Sinuva Kit(Mometasone Furoate)
SINUVA Rx
Generic Name and Formulations:
Mometasone furoate 1350mcg; per sinus implant.
Company:
Intersect ENT, Inc.
Select therapeutic use: Rhinitis/rhinorrhea (intranasal products)
RECENT UPDATES Monograph added.
Indications for SINUVA:
Nasal polyps in patients ≥18yrs who have had ethmoid sinus surgery.
Adult:
To be used by physicians trained in otolaryngology for placement in ethmoid sinus under endoscopic visualization. Insert 1 implant for 90 days. Implant can be removed at Day 90 or earlier based on physician's discretion. Do not reprocess or reuse.
Children:
<18yrs: not established.
Warnings/Precautions:
Respiratory tract tuberculosis. Systemic infections. Ocular herpes simplex. Immunosuppression. If exposed to measles or chickenpox, consider anti-infective prophylactic therapy. Nasal ulcers or trauma: avoid. Monitor nasal mucosa for epistaxis, irritation, infection, perforation. Change in vision, history of increased intraocular pressure, glaucoma, and/or cataracts: monitor closely. Monitor post-operatively and during periods of stress for adrenal response. Consider implant removal if hypercorticism and adrenal suppression occurs. Hepatic impairment. Pregnancy. Nursing mothers.
Interactions:
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole).
Pharmacological Class:
Steroid.
Adverse Reactions:
Bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, epistaxis; hypersensitivity reactions, immunosuppression, HPA axis effects.
Generic Availability:
NO
How Supplied:
Kit—1 (implant + delivery system) |
