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Medications: Trintellix ® – vortioxetine

MEDICATIONS

Trintellix® – vortioxetine (View the FDA label)

TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) (1,14).

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 (2.3).

The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers (2.6).

Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting (6).

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).

Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.5).

Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) is coadministered (2.6 and 7.3).

Strong CYP Inducers: Consider increasing TRINTELLIX dose when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose (2.7 and 7.3).

Human Experience
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.

Management of Overdose
No specific antidotes for TRINTELLIX are known. In managing over dosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1­ 800-222-1222 for latest recommendations.

Uses

TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) (1,14).

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 (2.3).

The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers (2.6).

Side Effects

Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting (6).

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).

Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.5).

Interactions

Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) is coadministered (2.6 and 7.3).

Strong CYP Inducers: Consider increasing TRINTELLIX dose when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose (2.7 and 7.3).

Overdose

Human Experience
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.

Management of Overdose
No specific antidotes for TRINTELLIX are known. In managing over dosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1­ 800-222-1222 for latest recommendations.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

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