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:

    • It is recommended for the quick relief of adult migraines with or without aura.
    • It is not recommended for migraine prophylaxis.

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: 

  • 50 to 100 mg orally as a single dose initially.
  • Depending on the response and tolerability of the patient, the dose may be given once again after 2 hours or longer.
  • The maximum dose is 200 mg per day.
  • It has not been determined whether the medication is safe when used to treat 8 migraines or more each month.

Ubrogepant (Ubrelvy) Dosage adjustment for concomitant therapy:

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

    • The use of Ubrogepant (Ubrelvy) is contraindicated in patients taking these medicines.
  • Moderate CYP3A4 inhibitors like cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice, and verapamil):

    • 50 mg orally as a single dose.
    • Avoid the second dose within 24 hours.
    • The maximum dose in one day is 50 mg.
  • Weak CYP3A4 inhibitor:

    • 50 mg orally as a single dose initially.
    • Depending on the response and tolerability of the patient, the dose may be repeated once after 2 hours or more.
    • The maximum dose in a day is 100 mg.
  • Strong CYP3A4 inducer such as phenytoin, barbiturates, rifampin, and St. John's wort):

    • Avoid concurrent use.
  • Weak and moderate CYP3A4 inducers:

    • 100 mg orally as a single dose initially.
    • The dose may be repeated once after 2 hours or more, based on the patients' response and tolerability.
    • The maximum dose is 200 mg per 24 hours.
  • Breast cancer resistance protein and/ or P-glycoprotein only inhibitor such as quinidine, carvedilol, eltrombopag, and curcumin):

    • 50 mg orally as a single dose initially.
    • Depending on the response and tolerability of the patient, the dose may be given once again after 2 hours or longer.
    • The maximum dose in 24 hours is 100 mg.

Ubrogepant (Ubrelvy) use in Children:

The safety and efficacy of the drug in children has not been established.

Ubrogepant (Ubrelvy) Pregnany Risk Category: C

  • Ubrogepant (Ubrelvy).In animal reproduction studies, fetal harm has been shown.

Use while breastfeeding

  • It is unknown if the drug will be excreted into breastmilk.
  • Manufacturers recommend weighing the benefits of treating lactating mothers and the risks of drug exposure for infants.

 

Ubrogepant (Ubrelvy) dose adjustment in kidney disease:

  • CrCl >=30mL/minute

    • It is not necessary to adjust the dose.
  • CrCl 15 to 29, mL/minute

    • 50mg as a single dose in the beginning
    • In accordance with tolerance and response, the dose can be repeated up to two hours later.
    • Maximum daily intake is 100 mg.
  • CrCl 15mL/minute

    • These patients have not been able to study its use and it should be avoided.

 

Ubrogepant (Ubrelvy) dose adjustment in liver disease:

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

    • It is not necessary to adjust the dose.
  • Severe impairment (Child Puugh class C).

    • 50 mg is taken as a single dose when it's first administered.
    • The patient's response and tolerance may dictate if the dose is repeated after 2 hours.
    • Maximum daily intake is 100 mg

 

Side Effects of Ubrogepant (Ubrelvy) Include:

  • Central nervous system:

    • Drowsiness
  • Gastrointestinal:

    • Nausea
    • Xerostomia

 

Contraindication to Ubrogepant (Ubrelvy) Include:

Avoid using strong CYP3A4 inhibitors in conjunction.

Warnings and precautions

  • Hepatic impairment
    • In the case of significant liver impairment, a dose reduction is required.
  • Renal impairment
    • A reduction of the dose is necessary in severe renal disease.
    • People suffering from end-stage kidney disease should avoid it

 

How to administer Ubrogepant (Ubrelvy)?

It is administered with or without food.

Mechanism of action of Ubrogepant (Ubrelvy):

It blocks the receptor for the 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.

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