Migraine headaches affect one billion people worldwide. Migraines are more common in people who could become pregnant, and during pregnancy their frequency can increase, decrease, or stay the same. Last year we talked to Caroline about treating her migraine headache at five months of pregnancy. Now she has reached out to us to discuss treatment options before she tries to get pregnant again. Back when she was pregnant with her first child, she was using acetaminophen and sumatriptan, but found that her migraines were much less responsive to these products over time. Today, Caroline is considering the newer drugs that have come onto the market since her last pregnancy. She has never used a preventive medication and was curious about the data on the new products. Caroline’s healthcare provider has mentioned trying Emgality® (galcanezumab-gnlm) or Nurtec ODT® (rimegepant).
Since there are many new drugs marketed to treat and prevent migraines, let us start with an overview. These newer medications are called calcitonin gene-related peptide (CGRP) antagonists, CGRP receptor blockers and CGRP blockers, and are a new category of migraine treatments. Some treat migraine attacks, while some prevent migraines, and some do both (like those Caroline is interested in).
There are so many choices, so let’s look at what the data says when these medications are studied during pregnancy.
Medications that prevent chronic migraines:
- Qulipta® (atogepant) – oral; CGRP receptor antagonist
- Ajovy® (fremanezumab-vfrm)-injection; CGRP blocker
- Vyepti® (eptinezumab-jjmr)- injection; CGRP receptor blocker
- Aimovig® (erenumab-aooe)- injection; CGRP receptor blocker
- Emgality® (galcanezumab-gnlm)- injection; CGRP blocker
- Nurtec ODT® (rimegepant)- tabs; CGRP receptor antagonist
Medications that treat the symptoms of acute migraines:
- Emgality®(galcanezumab-gnlm) – injection; CGRP blocker
- Nurtec ODT® (rimegepant)- tabs; CGRP receptor antagonist
- Ubrelvy® (ubrogepant)- oral; CGRP receptor antagonist
Medications that prevent and treat migraines:
- Emgality®(galcanezumab-gnlm) – injection; CGRP blocker
- Nurtec ODT® (rimegepant)- tabs; CGRP receptor antagonist
Unfortunately, there is very little information involving human data on Quilipta®, Nurtec ODT® or Ubrelvy® so we are left without the information we need for a full risk assessment of these medications. However, there are some data in humans on the medications on Ajovy®, Vyepti®, Aimovig® and Emgality®. These data are limited, meaning we don’t have a lot of information.
Let’s begin by breaking down the information that we have on Ajovy®, Vyepti®, Aimovig® and Emgality®. These four medications are all monoclonal antibodies, which in scientific terms means they are extremely large molecules. That means that they are unlikely to cross the placenta until around mid-pregnancy after the baby’s structures and organs have developed. Therefore, these medications should not have a direct impact on the baby’s development. It cannot be said that there is no increased chance of the baby being affected, but these medications may not be high risk exposures. These medications stay in the person’s system for a very long time. So if Caroline would like to have any of these out of her system before she gets pregnant, it may take approximately 5 months to clear.
What are the specific reports that we have on Ajovy®, Vyepti®, Aimovig® and Emgality® that help us assess the risk of use in pregnancy?
There are 13 cases of exposure prior to pregnancy and 10 exposures during pregnancy in one report on Ajovy® (fremanezumab-vfrm). In these cases, there was no increase in pregnancy loss, and one child was born with kidney and GI issues that cannot be proven to be caused by the medication treatment at this time.
There are two cases of Vyepti® (eptinezumab-jjmr) use during pregnancy. Outcome was reported on only one pregnancy which resulted in a miscarriage. However, based on what we know about monoclonal antibodies and the size of this molecule potentially being too large to pass through the placenta, it also would not be expected to have an increased risk of problems when used in the first trimester. More data and studies are needed to support this statement, though.
There are 116 cases of Aimovig® (erenumab-aooe) in one report. These studies include one prior to pregnancy, 108 during pregnancy, five during lactation and two at an unknown time. There was no increase in pregnancy loss or pattern of birth defects seen in the cases with known outcome. There were six cases of early birth in this group. One infant had growth issues but that mother was on multiple medications. There are at least five other cases in the medical literature that resulted in infants born without adverse pregnancy outcome or birth defects.
Finally Emgality® (galcanezumab-gnlm) was suggested to Caroline. There are 125 cases with data to consider. Six cases were with use of the medication prior to pregnancy, 107 cases were with use during pregnancy, 5 were with use during lactation and 1 case was use of the medication by dad. Six cases had unknown timing of use. No increase chance for pregnancy loss or pattern of birth defects was reported in this group of cases.
Back to our call with Caroline, and how we advised her on the medications that she was interested in – remember these: Nurtec ODT® and Emgality®. Both of the choices offered to Caroline can treat and prevent migraines, so one doesn’t have an advantage over the other in that area. We discussed with Caroline that at this time there are no human studies on Nurtec ODT®. However, the animal data looks promising and low risk at this time. Additionally, it is a drug that quickly clears from the body. So she would not have to be off of it for months to have it clear from her body prior to pregnancy. In that time, there may be new human data reported that we could share with her closer to when she would try to conceive. Otherwise, the current human data on Emgality® looks promising. Caroline stated she plans to discuss these reproductive data with her prescribing healthcare provider and come up with a plan of action. Caroline may decide to try either of these medications now see how they work for her before trying to get pregnant knowing there may be waiting periods to have the medications clear from her body.
At the end of the day, dealing with a migraine might be a pain, but examining up-to-date data doesn’t have to be a headache. That’s why MotherToBaby is here to help!
