An interaction between alcohol and Ultomiris has not been established. However, alcohol can interfere with some treatments, so it is recommended that patients talk with their healthcare team regarding the effects of drinking alcoholic beverages while on Ultomiris.
There are no clinical data on the use of Ultomiris in pregnant patients. However, a similar compound, an anti-C5 antibody, caused harm to the developing fetus in animal models. Pregnancy in women with untreated paroxysmal nocturnal hemoglobinuria is related to an increased risk of complications for both mother and fetus. Patients who are pregnant or are planning to become pregnant should discuss this issue with their healthcare providers.
Neither hair loss nor weight gain has been reported in clinical trials as side effects of Ultomiris in patients with paroxysmal nocturnal hemoglobinuria. Patients are advised to speak with their healthcare provider if they experience any unusual symptoms while on the medication.
Some paroxysmal nocturnal hemoglobinuria (PNH) patients may see results as early as two weeks after starting treatment with Ultomiris. The ALXN1210-PNH-301 trial showed that, in adults who had never received a complement inhibitor, Ultomiris could rapidly lower mean lactate dehydrogenase (LDH) levels within two weeks. LDH is a biomarker of hemolysis, or red blood cell destruction. Normalization of LDH levels could be achieved after four weeks. However, each patient is unique and may respond differently to treatment. Therefore, a discussion with their healthcare team can help PNH patients better understand how Ultomiris may help in their particular case.
The U.S. Food and Drug Administration (FDA) approved Ultomiris for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in 2018. In 2021, its approval was expanded to children, ages 1 month and older. In addition to PNH, Ultomiris is approved in the U.S. for the treatment of atypical hemolytic uremic syndrome and generalized myasthenia gravis.