with
salmeterol, including QT
prolongation, palpitations and
sinus tachycardia.
NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE
Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone
individual dose ranging R(-) methadone Cmin ↓ 15% dosage is required when initiating
from 55 mg to 150 mg R(-) methadone Cmax ↓ 24% co-administration with boosted
once daily PREZISTA. However, adjustment
PREZISTA/cobicistat may, in contrast, of the methadone dose may be
increase methadone plasma necessary when concomitantly
concentrations (see cobicistat SmPC). administered for a longer period of
time. Therefore, clinical
monitoring is recommended, as
maintenance therapy may need to
be adjusted in some patients.
Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the
8/2 mg–16/4 mg once buprenorphine Cmin ↔ increase in norbuprenorphine
daily buprenorphine Cmax ↓ 8% pharmacokinetic parameters has
norbuprenorphine AUC ↑ 46% not been established. Dose
norbuprenorphine Cmin ↑ 71% adjustment for buprenorphine may
norbuprenorphine Cmax ↑ 36% not be necessary when
naloxone AUC ↔ co-administered with boosted
PREZISTA but a careful clinical
naloxone Cmin ND
monitoring for signs of opiate
naloxone Cmax ↔ toxicity 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) lomitapide (HOS-086160) cobicistat (HOS-088111) rosuvastatin (HOS-086307) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 5acbdf6c1f8cbcfa7417e6f43148a46845265b80041528b8854960cce50aae89 · Zeichen 63548–68815 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 63–64
HOS-116529 · Präparat HOS-094447
63
Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of
10 mg once daily rosuvastatin Cmax ↑ 144%║ rosuvastatin and PREZISTA
║
based on published data with co-administered with low dose
darunavir/ritonavir ritonavir is required, it is
recommended to start with the
lowest possible dose of
rosuvastatin and titrate up to the
desired clinical effect while
monitoring for safety.
OTHER LIPID MODIFYING AGENTS
Lomitapide Based on theoretical considerations Co-administration is
boosted PREZISTA is expected to contraindicated (see section 4.3).
increase the exposure of lomitapide when
co-administered.
(CYP3A inhibition)
H2-RECEPTOR ANTAGONISTS
Ranitidine # PREZISTA co-administered with
darunavir AUC ↔
150 mg twice daily #
darunavir Cmin ↔ low dose ritonavir can be
#
darunavir Cmax ↔ co-administered with H2-receptor
antagonists without dose
adjustments.
IMMUNOSUPPRESSANTS
Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the
Sirolimus immunosuppressants will be increased immunosuppressive agent must be
Tacrolimus when co-administered with PREZISTA done when co-administration
co-administered with low dose ritonavir. occurs.
(CYP3A inhibition)
Everolimus Concomitant use of everolimus
and PREZISTA co-administered
with low dose ritonavir is not
recommended.
INHALED BETA AGONISTS
Salmeterol Not studied. Concomitant use ofConcomitant use of salmeterol and
salmeterol and darunavir co-administered
PREZISTA co-administered with
with low dose ritonavir may increase
low dose ritonavir is not
plasma concentrations of salmeterol.
recommended. The combination
may result in increased risk of
cardiovascular adverse event with
salmeterol, including QT
prolongation, palpitations and
sinus tachycardia.
NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE
Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone
individual dose ranging R(-) methadone Cmin ↓ 15% dosage is required when initiating
from 55 mg to 150 mg R(-) methadone Cmax ↓ 24% co-administration with
once daily PREZISTA/ritonavir. However,
increased methadone dose may be
necessary when concomitantly
administered for a longer period of
time due to induction of
metabolism by ritonavir.
Therefore, clinical monitoring is
recommended, as maintenance
therapy may need to be adjusted in
some 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): methadone (HOS-086198) lomitapide (HOS-086160) rosuvastatin (HOS-086307) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) sirolimus (HOS-085172) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage f2f65869b04ef808ebdc5d5e920ff573b17a50545ae43721f20f184c9d93d8d0 · Zeichen 54354–58869 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 103–104
HOS-116619 · Präparat HOS-094447
103
Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of
10 mg once daily rosuvastatin Cmax ↑ 144%║ rosuvastatin and boosted
║
based on published data with PREZISTA is required, it is
darunavir/ritonavir recommended to start with the
lowest possible dose of
rosuvastatin AUC ↑ 93%§ rosuvastatin and titrate up to the
rosuvastatin Cmax ↑ 277%§ desired clinical effect while
rosuvastatin Cmin ND§ monitoring for safety.
§
with darunavir/cobicistat 800/150 mg
OTHER LIPID MODIFYING AGENTS
Lomitapide Based on theoretical considerations Co-administration is
boosted PREZISTA is expected to contraindicated (see section 4.3).
increase the exposure of lomitapide when
co-administered.
(CYP3A inhibition)
H2-RECEPTOR ANTAGONISTS
Ranitidine # Boosted PREZISTA can be
darunavir AUC ↔
150 mg twice daily #
darunavir Cmin ↔ co-administered with H2-receptor
#
darunavir Cmax ↔ antagonists without dose
adjustments.
IMMUNOSUPPRESSANTS
Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the
Sirolimus immunosuppressants will be increased immunosuppressive agent must be
Tacrolimus when co-administered with boosted done when co-administration
PREZISTA. occurs.
