Taking the Patient-Centered Approach to Mycophenolate Risk Mitigation

Introduction

Jennifer Simpson (Grand Canyon University): Hello and welcome to Taking the Patient-Centered Approach to Mycophenolate Risk Mitigation. The program is provided by the Boston University, Chobanian & Avedisian School of Medicine, Barry M. Manuel Center for Continuing Education in partnership with Clinical Care Options, and is supported by an educational grant from the Mycophenolate REMS Group.

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Steering Committee and Faculty

I’m Jennifer Simpson, nurse practitioner, and I’m excited to be joined today by Dr. Cara Dolin from Cleveland Clinic Lerner College of Medicine Case Western Reserve University School of Medicine in Cleveland, Ohio. And Dr. Diana Girnita from University of Cincinnati and Rheumatologists OnCall in Irvine, California.

These slides list the faculty steering committee and patients involved in this program.

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Disclosures

Here are the disclosures.

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Disclosure Information

Here are additional disclosures.

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Learning Objectives

Here are the learning objectives for today:

• Identify the pregnancy and fetal risks associated with mycophenolate use in female patients of reproductive potential;
• Educate and counsel female patients of reproductive potential on the need for pregnancy prevention and planning during mycophenolate treatment;
• Select safe mycophenolate alternatives for female patients who are pregnant or considering pregnancy; and
• Promptly report pregnancies that occur during mycophenolate treatment to the Mycophenolate Pregnancy Registry.

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Agenda

Through this discussion, we’ll follow the case of Lisa, who has a history of lupus, as she begins mycophenolate therapy, and then navigates family planning. So we’ll talk about getting started with mycophenolate treatment, navigating family planning with mycophenolate treatment, and then a collaborative approach to caring for mom and baby.

Getting Started With Mycophenolate Treatment

Jennifer Simpson: And now I’ll be joined by Dr. Diana Girnita.

Dr. Diana Girnita (University of Cincinnati): Thank you very much for the introduction. Today, I’m going to start about getting started with mycophenolate treatment.

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Mycophenolate as Immunosuppressants: Indications

There are 2 forms of mycophenolate that are used today as immunosuppressants, mycophenolate mofetil and mycophenolate acid. Mycophenolate mofetil is indicated for prophylaxis of organ rejection in adult and pediatric recipients of allogeneic kidney, heart, and liver transplant in combination with other immunosuppressants, and it is available as an oral capsule, tablet, suspension, or injection. Mycophenolic acid is indicated for prophylaxis of organ rejection in adult recipients of kidney transplants, but also in pediatric patients more than 5 years of age, who are more than 6 months post kidney transplant and can be used and should be used in combination with cyclosporine and corticosteroids (Question 1). And it is available as a delayedrelease tablet containing enteric-coated mycophenolate sodium.

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Mycophenolate: Immunosuppressant in Autoimmunity

Now, over the years, mycophenolate was also used in many autoimmune diseases from uveitis, lupus or lupus nephritis, graft versus heart disease, bullous pemphigoid, pemphigus vulgaris, systemic sclerosis, autoimmune hepatitis, dermatomyositis, focal segmental glomerulosclerosis, and interstitial lung disease. All of these diseases are using mycophenolate as an off-label type of medication.

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Adverse Pregnancy Outcomes Associated With Mycophenolate Use During Pregnancy

However, over the years, the FDA had to adjust for adverse pregnancy outcomes associated with the use of mycophenolate during pregnancy. If initially the warning was for pregnancy or during labor or delivery or nursing mothers, today we are talking about adverse pregnancy outcomes reaction in pregnancy, lactation, and now for females and males of reproductive potential.

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PLLR Pregnancy and Lactation Labeling

So there are some specific population where we have to be very careful, including pregnancy, lactation, and as I said, females and males of reproductive potential where not only that we have to adjust for the life of the people that are using the medication, but we also have to educate patients about pregnancy, testing, contraception, and the risk of infertility.

