TRINTELLIX 20 MG

What is TRINTELLIX?

TRINTELLIX 20 MG contains VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02432943, 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?

Adults: 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. In clinical trials conducted outside the United States, efficacy was demonstrated with 5 mg/day, 10 mg/day, 15 mg/day and 20 mg/day. In the clinical trials conducted in the United States, efficacy was demonstrated with 20 mg/day TRINTELLIX. The efficacy and safety of doses greater than 20 mg/day were not evaluated in controlled clinical trials. 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. Discontinuing Treatment: A gradual reduction in the dose, rather than an abrupt cessation, is recommended whenever possible. Patients should be monitored for discontinuation symptoms when discontinuing treatment with TRINTELLIX.

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 Trintellix after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

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) (e.g., linezolid, methylene blue). 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

Serious 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. Dependence/Tolerance: Although vortioxetine has not been systematically studied for its potential for abuse, there was no indication of drug-seeking behaviour in clinical trials with TRINTELLIX. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of TRINTELLIX. Discontinuation Symptoms: Abrupt discontinuation of TRINTELLIX in placebo-controlled trials was associated with discontinuation symptoms. Patients should be monitored when discontinuing treatment with TRINTELLIX. A gradual reduction in the dose, rather than an abrupt cessation, is recommended whenever possible. Adverse reactions particularly after abrupt discontinuation of serotonergic antidepressants include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Driving and Operating Machinery: Patients should exercise caution when driving or operating hazardous machinery until they are reasonably certain that TRINTELLIX does not adversely affect their ability to engage in such activities. Hematologic: SSRIs and serotonin/norepinephrine reuptake inhibitors (SNRIs), including TRINTELLIX, may increase the 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. Case reports and epidemiological studies have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Gastrointestinal and gynaecological bleeding have also been reported following treatment with TRINTELLIX. SSRIs/SNRIs including TRINTELLIX, may increase the risk of postpartum hemorrhage. Neurologic: Seizures are a potential risk with antidepressant drugs. TRINTELLIX 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. Serotonin Toxicity/Neuroleptic Malignant Syndrome: On rare occasions, 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. If serotonin toxicity or neuroleptic malignant syndrome is suspected, discontinuation of TRINTELLIX should be considered. Ophthalmologic: As with other antidepressants, TRINTELLIX can cause mydriasis, which may trigger an angle-closure attack in a patient with anatomically narrow ocular angles. Healthcare providers should inform patients to seek immediate medical assistance if they experience eye pain, changes in vision or swelling or redness in or around the eye. Psychiatric: Potential Association with Behavioral and Emotional Changes, Including Self-Harm. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. Activation of Mania/Hypomania: TRINTELLIX should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase. Aggression/agitati

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.