Please use the tables below to complete drug evaluation for the following question.

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:

                                                   

1. 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-