Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 19

HOS-086284 · Präparat HOS-083284

β2-agonist (long acting) Salmeterol Ritonavir inhibits CYP3A4 and as a result a pronounced increase in the plasma concentrations of salmeterol is expected. Therefore concomitant use 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): salmeterol (HOS-086285)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 51

HOS-086462 · Präparat HOS-083284

β2-agonist (long acting) Salmeterol Ritonavir inhibits CYP3A4 and as a result a pronounced increase in the plasma concentrations of salmeterol is expected. Therefore concomitant use 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): salmeterol (HOS-086285)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 20–21

HOS-108905 · Präparat HOS-093083

20 Benzodiazepines Midazolam Oral Midazolam: Kaletra must not be co-administered AUC: ↑ 13-fold with oral midazolam (see section Parenteral Midazolam: 4.3), whereas caution should be AUC: ↑ 4-fold used with co-administration of Due to CYP3A inhibition by Kaletra and parenteral midazolam. lopinavir/ritonavir If Kaletra is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage adjustment for midazolam should be considered especially if more than a single dose of midazolam is administered. Beta2-adrenoceptor agonist (long acting) Salmeterol Salmeterol: The combination may result in Concentrations are expected to increased risk of cardiovascular increase due to CYP3A inhibition adverse events associated with by lopinavir/ritonavir. salmeterol, including QT prolongation, palpitations and sinus tachycardia. Therefore, concomitant administration of Kaletra with salmeterol is not recommended (see section 4.4). Calcium channel blockers Felodipine, Nifedipine, and Felodipine, Nifedipine, Clinical monitoring of therapeutic Nicardipine Nicardipine: and adverse effects is Concentrations may be increased recommended when these due to CYP3A inhibition by medicines are concomitantly lopinavir/ritonavir. administered with Kaletra. Corticosteroids Dexamethasone Lopinavir: Clinical monitoring of antiviral Concentrations may be decreased efficacy is recommended when due to CYP3A induction by these medicines are concomitantly dexamethasone. administered with Kaletra.

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): nifedipine (HOS-086289) nicardipine (HOS-090619) felodipine (HOS-108908) calcium (HOS-085615) salmeterol (HOS-086285) dexamethasone (HOS-084535) midazolam (HOS-086167)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 56–57

HOS-109016 · Präparat HOS-093083

56 Benzodiazepines Midazolam Oral Midazolam: Kaletra must not be co-administered AUC: ↑ 13-fold with oral midazolam (see section Parenteral Midazolam: 4.3), whereas caution should be used AUC: ↑ 4-fold with co-administration of Kaletra and Due to CYP3A inhibition by parenteral midazolam. If Kaletra is lopinavir/ritonavir co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage adjustment for midazolam should be considered especially if more than a single dose of midazolam is administered. Beta2-adrenoceptor agonist (long acting) Salmeterol Salmeterol: The combination may result in Concentrations are expected to increased risk of cardiovascular increase due to CYP3A inhibition adverse events associated with by lopinavir/ritonavir. salmeterol, including QT prolongation, palpitations and sinus tachycardia. Therefore, concomitant administration of Kaletra with salmeterol is not recommended (see section 4.4). Calcium channel blockers Felodipine, Nifedipine, Felodipine, Nifedipine, Clinical monitoring of therapeutic and Nicardipine Nicardipine: and adverse effects is recommended Concentrations may be increased when these medicines are due to CYP3A inhibition by concomitantly administered with lopinavir/ritonavir. Kaletra. Corticosteroids Dexamethasone Lopinavir: Clinical monitoring of antiviral Concentrations may be decreased efficacy is recommended when these due to CYP3A induction by medicines are concomitantly dexamethasone. administered with Kaletra.

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): nifedipine (HOS-086289) nicardipine (HOS-090619) felodipine (HOS-108908) calcium (HOS-085615) salmeterol (HOS-086285) dexamethasone (HOS-084535) midazolam (HOS-086167)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 91–92

