TM Owner AbbVie
Ubrelvy 100mg Tablet
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Indications & Clinical Uses
- Ubrelvy 100 mg tablets contain ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, sometimes called a 'gepant'.
- It is FDA-approved for the acute treatment of migraine with or without aura in adults - taken once a migraine attack has started, not as a daily preventive medicine.
- Ubrelvy is not approved for migraine prevention and is a different drug class from older triptans such as sumatriptan, and from the CGRP monoclonal antibodies used for prevention.
- It is available in 50 mg and 100 mg tablet strengths; the sheet strength of 100 mg is one of the two FDA-approved doses.
- Ubrelvy is self-administered orally at home, on prescription, and can be taken with or without food.
Side Effects
- The most commonly reported side effects in clinical trials were nausea, sleepiness (somnolence) and dry mouth, each occurring in a small percentage of patients and generally mild.
- Ubrelvy carries no boxed warning on its current US label.
- Hypersensitivity reactions, including swelling of the face, lips, tongue or throat and difficulty breathing, have been reported and can occur days after a dose; seek urgent medical care if these occur.
- New or worsening high blood pressure and new or worsening Raynaud's phenomenon - cold, pale or blue fingers or toes - have also been reported and should be discussed with your prescriber.
- Contact your healthcare provider if migraine attacks become more frequent or severe despite treatment, as this needs medical review rather than repeated self-treatment.
Precautions & Warnings
- Ubrelvy is contraindicated with strong CYP3A4 inhibitors, which can raise ubrogepant levels to unsafe amounts.
- Use caution in patients with severe hepatic or severe renal impairment, or end-stage renal disease, where a lower 50 mg dose is recommended and no second dose within 24 hours should be taken.
- There is limited data on use in pregnancy; a pregnancy exposure registry is available, and animal studies suggest possible risk to the fetus, so use during pregnancy should be discussed with a healthcare provider.
- It is not known whether ubrogepant passes into human breast milk.
- Because sleepiness can occur, take care with driving or operating machinery until you know how Ubrelvy affects you.
- Do not exceed two doses (200 mg total) in a 24-hour period.
Avoid Interactions
- Tell your healthcare provider and pharmacist about all medicines and supplements you take.
- Ubrelvy must not be combined with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin or certain HIV protease inhibitors, since these markedly increase ubrogepant exposure and side-effect risk; this combination is contraindicated, not merely cautioned against.
- Moderate CYP3A4 inhibitors require a reduced 50 mg dose with no repeat dose within 24 hours.
- Strong CYP3A4 inducers such as rifampin can make Ubrelvy less effective and should generally be avoided; weak inducers require dose adjustment guidance from your prescriber.
- Inhibitors of the BCRP or P-glycoprotein transporters can also raise ubrogepant levels.
- There is no specific requirement to avoid grapefruit reported on the current label, but any CYP3A4 inhibitor should be discussed with your provider first.
References
Frequently Asked Questions
Ubrelvy (ubrogepant) treats a migraine attack once it has started, in adults, with or without aura. It is not a daily preventive medicine and belongs to a newer drug class called gepants, which block the CGRP receptor involved in migraine pain.
Take one Ubrelvy 50 mg or 100 mg tablet by mouth as soon as a migraine starts, with or without food. If needed, a second dose can be taken at least 2 hours later, up to a maximum of 200 mg in 24 hours.
The most common Ubrelvy side effects are nausea, sleepiness and dry mouth. Rarely, allergic reactions with facial or throat swelling can occur, sometimes days after a dose - seek urgent care if this happens. New high blood pressure or Raynaud's symptoms should be reported to your doctor.
Avoid strong CYP3A4 inhibitors such as ketoconazole or clarithromycin, which are contraindicated with Ubrelvy because they raise ubrogepant levels too high. Tell your healthcare provider about every medicine you take, since moderate inhibitors and some inducers also need dose adjustments.
You can take up to two Ubrelvy doses in 24 hours: an initial dose, then a second dose at least 2 hours later if the migraine has not fully resolved, up to a maximum total of 200 mg. Do not exceed this without checking with your prescriber.
There is limited safety data on Ubrelvy in pregnancy, and animal studies suggest possible risk to the developing baby, so discuss use with your healthcare provider first. A pregnancy exposure registry collects outcomes data. It is also not known if ubrogepant passes into breast milk.
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