Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-118451 · Präparat HOS-094825

Hypersensitivity to the active substance or to peanut or soya 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.

Gegenanzeigen · Celsentri

CELSENTRI 20 mg/mL oral solution · Abschnitt 4.3 · PDF-Seite 31

HOS-118496 · Präparat HOS-094825

Hypersensitivity to the active substance 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 · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-118452 · Präparat HOS-094825

Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5. Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic effects. Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations. Dose adjustment of maraviroc is recommended when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers. Further details for concomitantly administered medicinal products are provided below (see Table 2).

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

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-118453 · Präparat HOS-094825

Maraviroc is a substrate for the transporters P-glycoprotein and OATP1B1, but the effect of these transporters on the exposure to maraviroc is not known.

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

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-118454 · Präparat HOS-094825

Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low. In vitro studies have shown that maraviroc does not inhibit OATP1B1, MRP2 or any of the major P450 enzymes at clinically relevant concentrations (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4). Maraviroc had no clinically relevant effect on the pharmacokinetics of midazolam, the oral contraceptives ethinylestradiol and levonorgestrel, or urinary 6β-hydroxycortisol/cortisol ratio, suggesting no inhibition or induction of CYP3A4 in vivo. At higher exposure of maraviroc a potential inhibition of CYP2D6 cannot be excluded.

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): levonorgestrel (HOS-089677) midazolam (HOS-086167)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-118455 · Präparat HOS-094825

Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors. In vitro studies have shown that maraviroc does not inhibit any of the major renal uptake transporters at clinically relevant concentrations (OAT1, OAT3, OCT2, OCTN1, and OCTN2). Additionally, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc. In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics. Maraviroc inhibits P-glycoprotein in vitro (IC50 is 183 μM). However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo. It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.

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) trimethoprim (HOS-085184) digoxin (HOS-086172) lamivudine (HOS-085829) zidovudine (HOS-085837) dabigatran etexilate (HOS-086233)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-118456 · Präparat HOS-094825

7 Table 2: Interactions and adulta dose recommendations with other medicinal products

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

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-118457 · Präparat HOS-094825

Medicinal product by Effects on active substance levels Recommendations therapeutic areas Geometric mean change if not concerning co- (dose of CELSENTRI stated otherwise administration in adults used in study) ANTI-INFECTIVES Antiretrovirals Pharmacokinetic Enhancers Cobicistat Interaction not studied. CELSENTRI dose should be decreased to 150 mg Cobicistat is a potent CYP3A twice daily when co- inhibitor. administered with cobicistat containing regimen. Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Lamivudine 150 mg BID Lamivudine AUC12: ↔ 1.13 No significant interaction (maraviroc 300 mg BID) Lamivudine Cmax: ↔ 1.16 seen/expected. Maraviroc concentrations not CELSENTRI 300 mg measured, no effect is expected. twice daily and NRTIs can Tenofovir 300 mg QD Maraviroc AUC12: ↔ 1.03 be co-administered (maraviroc 300 mg BID) Maraviroc Cmax: ↔ 1.03 without dose adjustment. Tenofovir concentrations not measured, no effect is expected. Zidovudine 300 mg BID Zidovudine AUC12: ↔ 0.98 (maraviroc 300 mg BID) Zidovudine Cmax: ↔ 0.92 Maraviroc concentrations not measured, no effect is expected. Integrase Inhibitors Elvitegravir/ritonavir Maraviroc AUC12: ↑ 2.86 (2.33-3.51) Elvitegravir as a single 150/100mg QD Maraviroc Cmax: ↑ 2.15 (1.71-2.69) agent is indicated only in (maraviroc 150 mg BID) Maraviroc C12: ↑ 4.23 (3.47-5.16) combination with certain ritonavir boosted PIs. Elvitegravir AUC24: ↔ 1.07 (0.96-1.18) Elvitegravir per se is not Elvitegravir Cmax: ↔ 1.01 expected to affect (0.89-1.15) maraviroc exposure to a Elvitegravir C24: ↔ 1.09 (0.95-1.26) clinically relevant degree and the observed effect is attributed to 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): tenofovir (HOS-088083) cobicistat (HOS-088111) lamivudine (HOS-085829) zidovudine (HOS-085837) ritonavir (HOS-084521) elvitegravir (HOS-088110)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-118459 · Präparat HOS-094825

Thus, CELSENTRI dose should be modified in line with the recommendation for co-administration with respective PI/ritonavir combination (see ‘Protease Inhibitors’). Raltegravir 400 mg BID Maraviroc AUC12: ↓ 0.86 No clinically significant (maraviroc 300 mg BID) Maraviroc Cmax: ↓ 0.79 interaction seen. CELSENTRI 300 mg Raltegravir AUC12: ↓ 0.63 twice daily and raltegravir Raltegravir Cmax: ↓ 0.67 can be co-administered Raltegravir C12: ↓ 0.72 without dose adjustment.

