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Sinuva Generic Name & Formulations
Legal Class
Rx
General Description
Mometasone furoate 1350mcg; per sinus implant.
Pharmacological Class
Steroid.
How Supplied
Kit—1 (implant + delivery system)
Manufacturer
Generic Availability
NO
Sinuva Indications
Indications
Nasal polyps in patients ≥18yrs who have had ethmoid sinus surgery.
Sinuva Dosage and Administration
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.
Sinuva Contraindications
Not Applicable
Sinuva Boxed Warnings
Not Applicable
Sinuva Warnings/Precautions
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 Pharmacokinetics
Absorption
98–99% plasma protein bound.
Elimination
Half-life: ~5 hours.
Sinuva Interactions
Interactions
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole).
Sinuva Adverse Reactions
Adverse Reactions
Bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, epistaxis; hypersensitivity reactions, immunosuppression, HPA axis effects.
Sinuva Clinical Trials
See Literature
Sinuva Note
Not Applicable
Sinuva Patient Counseling
See Literature
