MoosAlert: New Drug Viibryd® (Vilazodone)

What It Is?

Viibryd® contains vilazodone which is a selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1A (5HT1A) receptors.

What is its indication?

Viibryd is indicated for the symptomatic relief of major depressive disorder in adults. Efficacy has only been established in trials of eight to ten weeks duration.

The initial dose of Viibryd is 10 mg, by mouth, once daily. After seven days, the dose can be increased to 20 mg once daily. After at least seven more days the dose can be increased to a max of 40 mg once daily. This dose titration is recommended to reduce adverse GI effects.2

A clinical response is usually seen after one to two weeks of treatment.

 

Dosage Forms/Appearance

Viibryd comes as tablets containing vilazodone 10 mg, 20 mg, and 40 mg in bottles of 30 tablets.

Viibryd tablets are oval and film-coated. They are pink (10 mg), orange (20 mg), and blue (40 mg).

The wholesale cost of Viibryd is about $95 for a 30-day supply (dose of 20 mg once daily).

Viibryd is also available in two different Patient Starter Kits:

• Seven 10 mg tablets, seven 20 mg tablets, and sixteen 40 mg tablets in a blister card.
• Seven 10 mg tablets and twenty-three 20 mg tablets in a blister card.

 

Drug interactions

Viibryd is contraindicated for use in combination with monoamine oxidase inhibitors (MAOIs), including linezolid and methylene blue, due to the risk of serious (sometimes fatal) drug interactions. There must be 14 days between MAOI therapy and the use of Viibryd.

Vilazodone is primarily metabolized by cytochrome P450 CYP3A4 and (minimally) by CYP2C19 and CYP2D6. Vilazodone is also a moderate inhibitor of CYP2C19 and CYP2D6.

• Strong inhibitors of CYP3A4 may increase levels of Viibryd. The daily dose of Viibryd should not exceed 20 mg if it is used with a strong CYP3A4 inhibitor (e.g., clarithromycin, ketoconazole, etc).
• Strong inducers of CYP3A4 (e.g., carbamazepine, etc) may decrease plasma concentrations of Viibryd. No dosage adjustment is recommended if Viibryd is used with a strong CYP3A4 inducer as doses above 40 mg/day have not been studied.

Viibryd, like all serotonergic drugs, has a risk of serotonin toxicity or serotonin syndrome when combined with other serotonergic drugs (e.g., SSRIs, SNRIs, St. John’s wort, fentanyl, tramadol, dextromethorphan, etc).

Monitoring of digoxin is recommended if used in combination with Viibryd due to a slight (clinically insignificant) increase in digoxin levels found in a single-dose Viibryd pharmacokinetic study in healthy patients.

As with other psychotropic meds, alcohol is not recommended in patients taking Viibryd.

Use Viibryd with caution in patients on medications that may increase the risk of bleeding (e.g., aspirin, NSAIDs, warfarin, and other anticoagulants). Viibryd may cause abnormal platelet aggregation, increasing the risk of bleeding events.

 

Administration

Viibryd should be taken with food to improve absorption. 

Viibryd should not be stopped abruptly due to a risk of withdrawal symptoms (dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, etc). If Viibryd must be stopped, the dose should be gradually decreased, if possible. If symptoms occur when stopping or decreasing Viibryd, the dose may be increased to where the patient did not have symptoms and then tapered off more slowly.

 

Place in Therapy

An antidepressant is chosen based on side effects, personal or family response history, drug interactions, comorbidities, and cost.²Vilazodone is generally considered a second-line antidepressant, after SSRIs and SNRIs.²

Four trials in outpatient adults of eight to ten weeks duration showed efficacy of Viibryd over placebo.^3-6 The number needed to treat (NNT) for response with vilazodone versus placebo is eight.⁷ The NNT for remission of depression is 14.⁷ This efficacy is comparable to the benefits seen with citalopram, duloxetine, escitalopram, sertraline, venlafaxine, and vortioxetine.^8,9

The mechanism of action of Viibryd is similar to vortioxetine (Trintellix), and their efficacy appears to be comparable.⁹ Their adverse effect profiles also appear similar, with the exception of diarrhea, which seems to be more common in patients taking Viibryd.

Adverse drug reactions often limit therapy with antidepressants.² Although direct comparisons of adverse drug reactions between vilazodone and other antidepressants are lacking, analysis of available data indicate that compared to other antidepressants, patients on vilazodone may have:²

• More nausea and diarrhea.
• Less increases in appetite, weight gain, somnolence, and slightly less insomnia. Viibryd may also have a lower risk of sexual side effects (sexual dysfunction in women and erectile dysfunction in men) than SSRIs.^2,8

Disadvantages of Viibryd include the required dose titration, its requirement to take with food, and cost.²

 

Side Effects

The most common adverse effects in patients taking Viibryd (incidence of 5% or more) are diarrhea, nausea, vomiting, and insomnia.

Due to a lack of data, use Viibryd with caution in patients with severe liver or renal impairment.

Seizures can occur in patients taking Viibryd. Use Viibryd with caution in patients with a seizure disorder.

Viibryd can cause mydriasis and should be used with caution in patients with increased intraocular pressure

 

For Patients taking this drug, Melvin says:

Patients taking Viibryd should be advised about the following:

• Always take Viibryd with food.
• Missed Viibryd doses should be taken as soon as you remember, with food. However, do not take two doses together.
• Store Viibryd at room temperature.
• Contact your prescriber immediately if, while taking Viibryd, you have signs of:
  • Mania/hypomania elevated or irritated mood, decreased need for sleep, and/or racing thoughts
  • Glaucoma: eye pain or blurred vision
  • Low sodium in your blood: tiredness, weakness, confusion, combined with achy, stiff, or uncoordinated muscles
  • Low platelets: bruising or unusual bleeding
• Seek immediate medical attention if you have seizures, symptoms of serotonin syndrome (confusion, restlessness, sweating, shivering, hallucinations, fast heartbeat), new or worsened emotional or behavioural problems, or a severe skin or hypersensitivity reaction while taking Viibryd.