(CYP3A inhibition)
Everolimus Concomitant use of everolimus
and boosted PREZISTA is not
recommended.
INHALED BETA AGONISTS
Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and
salmeterol and boosted darunavir may boosted PREZISTA is not
increase plasma concentrations of recommended. The combination
salmeterol. may result in increased risk of
cardiovascular adverse event with
salmeterol, including QT
prolongation, palpitations and
sinus tachycardia.
NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE
Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone
individual dose ranging R(-) methadone Cmin ↓ 15% dosage is required when initiating
from 55 mg to 150 mg R(-) methadone Cmax ↓ 24% co-administration with boosted
once daily PREZISTA. However, adjustment
PREZISTA/cobicistat may, in contrast, of the methadone dose may be
increase methadone plasma necessary when concomitantly
concentrations (see cobicistat SmPC). administered for a longer period of
time. Therefore, clinical
monitoring is recommended, as
maintenance therapy may need to
be adjusted in some patients.
Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the
8/2 mg–16/4 mg once buprenorphine Cmin ↔ increase in norbuprenorphine
daily buprenorphine Cmax ↓ 8% pharmacokinetic parameters has
norbuprenorphine AUC ↑ 46% not been established. Dose
norbuprenorphine Cmin ↑ 71% adjustment for buprenorphine may
norbuprenorphine Cmax ↑ 36% not be necessary when
naloxone AUC ↔ co-administered with boosted
PREZISTA but a careful clinical
naloxone Cmin ND
monitoring for signs of opiate
naloxone Cmax ↔ toxicity 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) lomitapide (HOS-086160) cobicistat (HOS-088111) rosuvastatin (HOS-086307) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 6e9aabce398149840c7621950bc6562a692bbfc641caaabe022d97e86d869ebf · Zeichen 62955–68223 im Abschnitt
Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)
Darunavir Viatris 75 mg film-coated tablets Darunavir Viatris 150 mg film-coated tablets Darunavir Viatris 300 mg film-coated tablets Darunavir Viatris 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19–20
HOS-134515 · Präparat HOS-097580
19
INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Medicinal products by Interaction Geometric mean change Recommendations concerning co-
therapeutic areas (%) administration
Pravastatin pravastatin AUC ↑ 81%¶ When administration of pravastatin
40 mg single dose pravastatin Cmin ND and darunavir co-administered with
pravastatin Cmax ↑ 63% low dose ritonavir is required, it is
¶
an up to five-fold increase was seen in recommended to start with the
a limited subset of subjects lowest possible dose of pravastatin
and titrate up to the desired clinical
effect while monitoring for safety.
Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of rosuvastatin
10 mg once daily rosuvastatin Cmax ↑ 144%║ and darunavir co- administered with
║
based on published data with low dose ritonavir is required, it is
darunavir/ritonavir recommended to start with the
lowest possible dose of rosuvastatin
and titrate up to the desired clinical
effect while monitoring for safety.
OTHER LIPID MODIFYING AGENTS
Lomitapide Based on theoretical considerations Co-administration is contraindicated
boosted darunavir is expected to (see section 4.3).
increase the exposure of lomitapide
when co-administered.
(CYP3A inhibition)
H2-RECEPTOR ANTAGONISTS
Ranitidine #
darunavir AUC ↔ Darunavir co-administered with low
150 mg twice daily #
darunavir Cmin ↔ dose ritonavir can be co-
#
darunavir Cmax ↔ administered with H2-receptor
antagonists without dose
adjustments.
IMMUNOSUPPRESSANTS
Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the
Sirolimus immunosuppressants will be increased immunosuppressive agent must be
Tacrolimus when co-administered with darunavir done when co-administration
co-administered with low dose occurs.
ritonavir. (CYP3A inhibition)
Everolimus Concomitant use of everolimus and
darunavir co-administered with low
dose ritonavir is not recommended.
INHALED BETA AGONISTS
Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and
salmeterol and darunavir co- darunavir co-administered with low
administered with low dose ritonavir dose ritonavir is not recommended.
may increase plasma concentrations of The combination may result in
salmeterol. increased risk of cardiovascular
adverse event with salmeterol,
including QT prolongation,
palpitations and sinus tachycardia.
NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE
Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone dosage
individual dose ranging R(-) methadone Cmin ↓ 15% is required when initiating co-
from 55 mg to 150 mg once R(-) methadone Cmax ↓ 24% administration with
daily darunavir/ritonavir. However,
increased methadone dose may be
necessary when concomitantly
administered for a longer period of
time due to induction of metabolism
by ritonavir.
Therefore, clinical monitoring is
recommended, as maintenance
therapy may need to be adjusted in
some 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): methadone (HOS-086198) lomitapide (HOS-086160) rosuvastatin (HOS-086307) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) sirolimus (HOS-085172) ritonavir (HOS-084521) pravastatin (HOS-086306)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-20T12:32:00Z · SHA-256 50f4771a683f17214737463c6df88a158b1e699bbb9916413602e547e369e804 · Passage 91cb16265fd620625247f76233e3f7fafba2de999fc1839d61db7146d156fb87 · Zeichen 53072–58684 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.