Biologics

Question 1

Anthrax biologic approved in

Answer 1

Raxibacumab

Question 2

Anthrax drug approved in 2016

Answer 2

Obiltoxaximab

Question 3

Nerve agent poisoning treatment approved with animal rule

Answer 3

Pyridostigmine brominde

Question 4

Animal rule requirements

Answer 4

1- well understood mechanism

2- effect demonstrated in more than one species

3- animal study endpoints clearly relate to desired benefit in humans

4- data allows for selection of an effective dose in humans

Question 5

Animals used for approval of anthrax biologic (beginning with R)

Answer 5

White rabbits and cynomologus macaque nonhuman primates

Question 6

Serogroups of cholera that cause outbreaks

Answer 6

01 and 0139

Question 7

Cholera treatment

Answer 7

Generally, oral rehydrating solution

Also, give appropriate antibiotics to diminish the duration of the diarrhea

Zinc supplementation in children reduced the duration of illness and the volume of diarrhea

Question 8

Cholera Vaccines

Answer 8

Vaxchora- live attenuated indicated against serogroup 01

Only FDA approved

90% efficacy

Shanchol & Euvichol - 65% protection for up to 5 years in endemic areas

Question 9

Mycobacterium avium complex

Answer 9

Affects people with compromised immune function

Fever, sweats, weight loss, abdominal pain, fatigue, chronic diarrhea

Question 10

MAC treatment

Answer 10

Clarithromycin and azithromycin

Surgical treatment in drug resistant

Clofazamine- new drug in clinical trials; FDA granted special investigational drug access (use outside of clinical trials)

Question 11

Expanded access uses

Answer 11

1- patient and physician both willing to participate

2- no comparable therapy available

3- probable risk less than disease

4- sufficient evidence of safety and effectiveness

5- no interference with completion of clinical investigation

6- protocol of use of the product

7- patient is unable to obtain the ID under another IND or to participate in a clinical trial

Question 12

Mucormycosis

Answer 12

Several different diseases caused by infection with fungi murcomycetes that affects people with weak immune system/ steam cell transplantation /diabetics

Question 13

Murcomycosis treatment

Answer 13

Amphotericin B and isavuconazole

Question 14

Aspergillosis

Answer 14

Caused by a common mold

Usually by inhalation

People with weakened immune system at greater risk

Several types

Question 15

Anti-fungal treatment for mucormycosis and aspergillosis

Answer 15

Isavuconazole

3A4 inhibitors or inducers can affect drug concentrations