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SINUVA
Rhinitis/rhinorrhea (intranasal products)
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Drug Name:

SINUVA Rx

Generic Name and Formulations:
Mometasone furoate 1350mcg; per sinus implant.

Company:
Intersect ENT, Inc.

Therapeutic Use:

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.

Pharmacological Class:

Steroid.

Interactions:

May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole).

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)

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