Vortioxetine - Brintellix- @-(Sept 2013)- Anti-depressants
Drug Name:Vortioxetine - Brintellix- @-(Sept 2013)- Anti-depressants
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
. Strong inhibitors of CYP2D6: Reduce BRINTELLIX dose by half when a strong
CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) is
coadministered
. Strong CYP Inducers: Consider increasing BRINTELLIX dose when a strong
CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered
for more than 14 days. The maximum recommended dose should not exceed
3 times the original dose (
Indication:
BRINTELLIX (vortioxetine) tablets, for oral use
Initial U.S. Approval: 2013
WARNING: SUICIDAL THOUGHTS AND BEHAVIOURS
See full prescribing information for complete boxed warning.
Increased risk of suicidal thinking and behavior in children, adolescents,
and young adults taking antidepressants
Monitor for worsening and emergence of suicidal thoughts and behaviors
BRINTELLIX has not been evaluated for use in pediatric patients
Drug Name- Brintellix
Active Ingredient - Vortioxetine
To treat adults with major depressive disorder
Indication-
Major depressive disorder
Approved by FDA on 30-9--2013 (Ref- FDA approved List- 2013)
Adverse Reaction:
Most common adverse reactions (incidence .5% and at least twice the rate of placebo)
were: nausea, constipation and vomiting
Contra-Indications:
CONTRAINDICATIONS
Hypersensitivity to vortioxetine or any components of the BRINTELLIX
formulation .
Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to
treat psychiatric disorders with BRINTELLIX or within 21 days of stopping
treatment with BRINTELLIX.
Do not use BRINTELLIX within 14 days of stopping an MAOI intended to
treat psychiatric disorders. In addition, do not start BRINTELLIX in a patient
who is being treated with linezolid or intravenous methylene blue
WARNINGS AND PRECAUTIONS
1. Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may
experience worsening of their depression and/or the emergence of suicidal
ideation and behavior (suicidality) or unusual changes in behavior, whether
or not they are taking antidepressant medications, and this risk may persist
until significant remission occurs.
Suicide is a known risk of depression and certain other psychiatric disorders,
and these disorders
Families and caregivers of patients being treated with antidepressants for MDD
or other indications, both psychiatric and nonpsychiatric, should be alerted
about the need to monitor patients for the emergence of agitation, irritability,
unusual changes in behavior, and the other symptoms described above,
as well as the emergence of suicidality, and to report such symptoms
immediately to healthcare providers. Such monitoring should include daily
observation by families and caregivers.
Screening Patients for Bipolar Disorder
A major depressive episode may be the initial presentation of bipolar disorder.
It is generally believed (though not established in controlled studies) that
treating such an episode with an antidepressant alone may increase
the likelihood of precipitation of a mixed/manic episode in patients
at risk for bipolar disorder
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been
reported with serotonergic antidepressants including BRINTELLIX, when used
alone but more often when used concomitantly with other serotonergic drugs
(including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol,
tryptophan, buspirone, and St. Johns Wort), and with drugs that impair
metabolism of serotonin (in particular,
MAOIs, both those intended to treat psychiatric disorders and also others,
such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes
(e.g., agitation)
Dosages/ Overdosage Etc:
Indication-
Major depressive disorder
INDICATIONS AND USAGE
BRINTELLIX is indicated for the treatment of major depressive disorder (MDD)
DOSAGE AND ADMINISTRATION
The recommended starting dose is 10 mg administered orally once daily
without regard to meals .
The dose should then be increased to 20 mg/day, as tolerated .
Consider 5 mg/day for patients who do not tolerate higher doses
BRINTELLIX can be discontinued abruptly. However, it is recommended
that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for
one week prior to full discontinuation if possible .
The maximum recommended dose is 10 mg/day in known CYP2D6
poor metabolizers .