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) raltegravir (HOS-086187) ritonavir (HOS-084521)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8–9

HOS-118460 · Präparat HOS-094825

8 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD Maraviroc AUC12: ↓ 0.55 CELSENTRI dose should (maraviroc 100 mg BID) Maraviroc Cmax: ↓ 0.49 be increased to 600 mg Efavirenz concentrations not twice daily when measured, no effect is expected. co-administered with efavirenz in the absence of a potent CYP3A4 inhibitor. For combination with efavirenz + PI, see separate recommendations below. Etravirine 200 mg BID Maraviroc AUC12: ↓ 0.47 Etravirine is only (maraviroc 300 mg BID) Maraviroc Cmax: ↓ 0.40 approved for use with boosted protease Etravirine AUC12: ↔ 1.06 inhibitors. For Etravirine Cmax: ↔ 1.05 combination with Etravirine C12: ↔ 1.08 etravirine + PI, see below. Nevirapine 200 mg BID Maraviroc AUC12: ↔ compared to Comparison to exposure (maraviroc 300 mg Single historical controls in historical controls Dose) Maraviroc Cmax: ↑ compared to suggests that historical controls CELSENTRI 300 mg Nevirapine concentrations not twice daily and nevirapine measured, no effect is expected. can be co-administered without dose adjustment. Protease Inhibitors (PIs) Atazanavir 400 mg QD Maraviroc AUC12 ↑ 3.57 CELSENTRI dose should (maraviroc 300 mg BID) Maraviroc Cmax: ↑ 2.09 be decreased to 150 mg Atazanavir concentrations not twice daily when measured, no effect is expected. co-administered with a PI; Atazanavir/ritonavir Maraviroc AUC12 ↑ 4.88 except in combination with 300 mg/100 mg QD Maraviroc Cmax: ↑ 2.67 tipranavir/ritonavir where (maraviroc 300 mg BID) Atazanavir/ritonavir concentrations the CELSENTRI dose not measured, no effect is expected. should be 300 mg BID. Lopinavir/ritonavir Maraviroc AUC12 ↑ 3.95 400 mg/100 mg BID Maraviroc Cmax: ↑ 1.97 (maraviroc 300 mg BID) Lopinavir/ritonavir concentrations not measured, no effect is expected. Saquinavir/ritonavir Maraviroc AUC12 ↑ 9.77 1000 mg/100 mg BID Maraviroc Cmax: ↑ 4.78 (maraviroc 100 mg BID) Saquinavir/ritonavir concentrations not measured, no effect is expected. Darunavir/ritonavir Maraviroc AUC12 ↑ 4.05 600 mg/100 mg BID Maraviroc Cmax: ↑ 2.29 (maraviroc 150 mg BID) Darunavir/ritonavir concentrations were consistent with historical data. Nelfinavir Limited data are available for co- administration with nelfinavir. Nelfinavir is a potent CYP3A4 inhibitor and would be expected to increase maraviroc 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): lopinavir (HOS-086269) atazanavir (HOS-086180) nelfinavir (HOS-084520) protease (HOS-085623) etravirine (HOS-088088) saquinavir (HOS-084522) darunavir (HOS-086181) efavirenz (HOS-087947) nevirapine (HOS-088064) ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9–10

HOS-118461 · Präparat HOS-094825

9 Indinavir Limited data are available for co- administration with indinavir. Indinavir is a potent CYP3A4 inhibitor. Population PK analysis in phase 3 studies suggests dose reduction of maraviroc when co-administered with indinavir gives appropriate maraviroc exposure. Tipranavir/ritonavir Maraviroc AUC12 ↔ 1.02 500 mg/200 mg BID Maraviroc Cmax: ↔ 0.86 (maraviroc 150 mg BID) Tipranavir/ritonavir concentrations were consistent with historical data.

