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Drugs-Maintenance Flashcards

1
Q

Tacrolimus: FDA approved indications

A

IR: adult or ped kidney, liver & heart txp
XL: adult or ped kidney txp
XR: adult kidney txp

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2
Q

Tacrolimus: Dosage Forms

A 
IR: 
 - Capsules 0.5, 1, 5 mg
 - Granules for oral susp: 0.2 mg or 1 mg packets
 - 5 mg/mL injection
XL: 
 - Capsules 0.5, 1, 5 mg
XR:
- Tablets: 0.75, 1, 4, mg
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3
Q

Tacrolimus: starting dose per PI

A

IR: 0.075 - 0.2 mg/kg/day divided
XL: 0.15 - 0.2 mg/kg/day
XR: 0.14 mg/kg/day

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4
Q

Tacrolimus IR –> XR Conversion. PI? ASTCOFF? ASERTAA?

A

PI: 80% IR TDD –> XR dose
ASTCOFF: 70% IR TDD –> XR dose
ASERTAA: 80% IR TDD –> XR dose (note AA population; majority CYP3A5*1 expresser)

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5
Q

Tacrolimus: PI recommendations regarding food

A

IR: consistently with or without
XL: empty stomach
XR: empty stomach (1 hour before a meal or at least 2 hours after a meal)

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6
Q

CPIC Recommendations for FK Dosing in CYP3A5*1 Expressers

A

1.5 - 2x usual starting dose (max 0.3 mg/kg/day)

For both heterozygous or homozygous for *1 allele

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7
Q

Cyclosporine: FDA approved indications

A

Kidney, liver, and heart txp

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8
Q

Cyclosporine: Dosage Forms

A

Capsule: 25, 100 mg
Oral soln: 100 mg/mL
IV (Sandimmune): 50 mg/mL

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9
Q

Cyclosporine: starting dose per PI

A

7 - 9 mg/kg/day divided Q12

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10
Q

Mycophenolate: FDA approved indications

A

MMF: Kidney, heart, liver txp
MFT: adult and ped kidney txp in combo with CsA adn CS

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11
Q

Mycophenolate: Dosage Forms

A

MMF: 250 caps, 500 tabs, 200 mg/mL suspension, 500 mg single-dose vial for IV use
MFT: 180 mg, 360 mg tablets

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12
Q

Mycophenolate: recommended pediatric dosing per PI

A

MMF: 600 mg/m2 BID
MFT: 400 mg/m2 BID

BSA = sqrt(ht*wt/3600)

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13
Q

IV MMF: Administration

A

Duration: over at least 2 hours
Periph or central
Reconstitute with D5W
Start infusion within 4 hours of reconstitution

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14
Q

PI Recs for missed MMF dose:

A

Take ASAP unless next dose is <2 hours away

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15
Q

PI recs for how soon to give MMF post-txp

A

Within 24 hours of txp

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16
Q

PI recs for how soon to give FK post-txp

A

Liver/Heart: no sooner than 6 hours post-txp

Kidney: within 24 hours but should be delayed until renal fxn has recovered

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17
Q

PI Recs for missed FK dose:

A

IR: ???
XR: ASAP if within 15 hours of missed dose; if >15 hours, wait

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18
Q

MPA TDM: If you were to do it, what trough or AUC would be your goal?

A

AUC: 30-60
Trough:
- CsA >1.3
- FK >1.9 (>2-3 for thoracic; >1-3.5 for peds, bowel, panc, liver)

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19
Q

Which drugs need to be separated from MMF by at least 2 hours per PI?

A
  1. Antacids with Mg or AlOH

2. Ca-Free Phosphate binders

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20
Q

AZA: FDA approved indications

A

Kidney txp

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21
Q

AZA: Dosage Forms

A

Tabs: 50 mg (as imuran, scored tablets)
Tabs: 75 mg, 100 mg (as Azasan)
Injection: 100 mg vial

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22
Q

AZA: Dosing per PI

A

3-5 mg/kg/day initially then 1-3 mg/kg/day

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23
Q

CPIC: AZA Recommendations for Intermediate & Poor Metabolizers

A

TPMT; where lack of fxn = accumulation of TGN and myelotoxicity

Intermediate Metabolizer (1 no fxn allele): 30 - 80% normal starting dose

Poor Metabolizer: Avoid therapy or 10-fold reduction and dose 3x weekly

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24
Q

AZA: Dose reduction with XO inhibitors per PI

A

DDI = inc conc of toxic metabolites
Allopurinol: Reduce AZA to 1/3 to 1/4 the usual dose
Febuxostat: Not recommended

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25
Q

Sirolimus: FDA indication

A

13+ YO post-txp in setting of chronic CsA + CS for high-risk recipients OR CsA withdrawal after 2-4 months post-txp in low-risk

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26
Q

Everolimus: FDA indication

A

Adult kidney (with CsA/CS/IL2RA) or liver txp (with FK/CS; not to be used within 1st 30 days)

27
Q

Sirolimus: PI dosing

A

Loading dose: 6-15 mg (3x initial dose)

Maintenance: 2-5 mg/d

28
Q

Sirolimus: Formulations

A

Tabs: 0.5, 1, 2 mg tablets
Soln: 1 mg/mL solution to be mixed in 2oz H2O or juice

Technically not bioequivalent but are interchangable

29
Q

Everolimus: Formulations

A

Tabs: 0.25, 0.5, 0.75, 1 mg tabs

30
Q

CsA & SRL administration per PI

A

Sirolimus tablets be taken 4 hours after administration of cyclosporine

31
Q

Sirolimus: PI recommendations for dose adjustments

A

TDM: proportion to determine new dose

Consider “load” when needing to increase SRL concentrations: 3x (new dose - old dose)

IF dose >40 mg = admin over 2 days

32
Q

Sirolimus: Black Box Warnings

A

Not rec’d in liver or lung txp recipients

  1. Liver txp: mortality, graft, loss, HAT (mostly within first 30d)
  2. Lung txp: Bronchial anastomotic dehiscence (when used de novo)
33
Q

Everolimus: PI dosing

A

Kidney: 0.75 mg BID
Liver: 1 mg BID starting 30 days post-txp

34
Q

Everolimus: Black Box Warnings

A
  1. Kidney: graft thrombosis - usually within first 30 days

2. Heart: Increased mortality often associated with infxn within 1st 3 months post-txp

35
Q

CNI & EVR DDI per PI

A

Both tacrolimus/cyclosporine doses and the target range for whole blood trough concentrations should be reduced, when given in a regimen with everolimus, in order to minimize the potential risk of nephrotoxicity

CsA: 100 to 200 ng/mL through Month 1 post-transplant, 75 to 150 ng/mL at Months 2 and 3 post-transplant, 50 to 100 ng/mL at Month 4 post-transplant, and 25 to 50 ng/mL
FK: 3 to 5 ng/mL by three weeks after the first dose of everolimus (approximately Month 2) and through Month 12 post-transplant.

36
Q

Everolimus: PI TDM Goal

A

3 - 8 using LC/MS/MS

37
Q

Belatacept: MOA

A

CTLA4 analog = binds CD80/86 on APC –> blocks CD28 mediated costimulation of T-cells

38
Q

Belatacept: FDA indication

A

Kidney txp w/ basiliximab, MMF, pred

39
Q

Belatacept Black Box Warnings

A
  1. Only EBV+ recipients dt PTLD risk

2. Do not use in OLT bc increased risk of graft loss and death

40
Q

Belatacept: PI dosing for Initial & Maintenance

A

Initial: 10 mg/kg Day 1, Day 5, Week 2, Week 4, Week 8, Week 12
Maintenance: 5 mg/kg Q4 weeks +/- 3 days

Dose should be divisible by 12.5 mg

41
Q

Belatacept: Administration

A 
Admin: 30 minutes
Reconstitute with NS, D5W, SWFI to concentration of 25 mg/mL; further dilute in NS or D5W
Vial size: 250 mg 
Filter: 0.2-1.2 microm
BUD: 24 hours fridge; 4 hr RT
42
Q

Belatacept: When to adjust dose

A

Change in body weight > 10%

43
Q

Belatacept & Anti-Thymocyte Globulin DDI per PI

A

Coadministration (at the same or nearly the same time) of anti-thymocyte globulin (or any other cell-depleting induction treatment) and belatacept in de novo kidney transplant recipients, especially those with other predisposing risk factors for venous thrombosis of the renal allograft, may pose a risk for venous thrombosis of the renal allograft

44
Q

BENEFIT Trial showed?

