1. Based in part on a similar antiproliferative mechanism of action, which of the following is the most common substitute for mycophenolate (MPA) products in transplant patients considering pregnancy?
A. Belatacept
B. Azathioprine
C. Sirolimus
D. Everolimus
E. Unsure
2. Which of the following is the major pregnancy-related risk associated with the use of MPA in pregnancy?
A. Preeclampsia
B. Gestational diabetes
C. Miscarriage
D. Ectopic pregnancy
E. Unsure
3. MPA exposure during pregnancy also has risks for the developing fetus. Which of the following is a major fetal risk of MPA exposure during pregnancy?
A. Ectopic pregnancy
B. Breech birth
C. Autism
D. Congenital malformation
E. Unsure
4. As part of the MPA REMS program, the FDA requires which of the following?
A. Black box warning
B. Restriction to Schedule III
C. Elements to assure safe use (ETASU)
D. Administration limited to doctor's offices and clinics
E. Unsure
5. When counseling a female transplant patient of reproductive age, which of the following MPA REMS materials should the prescriber give to the patient?
A. Patient Information Brochure: What You Need To Know About Mycophenolate
B. Healthcare Provider Brochure
C. Dear MPA Patient Letter
D. Medication guide for the MPA product prescribed
E. Unsure
6. Use this case to answer question #6
HC is a 21-year-old female with end stage renal disease secondary to familial Focal Segmental Glomerulosclerosis and Frasier Syndrome (nephrotic syndrome since 3-years-old) who is currently being treated with peritoneal dialysis. She is presenting to your hospital for her readiness evaluation one week before her living unrelated renal transplant from her friend. The immunosuppression plan is to begin enteric-coated mycophenolic acid the day before the transplant surgery, induce with rabbit antithymocyte globulin, begin a corticosteroid taper in the operating room, and to initiate tacrolimus monotherapy based on satisfactory renal function following the procedure.
As a clinician and prescriber of MPA preparations, you are aware that your institution wants you to follow the MPA REMS program. This program recommends that you should do which of the following prior to prescribing these agents?
A. Become familiar with the risk of myelosuppression associated with MPA and the risk it poses in terms of infectious complications
B. Become familiar with risks of birth defects associated with exposure to MPA during pregnancy
C. Document your training in transplantation and certify that you can prescribe immunosuppressants
D. Become familiar with the gastrointestinal adverse events associated with MPA post-transplant
E. Unsure
7. According to the MPA REMS program, what test must be completed prior to your patient beginning therapy with any MPA preparation?
A. Glucose tolerance test
B. Pregnancy test
C. Thiopurine methyltransferase (TPMT) test
D. Genetic test to examine the presence of the CYP3A5*1
E. Unsure
8. At the time of prescribing MPA prior to this patient's transplant, you meet with HC to educate her on MPA use. The REMS program recommends education on all of the following be covered with patients, with the exception of:
A. Educate this patient about the increased risks of MPA exposure during pregnancy
B. Provide this patient with a mycophenolate REMS Patient Information Brochure, entitled What You Need To Know About Mycophenolate
C. Ensuring the patient is aware that abstinence from sexual intercourse with men is the only REMS program recommendation to avoid pregnancy
D. Provide this patient with pregnancy planning education
E. Unsure
9. Use this case to answer question #9
AF is a 35-year-old female who received a deceased donor renal transplant at your institution 1 and a half years ago who presents today for follow-up in renal transplant clinic. The patient’s serum creatine is stable at 0.89 mg/dL. Her maintenance immunosuppression consists of extended-release tacrolimus 8 mg daily (recent trough level of 7.7 ng/mL; goal of 6-8 ng/mL) and enteric-coated mycophenolic acid 540 mg BID. The patient tells the prescriber that she and her husband have discussed starting a family and that the patient wants to get pregnant as soon as possible. AF is aware that she should not become pregnant while taking MPA. The prescriber asks for your input on advising the patient.
You suggest the following advice for the AF:
A. Stop taking MPA, begin therapy with azathioprine 150 mg QD and not to try to conceive until the patient has been off of MPA for at least 6 weeks
B. Not become pregnant at all due to the risk of MPA with early trimester miscarriage and embryofetal toxicity
C. Stop taking the extended-release tacrolimus, begin therapy with belatacept 5 mg/kg q2 weeks x 5 doses, followed by 5 mg/kg q28 days thereafter and not to try to conceive until the patient has been fully tapered off of the tacrolimus.
D. Stop taking MPA, begin therapy with azathioprine 150 mg QD and the patient can try to get pregnant as soon as possible.
E. Unsure
10. Use this case to answer question #10
FS is a 33-year-old female who received a deceased donor renal transplant secondary to systemic lupus erythematosus at your institution approximately 4 years ago. Her current immunosuppression consists of tacrolimus 6 mg BID (recent trough level of 6.1 ng/mL; goal of 4-6 ng/mL), MPA mofetil 750 mg BID and prednisone 5 mg QD. She presents to your transplant clinic for routine follow up and informs you that she has become pregnant and that her and her partner are thrilled. Her OB-GYN believes she is approximately 5 months pregnant.
The MPA REMS recommends that you do which of the following for FS?
A. Have a discussion with your patient regarding pregnancy termination
B. Encourage the patient to register for any clinical trials evaluating transplant and pregnancy outcomes
C. Convert the patient from MPA to azathioprine
D. Report the pregnancy to the Mycophenolate Pregnancy Registry
E. Unsure
Evaluation Questions
11. How confident are in your treatment choices for HC in the posttest?
A. Not at all confident
B. Somewhat confident
C. Confident
D. Highly confident
12. How confident are in your treatment choice for AF in the posttest?
A. Not at all confident
B. Somewhat confident
C. Confident
D. Highly confident
13. How confident are in your treatment choice for FS in the posttest?
A. Not at all confident
B. Somewhat confident
C. Confident
D. Highly confident