Xipere Drug Information

XIPERE ® (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for the treatment of macular edema associated with uveitis. XIPERE ® is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Dosing Information

For suprachoroidal injection using the SCS Microinjector ®. Slide the white plunger handle all the way back and forth multiple times to fill the entire syringe with drug and remove any remaining air (see Figure I, i and ii ). NOTE: The syringe should be handled by the clear barrel during filling, connecting and disconnecting procedures.

The white plunger handle has a stop to prevent complete removal of the plunger from the syringe. Adequate anesthesia and a broad-spectrum microbicide applied to the periocular skin, eyelid, and ocular surface are recommended to be given prior to the suprachoroidal injection. If continued resistance is experienced during injection attempts: Remove the needle from the eye and examine the eye for any issues.

If patient safety is not at risk, the physician may use medical judgment to restart the injection procedure at a new site adjacent to the original injection site. If resistance continues and patient safety is not at risk, the physician may use appropriate medical judgment to change to the additional included needle in the sterile tray. Twist to remove the needle and reconnect the syringe to the vial by twisting the syringe onto the vial adapter.

Repeat the preparation and injection process as stated in Steps 9 – 18 with the additional needle (allowing for any partial dose given with the first needle when completing preparation Step 12). Immediately following suprachoroidal injection, patients should be monitored for elevation of intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.

Following suprachoroidal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of eye, photophobia, blurring of vision) without delay. Each XIPERE ® package (microinjector syringe with vial adapter, 900-µm needle, 1100-µm needle, and vial of triamcinolone acetonide injectable suspension 40 mg/mL) is single-dose and should only be used for the treatment of one eye. After suprachoroidal injection, all drug product and components (used or unused) must be discarded appropriately.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XIPERE ® was studied in a multicenter, randomized, sham-controlled, double-masked study in patients with macular edema associated with uveitis. Table 1 summarizes data available from the clinical trial for XIPERE ® treated patients and control patients.

The most common ocular (study eye) adverse reactions occurring in ≥ 2% of patients and non-ocular adverse reactions occurring in ≥ 5% of patients are shown in Table 1. Table 1:

Pregnancy Risk Summary There are no adequate and well-controlled studies with XIPERE ® in pregnant women to inform drug-associated risks. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids has been shown to produce teratogenicity at clinically relevant doses. There is negligible systemic XIPERE ® exposure following suprachoroidal injection.

Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively.

Animal Data Animal reproduction studies using XIPERE ® have not been conducted. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids to pregnant mice and rabbits during organogenesis has been shown to produce cleft palate, embryofetal death, herniated abdominal viscera, hypoplastic kidneys, and craniofacial malformations.

Pediatric Use Safety and effectiveness of XIPERE ® in pediatric patients have not been established.

Ocular or Periocular Infections XIPERE ® is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Hypersensitivity XIPERE ® is contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.