Please use the tables below to complete drug evaluation for the following question.
Question 1:
Nivolumab (Opdivo) is a human monoclonal antibody that blocks the interaction between programmed death receptor (PD-1) and its legends, PD-L1 and PD-L2 that has FDA approval for the following indication:

Treatment of patients with unrespectable or metastatic melanoma
[Generic name (Brand®)]
Drug Information
Mechanism of Action
Requested Indication
(approved/unapproved)
Route of Administration
Dosage Forms
Dose
Adjustment required in
specific population
Liver ( Renal ( Not studied
Others, specify .......................................................................................
Indicator for pediatrics
( Yes ( No ( Not Studied ( Age group out off
Pharmacokinetics
Absorption
Distribution
Time To Peak
Metabolism
Excretion
Half Life
Others
SAFETY
Common Adverse
Reactions (%)
Serious adverse
Reactions (%)
Drug interactions 
Contra-indications / Precautions
Monitoring Requirements
Sound-Alike/ Look-Alike
Boxed warning or
alerts issued
High Alert 
( Yes ( No
Handling
( Hazardous/cytotoxic Precaution ( None ( Others.................. 
Cost
Cost/pack
Cost/patient/month (or treatment course)
Table 1: Summary of Published Evidence (Efficacy & Safety)
Ref
Design*
Drug regimens 
n
Duration
Outcome
Measures
Demographics
Results/Comments
NNT
1.
1.[TEXT]
2.[TEXT]
3.[TEXT]
4.[TEXT]
[Arm 1] [Arm 2] [Arm 3] [Arm4]
x xxx
x xxx
2.
1.[TEXT]
2.[TEXT]
3.[TEXT]
4.[TEXT]
[Arm 1] [Arm 2] [Arm 3] [Arm4]
x xxx
x xxx
3.
1.[TEXT]
2.[TEXT]
3.[TEXT]
4.[TEXT]
[Arm 1] [Arm 2] [Arm 3] [Arm4]
x xxx
x xxx
4.
1.[TEXT]
2.[TEXT]
3.[TEXT]
4.[TEXT]
[Arm 1] [Arm 2] [Arm 3] [Arm4]
x xxx
x xxx
*Study design abbreviations: DB=Double Blind, RTC=Randomized Control Trial, PC=Placebo Controlled, PG=Parallel Group, XO=Crossover, MC=Multi-center.
NNT (Number needed to treat)=100/Absolute risk reduction, calculated only if P value less than 0.05 (i.e.: statistically significant)
Summary of evidence:
Efficacy/Safety (details table 1)
Level 1a
Systematic review of a randomized controlled trials
A
There is good evidence to support the recommendation
Level 1b
Individual randomized controlled trial
B
There is fair evidence to support the recommendation
Level 2a
Systematic review of cohort studies
C
There is poor or no evidence to support the recommendation
Level 2b
Individual cohort study
Level 3a
Systematic review of case-controlled studies
Level 3b
Individual case-control study
Level 4
Case series
Level 5
Expert opinion
Levels of Evidence: Grades of Recommendations
Summary of the evaluation:
Pros
Cons
Uncertainty
1-
1-
1-
2-
2-
2-
3-
3-
3-
4-
4-
4-
Prepared by: Date:
References: