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Viibryd




Side Effects
Interactions

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The most commonly observed adverse reactions in VIIBRYD-treated patients with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia.

Patient Exposure

The safety of VIIBRYD was evaluated in 3,007 patients (18-70 years of age) diagnosed with MDD who participated in clinical studies, representing 676 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to VIIBRYD for a total of 348 patient-years.

The adverse reaction information presented below was derived from studies of VIIBRYD 20 mg and 40 mg daily in patients with MDD including:

  • Four placebo-controlled 8 to 10-week studies in 2,233 patients, including 1,266 VIIBRYD-treated patients; and
  • An open-label 52-week study of 599 VIIBRYD-treated patients.

These studies included a titration period of 10 mg daily for 7 days, followed by 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In these clinical trials, VIIBRYD was administered with food.

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment

In these studies, 7.3% of the VIIBRYD-treated patients discontinued treatment due to an adverse reaction, compared with 3.5% of placebo-treated patients. The most common adverse reaction leading to discontinuation in at least 1% of the VIIBRYD-treated patients in the placebo-controlled studies was nausea (1.4%).

Common Adverse Reactions In Placebo-Controlled Mdd Studies

Table 2 shows the incidence of common adverse reactions occuring in ≥ 2% of VIIBRYD-treated patients and greater than the rate of placebo-treated patients in MDD Studies. There were no dose-related adverse reactions between 20 mg and 40 mg reported.

Table 2: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients

System Organ Class Preferred Term Placebo
N=967
VIIBRYD 20 mg/day
N=288
VIIBRYD 40 mg/day
N=978
Gastrointestinal disorders
Diarrhea 10% 26% 29%
Nausea 7% 22% 24%
Dry mouth 5% 8% 7%
Vomiting 2% 4% 5%
Abdominal pain1 3% 7% 4%
Dyspepsia 2% 2% 3%
Flatulence 1% 3% 3%
Gastroenteritis 1% 1% 2%
Abdominal distension 1% 2% 1%
Nervous system disorders
Headache2 14% 15% 14%
Dizziness 5% 6% 8%
Somnolence 2% 4% 5%
Paresthesia 1% 1% 2%
Psychiatric disorders
Insomnia 2% 7% 6%
Abnormal dreams 2% 2% 3%
Restlessness3 1% 2% 3%
General disorders
Fatigue 3% 4% 3%
Cardiac disorders
Palpitations < 1% 1% 2%
Metabolism and nutrition disorders
Increased appetite 1% 1% 3%
Musculoskeletal and connective tissue disorders
Arthralgia 1% 2% 1%
Investigations
Increased weight 1% 1% 2%
1 Includes abdominal discomfort, abdominal pain upper, and abdominal pain.
2 Includes headache and tension headache
3 Includes restlessness, akathisia, and restless legs syndrome
Sexual adverse reactions are presented in Table 3

Sexual Adverse Reactions

Table 3 displays the most common sexual adverse reactions in the placebo-controlled MDD studies.

Table 3: Common Sexual Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients

Preferred Term Males Females
Placebo
N=416
VIIBRYD 20 mg/day
N=122
VIIBRYD 40 mg/day
N=417
Placebo
N=551
VIIBRYD 20 mg/day
N=166
VIIBRYD 40 mg/day
N=561
Abnormal Orgasm* < 1% 2% 2% 0% 1% 1%
Erectile dysfunction 1% 0% 3% - - -
Libido decreased < 1% 3% 4% < 1% 2% 2%
Ejaculation disorder 0% 1% 2% - - -
- Not applicable *Includes abnormal orgasm and anorgasmia

Other Adverse Reactions Observed In Clinical Studies

The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:

Cardiac disorders: infrequent: ventricular extrasystoles

Eye disorders: infrequent: dry eye, vision blurred, rare: cataracts

Nervous System: frequent: sedation, tremor; infrequent: migraine

Psychiatric disorders: infrequent: panic attack

Skin and subcutaneous tissue disorders: infrequent: hyperhidrosis, night sweats

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of VIIBRYD. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure. Reports of adverse reactions temporally associated with VIIBRYD that have been received since market introduction and that are not listed above include the following:

General Disorders and Administration Site Conditions: irritability

Psychiatric Disorders: hallucinations, suicide attempt, suicidal ideation

Skin and subcutaneous tissue disorders: rash, generalized rash, urticaria, drug eruption

Read the Viibryd (vilazodone hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs Having Clinically Important Interactions With VIIBRYD

Table 4: Clinically Important Drug Interactions with VIIBRYD

Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation
Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of MAOIs and serotonergic drugs including VIIBRYD increases the risk of serotonin syndrome. VIIBRYD is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION, and WARNINGS AND PRECAUTIONS].
Other Serotonergic Drugs The concomitant use of serotonergic drugs including VIIBRYD and other serotonergic drugs increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during VIIBRYD initiation. If serotonin syndrome occurs, consider discontinuation of VIIBRYD and/or concomitant serotonergic drugs [see WARNINGS AND PRECAUTIONS].
Antiplatelet Agents and Anticoagulants Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with VIIBRYD may potentiate the risk of bleeding. Inform patients of the increased risk of bleeding with the concomitant use of VIIBRYD and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing VIIBRYD [see WARNINGS AND PRECAUTIONS].
Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin, voriconazole) The concomitant use of VIIBRYD and strong CYP3A4 inhibitors increased the exposure of vilazodone compared to the use of VIIBRYD alone [see CLINICAL PHARMACOLOGY]. The VIIBRYD dose should not exceed 20 mg once daily with the concomitant use of a strong CYP3A4 inhibitor [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].
Strong CYP3A4 Inducers (e.g., carbamazepine, phenytoin, rifampin) The concomitant use of VIIBRYD and strong CYP3A4 inducers decreased the exposure of vilazodone compared to the use of VIIBRYD alone [see CLINICAL PHARMACOLOGY]. Based on clinical response, consider increasing the dosage of VIIBRYD, over 1 to 2 weeks in patients taking strong CYP3A4 inducers for greater than 14 days [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].
Digoxin Digoxin is a narrow therapeutic index drug. Concomitant use of VIIBRYD increased digoxin concentrations [see CLINICAL PHARMACOLOGY]. Measure serum digoxin concentrations before initiating concomitant use of VIIBRYD. Continue monitoring and reduce digoxin dose as necessary.

Drugs Having No Clinically Important Interactions With VIIBRYD

Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are substrates of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and/or P-glycoprotein (except narrow therapeutic index drugs, e.g., digoxin), when VIIBRYD is administered concomitantly [see Drugs Having Clinically Important Interactions With VIIBRYD above and CLINICAL PHARMACOLOGY].

Drug Abuse And Dependence

Controlled Substance

VIIBRYD is not a controlled substance.

Abuse And Dependence

VIIBRYD has been systematically studied in animals and did not demonstrate abuse or dependence potential. While VIIBRYD has not been systematically studied in humans for its potential for abuse, there was no suggested evidence of drug-seeking behavior in the clinical studies.

Read the Viibryd Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/9/2016

Side Effects
Interactions

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