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Checking Pregnancy Status Prior to Initiating Mycophenolate and Monitoring Status During Tx

Now, we have to check for pregnancy status prior to initiating this type of treatment with mycophenolate, but we also have to monitor during the treatment. We have to tell patients about one pregnancy test with a high sensitivity that should be done immediately before starting the therapy with mycophenolate. But we also have to educate patients about another pregnancy test with the same sensitivity that should be done 8-10 days later. We have to repeat pregnancy test that should be performed with every routine follow-up visit, and the results of those pregnancy tests should be discussed with the patient.

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Pregnancy and Fetal Risks Associated With Mycophenolate Use During Pregnancy: Pregnancy Loss

The pregnancy and fetal risk associated with the use of mycophenolate used during pregnancy did change over the years. And regarding pregnancy loss, according to the National Transplantation Pregnancy Registry Report in 2006, there were 24 females that were transplant patients that reported 33 mycophenolate-exposed pregnancies. Out of those, 45% had spontaneous miscarriages and 22% had structural malformation. We also have data post marketing in 77 females exposed to systemic treatment during pregnancy where it was founded, 32% had spontaneous abortion and 22% had a malformed fetus or infant (Question 2).

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Pregnancy and Fetal Risks Associated With Mycophenolate

If you look at these graphs, you’re going to see that preconception and post concept, the number of patients that develop miscarriages is completely different. If you look at the first graph, you’re going to see that if the mycophenolate was discontinued before the pregnancy, the number of miscarriages is significantly lower compared to patients that had the medication discontinue after conception. And the same pattern we are going to observe for birth defects. If the treatment was discontinued before conception, the risk of birth defect is significantly lower compared to if the treatment was stopped after conception.

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Mycophenolate Exposure in Female Kidney Transplant Recipients: Miscarriages

If we look even deeper, we are going to find out that mycophenolate exposure in females that received the kidney transplant in a study that was retrospective was also prospective from the same database, it was found that about 30% of these patients that had a pregnancy suffered a miscarriage. However, patients who discontinued mycophenolate more than 6 weeks prior to pregnancy did not show a significant difference in the risk of miscarriages versus patients who discontinued before 6 weeks prior to the pregnancy. So if you look at these numbers, if the patient discontinued the treatment less than 6 weeks prior to conception, you’re going to see an odds ratio or an increased risk of almost 1.12, compared to patients that discontinue the treatment more than 6 weeks after preconception. If they discontinue the treatment during the first trimester, the risk increases. But if they discontinue the medication during the second trimester, this risk is significantly higher, almost 10.

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Mycophenolate Exposure in Female Kidney Transplant Recipients: Birth Defects

When we look for birth defects, the same study shows that 9% of those patients who were exposed to mycophenolate have experienced birth defects. And the same pattern applies here. When we look for patients that discontinue the therapy less than 6 weeks prior to preconception, the risk is significantly lower compared to patients that discontinue during the first trimester or discontinue the medication during the third trimester, where the risk was 6 times higher.

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Pregnancy Outcomes Related to Mycophenolate Exposure in Female Kidney Transplant Recipients

If the patient had multiple pregnancy, the risk increases with the number of pregnancies.

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Birth Defects Associated With Mycophenolate Use During Pregnancy

Now, what are the types of birth defects that are associated with the use of mycophenolate mofetil during pregnancy? As you can see, ear and orofacial and ocular type of birth defects are the most frequent ones. And then we also have birth defects at the visceral level, heart, distal limbs and central nervous system.

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Fetal Risks Associated With Mycophenolate Use During Pregnancy: Cleft Lip

This is a picture of an infant with a cleft lip.

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Fetal Risks Associated With Mycophenolate Use During Pregnancy: Cleft Palate

And these are different types of cleft palate birth defects that can happen in infants that were exposed to mycophenolate during pregnancy.

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Fetal Risks Associated With Mycophenolate Use During Pregnancy: External Ear Abnormality

And this is another common birth defect. This is an external ear abnormality in an infant that was exposed during pregnancy during his mom’s pregnancy to mycophenolate mofetil.