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): indinavir (HOS-084518) ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-118462 · Präparat HOS-094825

Fosamprenavir/ritonavir Maraviroc AUC12: ↑ 2.49 Concomitant use is not 700 mg/100 mg BID Maraviroc Cmax: ↑ 1.52 recommended. Significant (maraviroc 300 mg BID) Maraviroc C12: ↑ 4.74 reductions in amprenavir Cmin observed may result Amprenavir AUC12: ↓ 0.65 in virological failure in Amprenavir Cmax: ↓ 0.66 patients Amprenavir C12: ↓ 0.64

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): amprenavir (HOS-086183) fosamprenavir (HOS-086182) ritonavir (HOS-084521)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-118464 · Präparat HOS-094825

Ritonavir AUC12: ↓ 0.66 Ritonavir Cmax: ↓ 0.61 Ritonavir C12: ↔ 0.86

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): ritonavir (HOS-084521)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-118465 · Präparat HOS-094825

NNRTI + PI Efavirenz 600 mg QD + Maraviroc AUC12: ↑ 2.53 CELSENTRI dose should lopinavir/ritonavir Maraviroc Cmax: ↑ 1.25 be decreased to 150 mg 400mg/100 mg BID Efavirenz, lopinavir/ritonavir twice daily when (maraviroc 300 mg BID) concentrations not measured, no co-administered with effect expected. efavirenz and a PI (except Efavirenz 600 mg QD + Maraviroc AUC12: ↑ 5.00 tipranavir/ritonavir where saquinavir/ritonavir Maraviroc Cmax: ↑ 2.26 the dose should be 600 mg 1000 mg/100 mg BID Efavirenz, saquinavir/ritonavir twice daily). (maraviroc 100 mg BID) concentrations not measured, no effect expected. Concomitant use of Efavirenz and Not studied. Based on the extent of CELSENTRI and atazanavir/ritonavir or inhibition by atazanavir/ritonavir or fosamprenavir/ritonavir is darunavir/ritonavir darunavir/ritonavir in the absence of not recommended. efavirenz, an increased exposure is expected.

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): lopinavir (HOS-086269) atazanavir (HOS-086180) saquinavir (HOS-084522) darunavir (HOS-086181) efavirenz (HOS-087947) fosamprenavir (HOS-086182) ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10–11

HOS-118466 · Präparat HOS-094825

10 Etravirine and Maraviroc AUC12: ↑ 3.10 CELSENTRI dose should darunavir/ritonavir Maraviroc Cmax: ↑ 1.77 be decreased to 150 mg (maraviroc 150 mg BID) twice daily when Etravirine AUC12: ↔ 1.00 co-administered with Etravirine Cmax: ↔ 1.08 etravirine and a PI. Etravirine C12: ↓ 0.81 Concomitant use of Darunavir AUC12: ↓ 0.86 CELSENTRI and Darunavir Cmax: ↔ 0.96 fosamprenavir/ritonavir is Darunavir C12: ↓ 0.77 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): etravirine (HOS-088088) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-118467 · Präparat HOS-094825

Ritonavir AUC12: ↔ 0.93 Ritonavir Cmax: ↔ 1.02 Ritonavir C12: ↓ 0.74 Etravirine and Not studied. Based on the extent of lopinavir/ritonavir, inhibition by lopinavir/ritonavir, saquinavir/ritonavir or saquinavir/ritonavir or atazanavir/ritonavir atazanavir/ritonavir in the absence of etravirine, an increased exposure is expected. ANTIBIOTICS Sulphamethoxazole/ Maraviroc AUC12: ↔ 1.11 CELSENTRI 300 mg Trimethoprim Maraviroc Cmax: ↔ 1.19 twice daily and 800 mg/160 mg BID Sulphamethoxazole/trimethoprim sulphamethoxazole/ (maraviroc 300 mg BID) concentrations not measured, no trimethoprim can be effect expected. co-administered without dose adjustment. Rifampicin 600 mg QD Maraviroc AUC: ↓ 0.37 CELSENTRI dose should (maraviroc 100 mg BID) Maraviroc Cmax: ↓ 0.34 be increased to 600 mg Rifampicin concentrations not twice daily when measured, no effect expected. co-administered with rifampicin in the absence of a potent CYP3A4 inhibitor. This dose adjustment has not been studied in HIV patients. See also section 4.4. Rifampicin + efavirenz Combination with two inducers has Concomitant use of not been studied. There may be a risk CELSENTRI and of suboptimal levels with risk of loss rifampicin + efavirenz is of virologic response and resistance not recommended. development.

