Product Monograph

PATIENT INFORMATION

Important Safety Information

UBRELVY is indicated for the acute treatment of migraine, with or without aura, in adults.

DOSING AND ADMINISTRATION

FLEXIBLE DOSING FOR YOUR PATIENTS

UBRELVY PACKETS

Tablets not actual size.

The recommended dose of UBRELVY is 50 mg or 100 mg

Taken orally, with or without food

A second dose can be taken at least 2 hours after the initial dose if needed

Maximum daily dose is 200 mg. The safety of taking more than 16 doses in a 30-day period has not been established.

Please refer to the UBRELVY Product Monograph for complete dosing and administration instructions.

DOSING AND ADMINISTRATION

FLEXIBLE DOSING FOR YOUR PATIENTS

UBRELVY PACKETS

Tablets not actual size.

The recommended dose of UBRELVY is 50 mg or 100 mg

Taken orally, with or without food

A second dose can be taken at least 2 hours after the initial dose if needed

Maximum daily dose is 200 mg. The safety of taking more than 16 doses in a 30-day period has not been established.

Please refer to the UBRELVY Product Monograph for complete dosing and administration instructions.

SAFETY INFORMATION

Click here for additional safety information and for a link to the Product Monograph discussing:

●Contraindications with concomitant use of strong CYP3A4 inhibitors.

●Relevant warnings and precautions regarding driving and operating machinery, hypersensitivity reactions, may reduce effectiveness of oral contraceptives, use in pregnant or breast-feeding women and dose selection in geriatric patients.

●Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.

FOR MORE INFORMATION

For any questions related to UBRELVY, you can contact AbbVie Medical Information at 1-844-241-5011.

SAFETY INFORMATION

Click here for additional safety information and for a link to the Product Monograph discussing:

●Contraindications with concomitant use of strong CYP3A4 inhibitors.

●Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.

FOR MORE INFORMATION

For any questions related to UBRELVY, you can contact AbbVie Medical Information at 1-844-241-5011.

SAFETY INFORMATION

Click here for additional safety information and for a link to the Product Monograph discussing:

●Contraindications with concomitant use of strong CYP3A4 inhibitors.

●Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.

FOR MORE INFORMATION

For any questions related to UBRELVY, you can contact AbbVie Medical Information at
1-844-241-5011.

Reference:

1. UBRELVY (ubrogepant) Product Monograph. AbbVie Corporation.

UBRELVY and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company, used under license by AbbVie Corporation.

CA-UBR-230004A / JN24

UBRELVY and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company, used under license by AbbVie Corporation.

CA-UBR-230004A / JN24

DOSING CONSIDERATIONS¹

POPULATION	DOSING CONSIDERATION
	*Initial Dose*	Max Daily Dose
Hepatic Insufficiency
Severe hepatic impairment (Child-Pugh Class C)	50 mg	100 mg
Renal Insufficiency
Severe renal impairment (CrCl 15-29 mL/min)	50 mg	100 mg
End stage renal disease (CrCl <15 mL/min)	UBRELVY is not recommended
Geriatrics (≥65)
Exercise caution when using UBRELVY in elderly patients	50 mg	100 mg

No dose adjustment required for patients with mild or moderate hepatic or renal impairment.

Drug-Drug Interactions

CONCOMITANT DRUGS	DOSING CONSIDERATION
	Clinical Comment
Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin)	Concomitant use is contraindicated.
Moderate CYP3A4 inhibitors (e.g. verapamil, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice)	Use a single 50 mg dose (avoid taking a second dose within 24 hrs).
Weak CYP3A4 inhibitors (e.g. cimetidine)	Use a single 50 mg dose for the initial dose and optional second dose.
Strong CYP3A4 inducers (e.g. phenytoin, rifampin, St. John’s Wort)	Avoid concomitant use with UBRELVY.
Weak or moderate CYP3A4 inducers (e.g. armodafinil, modafinil, rufinamide, bosentan, efavirenz, etravirine, phenobarbital, primidone)	The 100 mg dose should be considered. Co-administration with weak or moderate CYP3A4 inducers was not evaluated.
BCRP inhibitors and/or P-gp efflux transporters (e.g. quinidine, carvedilol, eltrombopag, curcumin)	Use 50 mg for the initial and optional second dose. Clinical DI studies with inhibitors of these transporters have not been conducted.
Other ‘gepants’ (e.g. atogepant)	Concomitant use is not recommended. Co-administration of UBRELVY with other gepants has not been investigated.
Oral contraceptives (OC)	Although not expected to be clinically significant, take into consideration reduction in peak plasma concentrations of ethinyl estradiol when selecting OC doses.

