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Berotralstat (Oral)

Medically reviewed by Drugs.com. Last updated on Sep 18, 2022.

Commonly used brand name(s)

In the U.S.

  • Orladeyo

Available Dosage Forms:

  • Capsule

Uses for berotralstat

Berotralstat is used to prevent attacks of hereditary angioedema (HAE) attacks. HAE is a rare disease that causes swelling of the face, hands, feet, throat, stomach, bowels, or genitals.

Berotralstat is available only with your doctor's prescription.

Before using berotralstat

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 berotralstat, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to berotralstat 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 berotralstat in children younger than 12 years of age. 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 berotralstat in the elderly.

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 berotralstat, 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 berotralstat 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.

  • Alfentanil
  • Amiodarone
  • Apalutamide
  • Carbamazepine
  • Carvedilol
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Cyclosporine
  • Darolutamide
  • Digoxin
  • Dihydroergotamine
  • Dofetilide
  • Dronedarone
  • Eltrombopag
  • Ergotamine
  • Erythromycin
  • Fentanyl
  • Flibanserin
  • Fosphenytoin
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Oxycodone
  • Phenytoin
  • Pimavanserin
  • Pimozide
  • Quinidine
  • Ranolazine
  • Rifampin
  • Ritonavir
  • Sirolimus
  • St John's Wort
  • Tacrolimus
  • Telaprevir
  • Temsirolimus
  • Thioridazine
  • Tipranavir
  • 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. 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 berotralstat. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hereditary angioedema attacks, acute—Should not be used to treat an HAE attack that has already started.
  • Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of berotralstat

Take berotralstat exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Berotralstat should be taken with food.

Dosing

The dose of berotralstat 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 berotralstat. 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 (capsules):
    • For prevention of hereditary angioedema (HAE) attacks:
      • Adults and children 12 years of age and older—150 milligrams (mg) once a day with food.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of berotralstat, 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 while using berotralstat

It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Berotralstat may increase your risk for heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you or your child have dizziness, fainting, or fast or irregular heartbeat.

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.

Berotralstat 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

  • Dizziness
  • fainting
  • fast or irregular heartbeat

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

  • Back pain
  • diarrhea
  • heartburn
  • stomach pain
  • vomiting

Less common

  • Bloated
  • excess air or gas in the stomach or bowels
  • full feeling
  • headache
  • passing gas
  • 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.

Further information

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