CE / CME
Pharmacists: 1.00 contact hour (0.1 CEUs)
Physician Assistants/Physician Associates: 1.00 AAPA Category 1 CME credit
Physicians: maximum of 1.00 AMA PRA Category 1 Credit™
Nurses: 1.00 Nursing contact hour of which 1.00 are eligible for pharmacology credit
Released: February 25, 2025
Expiration: May 29, 2025
Patient Case: Lisa (continued)
Watch this brief video of the discussion between Lisa and her rheumatologist to learn more about the next steps that Lisa should take.
Contraception Counseling and Acceptable Contraceptive Methods
Next, let’s consider contraception options and how to counsel patients using mycophenolate about reliable and effective contraception during treatment. HCPs have a critical responsibility to engage in comprehensive family planning discussions with patients being treated with mycophenolate. These conversations should address both current contraceptive needs and future family planning intentions.
It is essential to emphasize that patients should communicate their intentions to conceive well in advance, allowing for appropriate medication transitions to pregnancy-safe alternatives. For female patients of reproductive potential who are sexually active with male partners, reliable and effective contraception is mandatory throughout the entire course of mycophenolate therapy and for 6 weeks after discontinuation.
Contraception options can be organized into 3 tiers of effectiveness, which are discussed below. This tiered approach helps guide appropriate contraception choices based on individual patient needs and preferences.7
Emergency Contraception: Oral Options
Emergency contraception should also be addressed. Because unintended pregnancies occur, patients should be aware of available emergency contraception options. Levonorgestrel, available over the counter without age restriction, is approved for use up to 72 hours after unprotected intercourse, but there are data that show it can be effective up to 120 hours after. Ulipristal requires a prescription and is approved for use up to 120 hours after unprotected intercourse, but it should not be used concurrently with other progesterone contraceptives.12-14
Emergency Contraception: Intrauterine Options
Another option for emergency contraception is the intrauterine device (IUD), which can be used up to 5 days after unprotected intercourse and potentially until there is a positive pregnancy test result. IUDs offer high efficacy regardless of body mass index, unlike levonorgestrel, which is less effective in patients with obesity. IUDs can be used anytime during the menstrual cycle. Although placement requires a clinical visit, the IUD can serve as long-term, reliable, reversible contraception after providing emergency contraception.15-19
Birth Control Options
Here are some effective birth control options. In tier A, we have the most reliable methods that should be recommended. When discussing family planning, it is essential to ask patients about their intentions, such as whether they are finished having children or prefer not to have any. Permanent sterilization, through tubal sterilization, is very reliable and effective.
For patients who desire future fertility but not immediate fertility, an IUD is a great choice. It is the top recommendation for patients receiving mycophenolate, providing protection that results in less than 1 pregnancy per 100 women per year. The IUD is convenient, because it does not require daily attention or regular injections. It can stay in place for years, and fertility typically returns quickly after removal, allowing patients to transition to safer medications and attempt pregnancy soon thereafter.7
Birth Control Options (continued)
In tier B, we have different hormonal options, including progesterone alone and combined progesterone–estrogen methods such as injections, birth control pills, patches, vaginal rings, and implants. However, mycophenolate can reduce the efficacy of these methods, so patients should use one of these options along with a barrier method from tier C for additional protection.
Using 2 barrier methods together is not recommended because of low efficacy but may be considered if a patient is unwilling to use a hormonal method or an IUD. However, it is important to emphasize that although this approach provides some protection, it is less effective and should only be used as a last resort.7,20
Special Considerations
This slide highlights key considerations about contraception in specific patient populations. Estrogen-containing contraceptives and the progesterone-only injection are contraindicated in patients with a history of thrombotic events or high risk of thrombosis. This contraindication extends to patients with antiphospholipid antibodies, including many patients with lupus. Antiphospholipid antibodies increase the risk of venous thrombotic events, so estrogen-containing contraception should be avoided in patients with these antibodies. The progesterone-only injection is also not recommended for patients who are at increased risk of osteoporosis, whether because of age or underlying disease states. In addition, patients with poorly controlled or highly active disease should also avoid estrogen-containing contraceptives. Because of this, IUDs are the most effective, the safest, and the most reliable contraception option and should be strongly considered for patients treated with mycophenolate.21
Confirming Menopause
Although patients who have undergone menopause no longer require contraception because of the absence of pregnancy risk, it is essential that menopause status be clinically confirmed by an HCP. Menopause is defined as the permanent end of menstruation and fertility. Menopause can be confirmed through documentation of 12 months of spontaneous amenorrhea or after bilateral oophorectomy. Although elevated follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels can aid in diagnosis, these values alone are not enough for definitive confirmation of menopausal status.7
Monitoring Pregnancy Status
Monitoring pregnancy status is crucial for patients receiving mycophenolate. A high-sensitivity pregnancy test should be performed immediately before initiating mycophenolate treatment and should be repeated 8-10 days later. Subsequently, regular pregnancy testing should be conducted at all routine follow-up visits and any time a patient suspects that she may be pregnant. Pregnancy test results should be promptly communicated to the patient, and the patient should also be counseled to immediately report any positive home pregnancy test results to her HCP.7
Patients Who Want to Become Pregnant
Patients being treated with mycophenolate who would like to become pregnant should be educated about the importance of informing their HCP before they start trying to conceive. This would be the time to determine whether alternative treatment options should be used that are less teratogenic or have less potential for embryofetal toxicity. Referral for preconception counseling with an obstetrician, ideally a high-risk specialist such as a maternal–fetal medicine specialist or fertility specialist, is recommended. Continued multidisciplinary care involving the patient's obstetric team, rheumatologist, and primary HCP is important.