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Pregnancy Loss and Birth Defects Associated With Mycophenolate During Pregnancy

Dr. Girnita: So, as you can see, it is extremely important to educate females of reproductive potential, including girls who have entered puberty and all women who have a uterus and ovaries and have not passed through menopause. Because it’s important to know that educating women of reproductive potential will increase the risk of first trimester pregnancy loss and birth defects.

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Pregnancy Loss and Birth Defects Associated With Mycophenolate During Pregnancy: Patient Education

For pregnancy loss and birth defects associated with mycophenolate during pregnancy, it is important to offer patient education. It is important to refer them to medication prescribing information for different type of population and refer them to the most recent data on the risk of pregnancy loss and congenital malformation.

And it is also important to provide patient education about pregnancy prevention and planning during mycophenolate treatment to discuss acceptable methods of contraception and appropriate duration of contraception. But not only that, but advise patients to let providers know if they are considering pregnancy.

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Mycophenolate REMS: Patient Counseling Materials

Patients can use REMS material, and they can find out about the pregnancy risk and counsel them about the types of contraception and the pregnancy planning. It is important to provide to patients with treatment options if they are considering pregnancy and also discuss about immunosuppressive efficacies and safety profile of available therapies that will replace mycophenolate. Through this program, mycophenolate mofetil, we can offer patients with brochures, but we can also offer prescribers with a healthcare provider brochure.

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Faculty Discussion

Jennifer Simpson: So, let’s discuss what we just heard about from Dr. Girnita. So very important, we need to be discussing this at every visit with our patients. Wouldn’t you agree, Dr. Girnita, that we need to make this a priority, that our childbearing women who have the potential to get pregnant, we need to be touching with them on every level with us?

Dr. Girnita: Yes, that’s correct. We have to open the discussion and to continue the discussion with every visit that they have with us. And remind them that there are options if they consider to remain pregnant.

Jennifer Simpson: And tell me, what are your strategies of opening up this conversation with your patients? What do you say to them to help them feel comfortable that they can be discussing this with you?

Dr. Girnita: I will always ask them if they change their mind, if they consider at this point to remain pregnant, especially females that are childbearing age. This is extremely important to remind them about the side effects of the medication, but also that there are alternatives if they consider pregnancy.

Jennifer Simpson: Yeah, I think that’s great to point out that they do have other options, that there are alternatives that we can offer them if their lifestyle or what they’re trying to plan for in the future has changed. Right. And I think definitely making them feel comfortable that whatever they are foreseeing that to be is perfectly okay.  Dr. Dolin, do you have anything to add as far as if you’re seeing a patient in the office that you know is on mycophenolate, they’re using contraception, are you having conversations with them about the importance of that?

Dr. Cara Dolin (Cleveland Lerner College of Medicine): As a maternal–fetal medicine subspecialist, I’m often seeing these people after they’re pregnant, sometimes for preconception visits, which I think we’re going to talk about a little bit later. But I love what Dr. Girnita is saying—how she talks about this at her appointments as a rheumatologist. So, I think this discussion really needs to happen outside of the OB/GYN world, essentially. And I always teach my medical students who aren’t going into OB that if they take anything away from their rotation or the time they spend with us, it’s that in their patients of reproductive potential to always ask about pregnancy plans. And so at every visit, especially on a patient that’s on a medication that isn’t compatible with pregnancy like mycophenolate, you should be asking, “Do you plan to become pregnant in the next year?” And so that really opens the door. If they say no: “Okay, what contraception are you using? Is it appropriate? And if you’re not using contraception, can I prescribe you something or can I refer you to a gynecologist that can counsel you and prescribe you appropriately?”

And if the answer is yes, then it’s “Okay, let’s review where you are with your disease. How can we optimize your preconception health and how can we transition you to some medications that are compatible with pregnancy?” And specifically with someone that’s on mycophenolate, it’s having this conversation and making sure that they have a clear family planning plan in place. Because we do know that 50% of pregnancies are unintended, and so it seems simple that people should be preventing pregnancy and thinking about their family planning. But oftentimes people aren’t, even people with underlying medical conditions and on medications that aren’t compatible with pregnancy. So I think this is a really important discussion to have.

