Description
Atogepant is used to prevent migraine headaches, including episodic and chronic migraines. This medicine is not an ordinary pain reliever. It will not relieve pain other than from migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, 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 atogepant 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 atogepant in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving atogepant.
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 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.
- Apalutamide
- Armodafinil
- Asciminib
- Boceprevir
- Bosentan
- Carbamazepine
- Ceftobiprole Medocaril
- Cenobamate
- Clarithromycin
- Cobicistat
- Conivaptan
- Cyclosporine
- Darolutamide
- Dexamethasone
- Efavirenz
- Elexacaftor
- Eltrombopag
- Enasidenib
- Enzalutamide
- Eslicarbazepine Acetate
- Etravirine
- Fosphenytoin
- Fostemsavir
- Gemfibrozil
- Grazoprevir
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir
- Lorlatinib
- Lumacaftor
- Mitotane
- Modafinil
- Nafcillin
- Nefazodone
- Nelfinavir
- Nevirapine
- Oxcarbazepine
- Paritaprevir
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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, severe or end-stage—For chronic migraine, use is not recommended. For episodic migraine, use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe—Use is not recommended in patients with this condition.
Proper Use
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 of this medicine may increase the chance of side effects.
Do not use this medicine for a headache that is different from your usual migraines. Talk to your doctor about what to do for regular headaches.
Ask your doctor ahead of time about any other medicine you might take if atogepant does not work. After you use the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by atogepant are sometimes caused by conditions that need other treatment.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
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 prevention of episodic migraine:
- Adults—One tablet once a day. Each tablet contains 10, 30, or 60 milligrams (mg) of atogepant.
- Children—Use and dose must be determined by your doctor.
- For prevention of chronic migraine:
- Adults—One tablet once a day. Each tablet contains 60 milligrams (mg) of atogepant.
- Children—Use and dose must be determined by your doctor.
- For prevention of episodic migraine:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.
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. Tell your doctor if you drink grapefruit juice.
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
- trouble breathing
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:
More common
- Constipation
- nausea
- sleepiness or unusual drowsiness
- unusual tiredness or weakness
Less common
- Decreased appetite
- decreased weight
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-20523241