DOSAGE FORMS AND STRENGTHS
BRINTELLIX is available as 5 mg, 10 mg, 15 mg, and 20 mg
immediate release tablets
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide)
Advise patients and their caregivers about the benefits and risks associated
with treatment with BRINTELLIX and counsel them in its appropriate use.
Advise patients and their caregivers to read the Medication Guide
and assist them in understanding its contents.
Suicide Risk
Advise patients and caregivers to look for the emergence of suicidal ideation
and behavior, especially early during treatment and when the dose is adjusted
up or down
Discontinuation of Treatment
Patients who are on BRINTELLIX 15 mg/day or 20 mg/day may experience headache,
muscle tension, mood swings, sudden outburst of anger, dizziness and runny nose
if they abruptly stop their medicine. Advise patients not stopping BRINTELLIX
without talking to their healthcare provider
Concomitant Medication
Advise patients to inform their physicians if they are taking, or plan to take,
any prescription or over-the-counter medications because of a potential for
interactions. Instruct patients not to take BRINTELLIX with an MAOI or within
14 days of stopping an MAOI and to allow 21 days after stopping BRINTELLIX
before starting an MAOI .
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the
concomitant use of BRINTELLIX and triptans, tricyclic antidepressants,
fentanyl, Lithium, tramadol, tryptophan supplements, and St. Johns Wort
supplements
Abnormal Bleeding
Caution patients about the increased risk of abnormal bleeding when BRINTELLIX
is given with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation
Activation of Mania/Hypomania
Advise patients and their caregivers to look for signs of activation of mania/hypomania
Hyponatremia
Advise patients that if they are treated with diuretics, or are otherwise volume
depleted, or are elderly, they may be at greater risk of developing hyponatremia
while taking BRINTELLIX
Nausea
Advise patients that nausea is the most common adverse reaction, and is
dose related. Nausea commonly occurs within the first week of treatment,
then decreases in frequency but can persist in some patients.
Alcohol
A clinical study has shown that BRINTELLIX (single dose of 20 or 40 mg/day)
did not increase the impairment of mental and motor skills caused by alcohol.
Allergic Reactions
Advise patients to notify their healthcare provider if they develop an allergic
reaction such as rash, hives, swelling, or difficulty breathing.
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant
or intend to become pregnant during therapy with BRINTELLIX.
Nursing Mothers
Advise patients to notify their healthcare provider if they are breast-feeding an
infant and would like to continue or start BRINTELLIX
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
The mechanism of the antidepressant effect of vortioxetine is not fully understood,
but is thought to be related to its enhancement of serotonergic activity in the
CNS through inhibition of the reuptake of serotonin (5-HT).
It also has several other activities including 5-HT3 receptor antagonism and
5-HT1A receptor agonism. The contribution of these activities to vortioxetines
antidepressant effect has not been established.
2. Pharmacokinetics
Vortioxetine pharmacological activity is due to the parent drug.
The pharmacokinetics of vortioxetine (2.5 mg to 60 mg) are linear and
dose-proportional when vortioxetine is administered once daily.
The mean terminal half-life is approximately 66 hours, and steady-state
plasma concentrations are typically achieved within two weeks of dosing.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category C
Risk Summary
There are no adequate and well-controlled studies of BRINTELLIX in pregnant women.
Vortioxetine caused developmental delays when administered during pregnancy
to rats and rabbits at doses 15 and 10 times the maximum recommended human
dose (MRHD) of 20 mg, respectively.
Excercise caution if required to be administered
2. Nursing Mothers
It is not known whether vortioxetine is present in human milk. Vortioxetine is present
in the milk of lactating rats. Because many drugs are present in human milk and
because of the potential for serious adverse reactions in nursing infants
from BRINTELLIX, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of the drug
to the mother.
3.Pediatric Use
Clinical studies on the use of BRINTELLIX in pediatric patients have not been
conducted; therefore, the safety and effectiveness of BRINTELLIX in the pediatric
population have not been established.
4. Geriatric Use
No dose adjustment is recommended on the basis of age. 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.