Jennifer Simpson: Well, and I think even taking that step just to ask them, “What are you planning? Where do you foresee yourself in the next year with that? And then what’s your plan according to how that fits?“ Right. I think even just putting that in the minds of our female patients will help them to be like, “Okay, I definitely need to be thinking about this, and I need to be aware of the risks, so that way I’m making the appropriate decision for myself and for my future children too.”

Dr. Dolin: Absolutely.

Navigating Family Planning With Mycophenolate Treatment

Jennifer Simpson: So now we’re going to talk about navigating family planning with mycophenolate treatment.

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Contraception Counseling and Acceptable Contraceptive Methods

Dr. Dolin: Hi. Okay. So now I’m going to go through some of the contraception options and how to counsel patients on mycophenolate about reliable and effective contraception while they’re taking this drug. So, as we just talked about, it’s very important for all healthcare providers that are taking care of patients on mycophenolate to counsel them about their family planning intentions and appropriate contraception. And to let them know to communicate when they’re ready to start a family or start to try to conceive, and so they can be transitioned to the right medication that’s going to going to be safe for pregnancy.

Any patient of reproductive potential who is sexually active with a man needs to be on a reliable and effective form of contraception for the entire treatment course while they’re on mycophenolate and for 6 weeks after stopping the drug. This part’s really important. So this chart here goes through 3 different levels of different contraception options that we’re going to go through in a little more detail in the following slides. This is just an overview.

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Emergency Contraception: Oral Options

Before we get into that, we do want to touch on emergency contraception. So as I said, many pregnancies are unintended and sometimes things happen where people didn’t have the appropriate contraception in place.

And so it’s important that patients know that emergency contraception exists and there’s multiple options. And so listed on the slide here are 2 options that are available just at the drugstore, so they don’t need to see a provider. So one is levonorgestrel. This is effective up until the LH surge. It’s approved for use up to 72 hours after unprotected intercourse, but can be used off-label for up to 120 hours after unprotected intercourse. It’s available over the counter without regard to age, so there’s no age restrictions. So there really should be very few barriers to a patient obtaining this medication in the instance that they need emergency contraception.

Ulipristal is another medication that does require a prescription, but is approved for use up to 120 hours after unprotected intercourse. Importantly, this one cannot also be used with other progesterone contraceptives.

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Emergency Contraception: Intrauterine Options

Another option for emergency contraception is the intrauterine device or an IUD. So this can be used for up to 5 days after unprotected intercourse, but may actually be effective at any time before a positive pregnancy test. One of the benefits of this is that it’s highly effective regardless of BMI. So the levonorgestrel has less efficacy with patients with obesity. And can be used anytime within the menstrual cycle. A downside of this is, obviously, patients need to go in and see a clinician to have the IUD placed. But another benefit is while working as emergency contraception, it can then be their long-term reliable, reversible form of contraception. So they had this, oops, they are treating it with their emergency contraception, and now they have a reliable form of birth control in place.

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Birth Control Options

So here are some of the other acceptable birth control options. So on this first tier, tier A, these are really our most effective options and really the ones that we should recommend for patients. It’s important that when we’re asking patients about their family planning intentions to ask if they’re finished their childbearing, maybe they already have a few kids, or maybe they don’t even want children. And then a form of permanent sterilization is always an option and is very, very reliable and effective. And so the 2 forms of that is the woman can get a tubal sterilization or her partner can get a vasectomy.

If the patient does desire future fertility, but just not at this time, then IUD is a great choice. And really this is our first-line, number one recommended option for patients on mycophenolate. It works very well, less than one pregnancy per 100 women per year. Patients don’t have to remember to take a pill every day, they don’t have to come back for an injection. It’s placed and it can stay for years. And then when it’s removed, the return to fertility is actually quite quick. And so, usually, once we remove it, if people are interested in becoming pregnant, and we’ve transitioned to them to their safe medications, they can often achieve fertility pretty quickly, which is great.

