Dosing & Uses
Dosage Forms & Strengths
sinus implant
- 370mcg, 23mm nominal length (Propel)
- 370mcg, 16mm nominal length (Propel Mini)
- 370mcg, 8mm nominal length (Propel Contour)
- 1350mcg, 20 mm nominal length (Sinuva)
Postoperative intervention for chronic sinusitis surgery
Bioabsorbable implant indicated for adults (aged ≥18 yr) following sinus surgery to maintain sinus patency; prevents sinus obstruction from adhesions, reduces inflammation, and reduces the need for postoperative intervention (eg, adhesion lysis, oral corticosteroids)
Ethmoid sinus: Use Propel
Ethmoid and frontal sinuses: Use Propel mini
Frontal and maxillary sinuses: Use Propel Contour
See Administration
Nasal Polyps
Sinuva: Indicated for nasal polyps in adults aged ≥18 years who have had ethmoid sinus surgery
The implant is loaded into a delivery system and placed in the ethmoid sinus under endoscopic visualization
The Implant may be left in the sinus to gradually release the corticosteroid over 90 days
Can be removed at Day 90 or earlier at the physician's discretion using standard surgical instruments
To be inserted by physicians trained in otolaryngology
Repeat administration has not been studied
See Administration
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (7)
- axicabtagene ciloleucel
mometasone sinus implant, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Consider the use of prophylactic corticosteroid in patients after weighing the potential benefits and risks. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- brexucabtagene autoleucel
mometasone sinus implant, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- ciltacabtagene autoleucel
mometasone sinus implant, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- idecabtagene vicleucel
mometasone sinus implant, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- lisocabtagene maraleucel
mometasone sinus implant, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- macimorelin
mometasone sinus implant, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin. .
- tisagenlecleucel
mometasone sinus implant, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
Monitor Closely (12)
- cyclosporine
mometasone sinus implant, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may increase or decrease cyclosporine concentrations. Also, cyclosporine may increase the plasma concentrations of the corticosteroids. Monitor for changes in cyclosporine concentrations and for toxicities of corticosteroids and/or cyclosporine.
- dengue vaccine
mometasone sinus implant decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- isavuconazonium sulfate
mometasone sinus implant and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lonapegsomatropin
lonapegsomatropin decreases effects of mometasone sinus implant by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
mometasone sinus implant decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.
mometasone sinus implant decreases effects of lonapegsomatropin by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations. - ozanimod
ozanimod, mometasone sinus implant. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.
- ponesimod
ponesimod and mometasone sinus implant both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of mometasone sinus implant by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of mometasone sinus implant by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- somapacitan
somapacitan decreases effects of mometasone sinus implant by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
mometasone sinus implant decreases effects of somapacitan by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations. - somatrogon
mometasone sinus implant decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- somatropin
mometasone sinus implant decreases effects of somatropin by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- ublituximab
ublituximab and mometasone sinus implant both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
1-10%
Sinuva implants
- Asthma (4.7%)
- Headache (3.5%)
- Epistaxis (2.4%)
- Presyncope (2.4%)
- Bronchitis (2%)
- Otitis media (2%)
- Nasopharyngitis (1.2%)
Frequency Not Defined
Propel implants
- Premature displacement of implant or implant fragments
- Swallowing implant or implant fragments
- Pain
- Pressure
- Headache
- Foreign body response
Postmarketing Reports
Nasal pain
Warnings
Contraindications
Suspected or confirmed intolerance to mometasone furoate or any of the copolymers
Propel implant copolymers: Lactide, glycolide, or caprolactone copolymers
Sinuva copolymers: poly(DL-lactide-co-glycolide), polyethylene glycol
Cautions
Propel implants
- Confirm no antimicrobial properties are present; possible foreign body reaction may occur
- Reports of sinus surgery-associated physiochemical condition, with or without sinus implants and packing
- Risk of toxic shock syndrome
Sinuva implants
- Monitor nasal mucosa adjacent to implant for any signs of bleeding, irritation, infection, or perforation; avoid use with nasal ulcers or trauma
- Glaucoma, cataracts, and clinically significant elevated IOP were not observed in patients from the treatment group of 1 randomized controlled clinical study (N = 53) who underwent bilateral implant placement; however, close monitoring is warranted in patients vision changes or history of increased IOP, glaucoma, and/or cataracts
- Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with use of corticosteroids
