Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Leflunomide Zentiva (previously Leflunomide Winthrop)

Leflunomide Zentiva 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 26

HOS-122435 · Präparat HOS-095511

Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726. However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity. If used together, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution. Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.

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): daunorubicin (HOS-089674) sulfasalazine (HOS-089673) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) nateglinide (HOS-089675) topotecan (HOS-086047) doxorubicin (HOS-084538) repaglinide (HOS-086935) pravastatin (HOS-086306) methotrexate (HOS-087522)

Wechselwirkungen · Leflunomide Zentiva (previously Leflunomide Winthrop)

Leflunomide Zentiva 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 43

HOS-122495 · Präparat HOS-095511

Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726. However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity. If used together, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution. Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.

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): daunorubicin (HOS-089674) sulfasalazine (HOS-089673) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) nateglinide (HOS-089675) topotecan (HOS-086047) doxorubicin (HOS-084538) repaglinide (HOS-086935) pravastatin (HOS-086306) methotrexate (HOS-087522)

Wechselwirkungen · Votrient

Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-122580 · Präparat HOS-095539

Concomitant use of pazopanib and simvastatin increases the incidence of ALT elevations. Results from a meta-analysis using pooled data from clinical studies with pazopanib show that ALT >3x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of simvastatin (p = 0.038). If a patient receiving concomitant simvastatin develops ALT elevations, follow guidelines for pazopanib posology and discontinue simvastatin (see section 4.4). In addition, concomitant use of pazopanib and other statins should be undertaken with caution as there are insufficient data available to assess their impact on ALT levels. It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin).

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) simvastatin (HOS-086158) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306)

Wechselwirkungen · Leflunomide medac

Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-213061 · Präparat HOS-155028

Effect on BCRP (Breast Cancer Resistance Protein) and/or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726. However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity. If used together, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g. methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution. Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.

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): daunorubicin (HOS-089674) sulfasalazine (HOS-089673) atorvastatin (HOS-086304) simvastatin (HOS-086158) rosuvastatin (HOS-086307) nateglinide (HOS-089675) topotecan (HOS-086047) doxorubicin (HOS-084538) repaglinide (HOS-086935) pravastatin (HOS-086306) methotrexate (HOS-087522)

Gegenanzeigen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.3 · PDF-Seite 3

HOS-123817 · Präparat HOS-095735

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3 fold the upper limit of normal (ULN) (see section 4.4). - Children and adolescents (age below 18 years). - Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min). - Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen. - Gallbladder disease (see section 4.4). - Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4). - Pregnancy and breast-feeding (see section 4.6). - Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase (CK) elevation above 5 times the ULN under previous statin treatment (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): ketoprofen (HOS-089671) creatine (HOS-123819) creatinine (HOS-086273)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123820 · Präparat HOS-095735

There have been no formal interaction studies for Pravafenix; however the concomitant use of the active substances in patients in clinical studies has not resulted in any unexpected interactions. The following statements reflect the information available on the individual active substances (fenofibrate and pravastatin).

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123821 · Präparat HOS-095735

Interactions relevant to pravastatin Colestyramine/Colestipol Concomitant administration resulted in approximately 40 to 50% decrease in the bioavailability of pravastatin. There was no clinically significant decrease in bioavailability or therapeutic effect when pravastatin was administered one hour before or four hours after colestyramine or one hour before colestipol.

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): colestipol (HOS-089168)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123822 · Präparat HOS-095735

Ciclosporin Concomitant administration of pravastatin and ciclosporin leads to an approximately 4 fold increase in pravastatin systemic exposure. In some patients, however, the increase in pravastatin exposure may be larger. Clinical and biochemical monitoring of patients receiving this combination is recommended.

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123823 · Präparat HOS-095735

Medicinal products metabolised by cytochrome P450 Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system. This is why medicinal products that are metabolised by, or are inhibitors of, the cytochrome P450 system can be added to a stable regimen of pravastatin without causing significant changes in the plasma levels of pravastatin, as have been seen with other statins. The absence of a significant pharmacokinetic interaction with pravastatin has been specifically demonstrated for several medicinal products, particularly those that are substrates/inhibitors of CYP3A4 e.g. diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice and CYP2C9 inhibitors (e.g. fluconazole).

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) protease (HOS-085623) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) itraconazole (HOS-084516) fluconazole (HOS-087945) verapamil (HOS-090602)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123824 · Präparat HOS-095735

In one of two interaction studies with pravastatin and erythromycin a statistically significant increase in the area under the curve (AUC) (70%) and Cmax (121%) of pravastatin was observed. In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed. Although these changes were minor, caution should be exercised when associating pravastatin with erythromycin or clarithromycin.

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): clarithromycin (HOS-084517) erythromycin (HOS-084514)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123825 · Präparat HOS-095735

Fusidic acid The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins. The mechanism of this interaction (whether it is pharmacodynamic or pharmacokinetic, or both) is yet unknown. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. If treatment with systemic fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment. Also 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): fusidic acid (HOS-086146)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123827 · Präparat HOS-095735

Glecaprevir/pibrentasvir Concomitant use of pravastatin and glecaprevir/pibrentasvir may increase the plasma concentration of pravastatin and may lead to an increase of dose-dependent adverse events including myopathy risk. Patients treated with glecaprevir/pibrentasvir should not exceed 20 mg per day of pravastatin. Therefore Pravafenix is not recommended in those 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): pibrentasvir (HOS-086298) glecaprevir (HOS-086297) lead (HOS-085592)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123828 · Präparat HOS-095735

Other medicinal products In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid, antacids (when given one hour prior to pravastatin), nicotinic acid or probucol.

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): probucol (HOS-123007)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6

HOS-123829 · Präparat HOS-095735

Interactions relevant to fenofibrate Bile acid resin

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6–7

HOS-123830 · Präparat HOS-095735

6 Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate.

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-123831 · Präparat HOS-095735

Oral anticoagulants Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding. It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring. This combination is, therefore, not recommended.

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-123832 · Präparat HOS-095735

Ciclosporin Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-123833 · Präparat HOS-095735

Glitazones Some cases of reversible paradoxical reduction of HDL-cholesterol have been reported during concomitant administration of fenofibrate and glitazones. Therefore, it is recommended to monitor HDL-cholesterol if Pravafenix is co-administered with a glitazone and to stop one of the two treatments if HDL-cholesterol is too low.

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): cholesterol (HOS-087961)

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-123835 · Präparat HOS-095735

Food interaction Pravafenix must be taken with food, as food enhances the bioavailability of fenofibrate (see sections 4.2 and 5.2).

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

Wechselwirkungen · Pravafenix

Pravafenix 40 mg/160 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7

HOS-123836 · Präparat HOS-095735

In all clinical trials, patients were instructed to take Pravafenix daily during the evening meal and dietary restrictions instituted before therapy should be continued. Since current safety and efficacy data are based upon administration with food and with dietary restrictions, it is recommended that Pravafenix is administered with food. (see sections 4.2 and 5.2).

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