So on the second tier, tier B, we have the different hormonal options. And so these include progesterone-only or combined progesterone- and estrogen-type options. This includes the progesterone-only injection, birth control pill, which can either be a progesterone-only or a combined progesterone-estrogen pill, the progesterone patch, the vaginal ring, which is estrogen, and then the progesterone implant. Very important when it comes to these different hormonal methods is that when patients are on mycophenolate, it decreases the efficacy of these options. So patients need to use an option from tier B along with an option from C. And so these are different barrier methods.

And then a final option is to use 2 barrier methods together. This is really not recommended. It is the least effective, and we now all know all of the risks of being on mycophenolate and becoming pregnant. And so we really don’t recommend this. But if a patient absolutely won’t take a hormonal method or isn’t interested in IUD or permanent sterilization, then obviously, this is better than nothing, but they really need to use 2 to increase the efficacy.

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Special Considerations

This slide is really important. So when it comes to estrogen-containing contraception as well as the progesterone-only injection, people who have a history of a thrombotic event or have a high risk of thrombosis, really any estrogen-containing contraception is contraindicated because of that thrombosis risk. This also includes patients that have antiphospholipid antibodies, and we know that many of our patients with lupus also have these antibodies, which puts them at a higher risk of a venous thrombotic event. So they really shouldn’t be using these estrogen-containing contraception. Likewise, patients that have a higher risk of osteoporosis, maybe because of their other disease states or their age, should not be using the progesterone-only injections. And then also people who their disease is not very well controlled, who have very active disease also shouldn’t be using an estrogen-containing contraception. So this comes back to what I said on the last slide, really, an IUD is the most effective, it’s the safest, it’s the most reliable and really should be what we’re counseling our patients to use if they’re taking mycophenolate.

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Confirming Menopause

Obviously, if a patient has gone through menopause, then they are no longer at risk of pregnancy, but it’s really important that menopause is clinically confirmed by a healthcare professional. And so the definition of menopause is a permanent end of menstruation and fertility. And so this can be diagnosed either by 12 months of spontaneous amenorrhea, so a patient not having menses for 12 months, it can also occur from post surgical. So, if a patient has had a bilateral oophorectomy, so no longer has their ovaries, and usually isn’t confirmed solely on elevated FSH and LH, but this can be used to help make the diagnosis as well.

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Monitoring Pregnancy

As we said earlier, it’s very important to be monitoring for pregnancy when patients are on mycophenolate. Patients should have a pregnancy test with a high sensitivity done immediately prior to starting mycophenolate, and then that test should be repeated about 8-10 days later. And then they’re going to need regular repeat pregnancy tests at all routine follow-up visits or if at any time when they think they may become pregnant. And it’s very important that obviously, that we’re telling the patients the results of these pregnancy tests, but that also, if a patient takes a pregnancy test at home and finds out they’re pregnant, that they let us know right away.

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Patients Who Want to Get Pregnant

So patients who want to get pregnant, very important to counsel patients on mycophenolate to let us know that they would like to become pregnant before they start trying, hopefully. This is a great time to determine whether there are other appropriate treatment options that are less teratogenic or have less potential for embryo–fetal toxicity. It’s a time to refer patients for a preconception counseling visit with their obstetrician or a high-risk obstetrician like a maternal–fetal medicine or fertility specialist. And there needs to be continued multidisciplinary care with the patient’s obstetric team, their rheumatologist, and their primary healthcare providers.

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2020 ACR Guideline: Medications Use Before and During Pregnancy, and During Breastfeeding

So on this slide, we have the 2020 American College of Rheumatology guidelines for medications to use before and during pregnancy and during lactation. And I’m not going to go through all of this now. All of this will be available on the downloads that accompany this course, but you can see that there are multiple medications to choose from that are compatible with pregnancy that can be used as an alternative to mycophenolate (Question 4).

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Safe Alternatives

And so here are just some of those safe alternatives in a little bit more detail. Many, as you can see up here, hydroxychloroquine, sulfasalazine can be used preconception, during pregnancy and breastfeeding. And so if this is a medication that you can transition your patient to, these are great choices.

