UBRELVY 100 mg/1 (Ubrogepant TABLET) 100 mg/1

UBRELVY is a CGRP receptor antagonist used to treat acute migraine attacks. It is not intended for the prevention of migraines but rather for the relief of symptoms once they occur.

• Migraine with aura: Provides relief from migraine attacks that are preceded by sensory disturbances such as visual disturbances, numbness, or speech difficulties.
• Migraine without aura: Effective in treating migraine attacks that occur without any preceding sensory disturbances.
• Acute treatment: Designed to reduce the severity and duration of migraine pain and associated symptoms such as nausea and sensitivity to light and sound.

• UBRELVY works by selectively antagonizing the calcitonin gene-related peptide (CGRP) receptor. CGRP is a protein that is released during migraine attacks and contributes to vasodilation and neurogenic inflammation. By blocking the CGRP receptor, UBRELVY inhibits these processes, thereby reducing the pain and other symptoms associated with migraines.

UBRELVY may cause various side effects, ranging from common to serious or rare. It is important to be aware of these potential reactions and consult a healthcare provider if they occur.

Common Side Effects

• Nausea: A feeling of sickness in the stomach that may or may not lead to vomiting.
• Sleepiness: A feeling of drowsiness or fatigue that may affect daily activities.
• Dry mouth: A condition characterized by a lack of saliva, leading to discomfort in the mouth.
• Dizziness: A sensation of lightheadedness or unsteadiness.
• Fatigue: A feeling of extreme tiredness or lack of energy.
• Constipation: Difficulty in passing stools, which may cause discomfort and bloating.

Serious or Rare Side Effects

• Hypersensitivity reactions: Allergic reactions that may include symptoms such as rash, itching, swelling, severe dizziness, or trouble breathing.
• Liver problems: Symptoms may include jaundice (yellowing of the skin or eyes), dark urine, or persistent nausea and vomiting.
• Increased blood pressure: Elevated blood pressure levels that may require medical attention.

UBRELVY should be used with caution and under the supervision of a healthcare provider. Certain precautions and warnings should be considered to ensure safe and effective use.

• Allergic reactions: Discontinue use and seek immediate medical attention if signs of a serious allergic reaction occur, such as difficulty breathing, swelling of the face and throat, or severe rash.
• Liver function: Inform your healthcare provider if you have a history of liver problems or if you experience symptoms of liver dysfunction while taking UBRELVY.
• Drug interactions: Avoid taking UBRELVY with strong CYP3A4 inhibitors, as they can increase the risk of side effects. Consult your healthcare provider before taking UBRELVY with other medications.
• Pregnancy and breastfeeding: The safety of UBRELVY during pregnancy and breastfeeding has not been established. Consult your healthcare provider for personalized advice.
• Grapefruit and grapefruit juice: Avoid consuming grapefruit or grapefruit juice, as it can increase the levels of UBRELVY in your body and raise the risk of side effects.
• Store below 25°C: Keep in the original pack, protect from moisture.

UBRELVY may interact with other medications, potentially altering its effectiveness or increasing the risk of side effects. It is important to be aware of these interactions and consult a healthcare provider before combining treatments.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors: Medications such as ketoconazole, itraconazole, and clarithromycin can significantly increase the levels of UBRELVY in the body, raising the risk of side effects.
• BCRP and P-gp inhibitors: Drugs like carvedilol, quinidine, and eltrombopag can also increase the levels of UBRELVY, potentially leading to adverse reactions.
• CYP3A4 inducers: Medications such as rifampin and phenytoin can decrease the effectiveness of UBRELVY by reducing its levels in the body.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors: Drugs like cyclosporine can moderately increase the levels of UBRELVY, requiring close monitoring for potential side effects.
• Hormonal birth control: UBRELVY may decrease the effectiveness of hormonal birth control methods, necessitating the use of additional contraceptive measures.