INDICATION AND USES:
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults (1).
DOSAGE AND ADMINISTRATION
- The recommended starting dose is 10 mg administered orally once daily without regard to meals (2.1).
- The dose should then be increased to 20 mg/day, as tolerated (2.1).
- Consider 5 mg/day for patients who do not tolerate higher doses (2.1).
- TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible (2.2).
- The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers (2.5).
SIDE EFFECTS:
Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were nausea, constipation and vomiting (6).
CONTRAINDICATIONS:
- Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation (4).
- Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue (4).
WARNINGS AND PRECAUTIONS:
- Serotonin Syndrome has been reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with TRINTELLIX, both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue TRINTELLIX and initiate supportive treatment. If concomitant use of TRINTELLIX with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).
- Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when TRINTELLIX is coadministered with nonsteroidal antiinflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation (5.3).
- Activation of Mania/Hypomania can occur with antidepressant treatment. Screen patients for bipolar disorder (5.4).
- Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.5).
- Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.6).
DRUG INTERACTIONS:
- Strong Inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered (2.5, 7.1).
- Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose (2.6, 7.1).
OVERDOSE:
There is limited clinical trial experience regarding human overdosage with TRINTELLIX. In premarketing clinical studies, cases of overdose were limited to patients who accidentally or intentionally consumed up to a maximum dose of 40 mg of TRINTELLIX. The maximum single dose tested was 75 mg in men. Ingestion of TRINTELLIX in the dose range of 40 to 75 mg was associated with increased rates of nausea, dizziness, diarrhea, abdominal discomfort, generalized pruritus, somnolence, and flushing.
There have been postmarketing reports of overdoses of TRINTELLIX. The most frequently reported symptoms with overdoses up to 80 mg (four times the maximum recommended daily dose) were nausea and vomiting. With overdoses greater than 80 mg, a case of serotonin syndrome in combination with another serotonergic drug, and a case of seizure, have been reported.
No specific antidotes for TRINTELLIX are known. In managing overdosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.
- Uses
-
INDICATION AND USES:
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults (1).
DOSAGE AND ADMINISTRATION
- The recommended starting dose is 10 mg administered orally once daily without regard to meals (2.1).
- The dose should then be increased to 20 mg/day, as tolerated (2.1).
- Consider 5 mg/day for patients who do not tolerate higher doses (2.1).
- TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible (2.2).
- The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers (2.5).
- Side Effects
-
SIDE EFFECTS:
Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were nausea, constipation and vomiting (6).
- Precautions
-
CONTRAINDICATIONS:
- Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation (4).
- Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue (4).
WARNINGS AND PRECAUTIONS:
- Serotonin Syndrome has been reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with TRINTELLIX, both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue TRINTELLIX and initiate supportive treatment. If concomitant use of TRINTELLIX with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).
- Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when TRINTELLIX is coadministered with nonsteroidal antiinflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation (5.3).
- Activation of Mania/Hypomania can occur with antidepressant treatment. Screen patients for bipolar disorder (5.4).
- Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.5).
- Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.6).
- Interactions
-
DRUG INTERACTIONS:
- Strong Inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered (2.5, 7.1).
- Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose (2.6, 7.1).
- Overdose
-
OVERDOSE:
There is limited clinical trial experience regarding human overdosage with TRINTELLIX. In premarketing clinical studies, cases of overdose were limited to patients who accidentally or intentionally consumed up to a maximum dose of 40 mg of TRINTELLIX. The maximum single dose tested was 75 mg in men. Ingestion of TRINTELLIX in the dose range of 40 to 75 mg was associated with increased rates of nausea, dizziness, diarrhea, abdominal discomfort, generalized pruritus, somnolence, and flushing.
There have been postmarketing reports of overdoses of TRINTELLIX. The most frequently reported symptoms with overdoses up to 80 mg (four times the maximum recommended daily dose) were nausea and vomiting. With overdoses greater than 80 mg, a case of serotonin syndrome in combination with another serotonergic drug, and a case of seizure, have been reported.
No specific antidotes for TRINTELLIX are known. In managing overdosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.