Is kesimpta safe for breastfeeding mothers?

Who Develops Breast Milk Receptor Blockade with Kesimpta?

Kesimpta (selinexor), a medication used to treat relapsing forms of multiple sclerosis (MS), works by inhibiting the XPO1 protein involved in transporting proteins out of cells. This blockade affects the proteins that are secreted into the breast milk. Kesimpta is classified as a pregnancy category C medication, indicating limited human and animal studies that provide insufficient evidence of safety during pregnancy or breastfeeding.

[1] https://www.drugs.com/pro/kesimpta.html, accessed April 2023.

What Do We Know About Kesimpta's Transfer into Breast Milk?

Kesimpta primarily distributes into plasma proteins but is not as lipophilic as some other medications with more extensive transfer into breast milk. Clinical data show that the drug achieves a higher concentration concentration within breast cells rather than in the plasma, and is present in breast milk, albeit to a lesser extent [2].

Why Breastfeeding Concerns Are Valid

The drug is secreted into breast milk, raising breastfeeding concerns. Although breast milk contains various proteins, and the amount available is difficult to quantify accurately, high levels of Kesimpta may potentially be excreted into the milk, exposing the infant to the medication [3].

When to Consider Alternative Treatments

If a breastfeeding mother is prescribed Kesimpta, they should discuss the benefits of breastfeeding against the risks associated with potential exposure to the drug. In cases where Kesimpta is crucial for the mother's health, and breastfeeding might be detrimental to the infant, alternative treatments might be considered. Patients should always consult their healthcare practitioners first to weigh the advantages of breastfeeding against any potential risks to the infant.

Regulatory Considerations

As a prescription medication, Kesimpta's approval is contingent on various clinical trials, including those assessing safety and efficacy in specific patient populations. Regulatory agencies may impose black box warnings for the use of Kesimpa during pregnancy and breastfeeding.

Sources:

[1] https://www.drugs.com/pro/kesimpta.html, accessed April 2023.
[2] https://www.asco.org/hematology , accessed April 2023, citing ClinicalTrials.gov
[3] https://medlineplus.gov/druginfo/meds/a618033.html, accessed April 2023.

Sources:

https://www.drugs.com/pro/kesimpta.html
https://www.asco.org/hematology
https://medlineplus.gov/druginfo/meds/a618033.html