Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 12

HOS-086195 · Präparat HOS-083284

Fentanyl Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl. Careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when fentanyl is concomitantly administered with ritonavir.

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): fentanyl (HOS-086196)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 44–45

HOS-086408 · Präparat HOS-083284

44  Ritonavir effects on Non-antiretroviral Co-administered Medicinal Products Co-administered Medicinal Products Dose of Co-administered Medicinal Dose of Effect on Co- Effect on Co- Products (mg) NORVIR administered administered (mg) Medicinal Medicinal Products Products Cmax AUC Fentanyl Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl. Careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when fentanyl is concomitantly administered with ritonavir.

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): fentanyl (HOS-086196)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 12

HOS-108860 · Präparat HOS-093083

Lopinavir: ↔ Ranitidine (150 mg single Ranitidine: ↔ No dose adjustment necessary dose) Alpha1 adrenoreceptor antagonist Alfuzosin Alfuzosin: Concomitant administration of Due to CYP3A inhibition by Kaletra and alfuzosin is contra- lopinavir/ritonavir, concentrations indicated (see section 4.3) as of alfuzosin are expected to alfuzosin-related toxicity, increase. including hypotension, may be increased. Analgesics Fentanyl Fentanyl: Careful monitoring of adverse Increased risk of side-effects effects (notably respiratory (respiratory depression, sedation) depression but also sedation) is due to higher plasma recommended when fentanyl is concentrations because of

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): alfuzosin (HOS-086139) ranitidine (HOS-085660) fentanyl (HOS-086196)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 48–49

HOS-109005 · Präparat HOS-093083

48 (Lopinavir/ritonavir resulted in a higher incidence of 400/100 mg BID) gastrointestinal adverse events and elevations in triglycerides with the or combination regimen without increases in virological efficacy, Fosamprenavir when compared with standard doses (1400 mg BID) of fosamprenavir/ritonavir. Concomitant administration of these (Lopinavir/ritonavir medicinal products is not 533/133 mg BID) recommended. Kaletra must not be administered once daily in combination with amprenavir. Tipranavir/ritonavir Lopinavir: Concomitant administration of these (500/100 mg BID) AUC: ↓ 55% medicinal products is not Cmin: ↓ 70% recommended. Cmax: ↓ 47% Acid reducing agents Omeprazole (40 mg Omeprazole: ↔ No dose adjustment necessary QD) Lopinavir: ↔ Ranitidine (150 mg Ranitidine: ↔ No dose adjustment necessary single dose) Alpha1 adrenoreceptor antagonist Alfuzosin Alfuzosin: Concomitant administration of Due to CYP3A inhibition by Kaletra and alfuzosin is contra- lopinavir/ritonavir, concentrations indicated (see section 4.3) as of alfuzosin are expected to alfuzosin-related toxicity, including increase. hypotension, may be increased. Analgesics Fentanyl Fentanyl: Careful monitoring of adverse effects Increased risk of side-effects (notably respiratory depression but (respiratory depression, sedation) also sedation) is recommended when due to higher plasma fentanyl is concomitantly concentrations because of administered with Kaletra. CYP3A4 inhibition by lopinavir/ritonavir. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase.

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): alfuzosin (HOS-086139) amprenavir (HOS-086183) ranitidine (HOS-085660) fentanyl (HOS-086196) fosamprenavir (HOS-086182) ranolazine (HOS-086141) tipranavir (HOS-086184) omeprazole (HOS-085912)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 84–85

HOS-109080 · Präparat HOS-093083

84 Fentanyl Fentanyl: Careful monitoring of adverse Increased risk of side-effects effects (notably respiratory (respiratory depression, sedation) depression but also sedation) is due to higher plasma recommended when fentanyl is concentrations because of concomitantly administered with CYP3A4 inhibition by Kaletra. lopinavir/ritonavir. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase. Antiarrhythmics Amiodarone, Amiodarone, Dronedarone: Concomitant administration of Dronedarone Concentrations may be increased Kaletra and amiodarone or due to CYP3A4 inhibition by dronedarone is contraindicated (see lopinavir/ritonavir. section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased. Digoxin Digoxin: Caution is warranted and Plasma concentrations may be therapeutic drug monitoring of increased due to P-glycoprotein digoxin concentrations, if available, inhibition by lopinavir/ritonavir. is recommended in case of The increased digoxin level may co-administration of Kaletra and lessen over time as P-gp digoxin. Particular caution should induction develops. be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on P-gp is expected to significantly increase digoxin levels. Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations. Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and Lidocaine, and Quinidine: therapeutic drug concentration Quinidine Concentrations may be increased monitoring is recommended when when co-administered with available. lopinavir/ritonavir. Antibiotics Clarithromycin Clarithromycin: For patients with renal impairment Moderate increases in (CrCL < 30 ml/min) dose reduction clarithromycin AUC are expected of clarithromycin should be due to CYP3A inhibition by considered (see section 4.4). lopinavir/ritonavir. Caution should be exercised in administering clarithromycin with Kaletra to patients with impaired hepatic or renal function. Anticancer agents and kinase inhibitors Abemaciclib Serum concentrations may be Co-administration of abemaciclib increased due to CYP3A and Kaletra should be avoided. If inhibition by ritonavir. this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations. Monitor for ADRs related to abemaciclib.

