HIGHLIGHTS OF PRESCRIBING INFORMATION (excerpt)
XYLEVA (halomectinib) tablets, for oral use
Initial U.S. Approval: 2023

--- SYNTHETIC DEMONSTRATION DOCUMENT — NOT A REAL FDA LABEL ---

Marketing Authorization Holder
Halcyon Bio Corp
Andover, Massachusetts, United States
DUNS: 099003321
FDA Establishment Identifier (holder): 3009111000

Active Ingredient
Halomectinib (International Nonproprietary Name)
Sponsor Development Code: HB-207
Brand Name: XYLEVA
Modality: Small molecule (sulfonyl-urea class successor)
Approval Status: Approved

INDICATIONS AND USAGE
XYLEVA is a glucagon-suppressing agent indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus (T2DM; MeSH: D003924).

Approving Regulator: U.S. Food and Drug Administration
Initial U.S. Approval: May 12, 2023
Pediatric Use: Not established; not indicated for patients under 18.

DOSAGE AND ADMINISTRATION
Recommended starting dose: 25 mg orally once daily. Titrate at 4-week intervals to 50 mg or
100 mg once daily based on glycemic response and tolerability.

MANUFACTURING SITES
Drug Substance:
    Halcyon Bio Corp — Andover, Massachusetts, United States
    FDA Establishment Identifier: 3009123456
    cGMP Certified: 21 CFR Part 210 & 211 (certified July 2022; valid through July 2027)

Drug Product (contract manufacturer):
    Meridian Biopharm, Inc. — Bedford, Massachusetts, United States
    FDA Establishment Identifier: 3009654321
    cGMP Certified: 21 CFR Part 210 & 211 (certified January 2020; valid through January 2025)

WARNINGS AND PRECAUTIONS
Hypoglycemia. Hypoglycemia was reported in 12% of patients receiving XYLEVA in pivotal trials.
Consider dose adjustment when co-administered with insulin or a sulfonylurea.

Pancreatitis. Acute pancreatitis has been reported in less than 1% of patients receiving
XYLEVA. Discontinue promptly if pancreatitis is suspected.

Hypersensitivity. Serious hypersensitivity reactions including angioedema have been reported
in clinical experience.

ADVERSE REACTIONS (reported on label)
    Hypoglycemia (common; ≥5% incidence)
    Pancreatitis (rare; <1% incidence)
    Angioedema (rare; hypersensitivity)
    Nausea (common)
    Headache (common)
