Description
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. This medicine is usually used in people whose headaches are not helped or relieved by acetaminophen (Tylenol®), aspirin, or other pain relievers.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would 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 this medicine.
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.
Drug Interactions
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 this medicine, 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 this medicine 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
- Ceritinib
- Clarithromycin
- Cobicistat
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Mifepristone
- Nefazodone
- Nelfinavir
- Nirmatrelvir
- Paritaprevir
- Posaconazole
- Ribociclib
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Troleandomycin
- Tucatinib
- Voriconazole
Using this medicine 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.
- Adagrasib
- Amiodarone
- Apalutamide
- Aprepitant
- Armodafinil
- Asciminib
- Atazanavir
- Avacopan
- Berotralstat
- Bosentan
- Capmatinib
- Carbamazepine
- Carvedilol
- Ciprofloxacin
- Conivaptan
- Cyclosporine
- Dabrafenib
- Daclatasvir
- Danicopan
- Darolutamide
- Dasabuvir
- Dexamethasone
- Diltiazem
- Dronedarone
- Duvelisib
- Efavirenz
- Elacestrant
- Elagolix
- Elbasvir
- Eltrombopag
- Enasidenib
- Encorafenib
- Enzalutamide
- Erythromycin
- Eslicarbazepine Acetate
- Etravirine
- Febuxostat
- Fedratinib
- Flibanserin
- Fluconazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
Other Interactions
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 this medicine 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 this medicine, 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Hypertension (high blood pressure) or
- Raynaud's phenomenon (blood vessel disease), history of—Use with caution. May make these conditions worse.
- Kidney disease, end-stage—Use is not recommended in patients with this condition.
- 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
Do not use this medicine 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 this medicine 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 this medicine 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.
This medicine 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 this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
Dosing
The dose of this medicine 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 this medicine. 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.
- For migraine headaches:
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
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.
Do not use this medicine 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 this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness.
This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat within 7 days after starting treatment with this medicine.
This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.
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.
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:
Incidence not known
- Blurred vision
- chest tightness
- cough
- difficulty swallowing
- dizziness
- headache
- hives, itching, skin rash
- nervousness
- paleness or cold feeling in the fingertips and toes
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slow or fast heartbeat
- tingling or pain in the fingers or toes when exposed to cold
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
- nausea
- sleepiness or unusual drowsiness
- unusual tiredness or weakness
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.
DRG-20481621