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Medications to Discontinue at Contraception and to AVOID

And then if a patient does become pregnant while taking any of these medications, these are the recommendations. And so for the majority of them, it’s to stop. And as we’ve already touched on with mycophenolate, we want to stop it at least 6 weeks prior to conception as well as not using it during pregnancy or during lactation.

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Positive Pregnancy Test: Counseling Our Patients

So it’s important to counsel our patients what to do if they do have a positive pregnancy test. So if there is a risk of maternal mortality after stopping mycophenolate, we can consider continuing it, especially if it’s after the first trimester because that’s when a lot of organogenesis happens. And so if they’re already past the first trimester, and we think the risk of them stopping this medication outweighs the risk to the fetus, especially if any effect has already happened, then we can consider continuing it. But that needs to be in a multidisciplinary fashion with their maternal–fetal medicine provider and the rheumatologist.

If possible, we try to find an acceptable alternative to transition them to, so they can stop the mycophenolate. And then we always discuss the potential risk to the baby. So there’s the risk of miscarriage, but also those different risks of birth effects. And so from our standpoint as obstetricians, we may do additional ultrasounds or earlier ultrasounds so that we can find out if there is a congenital malformation or some issue sooner than later and be able to make a plan for the pregnancy. And then finally, as I mentioned, referring to maternal–fetal medicine for that interdisciplinary care and counseling.

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Faculty Discussion

Dr. Dolin: And so now, I’d love to open it up to the group to talk about what to do in cases of unplanned pregnancy.

Jennifer Simpson: Have you had this happen before, Dr. Dolin, where you’ve had a patient who had an unplanned pregnancy come in and was still taking their mycophenolate?

Dr. Dolin: I have had this in the past, and with that patient, I was able to communicate with their rheumatologist and together, as a group, decided that the patient, there were acceptable alternatives. And so we had her stop right away as soon as we found out, and transitioned to her to a medication that was compatible with pregnancy. And then we did do additional ultrasound surveillance to check on the fetus and make sure it was developing normally. And luckily, she actually had a great outcome. And I think that’s a really important point because even though we put up those slides earlier that there is a high risk of miscarriage and a high risk of congenital anomalies, the majority don’t. Right? And so it is important to give those patients that reassurance once whatever has happened, has happened, moving forward, that we’re going to watch you in the baby closely, but that the most likely outcome is that everything’s going to be okay.

Jennifer Simpson: That’s good to reassure them. I’m sure that’s a nerve-wracking situation for a mom to be in, so I’m sure that’s great to have their OB to help them guide them through that situation. Have you had that happen, Dr. Girnita, where you had a patient on mycophenolate who had an unplanned pregnancy?

Dr. Girnita: Yes, I did. And I think like Dr. Dolin said, it’s very important for the patient to know that the risk exists, but not all the patients will have these outcomes. With the right planning and with the right team, the patients have the ability to overcome this very stressful period in their life. And I think that if we educate them that there are alternatives and switch the treatment, as soon as we find out about the unplanned pregnancy, the risk is smaller, closer to the time of disclosing the pregnancy. So it’s important to have that open channel of communication and the team to support the patient going forward.

Jennifer Simpson: Yeah, I definitely agree about open communication. I think, again, having that relationship with your patients where they can feel comfortable asking you questions and not feeling shame if something happens, especially if you’ve been having this conversation with them and saying, “Hey, I want you to make sure you let me know if your plans have changed, if you’re wanting to become pregnant in the next year.” And then it turns out that, oops, whatever did happen, they do become pregnant, it wasn’t planned, that they don’t feel, then shame that they can’t come to you and say, “This is what happened, and I believe I’m pregnant.” And that way you can mitigate what’s going on, get through the appropriate channels, get them over to the registry and make sure all of that is documented and then tracked going forward, and make sure they feel comfortable in that situation to have those conversations. It’s one of the most important things I think we could do as the providers.

Dr. Dolin: And enrolling in the registry is key. As we saw in the earlier slides, we have pretty small numbers, and so really, knowing about every pregnancy that is exposed to mycophenolate and being able to put all that information together really helps us with counseling patients in the future. So it’s super important, and in my experience, patients are really open to joining the registry. They really like to contribute to the science and the knowledge and be able to help other women that are in their similar situation in the future.