  • Rejection
  • Graft & Patient Survival
  • DSA
  • Kidney Fxn
A
  • Rejection: CsA > Bela
  • Graft & Patient Survival (composite outcome): Bela > CsA @ 7 years
  • DSA: Bela > CsA
  • Kidney Fxn: Bela : CsA
45
Q

ELITE-SYMPHONY showed?

  • Rejection
  • Graft & Patient Survival
  • Kidney Fxn
  • ADEs
A
  • Rejection: FK > others
  • Graft Survival: FK > other (no diff patient survival)
  • Kidney Fxn: FK > others
  • ADEs: worse with SRL
46
Q

What comprises the Edmonton Protocol

A

Induction: IL2RA
Maintenance: FK (3-6), SRL (12-15 initially, then 7-10)
NO STEROIDS

47
Q

Efficacy data on steroid withdrawal in panc txp.

A

Associated with inc risk of rejection requiring reinitiating of steroids. No diff in patient or graft survival.

48
Q

Efficacy data on steroid withdrawal in kidney txp.

A

Associated with inc risk of rejection. No diff in patient or graft survival.

49
Q

Efficacy data on mTORi in panc txp.

A
  • Some variable outcomes; 2 studies showed SRL-FK > MPA-FK in terms of rejection and pancreas survival
  • Not seen in study with everolimus
  • No difference in patient outcomes
50
Q

Role of mTORi in heart trasnplant:

A
  1. Reduce CAV (replace CNI or in addition to CNI or replace antimetabolite)
  2. Renal protection (replace CNI or reduce CNI)
  3. Poss reduce mortality
  4. Cancer (CNI replacement)
  5. Intolerance (antimetab replacement)
51
Q

Kidney txp: MMF vs AZA - which is better?

A

MMF = Less rejection; also associated with composite of reduced BPAR, graft loss, patient death, or drug discontinuation

52
Q

Liver txp: FK vs CsA - which is better?

A

FK = less rejection; similar patient and graft survival

53
Q

Pancreas txp: FK vs CsA - which is better?

A

FK = less severe rejection, improved pancreas survival

54
Q

Pancreas txp: MMF vs AZA - which is better?

A

MMF = less rejection, possibly improved kidney and pancreas survival

55
Q

Heart txp: FK vs CsA - which is better?

A

FK = less rejection

56
Q

Heart txp: MMF vs AZA - which is better?

A

MMF = less rejection & CAV and increased survival

57
Q

Lung txp: FK vs CsA - which is better?

A

FK = reduced rejection and BOS

58
Q

Lung txp: MMF vs AZA - which is better?

A

Studies do not show clinically different outcomes… but benefit of mTORi is greater when replacing AZA than MMF

59
Q

Mycophenolate dose adjustment recommended for neutropenia

A

When ANC <1.3, hold or reduce mycophenolate dose

60
Q

MMF & Oral contraceptive DDI

A

Inhibits OC enterohepatic recirculation = decreased exposure = potentially reduced OC efficacy

61
Q

Mycophenolate REMS requirements for providers

A
  1. (MD) Prescribing Training Confirmation Form
  2. Patient education on risk of miscarriage & birth defects
  3. Preg test BEFORE starting MMF, 8-10 days later, then at routine follow-up tests
  4. Report pregnancies to Mycophenolate Pregnancy Registry
62
Q

Acceptable BC options for MMF REMS

A
  1. ALONE - IUD, sterilization
  2. Hormone + barrier
  3. Barrier + barrier
63
Q

How long to use contraception after DC of MMF

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