Trintellix (Page 3 of 8)

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of TRINTELLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine disorders — hyperprolactinemia

Gastrointestinal System — acute pancreatitis

Immune system disorders — hypersensitivity reactions (including anaphylaxis and urticaria)

Metabolic disorders — weight gain

Nervous system disorders — seizure, headache

Psychiatric disorders — aggression, agitation, anger, hostility, irritability

Skin and subcutaneous tissue disorders — rash, generalized rash, hyperhidrosis

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with TRINTELLIX

Table 4: Clinically Important Drug Interactions with TRINTELLIX

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact

The concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs increases the risk of serotonin syndrome.

Intervention

Concomitant use of TRINTELLIX is contraindicated:

1.
With an MAOI intended to treat psychiatric disorders or within 21 days of stopping treatment with TRINTELLIX.
2.
Within 14 days of stopping an MAOI intended to treat psychiatric disorders.
3.
In a patient who is being treated with linezolid or intravenous methylene blue.

[see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.2)].

Examples

selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue

Other Serotonergic Drugs

Clinical Impact

Concomitant use of TRINTELLIX with other serotonergic drugs increases the risk of serotonin syndrome.

Intervention

Monitor for symptoms of serotonin syndrome when TRINTELLIX is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of TRINTELLIX and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)].

Examples

Other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John’s Wort

Strong Inhibitors of CYP2D6

Clinical Impact

Concomitant use of TRINTELLIX with strong CYP2D6 inhibitors increases plasma concentrations of vortioxetine.

Intervention

Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor is coadministered [see Dosage and Administration (2.5)].

Examples

bupropion, fluoxetine, paroxetine, quinidine

Strong CYP Inducers

Clinical Impact

Concomitant use of TRINTELLIX with a strong CYP inducer decreases plasma concentrations of vortioxetine.

Intervention

Consider increasing the TRINTELLIX dose when a strong CYP inducer is coadministered. The maximum dose is not recommended to exceed three times the original dose [see Dosage and Administration (2.6)].

Examples

rifampin, carbamazepine, phenytoin

Drugs that Interfere with Hemostasis (antiplatelets agents and anticoagulants)

Clinical Impact

Concomitant use of TRINTELLIX with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding.

Intervention

Inform patients of the increased risk of bleeding associated with the concomitant use of TRINTELLIX and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions (5.3), Drug Interactions (7.2)].

Examples

aspirin, clopidogrel, heparin, warfarin

Drugs Highly Bound to Plasma Protein

Clinical Impact

TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein may increase free concentrations of TRINTELLIX or other tightly-bound drugs in plasma.

Intervention

Monitor for adverse reactions and reduce dosage of TRINTELLIX or other protein bound drugs as warranted [see Drug Interactions (7.2)].

Examples

Warfarin

7.2 Effect of TRINTELLIX on Other Drugs

Other CNS Active Agents

No clinically relevant effect was observed on steady-state lithium exposure following coadministration with multiple daily doses of TRINTELLIX. Multiple doses of TRINTELLIX did not affect the pharmacokinetics or pharmacodynamics (composite cognitive score) of diazepam [see Clinical Pharmacology (12.3)].

A clinical study has shown that TRINTELLIX (single dose of 20 or 40 mg) did not increase the impairment of mental and motor skills caused by alcohol (single dose of 0.6 g/kg) [see Clinical Pharmacology (12.3)].

Drugs That Interfere with Hemostasis

Following coadministration of stable doses of warfarin (1 to 10 mg/day) with multiple daily doses of TRINTELLIX, no significant effects were observed in INR, prothrombin values or total warfarin (protein bound plus free drug) pharmacokinetics for both R- and S-warfarin. Coadministration of aspirin 150 mg/day with multiple daily doses of TRINTELLIX had no significant inhibitory effect on platelet aggregation or pharmacokinetics of aspirin and salicylic acid [see Clinical Pharmacology (12.3)]. Patients receiving other drugs that interfere with hemostasis should be carefully monitored when TRINTELLIX is initiated or discontinued [see Warnings and Precautions (5.3), Drug Interactions (7.1)].

Highly Protein Bound Drugs

In a clinical study with coadministration of TRINTELLIX (10 mg/day) and warfarin (1 mg/day to 10 mg/day), a highly protein bound drug, no significant change in INR was observed [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

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