Jennifer Simpson: I agree with that. Dr. Girnita, would you say there’s any specific strategies that you do when you’re communicating with our OB/GYN colleagues in this situation?

Dr. Girnita: I think the most important thing is to have that channel of communication to pick up the phone and find the colleague that will immediately see the patient and counsel the patient going forward and telling the patient, like you said, there is no shame in that, things like this happen. As Dr. Dolin said, 50% of our patients will have an unplanned pregnancy and there is nothing to be ashamed about, things like that happen. And between us and patients, it should always be this way of communicating that you are there to help them and doesn’t matter what happens, we will find something to help them, or we will try to find the best things or the best methods that we can use to help them going forward. As a strategy to communicate, I think we have multiple channels of communications between us as medical providers, but finding one that is very comfortable to take these patients and counsel them forward, I think it’s also important for the patient.

Jennifer Simpson: Dr. Dolin, would you say there’s any specific strategies that you’ve employed in dealing with situations, like maybe if there was a situation where a patient had come to you with an unplanned pregnancy prior to them being able to have that conversation with their rheumatologist or maybe a different provider that had them on a medicine that had these risks?

Dr. Dolin: I echo what was just said. I think the most important thing is having that relationship with your colleagues and being able to take care of these patients in a multidisciplinary fashion. And so there’s oftentimes where I’ll have that patient in front of me and say, “Let’s call right now,” and I’ll call up a colleague and ask because as a maternal–fetal medicine physician, while I’m aware of some of the safe alternatives, it’s not really my area of expertise to transition them for their underlying disease process. And so I will call up their physician that is the expert in that area and say, “Okay, she’s pregnant. What’s our plan moving forward? What medication can we switch her to?” Because we want to do it right there as soon as possible. I don’t want to wait until she has an appointment in 2 weeks with that provider and then figure out a plan. And so I agree. It’s just being proactive and reaching out to our colleagues, and we’re all in this together to take really good care of patients and make sure that they have healthy pregnancies and also that they stay healthy with their underlying disease process.

Jennifer Simpson: And I think that’s definitely a good point, is hopefully that transition happens very smoothly because I’m sure what we’re all kind of worried about in this situation too is not just, of course, the harm to the fetus, but also this patient and are they going to flare? Are they going to have a worse outcome? Which, of course, is not going to be good for the pregnancy either, and which is why it’s always important for us to be having this conversation with a patient prior to the pregnancy is that way, hopefully they’re in a good preconception health to not flare, have a safe pregnancy for mom and for baby. So, I think that is definitely highlighting that for our patients and them understanding this is why this is important, is that we want you to be healthy. We want your future pregnancies to be as healthy as possible and for you to have the best outcomes.

Dr. Girnita: I think the best outcomes come from a group effort, like a multidisciplinary effort because as Dr. Dolin said, if you have a patient that is not only having lupus but has a high risk for thrombotic events because of antiphospholipid syndrome, or has other complications like lupus nephritis, you have to be very careful and take care of the patient, but also foresee what is going to happen with the pregnancy. So I think that all of us, we play a big role into the life of that patient, but without each of us, that patient cannot have a good outcome. Because we all have to come in, put our heads together to optimize the health of the patient to have a good outcome regarding the pregnancy.

A Collaborative Approach to Caring for Mom and Baby

Jennifer Simpson: And now we’ll talk about a collaborative approach to caring for mom and baby.

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Faculty Discussion

Jennifer Simpson: So strategies for coordinating care among the care team, as we’ve talked about between our rheumatologists and our OB/GYN, just, it’s developing relationships within the community, and making sure we have those open lines of communication to be able to contact a colleague when we need to be able to get our patient in. And I think a lot of this is kind of setting the expectations for our patients as well, that they know how important it is ahead of time.

Dr. Girnita, do you have any thoughts on how you would incorporate nurse practitioners or PAs into this care team strategy?

