FDA expands Qulipta indication to include chronic migraine prevention

Do not take Qulipta unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Do not share Qulipta with other people, even if they have the same condition as you. It may harm them. Keep Qulipta out of the reach of children. Qulipta can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Qulipta affects you.

For preventing episodic migraine, two studies were done to see if Qulipta was effective, compared to a placebo containing no medicine. People in the studies did not know if they were getting Qulipta or the placebo. Both studies included people who had a history of migraine with or without aura for at least a year. People could take medicines to treat an acute headache (including acetaminophen, ibuprofen, or a triptan) as needed. They could not take other medicines that affected CGRP, and they could not take other medicines to prevent migraine (such as topiramate, propranolol, or amitriptyline). In these studies, people took a placebo or Qulipta at a dose of 10 milligrams, 30 milligrams, or 60 milligrams once daily for 3 months. Efficacy was measured by the change in the average number of monthly migraine days during that time frame. People in these studies had an average of about 8 migraine days per month before the study started. Most people in the studies were female (over 85%) and White (over 76%). The average age of people in the studies was 40 to 42 years. People in the studies who took Qulipta to prevent episodic migraine had fewer migraine days per month than people who took the placebo. The people who took Qulipta had 3.6 to 4.2 fewer migraine days per month over 3 months, depending on their daily dose of Qulipta. People who took the placebo had about 2.5 fewer migraine days per month. For preventing chronic migraine, a study was done to see if 60 milligrams of Qulipta once daily was effective, compared to a placebo containing no medicine. Again, people in the studies did not know if they were getting Qulipta or the placebo. Everyone in the study had a history of chronic migraine for at least a year. People in the study could take medicines to treat an acute headache (including acetaminophen, ibuprofen, or a triptan) as needed. About 11% of people in the study were allowed to use one other medicine to prevent migraine (such as topiramate, propranolol, or amitriptyline). They could not take other medicines that affected CGRP. People in this study had an average of about 19 migraine days per month before the study started. Most people in this study were female (87%) and White (60%). The average age of people in the study was 42 years. Efficacy was measured by the change in the average number of monthly migraine days during the 3 months the study lasted. The people who took 60 milligrams of Qulipta once daily to prevent chronic migraine had about 7 fewer migraine days per month, while people who took the placebo had about 5 fewer migraine days per month. Your results may differ from what was seen in clinical studies.

If you miss a dose of Qulipta, take it as soon as possible. However, if it’s nearly time for your next dose, skip the missed dose and take your next scheduled dose as usual. You should not take extra doses to make up for a missed dose.