Ubrogepant (Ubrelvy) - Uses, Dose, Side effects

Ubrogepant (Ubrelvy) is available as U50 and U100 tablets indicating the strength of the tablets (50 mg and 100 mg respectively.

Ubrogepant (Ubrelvy) Uses:

  • An acute attack of Migraine:

    • This medicine is good for quickly stopping migraines in adults, whether they come with or without warning signs.

    • But it's not meant to prevent migraines from happening in the first place.

Complete prescribing information of Ubrogepant (Ubrelvy) can be accessed here (PDF format)

Ubrogepant dose in adults:

Ubrogepant (Ubrelvy) dose in the treatment of Acute attack of Migraine: 

  • Take 50 to 100 mg of this medicine by mouth as a single dose at first. Depending on how well you respond and tolerate the medicine, you can take another dose after 2 hours or later.

  • The most you should take in one day is 200 mg. It's not known if this medication is safe for treating 8 or more migraines each month.

Ubrogepant (Ubrelvy) Dosage adjustment for concomitant therapy:

  • Strong CYP3A4 inhibitors like ketoconazole, itraconazole, and clarithromycin):

    • People who are taking certain medications should not use Ubrogepant (Ubrelvy) because it can be harmful or cause unwanted effects.

    • "Contraindicated" means that it is strongly advised against or prohibited to use Ubrogepant in conjunction with these specific medicines.

    • Always consult with a healthcare professional to ensure the safe and appropriate use of medications, especially if there is a concern about potential interactions.

  • Moderate CYP3A4 inhibitors like cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice, and verapamil):

    • Take 50 mg of this medication by mouth as a single dose.

    • Do not take a second dose within 24 hours.

    • The most you should take in one day is 50 mg. It's important to follow these dosing instructions to ensure safe and effective use of the medication.

  • Weak CYP3A4 inhibitor:

    • Take 50 mg of this medication by mouth as a single dose initially.
    • Depending on how you respond and tolerate the medication, you may repeat the dose once after 2 hours or longer.
    • The maximum dose in a day should not exceed 100 mg. Always follow these dosing instructions as prescribed by your healthcare provider to ensure safe and effective use.
  • Strong CYP3A4 inducer such as phenytoin, barbiturates, rifampin, and St. John's wort):

    • Do not use simultaneously or at the same time.

  • Weak and moderate CYP3A4 inducers:

    • Take 100 mg of this medication orally as a single dose initially.
    • Depending on how you respond and tolerate the medication, you may repeat the dose once after 2 hours or more.
    • However, the maximum total dose in a 24-hour period should not exceed 200 mg. Always follow these dosing instructions as prescribed by your healthcare provider for safe and effective use.
  • Breast cancer resistance protein and/ or P-glycoprotein only inhibitor such as quinidine, carvedilol, eltrombopag, and curcumin):

    • Take 50 mg of this medication orally as a single dose initially.

    • Depending on how you respond and tolerate the medication, you may take another dose once after 2 hours or longer.

    • However, the maximum total dose within a 24-hour period should not exceed 100 mg. Always adhere to these dosage instructions as directed by your healthcare provider for safe and effective use.

Ubrogepant (Ubrelvy) use in Children:

The safety and effectiveness of the medication have not been proven in children.

Ubrogepant (Ubrelvy) Pregnany Risk Category: C

  • For Ubrogepant (Ubrelvy), studies in animals have indicated potential harm to fetal development.
  • Regarding its use during breastfeeding, it's uncertain whether the drug will pass into breast milk.
  • Manufacturers suggest considering the advantages of treating lactating mothers against the potential risks of exposing infants to the drug.
  • In such cases, the decision should be made after careful consideration of the potential benefits and risks, and consultation with a healthcare professional is advised.

 

Ubrogepant (Ubrelvy) dose adjustment in kidney disease:

  • CrCl >=30mL/minute

    • No dosage adjustment is required.
  • CrCl 15 to 29, mL/minute

    • Take 50 mg as a single dose initially.

    • Depending on your tolerance and response, you can repeat the dose up to two hours later.

    • The maximum daily intake should not exceed 100 mg.

    • Always follow these dosing instructions as directed by your healthcare provider for safe and effective use.

  • CrCl 15mL/minute

    • Patients in this group have not been studied regarding the use of this medication, and it is recommended to avoid its use in this population.

Ubrogepant (Ubrelvy) dose adjustment in liver disease:

  • Mild to moderate impairment (Child Puugh class A or B)

    • No dosage adjustment is required.
  • Severe impairment (Child Puugh class C).

    • Take 50 mg as a single dose when first administered.
    • Depending on the patient's response and tolerance, the dose may be repeated after 2 hours.
    • The maximum daily intake should not exceed 100 mg.
    • Always adhere to these dosing instructions as directed by your healthcare provider for safe and effective use.

Side Effects of Ubrogepant (Ubrelvy) Include:

  • Central nervous system:

    • Drowsiness
  • Gastrointestinal:

    • Nausea
    • Xerostomia

Contraindication to Ubrogepant (Ubrelvy) Include:

Do not use strong CYP3A4 inhibitors at the same time.

Warnings and precautions

  • Hepatic impairment
    • If there is significant liver impairment, a reduction in dose is necessary.
  • Renal impairment
    • A dose reduction is necessary in cases of severe renal disease.
    • Individuals with end-stage kidney disease should avoid using it.

How to administer Ubrogepant (Ubrelvy)?

It is administered with or without food.

Mechanism of action of Ubrogepant (Ubrelvy):

It inhibits the receptor for calcitonin-related peptide.

The C-max and absorption

  • When a high-fat meal is consumed, they can be delayed.

Protein-bound

  • 87%

Metabolism

  • It is primarily found in the liver hepatic via CYP3A4.

Half-life Elimination:

  • The average time of taking the drug is between 5 and 7 hours. It takes time to get there

Peak serum concentration

  • It takes approximately 1.5 hours.

Excretion

  • 42% of the drug is excreted as unchanged in the feces
  • 6% is excreted into the urine.

International Brands of Ubrogepant:

  • Ubrelvy

 Price of Ubrogepant (Ubrelvy) Tablets in the US: 

Each 50 mg Tablet costs: $102.00

Each 100 mg tablet costs: $102.00

Ubrogepant Brand Names in Pakistan:

No Brands Available in Pakistan.