Dr. Girnita: I think that educating everyone around us about the risk of mycophenolate, it’s the most important thing. The patient is aware with every visit, if you remind them about the risk, they will be surely aware that there is a risk if there is an unplanned pregnancy, or there is a strategy that we need to apply for that case when they plan a pregnancy. But even in our team or colleagues of us, including nurse practitioners, PAs, and our nurses, or our medical assistant, if we educate them, they also interact with the patient, and sometimes they do spend a little bit more time with the patient than we have during our visits. So if they are able to reinforce these kind of strategies, it’s extremely important for the team that, in that way, the patient will see and will hear the same message from a team, not only from one person.

Jennifer Simpson: I think that’s great feedback. Dr. Dolin, would you say that you have any experience dealing with pharmacists in this particular instance?

Dr. Dolin: I’m trying to think. Pharmacists are definitely a key member of the healthcare team. I often reach out to a pharmacist to clarify dosage, drug-drug interaction and impact on a pregnancy and lactation.

Jennifer Simpson: Would you say you’ve ever had a pharmacist reach out to you about a pregnancy-related issue with Mycophenolate specifically?

Dr. Dolin: And I’ll just say that, that preconception referral is so important as a maternal–fetal medicine subspecialist, I love seeing these patients before they’re pregnant. It’s the opportunity, not just to make sure that they’re transitioning to drugs that are compatible with their pregnancy, but also optimizing their preconception health. And so we know, for example, patients with lupus, if they conceive when their disease is quiescent, they have much better pregnancy outcomes than when they conceive when their disease is flaring, and likewise with a lot of other autoimmune diseases. So it’s really important to see these patients before they even start trying to conceive, so we can work together as a team, coordinating their care, optimizing their preconception health, making sure that they’re on their prenatal vitamin and that contains folic acid. Those little things can be really important for a healthy pregnancy.

[00:54:18]

Mycophenolate Pregnancy Registry

So this is the information about the Mycophenolate Pregnancy Registry. So very important to report any pregnancy that occurs while a patient is on mycophenolate treatment, or within 6 weeks following discontinuation (Question 3). It’s important to inform the patient and that you may report this pregnancy. And like I said, in my experience, patients are really open to this and supportive of it. We encourage our patients to participate in the registry too, themselves, and we always make sure that they know that these reports are covered by HIPAA, so all this information is kept confidential.

[00:55:05]

Additional HCP and Patient Educational Resources

These are some additional resources for both healthcare professionals and patients. They can all be found at the Mycophenolate REMS website. For prescribers, they can complete the online training, obtain patient signatures on patient prescriber acknowledgement forms. There’s the voluntary report to mycophenolate pregnancy exposures, to the MPA Pregnancy Registry, as we just discussed. And so all this is available on the website.

There are additional healthcare provider and patient educational resources available. The American College of Rheumatology has a reproductive health in rheumatic and musculoskeletal disease guideline. The American College of Obstetrics and Gynecology has a clinical opinion article that goes through different immune-modulating therapies that can be used in pregnancy and lactation, which is a great resource when thinking about what medications are safe to transition your patients to, who are currently on mycophenolate. Clinicaloptions.com/immunology has more information for both healthcare providers and patients, as well as the Boston University websites.

[00:56:21]

Go Online for More CCO Coverage of a Patient-Centered Approach to Mycophenolate Risk Mitigation!

Jennifer Simpson: You can go online for more CCO coverage of a patient-centered approach to mycophenolate risk mitigation. There’s a downloadable PDF infographic communication guide about sharing family planning decision-making with patients who are prescribed mycophenolate. There’s also a downloadable PDF infographic handout for patient education that is available in 5 different languages, an animated patient counseling video available in English and Spanish, and an additional downloadable slide set, with slide notes with expert faculty commentary. You can go to clinicaloptions.com/immunology to access these.

I want to thank our panel today for their invaluable insights on a patient-centered approach to mycophenolate risk mitigation, and thank you to our audience for tuning in. We hope you found the information useful and applicable to your own practice. To earn CME CE credit for this activity, please click the Claim Credit button on the left of your screen. And thank you for participating.

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