Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Revlimid

Revlimid 2.5 mg hard capsules Revlimid 5 mg hard capsules Revlimid 7.5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 20 mg hard capsules Revlimid 25 mg hard capsules · Abschnitt 4.5 · PDF-Seite 24

HOS-117074 · Präparat HOS-094537

Digoxin Concomitant administration with lenalidomide 10 mg once daily increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%]. It is not known whether the effect will be different in the clinical use (higher lenalidomide doses and concomitant treatment with dexamethasone). Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.

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): digoxin (HOS-086172) dexamethasone (HOS-084535)

Wechselwirkungen · Revlimid

Revlimid 2.5 mg hard capsules Revlimid 5 mg hard capsules Revlimid 7.5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 20 mg hard capsules Revlimid 25 mg hard capsules · Abschnitt 4.5 · PDF-Seite 24

HOS-117076 · Präparat HOS-094537

Dexamethasone Co-administration of single or multiple doses of dexamethasone (40 mg once daily) has no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide (25 mg once daily).

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): dexamethasone (HOS-084535)

Wechselwirkungen · Ivemend

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

HOS-117435 · Präparat HOS-094609

The following information was derived from studies conducted with oral aprepitant and studies conducted with intravenous single dose fosaprepitant co-administered with dexamethasone, midazolam, or diltiazem.

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): diltiazem (HOS-086288) aprepitant (HOS-112506) dexamethasone (HOS-084535) midazolam (HOS-086167)

Wechselwirkungen · Ivemend

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

HOS-117437 · Präparat HOS-094609

Corticosteroids Dexamethasone: The oral dexamethasone dose should be reduced by approximately 50 % when co-administered with fosaprepitant (see section 4.2). Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0-24hr of dexamethasone, a CYP3A4 substrate, by 100 % on Day 1, 86 % on Day 2 and 18 % on Day 3 when dexamethasone was co-administered as a single 8 mg oral dose on Days 1, 2, and 3.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dexamethasone (HOS-084535)

Wechselwirkungen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-119740 · Präparat HOS-095005

11 ANTIMALARIALS Artemether/ artemether Close monitoring of Lumefantrine AUC ↓ 0.62 (0.48-0.80) antimalarial response is 80/480 mg, 6 doses at 0, Cmin ↓ 0.82 (0.67-1.01) warranted when 8, 24, 36, 48, andCmax ↓ 0.72 (0.55-0.94) co-administering 60 hours dihydroartemisinin INTELENCE and AUC ↓ 0.85 (0.75-0.97) artemether/lumefantrine as a Cmin ↓ 0.83 (0.71-0.97) significant decrease in Cmax ↓ 0.84 (0.71-0.99) exposure of artemether and lumefantrine its active metabolite, AUC ↓ 0.87 (0.77-0.98) dihydroartemisinin, may Cmin ↔ 0.97 (0.83-1.15) result in decreased Cmax ↔ 1.07 (0.94-1.23) antimalarial efficacy. No etravirine dose adjustment is needed for AUC ↔ 1.10 (1.06-1.15) INTELENCE. Cmin ↔ 1.08 (1.04-1.14) Cmax ↔ 1.11 (1.06-1.17) ANTIMYCOBACTERIALS Rifampicin Not studied. Rifampicin and rifapentine are Combination not Rifapentine expected to decrease plasma concentrations of recommended. etravirine. INTELENCE should be used in combination with a boosted PI. Rifampicin is contraindicated in combination with boosted Pis. Rifabutin With an associated boosted PI: The combination of 300 mg once daily No interaction study has been performed. Based INTELENCE with a boosted on historical data, a decrease in etravirine PI and rifabutin should be exposure may be expected whereas an increase used with caution due to the in rifabutin exposure and especially in risk of decrease in etravirine 25-O-desacetyl-rifabutin may be expected. exposure and the risk of increase in rifabutin and With no associated boosted PI (out of the 25-O-desacetyl-rifabutin recommended indication for etravirine): exposures. rifabutin Close monitoring for AUC ↓ 0.83 (0.75-0.94) virologic response and for Cmin ↓ 0.76 (0.66-0.87) rifabutin related adverse Cmax ↓ 0.90 (0.78-1.03) reactions is recommended. 25-O-desacetyl-rifabutin Please refer to the product AUC ↓ 0.83 (0.74-0.92) information of the associated Cmin ↓ 0.78 (0.70-0.87) boosted PI for the dose Cmax ↓ 0.85 (0.72-1.00) adjustment of rifabutin to be etravirine used. AUC ↓ 0.63 (0.54-0.74) Cmin ↓ 0.65 (0.56-0.74) Cmax ↓ 0.63 (0.53-0.74) BENZODIAZEPINES Diazepam Not studied. Etravirine is expected to increase Alternatives to diazepam plasma concentrations of diazepam. should be considered. CORTICOSTEROIDS Dexamethasone Not studied. Dexamethasone is expected to Systemic dexamethasone (systemic) decrease plasma concentrations of etravirine should be used with caution or alternatives should be considered, particularly for chronic use.

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): lumefantrine (HOS-114826) artemether (HOS-116383) rifabutin (HOS-086262) diazepam (HOS-085904) dexamethasone (HOS-084535) rifapentine (HOS-116386)

Wechselwirkungen · RoActemra

RoActemra 20 mg/mL concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 12

HOS-120235 · Präparat HOS-095117

When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) must be monitored as doses may need to be increased to maintain therapeutic effect. Given its long elimination half-life (t1/2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.

