REMS/ MS

Question 1

What are the initial therapies for MS?

Answer 1

1. Interferons
2. Copaxone
3. Gilenya
4. Mayzent
5. Aubagio
6. Tecfidera

Question 2

What are SEs with interferons?

Answer 2

1. flu-like symptoms
2. Depression!
3. increased liver enzymes
4. decreased WBCs, RBCs, and platelets
   5.altered thyroid hormones

Question 3

How are interferons administered?

Answer 3

SQ
IM (AVONEX)

Question 4

What are the interferons and how often are they administered?

Answer 4

Avonex- weekly
Betaseron- qod
Extavia-qod
Rebif- 3x weely
Plegridy- q14d

Question 5

How is Copaxone administered?

Answer 5

SQ daily

Question 6

What are SEs with Copaxone?

Answer 6

1. one time reaction- flushing, palpitations, chest pain, SOB, anxiety
2. sunken in skin (ROTATE INJECTION SITES)
3. urinary urgency
4. some flu-like symptoms/depression
5. acne

Question 7

How is fingolimod (GILENYA) administered?

Answer 7

one capsule PO QD with or without food (monitor for 6 hours after 1st dose)
May need monitored again if non compliant

Question 8

What are SEs with GILENYA?

Answer 8

1. BRADYCARDIA
2. Flu-like symptoms
3. Diarrhea
4. back pain
5. LFT elevation
6. cough
7. infections
8. macular edema
9. decreased PFTs
10. may cause fetal harm but Cat.C

Question 9

How is MAYZENT siponimod dosed?

Answer 9

1. PO dosed based on CYP2C9 genotype and titrated due to cardiac ADE
2. monitor for 6 hours after the

Question 10

What 3 drugs have the same SEs as fingolimod GILEYNA?

Answer 10

siponimod MAYZENT
ponesimod PONVORY
ozanimod ZEPOSIA

Question 11

What is the benefit of ponesimod PONVORY?

Answer 11

shorter half life; leave the blood in 1 week if treatment need to be stopped

Question 12

What are SEs with teriflunomide AUBAGIO?

Answer 12

1. pregnancy category x- do not use in anyone of child bearing potential even men
2. hepatotoxicity
3. bone marrow toxicities
4. peripheral neuropathy
5. AKI
6. hyperkalemia
7. serious skin reactions
8. respiratory and blood pressure effects

Question 13

How is dimethyl fumarate TECFIDERA dosed?

Answer 13

Swallow whole, take with or without food
Starting dose Po BID for 7 days, then maintenance dose BID

Question 14

What are SEs with dimethyl fumarate TECFIDERA ?

Answer 14

1. flushing
2. abdominal pain
3. nausea
4. diarrhea
5. lymphopenia

Question 15

What drugs have the same dosing and SEs as dimethyl fumarate TECFIDERA?

Answer 15

direximel fumarate (VUMERITY)
monomethyl fumarate (BAFIERTAM)

Question 16

What is a REMS program?

Answer 16

1. mandated by FDA
2. strategy to manage a known or potential serious risk associated with a drug or biological product
3. pharmacist, prescriber, and patient aware of risk vs benefit before a medication is taken

Question 17

What are medications we use after failing all of the initial medications?

Answer 17

Natalizumab TYSARBI
Alemtuzumab LEMTRADA
Mitoxantrone NOVANTRONE
Claddribine MAVENCLAD
Ocrelizumab OCREVUS
Ofatumumab KESIMPTA

Question 18

What are SEs with TYSARBI?

Answer 18

1. infusion reactions
2. PML- test for JCV virus at baseline and Q6mo
3. REMS program

Question 19

What are SEs with LEMTRADA?

Answer 19

1. autoimmune modulation- thyroid gland dysfunction and transfer of anti-thyroid antibodies to baby forver after one dose
2. malignancies

Question 20

What are SEs of Mitoxantrone?

Answer 20

1. cardiotoxicity-maximum lifetime dose
2. blue discoloration of the sclera of eyes, urine, and all other secretions
3. Pregnancy category D

Question 21

What are BBWs with Mitoxantrone?

Answer 21

1. extravasation
2. HF
3. neutropenia
4. malignancy

Question 22

What is the only drug indicated for RRMS and SPMS?

Answer 22

Cladribine MAVENCLAD- antineoplastic

Question 23

What is the only drug indicated for RRMS and PPMS?

Answer 23

Ocreveus

Question 24

What is the dosing for Kesimpta?

Answer 24

self-injected after first dose