VRAYLAR 1.5 MG

What is VRAYLAR?

VRAYLAR 1.5 MG contains CARIPRAZINE (CARIPRAZINE HYDROCHLORIDE) : 1.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02526794, held by ABBVIE CORPORATION, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 05-Jan-2024. 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 VRAYLAR used for?

VRAYLAR (cariprazine) is indicated for: • the treatment of schizophrenia in adults. In controlled clinical trials, VRAYLAR was found to improve both positive and negative symptoms. Bipolar I disorder VRAYLAR is indicated as monotherapy for: • Bipolar Mania: acute management of manic or mixed episodes associated with bipolar I disorder in adults, and • Bipolar Depression: acute management of depressive episodes associated with bipolar I disorder in adults. The efficacy of VRAYLAR for long-term use has not been systematically evaluated in controlled studies for bipolar mania and depression. The physician who elects to use VRAYLAR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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?

VRAYLAR is given orally once daily and can be taken with or without food. The usual starting dose is 1.5 mg, once a day. Schizophrenia: The recommended target dosage for VRAYLAR is 1.5 mg to 6 mg once daily. The dosage can be increased gradually in 1.5 mg increments. The maximum recommended dosage is 6 mg daily. Bipolar Mania: The recommended dosage range is 1.5 mg to 6 mg once daily. The starting dose is 1.5 mg and can be increased thereafter by 1.5 mg increments. The maximum recommended dosage is 6 mg daily. Bipolar Depression: The recommended dose is 1.5 mg once daily. The dosage can be increased to 3 mg once daily on Day 15. The maximum recommended dosage is 3 mg once daily. Missed Dose: If a patient misses a dose by a few hours, they should take it as soon as remembered. If most of the day has passed, they should wait until the next scheduled dose. Do not take 2 doses at once. Due to the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Prescribers should monitor patients for adverse reactions and treatment response for several weeks after starting VRAYLAR and after each dosage change.

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

How is it stored and handled?

Store between 15 and 30°C. Protect the 3 mg and 4.5 mg capsules from light to prevent potential color fading. Keep out of reach and sight of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

How is it supplied?

Bottles of 30 capsules: 1.5 mg, 3 mg, 4.5 mg and 6 mg. Physician's Sample available as a blister of 7 capsules: 1.5 mg, 3 mg, 4.5 mg and 6 mg.

Contraindications

VRAYLAR is contraindicated: • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • With concomitant use of strong and moderate CYP3A4 inhibitors. Due to the slow elimination of cariprazine and its metabolites, treatment with strong and moderate CYP3A4 inhibitors must be initiated at least 2 weeks after VRAYLAR discontinuation. • With concomitant use of strong and moderate CYP3A4 inducers.

Warnings and precautions

Increased Mortality in Elderly Patients with Dementia: Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. Late-Occurring Adverse Reactions: Adverse events may first appear several weeks after the initiation of VRAYLAR treatment, likely because plasma levels of cariprazine and its major metabolites accumulate over time. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after starting VRAYLAR and after each dosage increase. Consider reducing the dose or discontinuing the drug. Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex reported with antipsychotic drugs. Immediately discontinue VRAYLAR if NMS is suspected. Tardive Dyskinesia: A syndrome of potentially irreversible, involuntary, dyskinetic movements. Risk increases with duration of treatment and cumulative dose. Use the lowest dose and shortest duration for satisfactory clinical response. Discontinuation should be considered if signs appear. Suicide/Suicidal Thoughts or Clinical Worsening: Depressive episodes are associated with an increased risk of suicidal thoughts, self-harm, and suicide. Monitor patients closely until improvement occurs. Schizophrenia and manic episodes also carry an increased risk of suicide-related events. Counsel family members/caregivers to monitor for behavioral changes. Pregnancy: Women of childbearing potential must be advised to use highly effective contraceptive methods during treatment and for at least 12 weeks following discontinuation. VRAYLAR is not recommended during pregnancy unless benefits outweigh risks to the fetus.

What can be used instead?

Other Canadian products sharing ATC code N05AX15 CARIPRAZINE. 4 of 4 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.

Who else supplies CARIPRAZINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. CARIPRAZINE appears in 51 registered pack listings across 10 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.