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): lopinavir (HOS-086269) atazanavir (HOS-086180) trimethoprim (HOS-085184) etravirine (HOS-088088) saquinavir (HOS-084522) efavirenz (HOS-087947) ritonavir (HOS-084521)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-118468 · Präparat HOS-094825

11 Rifabutin + PI Not studied. Rifabutin is considered CELSENTRI dose should to be a weaker inducer than be decreased to 150 mg rifampicin. When combining twice daily when rifabutin with protease inhibitors that co-administered with are potent inhibitors of CYP3A4 a rifabutin and a PI (except net inhibitory effect on maraviroc is tipranavir/ritonavir where expected. the dose should be 300 mg twice daily). See also 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): protease (HOS-085623) rifabutin (HOS-086262) ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-118469 · Präparat HOS-094825

Concomitant use of CELSENTRI and fosamprenavir/ritonavir is not recommended. Clarithromycin, Not studied, but both are potent CELSENTRI dose should Telithromycin CYP3A4 inhibitors and would be be decreased to 150 mg expected to increase maraviroc twice daily when concentrations. co-administered with clarithromycin and telithromycin. ANTICONVULSANTS Carbamezepine, Not studied, but these are potent CELSENTRI dose should Phenobarbital, CYP3A4 inducers and would be be increased to 600 mg Phenytoin expected to decrease maraviroc twice daily when co- concentrations. administered with carbamazepine, phenobarbital or phenytoin in the absence of a potent CYP3A4 inhibitor. ANTIFUNGALS Ketoconazole 400 mg QD Maraviroc AUCtau: ↑ 5.00 CELSENTRI dose should (maraviroc 100 mg BID) Maraviroc Cmax: ↑ 3.38 be decreased to 150 mg Ketoconazole concentrations not twice daily when measured, no effect is expected. co-administered with ketoconazole. Itraconazole Not studied. Itraconazole, is a potent CELSENTRI dose should CYP3A4 inhibitor and would be be decreased to 150 mg expected to increase the exposure of twice daily when maraviroc. co-administered with itraconazole. Fluconazole Fluconazole is considered to be a CELSENTRI 300 mg moderate CYP3A4 inhibitor. twice daily should be Population PK studies suggest that a administered with caution dose adjustment of maraviroc is not when co-administered required. with fluconazole. ANTIVIRALS Anti-HBV Pegylated interferon Pegylated interferon has not been CELSENTRI 300 mg studied, no interaction is expected. twice daily and pegylated interferon can be co-administered without dose adjustment. Anti-HCV

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): phenobarbital (HOS-085617) ketoconazole (HOS-084513) carbamazepine (HOS-085618) telithromycin (HOS-084523) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) fosamprenavir (HOS-086182) ritonavir (HOS-084521) phenytoin (HOS-084531)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12–13

HOS-118470 · Präparat HOS-094825

12 Ribavirin Ribavirin has not been studied, no CELSENTRI 300 mg interaction is expected. twice daily and ribavirin can be co-administered without dose adjustment. DRUG ABUSE Methadone Not studied, no interaction expected. CELSENTRI 300 mg twice daily and methadone can be co-administered without dose adjustment. Buprenorphine Not studied, no interaction expected. CELSENTRI 300 mg twice daily and buprenorphine can be co-administered without dose adjustment. LIPID LOWERING MEDICINAL PRODUCTS Statins Not studied, no interaction expected. CELSENTRI 300 mg twice daily and statins can be co-administered without dose adjustment. ANTIARRHYTHMICS Digoxin 0.25 mg Digoxin. AUCt: ↔ 1.00 CELSENTRI 300 mg Single Dose Digoxin. Cmax: ↔ 1.04 twice daily and digoxin (maraviroc 300 mg BID) Maraviroc concentrations not can be co-administered measured, no interaction expected. without dose adjustment.

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) digoxin (HOS-086172) buprenorphine (HOS-086193) ribavirin (HOS-088127)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 13

HOS-118472 · Präparat HOS-094825

The effect of maraviroc on digoxin at the dose of 600 mg BID has not been studied. ORAL CONTRACEPTIVES Ethinylestradiol 30 mcg QD Ethinylestradiol. AUCt: ↔ 1.00 CELSENTRI 300 mg (maraviroc 100 mg BID) Ethinylestradiol. Cmax: ↔ 0.99 twice daily. and Maraviroc concentrations not ethinylestradiol can be measured, no interaction expected. co-administered without dose adjustment. Levonorgestrel 150 mcg Levonorgestrel. AUC12: ↔ 0.98 CELSENTRI 300 mg QD Levonorgestrel. Cmax: ↔ 1.01 twice daily and (maraviroc 100 mg BID) Maraviroc concentrations not levonorgestrel can be measured, no interaction expected. co-administered without dose adjustment. SEDATIVES Benzodiazepines Midazolam 7.5 mg Single Midazolam. AUC: ↔ 1.18 CELSENTRI 300 mg Dose Midazolam. Cmax: ↔ 1.21 twice daily and (maraviroc 300 mg BID) Maraviroc concentrations not midazolam can be measured, no interaction expected. co-administered without dose adjustment. HERBAL PRODUCTS

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): levonorgestrel (HOS-089677) digoxin (HOS-086172) midazolam (HOS-086167)