Patient Medication Information: uses, side effects, how to take - Viibryd (Abbvie, 10 mg / 20 mg)

What is VIIBRYD used for?

VIIBRYD has been prescribed for you by your healthcare professional to relieve your symptoms of depression which may include:

feeling sad
loss of interest in usual activities
significant change in weight or appetite
change in sleeping habits
having a hard time concentrating
feeling tired
having suicidal thoughts

How does VIIBRYD work?

VIIBRYD is an antidepressant medication. It is thought to work by increasing the activity of serotonin in your brain. Serotonin is a brain chemical that helps to improve mood. It works at two different receptors in the brain.

What are the ingredients in VIIBRYD?

Medicinal ingredients: vilazodone hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only), FD&C Red #40 (10 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

VIIBRYD comes in the following dosage forms:

Tablets; 10 mg (pink), 20 mg (orange), 40 mg (blue)

Do not use VIIBRYD if:

you are allergic to any of the ingredients in VIIBRYD.
you take a Monoamine Oxidase Inhibitor (MAOI).
- Ask your healthcare professional or pharmacist if you are not sure if you take a MAOI.
- Examples of MAOIs include linezolid which is an antibiotic, methylene blue which is a dye used in certain surgeries.
- If you stopped taking a MAOI within the last 14 days, only start VIIBRYD if your healthcare professional tells you to.
- Do not take a MAOI within 14 days of stopping VIIBRYD unless directed to do so by your healthcare professional.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VIIBRYD. Talk about any health conditions or problems you may have, including if you:

are taking or have recently taken a monoamine oxidase inhibitor (MAOI)
have high blood pressure that is not controlled by your medication or any heart problems
have a history of drug abuse
have a bleeding disorder
take certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g., warfarin, dabigatran), acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (e.g., ibuprofen)
have or had seizures or convulsions
have glaucoma or increased pressure in your eyes
have suicidal thoughts
have a family history of mania or bipolar disorder
are pregnant or plan to become pregnant. It is not known if VIIBRYD will harm your unborn baby.
Talk to your healthcare professional about the benefits and risks of treating depression during pregnancy.
are breastfeeding or plan to breastfeed. It is not known if VIIBRYD passes into breast milk. You and your healthcare professional should decide if you should take VIIBRYD while breastfeeding.
have any other medical conditions

VIIBRYD is not for use in children under 18 years of age.

Other warnings you should know about:

It is important to talk to your healthcare professional about the risks of treating depression and also the risk of not treating it. You should discuss all treatment options with your healthcare professional.

New or Worsened Emotional or Behaviour Problems:

Treatment with these types of medications is most safe and effective when you and your healthcare professional have good communication about how you are feeling. You may find it helpful to tell a relative or close friend that you are depressed. You might ask them to tell you if they think you are getting worse or if they are worried about changes in your behavior.

Some patients may feel worse instead of better when they first start taking drugs like VIIBRYD or when changing the dose. You may have:

new or worsened feelings of nervousness, tension, anger, agitation, or aggression
thoughts about suicide, hurting yourself or other people. Thoughts and actions about suicide can occur especially if you have had thoughts of hurting yourself in the past. Suicidal thoughts and actions can occur in any age group but may be more likely in patients 18 to 24 years old. If this happens, seek immediate medical help. Do NOT stop taking VIIBRYD on your own.

Effects on pregnancy and newborns:

If you are pregnant or are planning to become pregnant while taking VIIBRYD, talk to your healthcare professional about the risks and benefits of various treatment options. It is very important that you keep taking VIIBRYD until your healthcare professional tells you to stop.

When pregnant women took drugs in the same group of medications as VIIBRYD, some newborn babies had complications at birth. This happened especially when the medication was taken in the last three months of pregnancy. Some newborns:

required breathing support, tube feeding and a longer stay in the hospital
had difficulty feeding or breathing, seizures, tense or overly relaxed muscles and were jittery and cried constantly
had a serious condition called persistent pulmonary hypertension. This made the babies breathe faster and appear blue in color.

These symptoms normally go away over time. However, if your baby experiences any of these symptoms, consult your healthcare professional as soon as possible.

Risk of breaking a bone

You should tell your doctor if you:

are elderly and had a recent bone fracture or
were told you have osteoporosis or risk factors for osteoporosis.

Taking VIIBRYD may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. This is especially true when you first start taking VIIBRYD and soon after you stop taking it. Take extra care to avoid falling, especially if you get dizzy or have low blood pressure.

Discontinuation Symptoms:

If your healthcare professional recommends that you stop taking VIIBRYD, they will gradually lower the dose of VIIBRYD you are taking. This may help manage any symptoms of discontinuation, such as:

dizziness, headache, ringing in the ears, seizures
nausea, diarrhea, vomiting
tingling, burning, or prickling sensation of your skin, excessive sweating
feeling nervous, confused, irritated, restless, or having an unstable mood
fatigue, insomnia (inability to sleep), nightmares

These symptoms will usually disappear without needing treatment. Tell your healthcare professional immediately if you have these or any other symptoms. Your healthcare professional may adjust the dosage of VIIBRYD to alleviate the symptoms.