HOS-109092 · Präparat HOS-093083

91 Pimozide Due to CYP3A inhibition by Concomitant administration of lopinavir/ritonavir, concentrations Kaletra and pimozide is of pimozide are expected to contraindicated as it may increase increase. the risk of serious haematologic abnormalities or other serious adverse effects from this agent (see section 4.3) Quetiapine Due to CYP3A inhibition by Concomitant administration of lopinavir/ritonavir, concentrations Kaletra and quetiapine is of quetiapine are expected to contraindicated as it may increase increase. quetiapine-related toxicity. Benzodiazepines Midazolam Oral Midazolam: Kaletra must not be co-administered AUC: ↑ 13-fold with oral midazolam (see section Parenteral Midazolam: 4.3), whereas caution should be AUC: ↑ 4-fold used with co-administration of Due to CYP3A inhibition by Kaletra and parenteral midazolam. lopinavir/ritonavir If Kaletra is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage adjustment for midazolam should be considered especially if more than a single dose of midazolam is administered. Beta2-adrenoceptor agonist (long acting) Salmeterol Salmeterol: The combination may result in Concentrations are expected to increased risk of cardiovascular increase due to CYP3A inhibition adverse events associated with by lopinavir/ritonavir. salmeterol, including QT prolongation, palpitations and sinus tachycardia. Therefore, concomitant administration of Kaletra with salmeterol is not recommended (see section 4.4). Calcium channel blockers Felodipine, Nifedipine, Felodipine, Nifedipine, Clinical monitoring of therapeutic and Nicardipine Nicardipine: and adverse effects is recommended Concentrations may be increased when these medicines are due to CYP3A inhibition by concomitantly administered with lopinavir/ritonavir. Kaletra. Corticosteroids Dexamethasone Lopinavir: Clinical monitoring of antiviral Concentrations may be decreased efficacy is recommended when due to CYP3A induction by these medicines are concomitantly dexamethasone. administered with Kaletra.

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) nifedipine (HOS-086289) nicardipine (HOS-090619) felodipine (HOS-108908) calcium (HOS-085615) salmeterol (HOS-086285) dexamethasone (HOS-084535) pimozide (HOS-085600) midazolam (HOS-086167)

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)

Wechselwirkungen · Reyataz

REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 59–60

HOS-112202 · Präparat HOS-093615

59 Medicinal products by Interaction Recommendations therapeutic area concerning co-administration INHALED BETA AGONISTS Salmeterol Co-administration with REYATAZ may Co-administration of result in increased concentrations of salmeterol with REYATAZ is salmeterol and an increase in salmeterol- not recommended (see associated adverse events. 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): salmeterol (HOS-086285)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 16–17

HOS-114834 · Präparat HOS-094169

16  metabolising enzymes by St John’s wort is expected to John’s wort. substantially decrease tipranavir and ritonavir concentrations and may result in sub-optimal levels of tipranavir and lead to loss of virologic response and possible resistance to tipranavir. Inhaled beta agonists Salmeterol The concurrent administration of Concurrent administration of tipranavir and low dose ritonavir Aptivus, co-administered with may result in increased risk of low dose ritonavir, is not cardiovascular adverse events recommended. associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.

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): salmeterol (HOS-086285) lead (HOS-085592) ritonavir (HOS-084521)

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)

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)

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)

Wechselwirkungen · Zydelig

Zydelig 100 mg film-coated tablets Zydelig 150 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-132108 · Präparat HOS-097192

Atorvastatin ↑ serum concentrations Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered. Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered. IMMUNOSUPPRESSANTS Ciclosporin, sirolimus, ↑ serum concentrations Therapeutic monitoring is tacrolimus recommended. INHALED BETA AGONIST Salmeterol ↑ serum concentrations Concurrent administration of salmeterol and idelalisib is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.

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) salmeterol (HOS-086285) tacrolimus (HOS-085202) sirolimus (HOS-085172) pravastatin (HOS-086306) pitavastatin (HOS-125743)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 13–14

HOS-132872 · Präparat HOS-097310

13 Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Dexamethasone, Potential ↑in plasma concentrations of Careful monitoring. fluticasone, these drugs Dose adjustment of these medicinal methylprednisolone products may be required. Lipid Lowering Drugs Lovastatin, simvastatin, Potential ↑in plasma concentrations of Contraindicated due to an increased atorvastatin* these drugs risk of skeletal muscle toxicity, including rhabdomyolysis (see section 4.3). Respiratory Drugs Salmeterol Salmeterol Not recommended due to an AUC: ↑ 15-fold increased risk in QT prolongation. Cmax: ↑ 1.4-fold Urological Drugs Fesoterodine Fesoterodine active metabolite: Not recommended due to an Tolterodine AUC: ↑ 2.3-fold increased risk of QT prolongation. Solifenacin Cmax: ↑ 2.0-fold Fesoterodine and solifenacin are contraindicated in patients with renal Solifenacin: impairment (see section 4.3). AUC: ↑ 3.0-fold

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): solifenacin (HOS-116433) tolterodine (HOS-087792) fluticasone (HOS-108914) lovastatin (HOS-086157) atorvastatin (HOS-086304) methylprednisolone (HOS-088374) simvastatin (HOS-086158) salmeterol (HOS-086285) dexamethasone (HOS-084535) fesoterodine (HOS-116432)

