Viibryd

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
• hallucinations (seeing things or hearing voices that do not exist)
• lack of energy
• restlessness

Dosing Form & Strengths

tablet

• 10mg
• 20mg
• 40mg

Major Depressive Disorder

10 mg PO qDay for 7 days with food; THEN increase to 20 mg qDay with food

May increase further up to 40 mg/day after a minimum of 7 days between dosage increases

Target maintenance dose: 20-40 mg/day

Dosing Considerations

Gradually taper dose , upon discontinuation of antidepressant, to minimize withdrawal symptoms and allow for detection of re-emerging symptoms; in patients taking 40 mg/day, taper dose to 20 mg qDay for 4 ddays; follow by reducing dose to 10 mg qDay for 3 days; if patient is taking 20 mg/day, taper dose to 10 mg qDay for 7 days

Changing to or from MAO inhibitor therapy

• Do not administer vilazodone within 14 days of discontinuing a MAO inhibitor and initiating vilazodone when treating psychiatric disorders
• Do not administer MAO inhibitor within 14 days of discontinuing vilazodone and initiating MAO therapy when treating psychiatric disorders

Administration of products with MAO inhibitor activity

• In patients receiving linezolid or IV methylene blue, do not administer vilazodone; use alternate products to treat psychiatric condition
• If treatment with linezolid or IV methylene blue urgent in patient receiving vilazodone, discontinue vilazodone immediately, if benefits outweigh risks; administer linezolid or IV methylene blue and monitor for serotonin syndrome for 2 weeks or until 24 hr after last dose of linezolid or IV methylene blue, whichever comes first; may resume vilazodone 24 hr after last dose of IV methylene blue or linezolid

Dosing Modifications

Renal impairment (mild/moderate/severe): No dose adjustment recommended

Hepatic impairment (mild/moderate/severe): No dose adjustment recommended

CYP3A4 inhibitors

• Coadministration with strong CYP3A4 inhibitors (eg, ketoconazole): Not to exceed 20 mg PO qDay
• Coadministration with moderate CYP3A4 inhibitors (eg, erythromycin): Reduce dose to 20 mg/day if intolerable adverse events emerge

CYP3A4 inducers

• Coadministration with strong CYP3A4 inducers (eg, carbamazepine) for >14 days: Consider increasing vilazodone dose up to 2-fold (not to exceed 80 mg/day)

Dosing Considerations

Prior to initiating, screen patients for a personal or family history of bipolar disorder, mania, or hypomania

Safety and efficacy not established

Viibryd is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Forest Laboratories, Inc.

Viibryd is part of the drug class:

• Other antidepressants

Grapefruit and grapefruit juice may interact with Viibryd and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before starting Viibryd, tell your healthcare provider if you:

• have liver problems
• have kidney problems
• have or had seizures or convulsions
• have bipolar disorder (manic depression) or mania
• have low sodium levels in your blood
• have or had bleeding problems
• drink alcohol
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Viibryd passes into breast milk. You and your healthcare provider should decide if you should take Viibryd while breastfeeding.

If you take too much Viibryd, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• a seizure (convulsions);

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), blood in your urine or stools, purple or red pinpoint spots under your skin;

• racing thoughts, unusual risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness; or

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, fainting; or

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

Common side effects may include:

• vision changes;

• diarrhea, mild nausea; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Actions that are out of control
• anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• extra heartbeat
• fast, irregular, pounding, or racing heartbeat or pulse
• irritability
• shakiness in the legs, arms, hands, or feet
• sweating
• talking, feeling, and acting with excitement
• trembling or shaking of the hands or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness
• dry mouth
• nausea
• trouble sleeping

• Abdominal or stomach pain
• abnormal dreams
• aching or discomfort in the lower legs or sensation of crawling in the legs
• acid or sour stomach
• belching
• blindness
• bloated or full feeling
• blurred vision
• change in taste
• decreased interest in sexual intercourse
• decreased vision
• difficulty with moving
• drowsiness
• dry eyes
• excess air or gas in the stomach or intestines
• feeling jittery
• headache, severe and throbbing
• heartburn
• inability to have or keep an erection
• increased or decreased appetite
• increased sweating
• indigestion
• loss in sexual ability, desire, drive, or performance
• loss of appetite
• loss of taste
• muscle pain or stiffness
• night sweats
• not able to have an orgasm
• pain in the joints
• passing gas
• relaxed and calm
• restlessness
• sleepiness or unusual drowsiness
• stomach discomfort or upset
• unusual tiredness or weakness
• vomiting
• weakness

• Eye pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Viibryd® is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14)].