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) methylprednisolone (HOS-088374) theophylline (HOS-085910) phenprocoumon (HOS-091031) calcium (HOS-085615) dexamethasone (HOS-084535) phenytoin (HOS-084531) warfarin (HOS-085950)

Wechselwirkungen · RoActemra

RoActemra 162 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 45

HOS-120315 · Präparat HOS-095117

When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) must be monitored as doses may need to be increased to maintain therapeutic effect. Given its long elimination half-life (t1/2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.

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) methylprednisolone (HOS-088374) theophylline (HOS-085910) phenprocoumon (HOS-091031) calcium (HOS-085615) dexamethasone (HOS-084535) phenytoin (HOS-084531) warfarin (HOS-085950)

Wechselwirkungen · RoActemra

RoActemra 162 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 80

HOS-120388 · Präparat HOS-095117

When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) must be monitored as doses may need to be increased to maintain therapeutic effect. Given its long elimination half-life (t1/2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.

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) methylprednisolone (HOS-088374) theophylline (HOS-085910) phenprocoumon (HOS-091031) calcium (HOS-085615) dexamethasone (HOS-084535) phenytoin (HOS-084531) warfarin (HOS-085950)

Wechselwirkungen · Afinitor

Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets · Abschnitt 4.5 · PDF-Seite 9–10

HOS-210324 · Präparat HOS-154501

9  Potent and moderate CYP3A4 inducers Rifampicin AUC ↓63% Avoid the use of concomitant (range 0-80%) potent CYP3A4 inducers. If Cmax ↓58% patients require co-administration (range 10-70%) of a potent CYP3A4 inducer, an Dexamethasone Not studied. Decreased exposure Afinitor dose increase from 10 mg expected. daily up to 20 mg daily should be Carbamazepine, Not studied. Decreased exposure considered using 5 mg increments phenobarbital, phenytoin expected. or less applied on Day 4 and 8 Efavirenz, nevirapine Not studied. Decreased exposure following start of the inducer. This expected. dose of Afinitor is predicted to adjust the AUC to the range observed without inducers. However, there are no clinical data with this dose adjustment. If treatment with the inducer is discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction), before the Afinitor dose is returned to the dose used prior to initiation of the co-administration. St John’s Wort (Hypericum Not studied. Large decrease in Preparations containing St John’s perforatum) exposure expected. Wort should not be used during treatment with everolimus

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) carbamazepine (HOS-085618) dexamethasone (HOS-084535) efavirenz (HOS-087947) nevirapine (HOS-088064) phenytoin (HOS-084531)

Wechselwirkungen · Onglyza

Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-121459 · Präparat HOS-095365

The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite. Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4/5 inducer.

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) carbamazepine (HOS-085618) dexamethasone (HOS-084535) phenytoin (HOS-084531)

Wechselwirkungen · Temomedac

Temomedac 5 mg hard capsules Temomedac 20 mg hard capsules Temomedac 100 mg hard capsules Temomedac 140 mg hard capsules Temomedac 180 mg hard capsules Temomedac 250 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7–8

HOS-122294 · Präparat HOS-095503

7 Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ. Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.

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) valproic acid (HOS-088515) carbamazepine (HOS-085618) dexamethasone (HOS-084535) prochlorperazine (HOS-089543) ondansetron (HOS-086052) phenytoin (HOS-084531)

Wechselwirkungen · Temozolomide Accord

Temozolomide Accord 5 mg hard capsules. Temozolomide Accord 20 mg hard capsules. Temozolomide Accord 100 mg hard capsules. Temozolomide Accord 140 mg hard capsules. Temozolomide Accord 180 mg hard capsules. Temozolomide Accord 250 mg hard capsules. · Abschnitt 4.5 · PDF-Seite 8

HOS-212014 · Präparat HOS-154808

Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ. Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.

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) valproic acid (HOS-088515) carbamazepine (HOS-085618) dexamethasone (HOS-084535) prochlorperazine (HOS-089543) ondansetron (HOS-086052) phenytoin (HOS-084531)

Wechselwirkungen · Temozolomide Teva

Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-212046 · Präparat HOS-154816

Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ. Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.

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) valproic acid (HOS-088515) carbamazepine (HOS-085618) dexamethasone (HOS-084535) prochlorperazine (HOS-089543) ondansetron (HOS-086052) phenytoin (HOS-084531)

Gegenanzeigen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.3 · PDF-Seite 4

HOS-122524 · Präparat HOS-095531

• Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1. • Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. • Advanced glaucoma which cannot be adequately controlled by medicinal products alone. • Aphakic eyes with ruptured posterior lens capsule. • Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated intraocular lens and ruptured posterior lens capsule.

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

Wechselwirkungen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.5 · PDF-Seite 6

HOS-122525 · Präparat HOS-095531

No interaction studies have been performed. Systemic absorption is minimal and no interactions are anticipated.

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

Nebenwirkungen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.8 · PDF-Seite 6

HOS-122526 · Präparat HOS-095531

Summary of the safety profile The most commonly-reported adverse events reported following treatment with OZURDEX are those frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract formation and conjunctival or vitreal haemorrhage respectively).

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

Nebenwirkungen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.8 · PDF-Seite 6

HOS-122527 · Präparat HOS-095531

Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotizing retinitis, retinal detachment and retinal tear.

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

Nebenwirkungen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.8 · PDF-Seite 6

HOS-122528 · Präparat HOS-095531

With the exception of headache and migraine, no systemic adverse drug reactions were identified with the use of OZURDEX.

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

Nebenwirkungen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.8 · PDF-Seite 6

HOS-122529 · Präparat HOS-095531

Tabulated list of adverse reactions The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials (DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ class in the table below using the following convention:

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

Nebenwirkungen · Ozurdex

OZURDEX 700 micrograms intravitreal implant in applicator · Abschnitt 4.8 · PDF-Seite 6

HOS-122530 · Präparat HOS-095531

Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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