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

HOS-134017 · Präparat HOS-097520

Genvoya is not expected to have a clinically relevant effect on plasma concentrations of the active metabolite of prasugrel. INHALED BETA AGONIST Salmeterol Interaction not studied with any of Concurrent administration of the components of Genvoya. salmeterol and Genvoya is not recommended. Co-administration with Genvoya may result in increased plasma concentrations of salmeterol, which is associated with the potential for serious or life-threatening adverse reactions. HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/ Elvitegravir: Concentrations of rosuvastatin are Elvitegravir (150 mg once daily)/ AUC: ↔ transiently increased when Cobicistat (150 mg once daily) Cmin: ↔ administered with elvitegravir and Cmax: ↔ cobicistat. Dose modifications are not necessary when rosuvastatin is Rosuvastatin: administered in combination with AUC: ↑ 38% Genvoya. Cmin: N/A Cmax: ↑ 89% Atorvastatin (10 mg single Atorvastatin: Concentrations of atorvastatin are dose)/Elvitegravir (150 mg once AUC: ↑ 160% increased when co-administered daily)/Cobicistat (150 mg once Cmin: N/A with elvitegravir and cobicistat. daily)/Emtricitabine (200 mg once Cmax: ↑ 132% Start with the lowest possible dose daily)/Tenofovir alafenamide of atorvastatin with careful (10 mg once daily) Elvitegravir: monitoring upon co-administration AUC: ↔ with Genvoya. Cmin: ↔ Cmax: ↔ Pitavastatin Interaction not studied with any of Caution should be exercised when the components of Genvoya. co-administering Genvoya with pitavastatin. Concentrations of pitavastatin may be increased when administered with elvitegravir and cobicistat.

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) salmeterol (HOS-086285) prasugrel (HOS-112066) pitavastatin (HOS-125743)

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)

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 62

HOS-134631 · Präparat HOS-097580

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 ↔ Boosted darunavir can be co- 150 mg twice daily # darunavir Cmin ↔ 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 immunosuppressive agent must be Tacrolimus increased when co-administered done when co-administration occurs. Everolimus with boosted darunavir. (CYP3A Concomitant use of everolimus and inhibition) boosted darunavir is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and boosted darunavir boosted darunavir is not may increase plasma concentrations recommended. The combination may of salmeterol. 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% R(-) No adjustment of methadone dosage individual dose ranging from methadone Cmin ↓ 15% R(-) is required when initiating co- 55 mg to 150 mg once daily methadone Cmax ↓ 24% administration with boosted darunavir. However, adjustment of Darunavir/cobicistat may, in the methadone dose may be contrast, increase methadone necessary when concomitantly plasma concentrations (see administered for a longer period of cobicistat SmPC). time. 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) cobicistat (HOS-088111) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) sirolimus (HOS-085172)

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 15–16

HOS-138495 · Präparat HOS-098200

15 OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical Co-administration is considerations, Symtuza is contraindicated (see section 4.3). expected to increase the exposure of lomitapide when co- administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Cimetidine Based on theoretical Symtuza can be co-administered Famotidine considerations, no mechanistic with H2-receptor antagonists Nizatidine interaction is expected. without dose adjustments. Ranitidine IMMUNOSUPPRESSANTS Ciclosporin Based on theoretical considerations Concentration monitoring of the Sirolimus DRV/COBI is expected to increase immunosuppressive agent must Tacrolimus these immunosuppressant plasma be done when co-administration concentrations. with Symtuza occurs. (CYP3A inhibition) Co-administration of ciclosporin is expected to increase plasma concentrations of tenofovir alafenamide. (P-gp inhibition) Concomitant use of everolimus Everolimus and Symtuza is not recommended. INHALED BETA AGONISTS Salmeterol Based on theoretical considerations Concomitant use of salmeterol DRV/COBI is expected to increase and Symtuza is not salmeterol plasma concentrations. recommended. The combination (CYP3A inhibition) may result in increased risk of cardiovascular adverse events with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone Based on theoretical considerations Dose adjustment for DRV/COBI may increase buprenorphine may not be buprenorphine and/or necessary when co-administered norbuprenorphine plasma with Symtuza, but a careful concentrations. clinical monitoring for signs of opiate toxicity is recommended. Methadone Based on theoretical considerations No adjustment of methadone dose DRV/COBI may increase is expected when initiating methadone plasma concentrations. co-administration with Symtuza. Clinical monitoring is With ritonavir-boosted darunavir, a recommended, as maintenance small decrease in methadone therapy may need to be adjusted plasma concentrations was in some patients. observed. Consult the Summary of Product Characteristics for darunavir for further details. Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone DRV/COBI may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering Symtuza with (CYP2D6 and/or CYP3A these analgesics. inhibition)

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) nizatidine (HOS-138496) methadone (HOS-086198) cimetidine (HOS-085835) lomitapide (HOS-086160) oxycodone (HOS-109487) famotidine (HOS-112087) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) fentanyl (HOS-086196) tramadol (HOS-112871)

Gegenanzeigen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.3 · PDF-Seite 4

HOS-142715 · Präparat HOS-098862

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 6–7

HOS-142716 · Präparat HOS-098862

6 Interactions with beta blockers

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142717 · Präparat HOS-098862

Beta adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective β blockers should be avoided unless there are compelling reasons for their use. Potentially serious hypokalaemia may result from β2 agonist therapy (see section 4.4). Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, and diuretics.

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): xanthine (HOS-133925)