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Ponvory · 4.5 · Ponesimod has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive th
Eintrag öffnenPonvory · 4.5 · Ponesimod has not been studied in patients taking QT prolonging medicinal products (see section 4.4).
Eintrag öffnenPonvory · 4.5 · Ponesimod is not a substrate of P-gp, BCRP, OATP1B1 or OATP1B3 transporters. Medicinal products that are inhib
Eintrag öffnenPonvory · 4.5 · The negative chronotropic effect of co-administration of ponesimod and propranolol was evaluated in a dedicate
Eintrag öffnenPonvory · 4.5 · The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during pon
Eintrag öffnenPonvory · 4.5 · Vaccinations may be less effective if administered while being treated with ponesimod and up to 1 week after i
Eintrag öffnenPonvory · 4.5 · Vaccines
Eintrag öffnenPonvory · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenPonvory · 4.8 Undesirable effects · 1
Eintrag öffnenPonvory · 4.8 · 13 Table 2: Tabulated list of adverse reactions System Organ Very common Common Uncommon Class (SOC) urinary t
Eintrag öffnenPonvory · 4.8 · 14 Initiation of ponesimod treatment has been associated with transient AV conduction delays that follow a sim
Eintrag öffnenPonvory · 4.8 · 15 Hypertension was reported as an adverse reaction in 10.1% of ponesimod-treated patients and in 9.0% of pati
Eintrag öffnenPonvory · 4.8 · Adverse reactions reported with ponesimod in controlled clinical trials and uncontrolled extension trials are
Eintrag öffnenPonvory · 4.8 · Blood lymphocyte count reduction In OPTIMUM, 3.2% of ponesimod-treated patients compared to none of the patien
Eintrag öffnenPonvory · 4.8 · Bradyarrhythmia In the Phase 3 OPTIMUM study (see section 5.1), bradycardia at treatment initiation (sinus bra
Eintrag öffnenPonvory · 4.8 · Cutaneous neoplasm In OPTIMUM, a case of malignant melanoma and two cases of basal cell carcinoma (0.4%) were
Eintrag öffnenPonvory · 4.8 · Description of selected adverse reactions
Eintrag öffnenPonvory · 4.8 · In OPTIMUM, the rate of herpetic infections was not different between the ponesimod-treated patients and those
Eintrag öffnenPonvory · 4.8 · Increased blood pressure In OPTIMUM, ponesimod-treated patients had an average increase of 2.9 mmHg in systoli
Eintrag öffnenPonvory · 4.8 · Infections In the Phase 3 OPTIMUM study (see section 5.1), the overall rate of infections was comparable betwe
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