Xipere

Dosing Information

For suprachoroidal injection using the SCS Microinjector®. The recommended dose of XIPERE® is 4 mg (0.1 mL of the 40 mg/mL injectable suspension).

Preparation for Administration

Suprachoroidal injection is performed under aseptic conditions. The components for administration include: A. One single-dose glass vial of triamcinolone acetonide injectable suspension 40 mg/mL B. One SCS Microinjector® syringe with vial adapter attached C. One 30-G x 900-µm needle D. One 30-G x 1100-µm needle

Step 5
Figure E
Grasp and hold the long sides of the tray and invert the tray. Squeeze gently to release the sterile tray onto the appropriate sterile preparation surface (see Figure E, i – iii).

Administration

The suprachoroidal injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent), and a sterile cotton swab. 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:

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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.

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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 [see Patient Counseling Information (17)].

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.

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 [see Clinical Pharmacology (12.3)]. 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 2% to 4% and 15% to 20%, 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.

Lactation

Risk Summary

It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XIPERE® and any potential adverse effects on the breastfed infant from XIPERE®. There are no data on the effects of XIPERE® on milk production.

Pediatric Use

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

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients following XIPERE® administration.

Potential Corticosteroid-Related Effects

Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in patients with active ocular herpes simplex.

Alterations in Endocrine Function

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur following administration of a corticosteroid. Monitor patients for these conditions with chronic use.

Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.