Fetzima Pi

Question 0

Fetzima is considered a category c pregnancy drug. This means:

Answer 0

Animal reproduction studies have shown am adverse effect on the fetus, and there are no adequate well-controlled studies but potential benefits may warrant use of the drug in pregnant women despite potential risks

Question 1

According to the warnings and precautions section of fetzima pi, which of the following drugs should not be used at the same time as fetzima due to risk of serotonin syndrome ?

Answer 1

Intravenous methylene blue
Linezolid
SSRIs
SNRIs

Question 2

Mean change in systolic and diastolic bp from baseline to the end of treatment was _____ and _____ for fetzima-treated patients , compared to -0.4 and -0.0 for placebo-treated patients

Answer 2

+3.0 +3.2

Question 3

Based on the warnings and precautions section of fetzima pi, which of the following statements is true regarding fetzima use in patients with seizure disorders?

Answer 3

There is no clinical data on fetzima use in patients with seizure disorders, thus it should be used with caution

Question 4

What adverse events occurred in >/= 5% of patients and at least twice the rate of placebo. (NCHTEIVPE)

Answer 4

Nausea 17.           Vomiting 5
Constipation 9.     Palpitations 5
Hyperhidrosis 9.   Ejaculation dis. 5
Tachycardia 6
ED 6
Increased HR 6

Question 5

Levomilnacipran and it’s metabolites are eliminated primarily by _____ excretion, and therefor physicians should consider _____ dosage in patients with impairments in this organ system

Answer 5

Renal; decreasing

Question 6

According to the broad criteria for sustained hypertension listed in the pi, _____ of fetzima-treated patients experienced sustained hypertension compared to _____ of placebo patients.

Answer 6

1.8%; 1.2%

Question 7

The percentage of ingested levomilnacipran that is able to enter the blood circulation is know as it’s _____

Answer 7

Bioavailability

Question 8

Levomilnacipran binds with _____ affinity to the human _____ and _____ transporters

Answer 8

High; serotonin; norepinephrine

Question 9

Which of the following events were dose related, meaning the incidence of the adverse event increased as the dose increased?

Answer 9

Erectile dysfunction

Urinary hesitation

Question 10

Is fetzima recommended for use in patients with end-stage renal disease?

Answer 10

Use of fetzima is not recommended in patients with end stage renal disease

Question 11

Patients in all 3 clinical studies were treated with either fetzima or placebo one daily for a total of _____ weeks

Answer 11

8

Question 12

Fetzima may affect urethral resistance due to its effect on _____

Answer 12

Norandrenergic activity

Question 13

The therapeutic dose range for fetzima in the treatment of Mdd is _____ to _____ once daily

Answer 13

40 mg; 120 mg

Question 14

As a secondary endpoint. Fetzima demonstrated superiority of placebo as measured by improvement in the _____

Answer 14

Sheehan disability scale (SDS) functional impairment total score

Question 15

In the fetzima clinical studies, the _____ was used to assess improvement in depression symptoms, whereas the _____ was used to assess functional impairment

Answer 15

MADRS; SDS

Question 16

What are two true statements regarding cardiovascular effects seen in patients treated with fetzima

Answer 16

1. Fetzima treatment has been associated with elevated HR

2. Fetzima treatment has been associated with elevated BP

Question 17

How many patients were exposed to fetzima in short-term, placebo controlled studies?

Answer 17

1583

Question 18

What is the mean increase in HR in FETZIMA vs placebo

Answer 18

+7.4 in FETZIMA

-0.3 in placebo

Question 19

Mania and hypo mania were reported in ___% of FETZIMA and ___ % of placebo

Answer 19

.2; .2