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): dronedarone (HOS-086144) abemaciclib (HOS-086209) lidocaine (HOS-108866) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) clarithromycin (HOS-084517) fentanyl (HOS-086196) amiodarone (HOS-085596) ranolazine (HOS-086141)

Wechselwirkungen · Dynastat

Dynastat 40 mg powder for solution for injection · Abschnitt 4.5 · PDF-Seite 8

HOS-109373 · Präparat HOS-093187

Injectable anaesthetics Coadministration of IV parecoxib 40 mg with propofol (CYP2C9 substrate) or midazolam (CYP3A4 substrate) did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam. Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam. Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 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): alfentanil (HOS-109375) propofol (HOS-109374) fentanyl (HOS-086196) valdecoxib (HOS-109357) midazolam (HOS-086167)

Wechselwirkungen · Dynastat

Dynastat 40 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 24

HOS-109414 · Präparat HOS-093187

Injectable anaesthetics Coadministration of IV parecoxib 40 mg with propofol (CYP2C9 substrate) or midazolam (CYP3A4 substrate) did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam. Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam. Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 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): alfentanil (HOS-109375) propofol (HOS-109374) fentanyl (HOS-086196) valdecoxib (HOS-109357) midazolam (HOS-086167)

Wechselwirkungen · Vfend

VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-109484 · Präparat HOS-093201

16 Non-steroidal selective mineralocorticoid receptor (MR) antagonists Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax  20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-  100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax  114% needed. Diclofenac AUC0-  78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax  1.7-fold other long-acting opiates Oxycodone AUC0-  3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax  31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUC  47% reactions and toxicity related to S-methadone Cmax  65% methadone, including QTc S-methadone AUC  103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-  6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 g/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-  1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax  36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUC  61% related to oral contraceptives, in inhibitor] Norethisterone Cmax  15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUC  53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax  14% Voriconazole AUC  46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Wechselwirkungen · Vfend

VFEND 200 mg powder for solution for infusion · Abschnitt 4.5 · PDF-Seite 48–49

HOS-109554 · Präparat HOS-093201

48 Non-steroidal selective mineralocorticoid receptor (MR) antagonists Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax  20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-  100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax  114% needed. Diclofenac AUC0-  78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax  1.7-fold other long-acting opiates Oxycodone AUC0-  3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax  31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUC  47% reactions and toxicity related to S-methadone Cmax  65% methadone, including QTc S-methadone AUC  103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-  6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 g/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-  1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax  36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUC  61% related to oral contraceptives, in inhibitor] Norethisterone Cmax  15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUC  53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax  14% Voriconazole AUC  46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Wechselwirkungen · Vfend

VFEND 40 mg/ml powder for oral suspension · Abschnitt 4.5 · PDF-Seite 80–81

HOS-109619 · Präparat HOS-093201

80 Non-steroidal selective mineralocorticoid receptor (MR) antagonists Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax  20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-  100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax  114% needed. Diclofenac AUC0-  78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax  1.7-fold other long-acting opiates Oxycodone AUC0-  3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax  31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUC  47% reactions and toxicity related to S-methadone Cmax  65% methadone, including QTc S-methadone AUC  103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-  6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 g/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-  1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax  36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUC  61% related to oral contraceptives, in inhibitor] Norethisterone Cmax  15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUC  53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax  14% Voriconazole AUC  46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Wechselwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-110226 · Präparat HOS-093339

Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib. Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine). Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).

