Xipere Drug Information
Generic name: TRIAMCINOLONE ACETONIDE
Corticosteroid [EPC]
Uses of 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.
Dosage & Administration of Xipere
Suprachoroidal injection is performed under aseptic conditions. The components for administration include:
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Remove the tray from the carton (see Figure A).The tray consists of two compartments:
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| Examine the tray for damage (see Figure B). Ensure that the sealed compartment cover is intact and that there is no evidence of damage. If damage is present, do not use. | |
| Remove the vial from the tray (see Figure C). Examine the vial and ensure there is no evidence of damage. Set aside for use in Step 6. | |
| Peel off the compartment cover, exposing the sterile tray (see Figure D). | |
| 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– | |
| Figure FVigorously shake the vial for 10 seconds. Inspect the vial for clumping or granular appearance of the sterile contents. If clumping or granular appearance is present, do not use. Remove the protective plastic cap from the vial and clean the top of the vial with an alcohol wipe. Place the vial on a flat surface (see Figure F, | |
| Remove the syringe with attached vial adapter from the tray (see Figure G). Ensure the vial adapter is secured to the syringe by tightening the connection. | |
| Figure G | |
| Holding the clear barrel of the syringe, connect the vial adapter to the vial by firmly pushing the spike of the vial adapter straight through the center of the vial septum until it snaps securely into place (see Figure H).NOTE: Do not introduce additional air into the syringe prior to connecting the vial adapter to the vial. | |
| Figure H | |
Side Effects of Xipere
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: Ocular Adverse Reactions Reported in ≥ 2% of Patients and Non-ocular Adverse Reactions Reported in ≥ 5% of Patients a Includes intraocular pressure increased and ocular hypertension b Defined as not occurring on the day of the injection procedure, or occurring on the day of the injection procedure and not resolving the same day c Includes cataract, cataract cortical, and cataract subcapsular d Defined as occurring on the day of the injection procedure and resolving the same day Adverse Reaction XIPERE ® (N = 96) n (%) Control (N = 64) n (%) Ocular Increased intraocular pressure, non-acute a, b 13 (14%) 9 (14%) Eye pain, non-acute b 11 (12%) 0 Cataract c 7 (7%) 4 (6%) Increased intraocular pressure, acute a, d 6 (6%) 0 Vitreous detachment 5 (5%) 1 (2%) Injection site pain 4 (4%) 2 (3%) Conjunctival haemorrhage 4 (4%) 2 (3%) Visual acuity reduced 4 (4%) 1 (2%) Dry eye 3 (3%) 1 (2%) Eye pain, acute d 3 (3%) 0 Photophobia 3 (3%) 0 Vitreous floaters 3 (3%) 0 Uveitis 2 (2%) 7 (11%) Conjunctival hyperaemia 2 (2%) 2 (3%) Punctate keratitis 2 (2%) 1 (2%) Conjunctival oedema 2 (2%) 0 Meibomianitis 2 (2%) 0 Anterior capsule contraction 2 (2%) 0 Chalazion 2 (2%) 0 Eye irritation 2 (2%) 0 Eye pruritus 2 (2%) 0 Eyelid ptosis 2 (2%) 0 Photopsia 2 (2%) 0 Vision blurred 2 (2%) 0 Non-ocular Headache 5 (5%) 2 (3%)
Warnings & Cautions for Xipere
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.
Pregnancy Safety for Xipere
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 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.
Pediatric Use of Xipere
Pediatric Use Safety and effectiveness of XIPERE ® in pediatric patients have not been established.
Contraindications for Xipere
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.
Clinical Studies of Xipere
The efficacy of XIPERE ® was assessed in a 6-month, randomized, multicenter, double-masked, sham-controlled study in patients with macular edema associated with anterior-, intermediate-, posterior-, or pan-uveitis. Patients were treated at baseline and Week 12. The primary efficacy endpoint was the proportion of patients in whom best corrected visual acuity (BCVA) had improved by ≥ 15 letters from baseline after 24 weeks of follow-up (Table 2). Table 2: Number of Patients with ≥ 15 Letters Improvement from Baseline at Week 24 * The p-value was based on a Cochran Mantel Haenszel test for general association between treatment and response with stratification by country. Patients Who Gained ≥ 15 Letters from Baseline at Week 24 XIPERE ® (N = 96) Control (N = 64) n (%) 45 (47%) 10 (16%) Estimated Difference (95% CI) 31% (15%, 46%) CMH p-value* < 0.01 A statistically significantly greater proportion of patients treated with XIPERE ® achieved a ≥ 15-letter improvement in BCVA than control patients (p < 0.01) at Week 24. BCVA mean change from baseline at different visits is shown in Figure 1. Central subfield retinal thickness (CST) mean change from baseline at different visits is shown in Figure 2. Figure 1: Mean Change from Baseline in BCVA Figure 2: Mean Change from Baseline in CST IMAGE 19 IMAGE 20
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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