Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Caelyx pegylated liposomal

Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-085567 · Präparat HOS-083155

No formal medicinal product interaction studies have been performed with Caelyx pegylated liposomal, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies. Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride. Caelyx pegylated liposomal, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies. During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted. In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride. Caution must be exercised when giving any other cytotoxic agents, especially myelotoxic agents, at the same time.

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): mercaptopurine (HOS-085568) cyclophosphamide (HOS-084539)

Wechselwirkungen · Adenuric

ADENURIC 80 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 4

HOS-117800 · Präparat HOS-094697

Mercaptopurine/azathioprine On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to myelotoxicity. In case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose (see sections 4.4 and 5.3) The adequacy of the proposed dose adjustment, which was based on a modelling and simulation analysis from preclinical data in rats, was confirmed by the results of a clinical drug-drug interaction study in healthy volunteers, receiving azathioprine 100 mg alone and a reduced dose of azathioprine (25 mg) in combination with febuxostat (40 or 120 mg).

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): mercaptopurine (HOS-085568) azathioprine (HOS-089001)

Wechselwirkungen · Adenuric

ADENURIC 120 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-117832 · Präparat HOS-094697

Mercaptopurine/azathioprine On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to myelotoxicity. In case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose (see sections 4.4 and 5.3). The adequacy of the proposed dose adjustment, which was based on a modelling and simulation analysis from preclinical data in rats, was confirmed by the results of a clinical drug-drug interaction study in healthy volunteers, receiving azathioprine 100 mg alone and a reduced dose of azathioprine (25 mg) in combination with febuxostat (40 or 120 mg).

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): mercaptopurine (HOS-085568) azathioprine (HOS-089001)

Wechselwirkungen · Stelara

STELARA 130 mg concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 6–7

HOS-120459 · Präparat HOS-095137

6 explored. There were no indications of an interaction with these concomitantly administered medicinal products. The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6- mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.

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): mercaptopurine (HOS-085568) vedolizumab (HOS-120460) azathioprine (HOS-089001)

Wechselwirkungen · Stelara

STELARA 45 mg solution for injection STELARA 45 mg solution for injection in pre-filled syringe STELARA 90 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 32

HOS-120493 · Präparat HOS-095137

In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products. The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6- mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.

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): ibuprofen (HOS-087884) atorvastatin (HOS-086304) mercaptopurine (HOS-085568) vedolizumab (HOS-120460) azathioprine (HOS-089001) metformin (HOS-091032) levothyroxine (HOS-086339)

Wechselwirkungen · Stelara

STELARA 45 mg solution for injection in pre-filled pen STELARA 90 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 63

HOS-120526 · Präparat HOS-095137

In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products. The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6- mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.

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): ibuprofen (HOS-087884) atorvastatin (HOS-086304) mercaptopurine (HOS-085568) vedolizumab (HOS-120460) azathioprine (HOS-089001) metformin (HOS-091032) levothyroxine (HOS-086339)

Gegenanzeigen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.3 · PDF-Seite 5

HOS-213203 · Präparat HOS-155068

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.

Gegenanzeigen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.3 · PDF-Seite 5

HOS-213204 · Präparat HOS-155068

Concomitant use with yellow fever vaccine (see section 4.5).

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

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 7

HOS-213205 · Präparat HOS-155068

Effects of food on mercaptopurine The administration of mercaptopurine with food may decrease systemic exposure slightly but this is unlikely to be of clinical significance. Therefore, Xaluprine may be taken with food or on an empty stomach, but patients should standardise the method of administration. The dose should not be taken with milk or dairy products since they contain xanthine oxidase, an enzyme which metabolises mercaptopurine and might therefore lead to reduced plasma concentrations of mercaptopurine.

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): mercaptopurine (HOS-085568) lead (HOS-085592) xanthine (HOS-133925)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 7–8

HOS-213207 · Präparat HOS-155068

7 Effects of mercaptopurine on other medicinal products Vaccines Concomitant administration of yellow fever vaccine is contraindicated, due to the risk of fatal disease in immunocompromised patients (see section 4.3).

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): mercaptopurine (HOS-085568)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213208 · Präparat HOS-155068

Vaccinations with other live organism vaccines are not recommended in immunocompromised individuals (see section 4.4).