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): alfentanil (HOS-109375) simvastatin (HOS-086158) quinidine (HOS-085593) calcium (HOS-085615) docetaxel (HOS-084505) tacrolimus (HOS-085202) bortezomib (HOS-110227) pimozide (HOS-085600) sirolimus (HOS-085172) fentanyl (HOS-086196) ergotamine (HOS-086154) terfenadine (HOS-085607) cyclosporine (HOS-084512)

Wechselwirkungen · Emend

EMEND 125 mg hard capsules EMEND 80 mg hard capsules · Abschnitt 4.5 · PDF-Seite 5

HOS-112511 · Präparat HOS-093697

Effect aprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition As a moderate inhibitor of CYP3A4, aprepitant (125 mg/80 mg) can increase plasma concentrations of co-administered active substances that are metabolised through CYP3A4. The total exposure of orally administered CYP3A4 substrates may increase up to approximately 3-fold during the 3-day treatment with EMEND; the effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller. EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3). Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life-threatening reactions. Caution is advised during concomitant administration of EMEND and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfentanil (HOS-109375) cisapride (HOS-085610) quinidine (HOS-085593) tacrolimus (HOS-085202) pimozide (HOS-085600) everolimus (HOS-086310) astemizole (HOS-085608) sirolimus (HOS-085172) fentanyl (HOS-086196) ergotamine (HOS-086154) terfenadine (HOS-085607) cyclosporine (HOS-084512)

Wechselwirkungen · Emend

EMEND 125 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 22

HOS-112572 · Präparat HOS-093697

Effect of aprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition As a moderate inhibitor of CYP3A4, aprepitant (125 mg/80 mg) can increase plasma concentrations of co-administered active substances that are metabolised through CYP3A4. The total exposure of orally administered CYP3A4 substrates may increase up to approximately 3-fold during the 3-day treatment with EMEND; the effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller. EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3). Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life-threatening reactions. Caution is advised during concomitant administration of EMEND and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfentanil (HOS-109375) cisapride (HOS-085610) quinidine (HOS-085593) tacrolimus (HOS-085202) pimozide (HOS-085600) everolimus (HOS-086310) astemizole (HOS-085608) sirolimus (HOS-085172) fentanyl (HOS-086196) ergotamine (HOS-086154) terfenadine (HOS-085607) cyclosporine (HOS-084512)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 22–23

HOS-116419 · Präparat HOS-094447

22  Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When PREZISTA is Ethinylestradiol drospirenone Cmin ND€ co-administered with a (3 mg/0.02 mg once drospirenone Cmax ↑ 15%€ drospirenone-containing product, daily) ethinylestradiol AUC  30%€ clinical monitoring is recommended due to the potential ethinylestradiol Cmin ND€ for hyperkalaemia. ethinylestradiol Cmax  14%€ € with darunavir/cobicistat Alternative or additional contraceptive measures are Ethinylestradiol ethinylestradiol AUC ↓ 44%β recommended when Norethindrone ethinylestradiol Cmin ↓ 62%β oestrogen-based contraceptives are 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β co-administered with boosted norethindrone AUC ↓ 14%β PREZISTA. Patients using norethindrone Cmin ↓ 30%β oestrogens as hormone norethindrone Cmax ↔β replacement therapy should be β with darunavir/ritonavir clinically monitored for signs of oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was boosted PREZISTA is Avanafil observed for a single intake of 100 mg contraindicated (see section 4.3). Sildenafil sildenafil alone and a single intake of Concomitant use of other PDE-5 Tadalafil 25 mg sildenafil co-administered with inhibitors for the treatment of Vardenafil PREZISTA and low dose ritonavir. erectile dysfunction with boosted PREZISTA should be done with caution. If concomitant use of boosted PREZISTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours 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): tadalafil (HOS-086316) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

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 64–65

HOS-116530 · Präparat HOS-094447

64  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 PREZISTA/ritonavir but a careful naloxone Cmin ND clinical monitoring for signs of naloxone Cmax ↔ opiate toxicity is recommended. Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone Not studied with darunavir/ritonavir. When PREZISTA is co- Ethinylestradiol administered with a drospirenone- (3 mg/0.02 mg once containing product, clinical daily) monitoring is recommended due to the potential for hyperkalaemia.