- Caution with immunosuppressed patients or those using immunosuppressive drugs; increased risk of infection in these individuals
- Hypercorticism and adrenal suppression were not evaluated during clinical trials; monitor patients who may be at risk
-
Immunosuppression and risk of infections
- Persons who are using drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals; chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids; in such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure
- How the dose, route, and duration of corticosteroid administration affect risk of developing a disseminated infection is not known; safety and effectiveness of implant have not been established in pediatric patients less than 18 years of age and is not indicated for use in this population
Drug interaction overview
- Potent CYP3A4 inhibitors may increase mometasone plasma concentrations
Pregnancy & Lactation
Pregnancy
No data are available in pregnant women
Lactation
No data are available on the presence of mometasone in breast milk from the implants
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Corticosteroids have been shown to have a wide range of effects on multiple cell types (eg mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation
The mechanism for anti-inflammatory properties for eluted mometasone furoate is unknown
Administration
Sinus Implant Preparation
Special care should be taken to avoid bending, twisting or damaging the implant
Placement should be under endoscopic visualization; avoid modifications to implant; not intended to be compressed or loaded into delivery system >2 times
Propel implants
- Place funnel onto delivery system tip
- Remove implant holder top; avoid grasping or dislodging implant
- Gently grasp and compress implant between fingers
- Insert compressed implant into delivery system tip
- Carefully remove funnel without dislodging implant
- If implant withdraws from tip, replace funnel and gently squeeze delivery system tip
Sinuva implant
- Remove the crimper and the delivery system from their protective packaging using sterile technique
- Inspect the implant located inside of the crimper, but do not remove the implant from the crimper
- Prior to use, the implant must be crimped and loaded into the delivery system
- If the implant is not fully seated inside of the crimper, secure the implant before proceeding
- Do not leave the implant in the crimped state for more than 5 minutes before placement
- If necessary, the implant may be reloaded into the crimper for a second time; do not use if the second attempt to crimp is unsuccessful
- See prescribing information for full instructions and diagrams
Sinus Implant Administration
Propel implants
Ethmoid sinus
- Orient delivery system so distal tip curves superiorly toward the posterior roof of sinus cavity
- Align green plunger distal tip with middle turbinate anterior edge
- Insert implant via depressing the plunger while removing delivery system
- Confirm proximal loops of implant align with middle turbinate anterior edge; confirm implant is well applied to tissue for maximum drug delivery
Frontal sinus
- Orient delivery system so distal tip curves superiorly toward the frontal sinus
- Advance distal tip of delivery system to frontal sinus
- Insert implant via depressing the plunger while removing delivery system
- Confirm implant loops support frontal sinus opening align; confirm implant is well applied to tissue for maximum drug delivery
Sinus ostium
- Orient delivery system so distal tip curves superiorly toward the sinus ostium
- Depress plunger until coiled pusher aligns with green to clear transition; implant halfway deployed
- Slightly withdraw delivery system to visualize implant waist; align waist with sinus ostium; continue to withdraw delivery system via depressing the plunger and implant waist alignment
- Confirm waist aligns with sinus ostium
Sinuva implant
- Advance the delivery system under endoscopic visualization into the ethmoid sinus cavity
- Ensure that the delivery system is oriented such that the 10° curvature of the distal tip is curved superiorly; insert the delivery system such that the shaft is parallel to roof of ethmoid sinus
- If the implant becomes dislodged from the delivery system prior to placement into the ethmoid sinus, remove the implant and inspect for damage, reload the undamaged implant in the crimper, and recrimp the implant into the delivery system
- Note that the implant should not be loaded into the delivery system >2 times
- Release the implant by pressing down on the thumb rest while pulling back on the finger rests in a controlled manner
- Place the implant amongst the sinus polyps with the cap oriented toward the posterior ethmoid sinus, and with the implant positioned as superiorly as possible in the sinus
- The long ends of the implant should be in approximately the 2 o’clock, 4 o’clock, 8 o’clock, and 10 o’clock positions, respectively
- Confirm final placement by endoscopic visualization
- To adjust the implant position, use the seeker on the delivery system or standard endoscopic surgical instruments
Postoperative Care
Frequently spray, rinse, or irrigate nasal cavity maintaining the implant remains moist; routine debridement
Proper surgical instruments should be use when removing implant
Storage
Store at 59-86°C (15-30°C)
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Formulary
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