Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 12 January 2018
Indication(s)
Related Content
Advisory information
4 CONTRAINDICATIONS •Hypersensitivity to vortioxetine or any components of the formulation.
Angioedema has been reported in patients treated with BRINTELLIX. •The use of MAOIs intended to treat psychiatric
The use of BRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric
Starting BRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an
•Hypersensitivity to vortioxetine or any components of the BRINTELLIX formulation (4).
•Monoamine Oxidase Inhibitors (MAOIs): Do not
In addition, do not start BRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue (4).
6
•Hypersensitivity [see Contraindications (4)] •Clinical
To report SUSPECTED
6.1 Clinical Studies Experience Because clinical trials are conducted under widely
Patient Exposure BRINTELLIX was evaluated for
Patients from the 6 to 8 week studies continued into 12?month open-label studies.
Table 2 shows the incidence of
Table 2.
2 % of Patients Treated with any BRINTELLIX Dose and at Least
Approximately 10 % of patients taking BRINTELLIX 10 mg/day to 20 mg/
Sexual
In the MDD 6 to 8 week
These event terms have been aggregated and the overall incidence was as follows.
In male patients the overall incidence was 3 %, 4 %, 4 %, 5 % in BRINTELLIX 5 mg/day, 10 mg/day, 15 mg/day, 20 mg/day, respectively, compared to 2 % in placebo.
In female patients, the overall incidence was <1 %, 1 %, <1 %, 2 % in BRINTELLIX 5 mg/day, 10 mg/day, 15 mg/day, 20 mg/day, respectively, compared to <1 % in placebo.
Because voluntarily reported
The ASEX scale includes five questions that pertain to the following aspects of sexual function: 1) sex drive, 2)
The presence or
For
Physicians should routinely inquire about possible sexual side effects.
Table 3.
ASEX Incidence of Treatment Emergent Sexual
Sexual
clinical trials.
Some patients
BRINTELLIX 15 mg/day and 20 mg/day.
Laboratory Tests BRINTELLIX has not been associated with any clinically
Hyponatremia has been reported with the treatment of BRINTELLIX [see Warnings and Precautions (5.6)].
In the 6-month, double-blind, placebo-controlled phase of a
In the 6-month, double-blind, placebo-controlled phase of a
Other
Ear and labyrinth
Usage information
2 DOSAGE AND ADMINISTRATION •The
•Consider 5 mg/day for patients who do not tolerate higher doses (2.1).
However,
2.1 General Instruction for
The efficacy and safety of doses above 20 mg/day have not been evaluated in
2.2 Maintenance/Continuation/Extended Treatment It is generally agreed that
A maintenance study of BRINTELLIX demonstrated that
2.3
To avoid these
2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric
Conversely, at least 21 days should be allowed after stopping BRINTELLIX before starting an MAOI intended to treat psychiatric
2.5 Use of BRINTELLIX with Other MAOIs such as Linezolid or Methylene Blue Do not start BRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue because there is an
In
In some cases, a patient already receiving
If
The patient should be monitored for symptoms of serotonin syndrome for 21 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first.
Therapy with BRINTELLIX may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than
The clinician should, nevertheless, be
2.6 Use of BRINTELLIX in Known CYP2D6
Reduce the dose of BRINTELLIX by one-half when patients are receiving a CYP2D6 strong inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) concomitantly.
2.7 Use of BRINTELLIX in Patients Taking
8 USE IN SPECIFIC POPULATIONS •Pregnancy: Based on animal data, BRINTELLIX may cause fetal
•Nursing Mothers:
8.1 Pregnancy Pregnancy Category C Risk Summary There are
Vortioxetine caused developmental
Developmental
There were
The incidence of malformations in human pregnancies has not been
All human pregnancies, regardless of drug exposure, have a background rate of 2 to 4 % for major malformations, and 15 to 20 % for
BRINTELLIX should be used during pregnancy only if the potential
Clinical Considerations Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed
Such
Reported clinical findings have included respiratory
It should be noted that in some cases,
When treating a pregnant woman with BRINTELLIX during the third trimester, the physician should
Neonates exposed to
PPHN occurs in one to two per 1,000 live births in the general population and is associated with
Several recent epidemiologic studies suggest a
Other studies do not show a
A prospective longitudinal study was conducted of 201 pregnant women with a history of major
When treating a pregnant woman with BRINTELLIX, the physician should
Animal Data In pregnant
These doses are 77 and 58 times, in
Developmental
When vortioxetine was administered to pregnant
Additionally,
These effects were not seen at 10 mg/kg (5 times the MRHD).
8.3 Nursing Mothers It is not known whether vortioxetine is present in human milk.
Vortioxetine is present in the milk of lactating
Because many drugs are present in human milk and because of the
8.4 Pediatric Use Clinical studies on the use of BRINTELLIX in pediatric patients have not been conducted; therefore, the
8.5
Results from a single-dose pharmacokinetic study in elderly (>65 years old) vs. young (24 to 45 years old) subjects demonstrated that the pharmacokinetics were generally similar between the two age groups.
Of the 2616 subjects in clinical studies of BRINTELLIX, 11 % (286) were 65 and over, which
Serotonergic antidepressants have been associated with cases of clinically
8.6 Use in Other Patient Populations
In addition, the same dose can be administered in
BRINTELLIX has not been studied in
Therefore,
Figure 3.
Impact of Intrinsic Factors on Vortioxetine PK Figure3.jpg
8.3 Nursing Mothers It is not known whether vortioxetine is present in human milk.
Vortioxetine is present in the milk of lactating
Because many drugs are present in human milk and because of the
Interactions
More information
Category | Value |
---|---|
Authorisation number | NDA204447 |
Orphan designation | No |
Product NDC | 69189-0560 |
Date Last Revised | 11-01-2016 |
Type | HUMAN PRESCRIPTION DRUG |
RXCUI | 1439844 |
Marketing authorisation holder | Avera McKennan Hospital |
Warnings | WARNING: These studies did not show an In patients of all ages who are started on antidepressant therapy, Advise families and caregivers of the BRINTELLIX has not been evaluated for use in pediatric patients [see Use in Specific Populations (8.4)]. WARNING: • Monitor for • BRINTELLIX has not been evaluated for use in pediatric patients (8.4). |