VIIBRYD Product Monograph Flashcards
What is VIIBRYD indicated for and why is it different from other SSRIs?
MDD in adults. First SSRI and 5-HT (1a) a partial agonist
What is the VIIBRYDs drug class?
SSRI and 5HT (1a)
How is it dosed?
1-7 10mg (for 7 days)
8-14 20mg (for 7 days)
15+ 40mg
What are the 7 points for the Warning and Precautions? SSSAADH
Suicidality Serotonin syndrome Seizures Abnormal bleeding Activation of Mania/Hypomania Discontinuation of Treatment with V Hyponatremia (low sodium in blood)
In studies, Most common adverse events >= 5% and at least 2x rate of placebo in the studies were and %? (Do Not Inject VIIBRYD)
Diarrhea (28%) (only 8 days) Nausea (23%) (only 5 days) Insomnia (6%) Vomiting (5%) DNI were considered mild to moderate
No single adverse event reaction that led to discontinuation of treatment __% VIIBRYD in the studies?
> 1%
The overall rate of discontinuation for both studies due to adverse events was ___ for VIIBRYD and ___ for placebo
- 1% in VIIBRYD
3. 2% in Placebo
No more than __ of patients reported any one sexual side effect, such as decreased libido, abnormal orgasm, delayed ejac, erectile dysfxn, or sexual dystfxn
5%
The Safety of V was evaluated on ____ ages __-__ diagnosed with ____.
2177
18-70 yrs old
MDD
The LS mean difference in MADRS for patients using Viibryd vs Placebo was __ (Rickels) and __ (Khan)
-3.2 (Rickels)
-2.5 (Khan)
(negative 2 being considered statistically significant in the eyes of the studies)
VIIBRYD potently and selectively inhibits _____ _____ and binds selectively with high affinity to ____ __________
reuptake of serotonin
5-HT (1a) receptor partial agonist
ABSORPTION: Taken with food, the concentration peak at a median is ____ and terminal half life is ___ hours
4-5 hours t-max
25 hours
Strong inhibitors of CYP3A4 (ketoconazole) can ________ the metabolism of V and ______ exposure.
reduce
increase
VIIBRYD is extensively metabolized where?
in the liver, with only 1% recovered in the urine and 2% of feces
In order to be in the Rickels and Khan studies what were the criteria for each?
- 18-65 (Rickels) and 18-70 (Khan)
- Met DSM-4 criteria for MDD, single or recurrent
- Duration of current epis.was at least 4 weeks, and no more than 2 years
- HAM-D17 score >=22
- HAM-D17 item 1 (depressed mood) score >=2
What was the primary efficacy endpoint of both trials?
Mean change in MADRS total score from baseline to the end of treatment. (assessed at Week 1,2,4,6,8)
Rickels study showed a __ reduction over MADRS baseline or __% compared to placebo at ___ or ___%
- 12.9; 42%
- 9.6; 31%
Khan study showed a __ reduction over MADRES baseline or __% compared to placebo at ___ or ___%
- 13.3; 42%
- 10.8; 34%
VIIBRYD had ____ effect on body weight as measured from baseline in the 8 week study. Mean changes in weight were ___kg. In the 52 week study it was __kg.
NO effect
.16 kg in V vs. .18 kg in placebo
1 kg in 52 week study
True or False? VIIBRYD has been systematically studied beyond 8 weeks?
FALSE BITCH!!
At what week did the Rickels see a LS mean difference from placebo in change from baseline in MADRS total score vs. Khan’s?
Rickels: Week 1, 2, 4, 6, and 8
Khan: Week 6 and 8
Explain contraindications of V
MAOI 14 days vice versa methylene blue linazolid
Viibryd MOA
First and only SSRI and 5HT 1a partial agonist.
It is thought that this receptor plays a role in MODULATING serotonin induced transmission
How many were on the Robinson study and what %stayed on 40mg?
599 and 90% stayed on 40 mg
No single adverse reaction led to discontinuation in <= ___% of patients in phase 3 placebo controlled studies
<= 1%
Symptoms of MDD: SIGECAPS
Sleep Interest (lack of) Guilt Energy Concentration Appetite Psychomotor Suicide
5 R’s
Response Remission (partial or full) Relapse Recovery Recurrence
MADRS 10 core symptoms
Apparent Sadness Reported Sadness
Inner Tension Reduced Sleep
Reduced appetite Concentration difficulties
Lassitude Inability to feel
Pessimistic Thoughts Suicidal thoughts
Viibryd is treated for:
MDD in adults
How do you talk about V in regards weight
No significant effect on weight
Robinson, people stayed at 40 mg ___% of the time.
What were the 3 top AE?
90%
Diarrhea
Nausea
Headache
How many people were in the Rickels, Khan and Robinson study
410 - 481 - 599
What is the primary endpoint?
MADRS total score from baseline at week 8
What Preg category
Pregnancy C:
No Dose Adjustment for who?
Hep, Renal, Elderly, and Age and Gender
What is the absolute bioavailability of V? compared to oral bioavailability
72% compared to 147-160%
Seretonin Syndrome includes
Triptans Tricyclic antidepressants Tramadol, Tryptophan, Fentanyl Buspirone St. John's Wort MAOI's Intravenous methylene Blue Linozolid Lithium
Inhibitors of CYP3A4 like KETOCONAZOLE, how much do you dose and why?
20 mg because it can increase vilazadone plasma concentrations by approx. 50%
Viibryd main ingredient name is
vilazadone
What was the percent of MD-03 and MD-01
53% and 57%
