SINUVA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SINUVA (SINUVA).
SINUVA (mometasone furoate) sinus implant releases mometasone furoate, a corticosteroid with anti-inflammatory activity, locally within the sinus cavity. It reduces inflammation by inhibiting multiple inflammatory cytokines and mediators, including prostaglandins and leukotrienes, via glucocorticoid receptor binding.
| Metabolism | Metabolized primarily by CYP3A4 to multiple metabolites; undergoes extensive first-pass metabolism when absorbed systemically. |
| Excretion | Primarily eliminated via hepatic metabolism, with inactive metabolites excreted in feces (approximately 95%) and urine (less than 5% as unchanged drug). |
| Half-life | Approximately 15.9 hours following release from the implant; clinical effects persist for the duration of implant residence (up to 90 days) despite declining local mometasone furoate concentrations. |
| Protein binding | Approximately 98-99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Mean apparent volume of distribution (Vz/F) is approximately 332 L at steady state, indicating extensive tissue distribution. |
| Bioavailability | SINUVA implant delivers mometasone furoate locally to the nasal sinuses; systemic bioavailability is low (<1%) due to local deposition and first-pass metabolism. |
| Onset of Action | Local intranasal effect: reduction in nasal polyp size and symptom improvement observed within 2 weeks of implant placement. |
| Duration of Action | Continuous local delivery for up to 90 days post-placement; clinical benefit sustained over the implant lifespan, with gradual decline after removal. |
Intranasal spray: 1 spray (approximately 50 mcg of fluticasone propionate) per nostril once daily.
| Dosage form | IMPLANT |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Not recommended for pediatric patients under 18 years of age. |
| Geriatric use | No specific dose adjustment required; use caution due to potential for increased systemic sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SINUVA (SINUVA).
| Breastfeeding | It is not known whether mometasone furoate is excreted in human milk after intranasal or sinus administration. Systemic absorption following local sinus implantation is negligible. However, caution should be exercised when SINUVA is administered to a nursing woman. M/P ratio is not available due to negligible systemic concentrations. |
| Teratogenic Risk | SINUVA (mometasone furoate sinus implant) is a corticosteroid delivered locally to the sinus mucosa. Systemic absorption is minimal; however, corticosteroids in general should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal reproduction studies, mometasone furoate caused fetal malformations at subcutaneous doses lower than the maximum recommended human dose based on body surface area. For the first trimester, advise pregnant women of the potential risk to the fetus. For the second and third trimesters, use only if clearly needed; no specific fetal risks have been reported with local delivery. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to mometasone furoate or any component","Untreated localized nasal infection (e.g., fungal, bacterial, viral)"]
| Precautions | ["Local nasal effects: epistaxis, nasal ulceration, candidiasis; monitor for mucosal changes.","Hypercorticism and adrenal suppression with excessive doses or prolonged use.","Immunosuppression: increased risk of infections.","Impaired wound healing: avoid use in patients with recent nasal trauma or surgery until healing complete.","Ocular effects: increased intraocular pressure, glaucoma, cataracts."] |
Loading safety data…
| Fetal Monitoring | No specific maternal or fetal monitoring is required beyond standard obstetric care. Monitor for signs of systemic corticosteroid effects (e.g., hypercortisolism, adrenal suppression) if used concomitantly with systemic corticosteroids. Assess nasal and sinus symptoms regularly. |
| Fertility Effects | Studies in animals have shown no impairment of fertility at subcutaneous doses of mometasone furoate up to 134 mcg/kg/day. It is unlikely that local sinus administration of SINUVA affects human fertility, as systemic exposure is minimal. |