Trivaris
Generic Name: triamcinolone acetonide
Date of Approval: June 16, 2008
Company: Allergan, Inc.
Treatment for: Ocular Inflammatory Conditions
FDA Approves Trivaris
 | |||||||
 Feedback for Trivaris
| |||||||
The U.S. Food and Drug Administration (FDA) has approved Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL, a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via intravitreal injection, the ophthalmic indications for Trivaris include sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. These are inflammatory conditions that can result in vision loss.
Important Safety Information
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections.
The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes.
Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of possible corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.
Highlights of Trivaris Prescribing Information
These highlights do not include all the information needed to use Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL safely and effectively. See full prescribing information for Trivaris.
Indications and Usage
Trivaris is a corticosteroid indicated for:
- Ophthalmic Use
- Intramuscular Use
- Intra-articular Use
Dosage and Administration
- Intravitreal dosing: 4 mg per 0.05 mL (50 microliters of 80 mg/mL suspension).
- Intramuscular dosing: Initial dose is 60 mg injected into the gluteal muscle. Eight injections are required to administer a 60 mg dose.
- Intra-articular dosing: 2.5 to 5 mg for smaller joints and from 5 to 15 mg for larger joints depending on the disease being treated.
Dosage Forms and Strengths
- Single-use syringe containing 8 mg (80 mg/mL) of triamcinolone acetonide suspension.
Contraindications
- Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
- Corticosteroids should not be used in cerebral malaria.
Warnings and Precautions
- Trivaris is a suspension; it should not be administered intravenously.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia. Monitor patients for these conditions and taper doses gradually.
- Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection.
- Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure.
- Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels.
- Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
- GI perforation: Increased risk in patients with certain GI disorders.
- Decreases in bone density: Monitor bone density in patients receiving long term corticosteroid therapy.
- Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids.
- Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy.
- Use in pregnancy: Fetal harm can occur with first trimester use.
- Weight gain: May cause increased appetite.
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or www.allergan.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
NSAIDS including aspirin and salicylates: Increased risk of gastrointestinal side effects.
Patient Counseling Information
Patients should discuss with their physician if they have had recent or ongoing infections or if they have recently received a vaccine.
There are a number of medicines that can interact with corticosteroids such as triamcinolone. Patients should inform their health-care provider of all the medicines they are taking, including over-the counter and prescription medicines (such as phenytoin, diuretics, digitalis or digoxin, rifampin, amphotericin B, cyclosporine, insulin or diabetes medicines, ketoconazole, estrogens including birth control pills and hormone replacement therapy, blood thinners such as warfarin, aspirin or other NSAIDS, barbiturates), dietary supplements, and herbal products. If patients are taking any of these drugs, alternate therapy, dosage adjustment, and/or special test may be needed during the treatment.
Patients should be advised of common adverse reactions that could occur with corticosteroid use to include elevated intraocular pressure, cataracts, fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
In the days following intravitreal administration of Trivaris, patients are at risk for the development of endophthalmitis. If the eye becomes red, sensitive to light, painful or develops a change in vision, the patients should seek immediate care from an ophthalmologist.
For more information, please see Trivaris Prescribing Information at www.allergan.com.
 |
Link to Page |  |
Print Page |  |
Email Page |  | Add to List |
More Trivaris resources