●No clinically significant pharmacokinetic interactions were observed when UBRELVY was co-administered with acetaminophen, naproxen, sumatriptan, proton pump inhibitors, erenumab or galcanezumab.

Please refer to the UBRELVY Product Monograph for complete dosing and administration instructions.

DI=drug interaction.

Reference:

1. UBRELVY (ubrogepant) Product Monograph. AbbVie Corporation.

DOSING CONSIDERATIONS¹

POPULATION	DOSING CONSIDERATION
	*Initial Dose*	Max Daily Dose
Hepatic Insufficiency
Severe hepatic impairment (Child-Pugh Class C)	50 mg	100 mg
Renal Insufficiency
Severe renal impairment (CrCl 15-29 mL/min)	50 mg	100 mg
End stage renal disease (CrCl <15 mL/min)	UBRELVY is not recommended
Geriatrics (≥65)
Exercise caution when using UBRELVY in elderly patients	50 mg	100 mg

No dose adjustment required for patients with mild or moderate hepatic or renal impairment.

Drug-Drug Interactions

CONCOMITANT DRUGS	DOSING CONSIDERATION
	Clinical Comment
Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin)	Concomitant use is contraindicated.
Moderate CYP3A4 inhibitors (e.g. verapamil, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice)	Use a single 50 mg dose (avoid taking a second dose within 24 hrs).
Weak CYP3A4 inhibitors (e.g. cimetidine)	Use a single 50 mg dose for the initial dose and optional second dose.
Strong CYP3A4 inducers (e.g. phenytoin, rifampin, St. John’s Wort)	Avoid concomitant use with UBRELVY.
Weak or moderate CYP3A4 inducers (e.g. armodafinil, modafinil, rufinamide, bosentan, efavirenz, etravirine, phenobarbital, primidone)	The 100 mg dose should be considered. Co-administration with weak or moderate CYP3A4 inducers was not evaluated.
BCRP inhibitors and/or P-gp efflux transporters (e.g. quinidine, carvedilol, eltrombopag, curcumin)	Use 50 mg for the initial and optional second dose. Clinical DI studies with inhibitors of these transporters have not been conducted.
Other ‘gepants’ (e.g. atogepant)	Concomitant use is not recommended. Co-administration of UBRELVY with other gepants has not been investigated.
Oral contraceptives (OC)	Although not expected to be clinically significant, take into consideration reduction in peak plasma concentrations of ethinyl estradiol when selecting OC doses.

●No clinically significant pharmacokinetic interactions were observed when UBRELVY was co-administered with acetaminophen, naproxen, sumatriptan, proton pump inhibitors, erenumab or galcanezumab.

Please refer to the UBRELVY Product Monograph for complete dosing and administration instructions.

DI=drug interaction.

Reference:

1. UBRELVY (ubrogepant) Product Monograph. AbbVie Corporation.

DOSING AND ADMINISTRATION

FLEXIBLE DOSING FOR YOUR PATIENTS

UBRELVY PACKETS

DOSING AND ADMINISTRATION

FLEXIBLE DOSING FOR YOUR PATIENTS

UBRELVY PACKETS

SAFETY INFORMATION

FOR MORE INFORMATION

SAFETY INFORMATION

FOR MORE INFORMATION

SAFETY INFORMATION

FOR MORE INFORMATION

Reference:

DOSING CONSIDERATIONS1

Drug-Drug Interactions

Reference:

DOSING CONSIDERATIONS1

Drug-Drug Interactions

Reference:

DOSING CONSIDERATIONS¹

DOSING CONSIDERATIONS¹