2020 ACR Guideline: Medication Use Before and During Pregnancy, and During Breastfeeding
This slide presents the 2020 American College of Rheumatology (ACR) guideline for medication use before, during, and after pregnancy, including lactation. The complete guideline is available in the accompanying downloads of these course materials. It is important to note that several medications are compatible with pregnancy and can be used as alternatives to mycophenolate.21
Safe Alternatives
This slide details some safer alternatives to mycophenolate. Hydroxychloroquine and sulfasalazine can be used prior to conception, during pregnancy, and while breastfeeding. If your patient can transition to using these medications, they are good choices.21
Medications to Discontinue at Conception and to AVOID
The ACR guidelines also include recommendations for patients who become pregnant while receiving the listed medications. For most, discontinuation is recommended. As previously discussed, mycophenolate use should be stopped at least 6 weeks before conception and mycophenolate should not be used during pregnancy or lactation.21
Positive Pregnancy Test: Counseling Our Patients
Treating a patient who becomes pregnant while being treated with mycophenolate requires careful consideration. Referral to a maternal–fetal medicine specialist for multidisciplinary care and counseling remains crucial. If discontinuing mycophenolate poses a risk of maternal mortality, continuation may be considered, particularly after the first trimester when organogenesis is mostly complete. This decision, weighing the risks of medication cessation against potential fetal risks, should be made using a multidisciplinary approach, with the patient’s maternal–fetal medicine specialist and rheumatologist. When and if possible, transitioning to an acceptable alternative medication is preferred. A discussion of potential risks to the fetus, including miscarriage and birth defects, is important. The obstetrician may order additional or earlier ultrasounds to detect potential congenital malformations sooner rather than later. 7
Faculty Discussion
Cara D. Dolin, MD, MPH:
I have encountered a case of unplanned pregnancy with a patient being treated with mycophenolate. In this case, I immediately communicated with the patient’s rheumatologist, and together we determined suitable alternative medications. The patient discontinued mycophenolate right away, as soon as she found out that she was pregnant and transitioned to a medication that was compatible with pregnancy. We also monitored her with additional ultrasound surveillance to follow fetal development. Fortunately, the patient had a positive outcome. Although the risk of miscarriage and congenital anomalies is high, it is important to give patients reassurance that, with close monitoring, the most likely outcome is a healthy pregnancy.
Jennifer Simpson, DNP:
Providing reassurance is very important in these nerve-wracking situations for a mom-to-be, so I am sure the patient was thankful to have had her obstetrician help guide her through the situation. Dr Girnita, have you managed similar cases?
Diana Girnita, MD, PhD:
Yes, I have. I agree with what Dr Dolin said. It is very important for the patient to know that the risk of miscarriage and birth defects exists, but that not all the patients will have poor outcomes. With appropriate planning and a multidisciplinary team approach, patients can navigate this challenging period in their life successfully. Educating patients, quickly changing medication to alternatives upon unplanned pregnancy discovery, and open communication significantly reduce their risk.
Jennifer Simpson, DNP:
I completely agree about open communication. I believe fostering a comfortable environment for patients and building a trusting relationship, where patients feel comfortable asking questions and not shamed if they unexpectedly become pregnant, is very important. That way, if they do become pregnant, patients feel comfortable sharing this information and the need for changes in their plans. When patients feel safe to disclose their situation, we can act quickly, document the pregnancy in the REMS registry, and ensure proper follow-up.
Cara D. Dolin, MD, MPH:
Enrolling in the registry is key. As shown earlier, there are limited data to analyze so it is important to document every mycophenolate-exposed pregnancy case, to help improve future counseling. In my experience, patients are open to joining the registry, knowing that they are contributing to science to help other women who are in similar situations.
Jennifer Simpson, DNP:
Dr Girnita, are there any specific strategies that you use when collaborating with OB/GYN colleagues in these situations?
Diana Girnita, MD, PhD:
The most important thing is to establish clear communication channels so that patients can see an OB/GYN promptly and receive counseling. As emphasized by Dr Dolin, it is important to remind patients that there is no shame in these situations—unplanned pregnancies happen. Maintaining open communication reassures patients that we are here to help them navigate their options and provide the best care.
Jennifer Simpson, DNP:
Dr Dolin, what specific strategies do you use when a patient presents to you with an unplanned pregnancy before consulting their rheumatologist or primary HCP?
Cara D. Dolin, MD, MPH:
The most important thing is having that strong collaborative relationship with your colleagues and being able to take care of these patients in a multidisciplinary fashion. Often, I am with a patient and say, “Let’s call someone right now,” and I will call a colleague and ask questions. As a maternal–fetal medicine physician, I am familiar with some safe alternatives to mycophenolate, but it is not really my area of expertise to transition patients from mycophenolate to another medication for their underlying condition without the expertise of a rheumatologist or other specialist. Acting as soon as possible is very important; I do not want to wait until the patient has a follow-up appointment in 2 weeks with that specialist and then figure out a plan. It is about being proactive and reaching out to our colleagues to ensure the patient has a healthy pregnancy.
Jennifer Simpson, DNP:
That is a good point. The focus is not just on fetal health, but also on preventing maternal complications that could negatively affect the pregnancy. By addressing these concerns early on in pregnancy, we can optimize outcomes for both the mother and the baby.
Diana Girnita, MD, PhD:
Exactly. Achieving the best outcomes requires a multidisciplinary approach. For patients with complex conditions like lupus, antiphospholipid syndrome, or lupus nephritis, we must carefully manage both maternal health and potential pregnancy complications. Collaborative care ensures that we optimize the patient’s health and increases the likelihood of a successful pregnancy outcome.
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