Note: Ingredients listed on restricted chemical lists
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
EC/CAS
69-65-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
EC/CAS
200-711-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
General Information
Revision date
2020-01-03
Product name
Ubrogepant Tablets
Product Synonyms
Ubrelvy Tablets
1.2.1 Relevant identified uses
calcitonin gene-related peptide receptorant agonist indicated for the acute treatment of migraine with or without aura in adults
Manufacturer Name
Allergan plc
Emergency telephone
Call CHEMTREC Day or Night
Icons in SDS
Company Information
company name
Allergan plc
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@Allergan.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H319
Hazard statements
Code
Statements
H319
Causes serious eye irritation
Section 2
2.1 Classification of the substance or mixture
OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Serious eye damage/eye irritation Category 2A
2.2 Label elements
Emergency Overview Warning
Hazard statements
H319 - Causes serious eye irritation Appearance Tablet Physical state Solid Odor No information available Chemical Name Symptoms POVIDONE USP(PLASDONE K-29-32) Possible eye, skin, gastrointestinal and/or respiratory tract irritation. Possible allergic reaction to material if inhaled, ingested or in contact with skin. Overdose effects from ingestion of large amounts include abdominal cramps, flatulence, and fecal impaction. Ubrogepant (MK-1602) The most frequently reported clinical adverse events are nausea, dry mouth and somnolence. SODIUM CHLORIDE USP Skin, Eye and Respiratory Tract Irritation Chemical Name
Medical Conditions Generally Aggravated by Exposure
POVIDONE USP(PLASDONE K-29-32) Known hypersensitivity to this medication Ubrogepant (MK-1602) Ubrogepant is contraindicated in patients with hypersensitivity to ubrogepant or other CGRP receptor antagonists In summary, coadministration of a single dose of 20 mg ubrogepant with daily doses of400 mg ketoconazole (a strong CYP3A4 inhibitor) resulted in an approximate 10-foldincrease in exposure to ubrogepant. Therefore, concomitant use of moderate or strongCYP3A4 inhibitors should be avoided.
Precautionary statements
P264 - Wash face, hands and any exposed skin thoroughly after handling P280 - Wear protective gloves/protective clothing/eye protection/face protection P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P337 + P313 - If eye irritation persists: Get medical advice/attention
Further information
Unknown Acute Toxicity 20% of the mixture consists of ingredient(s) of unknown toxicity Over the counter drugs in their solid form are considered exempt under the criteria of the Federal OSHA Hazard Communication Standard 20 CFR 1910.1200. However, in an industrial setting where a component's occupational exposure limit may be surpassed, than can be considered hazardous
