General Information
Manufacturer: Abbvie
Medical Name: Ubrogepant
Purpose: Ubrelvy is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults.
Side Effects
| Side-Effect | Ubrelvy 50 mg | Ubrelvy 100 mg | Placebo |
|---|---|---|---|
| Nausea | 2% | 4% | 2% |
| Somnolence (sleepiness) | 2% | 3% | 1% |
| Fatigue | Not specified in all trials, but generally around 2-3% overall | 3% | 2% |
| Dry mouth | <1% | 2% | 1% |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Hypersensitivity reactions | These can occur minutes, hours, or days after administration and can include anaphylaxis, trouble breathing, facial or throat edema (swelling), rash, or hives. |
| New or worsening high blood pressure (hypertension). | |
| New or worsening Raynaud's phenomenon | This condition affects blood flow to the fingers and toes, causing pain and skin color changes. |
Contraindications - Do Not Use Ubrelvy
| Precondition | Description |
|---|---|
| Concomitant use with strong CYP3A4 inhibitors | Medications that strongly block the liver enzyme CYP3A4 can cause ubrogepant to build up to unsafe levels in the body, increasing the risk of side effects. Examples include:
|
| History of serious hypersensitivity | Patients who have had a severe allergic reaction to Ubrelvy or any of its components should not use it. Reactions can include anaphylaxis, trouble breathing (dyspnea), and swelling of the face or throat (edema). |
| Active Infections | Treatment should not begin in patients with clinically important active infections until they are resolved or adequately treated, as Skyrizi is an immunosuppressant and can increase infection risk. |
| Active Tuberculosis (TB) | Patients require evaluation for TB before starting treatment. Skyrizi is not recommended for patients with active TB. Patients with a history of latent or active TB without confirmed adequate treatment may need anti-TB therapy before starting Skyrizi. |
| Live Vaccines | Live vaccines should not be given to patients on Skyrizi. Age-appropriate vaccinations should be completed before initiating therapy. |
| Liver Problems (for IBD) | For Crohn's disease or ulcerative colitis treatment, liver enzyme and bilirubin levels are monitored due to the risk of drug-induced liver injury. Treatment should be stopped if drug-induced liver injury is suspected, and an alternative should be considered for patients with liver cirrhosis. |
Precautions and Conditions Requiring Consultation
Certain medical conditions and other medications require caution, dose adjustment, or close monitoring by a healthcare provider before using Ubrelvy:
| Severe kidney problems | Use is generally avoided in patients with end-stage renal disease (creatinine clearance <15 mL/min). A dose adjustment is recommended for severe renal impairment. |
| Severe liver problems | A lower dose of Ubrelvy is recommended for patients with severe hepatic impairment (Child-Pugh Class C). |
| Pregnancy and breastfeeding | It is not known if Ubrelvy is safe during pregnancy or breastfeeding, as there are no adequate studies in humans. The decision to use it should be made in consultation with a doctor, considering potential risks versus benefits. A pregnancy registry is available for monitoring outcomes. |
| Other medications | Interactions can occur with moderate or weak CYP3A4 inhibitors/inducers, and other transporter inhibitors (such as certain heart/blood pressure medications like verapamil, diltiazem, or rifampin, phenytoin, St. John's wort, and grapefruit juice), potentially requiring dose modifications. |
| High blood pressure | Ubrelvy may cause new-onset or worsening of pre-existing high blood pressure, requiring monitoring. |
| Raynaud's phenomenon | New onset or worsening of this circulation condition in the fingers and toes has been reported, and patients should be monitored. |
| Age | Safety and effectiveness in pediatric patients (under 18) have not been established. |