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): oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) naloxone (HOS-109490) fentanyl (HOS-086196) ritonavir (HOS-084521) tramadol (HOS-112871)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 104–105

HOS-116620 · Präparat HOS-094447

104  Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When PREZISTA is co- Ethinylestradiol drospirenone Cmin ND€ administered with a drospirenone- (3 mg/0.02 mg once drospirenone Cmax ↑ 15%€ containing product, clinical daily) ethinylestradiol AUC  30%€ monitoring is recommended due to the potential for hyperkalaemia. ethinylestradiol Cmin ND€ ethinylestradiol Cmax  14%€ Alternative or additional € with darunavir/cobicistat contraceptive measures are recommended when Ethinylestradiol ethinylestradiol AUC ↓ 44%β oestrogen-based contraceptives are Norethindrone ethinylestradiol Cmin ↓ 62%β co-administered with boosted 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β PREZISTA. Patients using norethindrone AUC ↓ 14%β oestrogens as hormone norethindrone Cmin ↓ 30%β replacement therapy should be norethindrone Cmax ↔β clinically monitored for signs of β with darunavir/ritonavir oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was boosted PREZISTA is Avanafil observed for a single intake of 100 mg contraindicated (see section 4.3). Sildenafil sildenafil alone and a single intake of Concomitant use of other PDE-5 Tadalafil 25 mg sildenafil co-administered with inhibitors for the treatment of Vardenafil PREZISTA and low dose ritonavir. erectile dysfunction with boosted PREZISTA should be done with caution. If concomitant use of boosted PREZISTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended. For the treatment of Not studied. Concomitant use of A safe and effective dose of pulmonary arterial sildenafil or tadalafil for the treatment of sildenafil for the treatment of hypertension pulmonary arterial hypertension and pulmonary arterial hypertension Sildenafil boosted PREZISTA may increase plasma co-administered with boosted Tadalafil concentrations of sildenafil or tadalafil. PREZISTA has not been (CYP3A inhibition) established. There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope). Therefore, co-administration of boosted PREZISTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3). Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with boosted PREZISTA is not recommended.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

Wechselwirkungen · Ivemend

IVEMEND 150 mg powder for solution for infusion. · Abschnitt 4.5 · PDF-Seite 7

HOS-117436 · Präparat HOS-094609

Effect of fosaprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition As a weak inhibitor of CYP3A4, the fosaprepitant 150 mg single dose can cause a transient increase in plasma concentrations of co-administered active substances that are metabolised through CYP3A4. The total exposure of CYP3A4 substrates may increase up to 2-fold on Days 1 and 2 after co- administration with a single 150 mg fosaprepitant dose. Fosaprepitant must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life- threatening reactions (see section 4.3). Caution is advised during concomitant administration of fosaprepitant and active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as ciclosporin, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfentanil (HOS-109375) cisapride (HOS-085610) quinidine (HOS-085593) tacrolimus (HOS-085202) pimozide (HOS-085600) everolimus (HOS-086310) astemizole (HOS-085608) sirolimus (HOS-085172) fentanyl (HOS-086196) ergotamine (HOS-086154) terfenadine (HOS-085607)

Wechselwirkungen · Tasigna

Tasigna 50 mg hard capsules Tasigna 150 mg hard capsules Tasigna 200 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11

HOS-118214 · Präparat HOS-094783

In CML patients, nilotinib administered at 400 mg twice daily for 12 days increased the systemic exposure (AUC and Cmax) of oral midazolam (a substrate of CYP3A4) 2.6-fold and 2.0-fold, respectively. Nilotinib is a moderate CYP3A4 inhibitor. As a result, the systemic exposure of other medicinal products primarily metabolised by CYP3A4 (e.g. certain HMG-CoA reductase inhibitors) may be increased when co-administered with nilotinib. Appropriate monitoring and dose adjustment may be necessary for medicinal products that are CYP3A4 substrates and have a narrow therapeutic index (including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, sirolimus and tacrolimus) when co-administered with nilotinib.

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): alfentanil (HOS-109375) tacrolimus (HOS-085202) sirolimus (HOS-085172) fentanyl (HOS-086196) ergotamine (HOS-086154) cyclosporine (HOS-084512) dihydroergotamine (HOS-086152) midazolam (HOS-086167)

Gegenanzeigen · Effentora

Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets · Abschnitt 4.3 · PDF-Seite 6

HOS-209204 · Präparat HOS-154273

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients without maintenance opioid therapy as there is an increased risk of respiratory depression. • Severe respiratory depression or severe obstructive lung conditions. • Treatment of acute pain other than breakthrough pain. • Patients being treated with medicinal products containing sodium oxybate.

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): sodium oxybate (HOS-113649)

Wechselwirkungen · Effentora

Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-209206 · Präparat HOS-154273

Agents that affect CYP3A4 activity Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.

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