Viibryd Starter Pack

Vilazodone is an antidepressant that acts as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist. The precise mechanism of the antidepressant action of vilazodone is unknown, but is believed to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through these dual actions.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Seizures
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition, which may be more likely to occur if you are taking certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, or vomiting
+ Severe headache

Other Possible Side Effects

Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Trouble sleeping
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dry mouth
Dizziness
Headache
* Feeling sleepy

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with glaucoma.
* If you are currently taking or have recently taken certain medications, including:
+ Linezolid
+ Methylene blue
+ Certain antidepressants or Parkinson's disease medications, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, refrain from consuming alcohol while on this medication.

Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. It may take several weeks for the full effects of this medication to become apparent.

Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage to minimize potential risks.

This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Certain individuals may be more prone to eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.

Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, this can be fatal. Consult with your doctor about this potential risk. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or may be pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy, as it may increase the risk of bleeding after delivery and potentially cause health problems in the newborn, particularly if taken during the third trimester.

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI or starting MAOI within 14 days of discontinuing vilazodone)

• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) - increased risk of serotonin syndrome.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - reduce vilazodone dose by half.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - consider increasing vilazodone dose up to 80 mg/day if tolerated and needed, or avoid concurrent use.
• Drugs that interfere with hemostasis (e.g., NSAIDs, aspirin, warfarin) - increased risk of bleeding.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil) - monitor for increased vilazodone effects.
• Moderate CYP3A4 inducers (e.g., efavirenz, bosentan) - monitor for decreased vilazodone efficacy.

• Not specifically identified as minor, but general caution with CNS depressants due to additive effects.

• New or worsening depression
• Anxiety
• Agitation
• Panic attacks
• Insomnia
• Irritability
• Hostility
• Impulsivity
• Akathisia (psychomotor restlessness)
• Hypomania
• Mania
• Suicidal ideation or behavior
• Serotonin syndrome symptoms (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Abnormal bleeding (e.g., ecchymoses, epistaxis, GI bleeding)
• Seizures
• Hyponatremia symptoms (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more acute symptoms include hallucinations, syncope, seizure, coma, respiratory arrest, death)
• Visual disturbances (e.g., acute angle-closure glaucoma symptoms like eye pain, changes in vision, swelling or redness in or around the eye)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Exposure during late pregnancy may lead to complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery.

Vilazodone is excreted into human milk. The decision to breastfeed during treatment should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for adverse reactions (e.g., sedation, poor feeding, poor weight gain).

Safety and effectiveness have not been established in pediatric patients (under 18 years of age) for Major Depressive Disorder. Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia and falls. Use with caution and monitor closely.

• Always take vilazodone with food. Taking it without food significantly reduces its absorption and effectiveness.
• The Viibryd Starter Pack is designed for gradual dose titration to minimize gastrointestinal side effects (nausea, diarrhea) which are common during initiation.
• Patients should be advised not to abruptly discontinue vilazodone due to the risk of discontinuation syndrome (e.g., dizziness, sensory disturbances, agitation, anxiety, nausea, sweating, tremor, confusion).
• Monitor for symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
• Vilazodone has a unique dual mechanism of action (SSRI + 5-HT1A partial agonist) which may offer different efficacy or tolerability profiles compared to traditional SSRIs.
• Consider dose adjustments for patients on strong CYP3A4 inhibitors or inducers, and for those with moderate to severe hepatic impairment.

• Other Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetine, desvenlafaxine, levomilnacipran)
• Atypical Antidepressants (e.g., bupropion, mirtazapine, vortioxetine, trazodone)
• Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT, Interpersonal Therapy - IPT)
• Electroconvulsive Therapy (ECT)
• Transcranial Magnetic Stimulation (TMS)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.