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

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213209 · Präparat HOS-155068

Anticoagulants Inhibition of the anticoagulant effect of warfarin, when given with mercaptopurine, has been reported. Monitoring of the INR (International Normalised Ratio) value is recommended during concomitant administration with oral anticoagulants.

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): mercaptopurine (HOS-085568) warfarin (HOS-085950)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213210 · Präparat HOS-155068

Antiepileptics Cytotoxic agents may decrease the intestinal absorption of phenytoin. Careful monitoring of the phenytoin serum levels is recommended. It is possible that the levels of other anti-epileptic medicinal products may also be altered. Serum antiepileptic levels should be closely monitored during treatment with Xaluprine, making dose adjustments as necessary.

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): phenytoin (HOS-084531)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213211 · Präparat HOS-155068

Effects of other medicinal products on mercaptopurine Allopurinol/oxipurinol/thiopurinol and other xanthine oxidase inhibitors Xanthine oxidase activity is inhibited by allopurinol, oxipurinol and thiopurinol, which results in reduced conversion of biologically active 6-thioinosinic acid to biologically inactive 6-thiouric acid. When allopurinol and Xaluprine are administered concomitantly it is essential that only a quarter of the usual dose of Xaluprine is given since allopurinol decreases the rate of metabolism of mercaptopurine via xanthine oxidase. Also other xanthine oxidase inhibitors, such as febuxostat, may decrease the metabolism of mercaptopurine and concomitant administration is not recommended as data are insufficient to determine an adequate dose reduction.

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): allopurinol (HOS-089178) mercaptopurine (HOS-085568) xanthine (HOS-133925) febuxostat (HOS-117798)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213213 · Präparat HOS-155068

Aminosalicylates As there is in vitro evidence that aminosalicylate derivatives (e.g. olsalazine, mesalazine or sulfazalazine) inhibit the TPMT enzyme, which metabolises mercaptopurine, they should be administered with caution to patients receiving concurrent Xaluprine therapy (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): mercaptopurine (HOS-085568) aminosalicylate (HOS-213214) olsalazine (HOS-213215)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213216 · Präparat HOS-155068

Infliximab Interactions have been observed between azathioprine, a pro-drug of mercaptopurine, and infliximab. Patients receiving azathioprine experienced transient increases in 6-TGN (6-thioguanine nucleotide, an active metabolite of azathioprine) levels and decreases in the mean leukocyte count in the initial weeks following infliximab infusion, which returned to previous levels after 3 months.

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): mercaptopurine (HOS-085568) azathioprine (HOS-089001) infliximab (HOS-089872) thioguanine (HOS-144457)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213220 · Präparat HOS-155068

Methotrexate Methotrexate (20 mg/m2 orally) increased mercaptopurine exposure (area under curve, AUC) by approximately 31% and methotrexate (2 or 5 g/m2 intravenously) increased mercaptopurine AUC by 69% and 93%, respectively. When administered concomitantly with high dose methotrexate, the mercaptopurine dose may need 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): mercaptopurine (HOS-085568) methotrexate (HOS-087522)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213221 · Präparat HOS-155068

Ribavirin Ribavirin inhibits the enzyme, inosine monophosphate dehydrogenase (IMPDH), leading to a lower production of the active thioguanine nucleotides (TGNs). Severe myelosuppression has been reported following concomitant administration of a prodrug of mercaptopurine and ribavirin; therefore concomitant administration of ribavirin and mercaptopurine is not advised (see section 5.2).

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): mercaptopurine (HOS-085568) ribavirin (HOS-088127) inosine (HOS-109809) thioguanine (HOS-144457)

Wechselwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 8

HOS-213224 · Präparat HOS-155068

Myelosuppressive agents When mercaptopurine is combined with other myelosuppressive agents caution should be used; dose reductions may be needed based on haematological monitoring (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): mercaptopurine (HOS-085568)

Nebenwirkungen · Xaluprine (previously Mercaptopurine Nova Laboratories)

Xaluprine 20 mg/ml oral suspension · Abschnitt 4.8 · PDF-Seite 9

HOS-213225 · Präparat HOS-155068

Summary of the safety profile

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