Serotonin toxicity (also known as Serotonin syndrome): VIIBRYD can cause Serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin toxicity if you take VIIBRYD with certain anti-depressants or migraine medications.

Serotonin toxicity symptoms include:

fever, sweating, shivering, diarrhea, nausea, vomiting;
muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
fast heartbeat, changes in blood pressure;
confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Driving and Using Machines:

VIIBRYD can make you feel sleepy or may affect your ability to think clearly, make decisions or react quickly. Wait until you know how you feel after you have taken VIIBRYD before you drive or use heavy machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with VIIBRYD:

other antidepressants
other drugs that affect serotonin such as lithium, linezolid, sibutramine, tryptophan, triptans, St.
John’s Wort
certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants
(e.g., warfarin, dabigatran), acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (e.g., ibuprofen)
certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
certain medicines used to treat cough, such as dextromethorphan
when taking certain medicines such as antifungals (e.g. ketoconazole); antibiotics (e.g.
erythromycin) or medicines used to treat seizures (carbamazepine). Your healthcare professional may adjust your dose of VIIBRYD when taking these medicines.
mephenytoin
diuretics

You should avoid drinking alcohol while taking VIIBRYD.

How to take VIIBRYD:

It is important to take VIIBRYD exactly as your healthcare professional has told you. Your healthcare professional may need to change the dose until it is right for you.

Always take VIIBRYD with food. VIIBRYD may not work as well if you take it on an empty stomach.
Even if you feel better, do not stop taking VIIBRYD without talking to your healthcare professional.
It is important to keep taking VIIBRYD as recommended by your healthcare professional.

Usual dose:

The usual adult dose is 20 mg to 40 mg once a day:

For the first 7 days, the dose is one 10 mg tablet once a day.
After 7 days, you will take a 20 mg tablet once a day.
If you are still not feeling better, your healthcare professional may increase your dose to a 40 mg tablet taken once a day.

Overdose:

If you think you, or a person you are caring for, have taken too much VIIBRYD, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of VIIBRYD, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of VIIBRYD at the same time.

What are possible side effects from using VIIBRYD?

These are not all the possible side effects you may have when taking VIIBRYD. If you experience any side effects not listed here, tell your healthcare professional.

Common side effects in people who take VIIBRYD include:

diarrhea
nausea or vomiting
trouble sleeping

	Serious side effects and what to do about them
Symptom / effect			Talk to your healthcare professional		Stop taking drug and
		Only if severe		In all cases	get immediate
					medical help
UNCOMMON
Mania/Hypomania: elevated or irritated mood, decreased need for sleep, racing thoughts
Seizures: loss of consciousness with uncontrollable shaking

	Serious side effects and what to do about them
Symptom / effect			Talk to your healthcare professional		Stop taking drug and
		Only if severe		In all cases	get immediate
					medical help
RARE
Serotonin toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (> 38°C), or rigid muscles
Glaucoma: increased pressure in the eyes, eye pain and blurred vision
Low sodium level in blood: symptoms of tiredness, weakness, confusion, combined with achy, stiff or uncoordinated muscles
UNKNOWN
Allergic reaction: red skin, hives, itching, swelling of the lips, face, tongue or throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes
Low platelets: bruising or unusual bleeding from the skin or other areas
New or worsened Emotional or Behavioural Problems: feeling angry, aggressive, worried, agitated, hostile or impulsive. Feeling violent or suicidal. Thoughts of hurting yourself or other people. Feeling like you are not yourself or that you are less inhibited
Swelling of the pancreas: symptoms include pain in your upper abdomen that may extend to your back, nausea and vomiting, fever, increased heart rate and loss of appetite
Sleep paralysis: temporary inability to move or talk for up to several minutes while you are going to sleep or waking up

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store VIIBRYD at room temperature (15-30°C).

Keep out of reach and sight of children.

If you want more information about VIIBRYD:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.abbvie.ca, or by calling 1-888-704-8271.

Last Revised: NOV 17, 2022

VIIBRYD and its design are trademarks of Allergan Sales, LLC, an AbbVie company, used under license by AbbVie Corporation.

Licensed from Merck KGaA, Darmstadt, Germany.

Rx or OTC	Prescription (Rx)?
DIN	02443759
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Vilazodone hydrochloride 10 MG / 20 MG
Dosage form(s)	Tablet, Kit
Route(s) of administration	Oral
Drug class (WHO ATC)	N Nervous system drugs N06 Psychoanaleptics N06A Antidepressants N06AX Other antidepressants N06AX24 Vilazodone
Company	ABBVIE CORPORATION
Current status	Cancelled Post Market
Current status date	July 20, 2023

Viibryd (Abbvie, 10 mg / 20 mg): Uses, Side Effects and Dosage