Select therapeutic use:

Miscellaneous respiratory disorders:

Indications for: SINUVA

Nasal polyps in patients ≥18yrs who have had ethmoid sinus surgery.

Adult Dosage:

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 Dosage:

<18yrs: not established.

SINUVA Warnings/Precautions:

Respiratory tract tuberculosis. Systemic infections (eg, fungal, bacterial, viral, parasitic). 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 postoperatively and during periods of stress for adrenal response. Consider implant removal if hypercorticism and adrenal suppression occurs. Hepatic impairment. Pregnancy. Nursing mothers.

SINUVA Classification:

Steroid.

SINUVA 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.

Metabolism:

Hepatic (primarily CYP3A4).

Drug Elimination:

Half-life: ~5 hours.

Generic Drug Availability:

NO

How Supplied:

Kit—1 (implant + delivery system)

Rhinitis/rhinorrhea (intranasal products):