What is TRINTELLIX?

TRINTELLIX 10 MG contains VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02432927, held by LUNDBECK CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 28-Oct-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TRINTELLIX used for?

TRINTELLIX (vortioxetine hydrobromide tablet) is indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of TRINTELLIX in providing symptomatic relief of MDD was demonstrated in double-blind, placebo-controlled clinical trials of up to 8 weeks duration. The efficacy of TRINTELLIX in maintaining an antidepressant response for up to 24 weeks was demonstrated in a double-blind, placebo-controlled trial in patients with MDD who initially responded to 12-weeks of acute, open label treatment with TRINTELLIX. Physicians who elect to use TRINTELLIX for extended periods should periodically re-evaluate the usefulness of the drug for individual patients.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The starting and recommended dose of TRINTELLIX is 10 mg vortioxetine once daily for adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily, as tolerated. A dose decrease to a minimum of 5 mg vortioxetine once daily may be considered for patients who do not tolerate higher doses. For geriatric patients (≥65 years of age), the lowest effective dose of 5 mg/day vortioxetine should always be used as the starting dose. TRINTELLIX should be administered as a single daily dose, with or without food. If a dose is missed, the next dose should be taken at the usual time. Patients should not take a double dose to make up for a missed dose. When discontinuing treatment, a gradual reduction in the dose, rather than an abrupt cessation, is recommended whenever possible.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature (15° - 30°C) protected from moisture. Do not use after the expiry date.

How is it supplied?

Blister: Pack size of 28. Tablets: 5 mg (pink), 10 mg (yellow), 15 mg (orange), or 20 mg (red).

Contraindications

TRINTELLIX is contraindicated in: • patients who are hypersensitive to vortioxetine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Angioedema has been reported in patients treated with TRINTELLIX. • patients with concomitant use of monoamine oxidase inhibitors (MAOIs). At least 14 days should be allowed after discontinuing treatment with a MAOI before starting treatment with vortioxetine. At least 21 days should elapse after discontinuing vortioxetine treatment before starting a MAOI.

Warnings and precautions

Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressants use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation type and/or suicidal thoughts and behaviors. Vortioxetine increases serotonergic neurotransmission and must not be used concomitantly in patients taking MAOIs, including linezolid, an antibiotic, methylene blue, a dye used in certain surgeries, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions. These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome or serotonin toxicity, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. Therefore, at least 14 days should be allowed after discontinuing treatment with a MAOI before starting treatment with vortioxetine. At least 21 days should elapse after discontinuing vortioxetine treatment before starting a MAOI. TRINTELLIX is not indicated for use in patients below the age of 18. Increased risk of bleeding events by causing abnormal platelet aggregation. Concomitant use of acetylsalicylic acid (ASA), nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin and other anticoagulants may add to the risk. Seizures are a potential risk with antidepressant drugs. Serotonin toxicity, also known as serotonin syndrome, has been reported with TRINTELLIX, particularly during combined use with other serotonergic drugs. Neuroleptic malignant syndrome has also been rarely reported with TRINTELLIX, particularly during combined use with neuroleptic/antipsychotic drugs. TRINTELLIX can cause mydriasis, which may trigger an angle-closure attack in a patient with anatomically narrow ocular angles. Potential for abuse has not been systematically studied, but no indication of drug-seeking behavior was observed in clinical trials.

What can be used instead?

Other Canadian products sharing ATC code N06AX26 VORTIOXETINE. 6 of 8 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.