Chemical formula: C₁₈H₂₂N₂S Molecular mass: 298.45 g/mol PubChem compound: 71768094
Vortioxetine interacts in the following cases:
Concomitant use of antidepressants with serotonergic effect like vortioxetine and herbal remedies containing St. John’s wort (Hypericum perforatum) may result in a higher incidence of adverse reactions including Serotonin Syndrome.
No effect on the pharmacokinetics of vortioxetine or ethanol and no significant impairment, relative to placebo, in cognitive function were observed when vortioxetine in a single dose of 20 mg or 40 mg was co-administered with a single dose of ethanol (0.6 g/kg) in healthy subjects. However, alcohol intake is not advisable during antidepressant treatment.
The exposure to vortioxetine increased 2.3-fold for area under the curve (AUC) when vortioxetine 10 mg/day was co-administered with bupropion (a strong CYP2D6 inhibitor 150 mg twice daily) for 14 days in healthy subjects. Co-administration resulted in a higher incidence of adverse reactions when bupropion was added to vortioxetine than when vortioxetine was added to bupropion. Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment.
Co-administration of medicinal products with serotonergic effect (e.g. tramadol, sumatriptan and other triptans) with vortioxetine may lead to serotonin syndrome.
Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance. Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible. Impact on human fertility has not been observed so far.
When vortioxetine was co-administered following 6 days of fluconazole 200 mg/day (a CYP2C9, CYP2C19, and CYP3A4/5 inhibitor) in healthy subjects, a 1.5-fold increase, in vortioxetine AUC was observed. No dose adjustment is needed.
When vortioxetine was co-administered following 6 days of ketoconazole 400 mg/day (a CYP3A4/5 and P-glycoprotein inhibitor) in healthy subjects, a 1.3-fold increase, in vortioxetine AUC was observed. No dose adjustment is needed.
Seizures are a potential risk with antidepressants. Therefore, vortioxetine should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy. Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency.
Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
There are limited data from the use of vortioxetine in pregnant women.
Studies in animals have shown reproductive toxicity.
The following symptoms may occur in the newborn after maternal use of a serotonergic medicinal product in the later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either discontinuation effects or excess serotonergic activity. In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN with vortioxetine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Vortioxetine should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Available data in animals have shown excretion of vortioxetine/vortioxetine metabolites in milk. It is expected that vortioxetine will be excreted into human milk.
A risk to the breastfeeding child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from vortioxetine treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance.
Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible. Impact on human fertility has not been observed so far.
Vortioxetine has no or negligible influence on the ability to drive and use machines. However, as adverse reactions such as dizziness have been reported, patients should exercise caution when driving or operating hazardous machinery, especially when starting treatment with vortioxetine or when changing the dose.
The most common adverse reaction was nausea.
Adverse reactions are listed below using the following convention: 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), not known (cannot be estimated from the available data). The list is based on information from clinical trials and post-marketing experience.
Not known*: Hyponatraemia
Common: Abnormal dreams
Common: Dizziness
Not known*: Serotonin Syndrome
Uncommon: Flushing
Very common: Nausea
Common: Diarrhoea, Constipation, Vomiting
Common: Pruritus, including pruritus generalised
Uncommon: Night sweats
Not known*: Angioedema, Urticaria
* Based on post-marketing cases
Nausea was usually mild or moderate and occurred within the first two weeks of treatment. The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years. For doses of 20 mg vortioxetine once daily, the incidences of nausea and constipation were higher in patients aged ≥65 years (42% and 15%, respectively) than in patients aged <65 years (27% and 4%, respectively).
In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. However, the 20 mg dose of vortioxetine was associated with an increase in sexual dysfunction (TESD).
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs). The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
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