Pregnancy

Risk Summary

There are no adequate and well-controlled studies of Viibryd in pregnant women. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. In animal reproduction studies, oral administration of vilazodone during the period of organogenesis at doses up to 48 and 17 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively, resulted in decreased fetal body weight gain and delayed skeletal ossification but no teratogenic effects were observed. Decreased fetal body weight and delayed skeletal ossification were not observed at doses up to 10 and 4 times the MRHD in rats and rabbits, respectively [see Data].

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Fetal/Neonatal adverse reactions

Exposure to SSRIs and SNRIs, including Viibryd, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to Viibryd in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [see Data)].

Data

Human Data

Third Trimester Exposure

Neonates exposed to SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs) late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [see Warnings and Precautions (5.2)].

Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997-2005 found a PPHN risk ratio of 2.4 (95% CI 1.2-4.3) associated with patient-reported maternal use of SSRIs "in early pregnancy" and a PPHN risk ratio of 3.6 (95% CI 1.2-8.3) associated with a combination of patient-reported maternal use of SSRIs "in early pregnancy" and an antenatal SSRI prescription "in later pregnancy."

Animal Data

No teratogenic effects were observed when vilazodone was given to pregnant rats or rabbits during the period of organogenesis at oral doses up to 200 and 36 mg/kg/day, respectively. These doses are 48 and 17 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 40 mg on a mg/m2 basis. Fetal body weight gain was reduced, and skeletal ossification was delayed in both rats and rabbits at these doses; these effects were not observed at doses up to 10 times the MRHD in rats or 4 times the MRHD in rabbits.

When vilazodone was administered to pregnant rats at an oral dose of 30 times the MRHD during the period of organogenesis and throughout pregnancy and lactation, the number of live born pups was decreased. There was an increase in early postnatal pup mortality, and among surviving pups there was decreased body weight, delayed maturation, and decreased fertility in adulthood. There was some maternal toxicity at this dose. These effects were not seen at 6 times the MRHD.

Lactation

Risk Summary

There are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production. However, vilazodone is excreted in rat milk [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Viibryd and any potential adverse effects on the breastfed child from Viibryd or from the underlying maternal condition.

Data

Animal Data

Administration of vilazodone to lactating rats at an oral dose of 30 times the maximum recommended human dose (MRHD), resulted in early postnatal pup mortality, and among surviving pups there was decreased body weight and delayed maturation.

Pediatric Use

Clinical studies on the use of Viibryd in pediatric patients have not been conducted; therefore, the safety and effectiveness of Viibryd in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning and Warnings and Precautions (5.1)].

Geriatric Use

Based on a pharmacokinetic study, no dosage adjustment of Viibryd is recommended on the basis of age (see Figure 2). Results from pharmacokinetic study of a single 20 mg Viibryd dose in geriatric subjects (> 65 years-old) vs. younger subjects (24-55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups [see Clinical Pharmacology (12.3)].

Clinical studies of Viibryd did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Of the 3,007 patients in clinical studies with Viibryd, 65 (2.2%) were 65 years of age or older, and 378 (12.6%) were 55 to 64 years of age. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.8)]. No other differences in adverse reactions were observed between geriatric and younger patients.

Use in Other Patient Populations

No dosage adjustment of Viibryd is necessary on the basis of gender, renal function (mild to severe renal impairment, glomerular filtration rate: 15-90 mL/minute), or hepatic function (mild to severe hepatic impairment, Child-Pugh score: 5-15 [see Clinical Pharmacology (12.3)].

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vilazodone can be fatal.

Taking Viibryd with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with vilazodone. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other antidepressant;

• a diuretic or "water pill";

• mephenytoin;

• St. John's wort;

• a blood thinner - warfarin, Coumadin, Jantoven;

• medicine to treat anxiety, mood disorders, thought disorders, or mental illness - amitriptyline, buspirone, desipramine, lithium, nortriptyline, and many others;

• medicine to treat ADHD or narcolepsy - Adderall, Concerta, Ritalin, Vyvanse, Zenzedi, and others;

• migraine headache medicine - rizatriptan, sumatriptan, zolmitriptan, and others; or

• narcotic pain medicine - fentanyl, tramadol.

This list is not complete and many other drugs can interact with vilazodone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.