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Ubrogepant (Oral)

Commonly used brand name(s)

In the U.S.

  • Ubrelvy

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antimigraine

Uses for ubrogepant

Ubrogepant is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches. Ubrogepant works in the brain to relieve the pain from migraine headaches.

Ubrogepant is not an ordinary pain reliever. It will not help with any kind of pain other than migraine headaches. Ubrogepant is usually used in people whose headaches are not helped or relieved by acetaminophen (Tylenol®), aspirin, or other pain relievers.

Ubrogepant is available only with your doctor's prescription.

Before using ubrogepant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ubrogepant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ubrogepant or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ubrogepant in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of ubrogepant have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of ubrogepant in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving ubrogepant.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ubrogepant, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ubrogepant with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Boceprevir
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Voriconazole

Using ubrogepant with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Apalutamide
  • Aprepitant
  • Armodafinil
  • Atazanavir
  • Bosentan
  • Capmatinib
  • Carbamazepine
  • Carvedilol
  • Ciprofloxacin
  • Cyclosporine
  • Darolutamide
  • Dexamethasone
  • Diltiazem
  • Dronedarone
  • Efavirenz
  • Elagolix
  • Eltrombopag
  • Enzalutamide
  • Erythromycin
  • Eslicarbazepine Acetate
  • Etravirine
  • Flibanserin
  • Fluconazole
  • Fluvoxamine
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Imatinib
  • Ivacaftor
  • Lapatinib
  • Larotrectinib
  • Letermovir
  • Lomitapide
  • Lorlatinib
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Nafcillin
  • Netupitant
  • Nevirapine
  • Nilotinib
  • Oxcarbazepine
  • Palbociclib
  • Phenobarbital
  • Phenytoin
  • Prednisone
  • Primidone
  • Quinidine
  • Ranitidine
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • St John's Wort
  • Velpatasvir
  • Vemurafenib
  • Verapamil
  • Voxilaprevir

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ubrogepant with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ubrogepant, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of ubrogepant. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease, severe or
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of ubrogepant

Do not use ubrogepant for a headache that is not a migraine headache. Talk to your doctor about what to do for regular headaches.

To relieve your migraine as soon as possible, use ubrogepant as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using ubrogepant.

If you feel much better after a dose of ubrogepant, but your headache comes back or gets worse after a while, wait at least 2 hours before taking another dose. However, use ubrogepant only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much ubrogepant may increase the chance of side effects.

Swallow the tablet whole. Do not crush, break, or chew it. You may take it with or without food.

Ubrogepant comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Do not eat grapefruit or drink grapefruit juice while you are using ubrogepant. Grapefruit and grapefruit juice may change the amount of ubrogepant that is absorbed in the body.

Dosing

The dose of ubrogepant will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ubrogepant. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For migraine headaches:
      • Adults—50 or 100 milligrams (mg) per day, as needed. If your migraine does not go away, or if the migraine comes back after being relieved, another dose may be taken 2 hours after the last dose. Do not take more than 200 mg in any 24-hour period.
      • Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using ubrogepant

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use ubrogepant together with clarithromycin (Biaxin®), itraconazole (Sporanox®), or ketoconazole (Nizoral®). Using these medicines together may cause serious unwanted side effects.

Tell your doctor if you are pregnant or planning to become pregnant during treatment with ubrogepant.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Ubrogepant side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Nausea
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Dry mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.