mometasone sinus implant (Rx)

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

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

Drug interaction overview

• Potent CYP3A4 inhibitors may increase mometasone plasma concentrations

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.

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

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)