triamcinolone acetonide extended-release injectable suspension (Rx)

Brand and Other Names:Zilretta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable, powder for reconstitution

  • 32mg/single-dose vial
  • When reconstituted, forms an extended-release suspension

Osteoarthritis

Indicated for management of osteoarthritis knee pain

32 mg as a single intra-articular injection in the knee

Also see Administration

Dosing Considerations

Not interchangeable with other formulations of injectable triamcinolone acetonide

Not suitable for use in small joints (eg, hand)

Limitations of use: Efficacy and safety of repeat administration have not been demonstrated

Safety and efficacy not established

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Interactions

Interaction Checker

and triamcinolone acetonide extended-release injectable suspension

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                Monitor Closely (13)

                • cyclosporine

                  triamcinolone acetonide extended-release injectable suspension, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may increase or decrease cyclosporine concentrations. Also, cyclosporine may increase the plasma concentrations of the corticosteroids. Monitor for changes in cyclosporine concentrations and for toxicities of corticosteroids and/or cyclosporine.

                • dengue vaccine

                  triamcinolone acetonide extended-release injectable suspension decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

                • lomustine

                  lomustine and triamcinolone acetonide extended-release injectable suspension both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

                • lonapegsomatropin

                  lonapegsomatropin decreases effects of triamcinolone acetonide extended-release injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.

                  triamcinolone acetonide extended-release injectable suspension decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.

                • ofatumumab SC

                  ofatumumab SC, triamcinolone acetonide extended-release injectable suspension. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

                • oxaliplatin

                  oxaliplatin and triamcinolone acetonide extended-release injectable suspension both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.

                • ozanimod

                  ozanimod, triamcinolone acetonide extended-release injectable suspension. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

                • ponesimod

                  ponesimod and triamcinolone acetonide extended-release injectable suspension both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

                • sodium sulfate/?magnesium sulfate/potassium chloride

                  sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of triamcinolone acetonide extended-release injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

                • sodium sulfate/potassium sulfate/magnesium sulfate

                  sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of triamcinolone acetonide extended-release injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

                • somapacitan

                  somapacitan decreases effects of triamcinolone acetonide extended-release injectable suspension by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.

                • trastuzumab

                  trastuzumab, triamcinolone acetonide extended-release injectable suspension. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

                • trastuzumab deruxtecan

                  trastuzumab deruxtecan, triamcinolone acetonide extended-release injectable suspension. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

                Minor (0)

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                  Adverse Effects

                  1-10%

                  Joint swelling (3%)

                  Contusion (2%)

                  Sinusitis (2%)

                  Cough (2%)

                  Contusions (2%)

                  Postmarketing Reports

                  Endocrine: Increased blood glucose (in diabetic patients)

                  General and administration site conditions: Pain including injection site pain or discomfort and leg pain

                  Immune system: Hypersensitivity reactions including pruritis, rash, angioedema, and anaphylaxis

                  Infections and infestations: Septic arthritis

                  Musculoskeletal: Arthralgia, joint swelling or effusion, muscle spasms

                  Nervous system: Headache.

                  Reproductive system: Postmenopausal vaginal bleeding (similar to a menstrual period)

                  Skin and subcutaneous tissue: Pruritis

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                  Warnings

                  Contraindications

                  Hypersensitivity

                  Cautions

                  Triamcinolone acetonide extended-release injectable suspension is for intra-articular use only, not for IV, IM, SC, intraocular, epidural, intraocular, or intrathecal (IT) use

                  Rare instances of anaphylaxis have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration (see Contraindications)

                  Intra-articular injection of corticosteroid may be complicated by joint infection; avoid injection into an infected site; intra-articular infection may result in damage to joint tissues

                  Intra-articularly injected corticosteroids are systemically absorbed; patients taking corticosteroids are more susceptible to infections than are healthy individuals

                  Corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression, potential for adrenal sufficiency after withdrawal of treatment, which may persist for months; institute corticosteroid replacement therapy in situations of stress (eg, stress) during that period

                  Corticosteroids may increase blood pressure, salt and water retention, and potassium and calcium excretion; monitor for signs or symptoms (eg, edema, weight gain, and imbalance in serum electrolytes) in congestive heart failure or hypertensive patients

                  Corticosteroid may be associated with development or exacerbation of increased intraocular pressure; monitor patients with elevated intraocular pressure for potential treatment adjustment

                  Increased risk of gastrointestinal perforation with certain GI disorders (eg, active or latent peptic ulcers, diverticulosis, diverticulitis, ulcerative colitis, fresh intestinal anastomoses)

                  Corticosteroids decrease bone formation and increase bone resorption through their effect on calcium regulation and inhibition of osteoblast function

                  Risk of behavioral and mood disturbances may be associated with corticosteroid use; advise patients and/or caregivers to immediately report any new or worsening behavior or mood disturbances

                  Serious neurologic adverse events with epidural or IT injection

                  • Serious neurologic events, some resulting in death, have been reported with epidural or IT injection
                  • Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke
                  • These serious neurologic events have been reported with and without use of fluoroscopy
                  • Safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use

                  Drug interaction overview

                  • Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression
                  • Concomitant with potassium-depleting agents (ie, amphotericin B, diuretics), observe for development of hypokalemia
                  • Cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure
                  • Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance
                  • Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis; if possible, withdraw anticholinesterase agents at least 24 hours before initiating corticosteroid therapy
                  • Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin; monitor INR
                  • Corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required
                  • Corticosteroids may decrease isoniazid serum concentrations
                  • Cholestyramine may increase corticosteroid clearance
                  • Increased activity of both cyclosporine and corticosteroids may occur when the 2 are used concurrently; convulsions have been reported with this concurrent use
                  • Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect
                  • Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia
                  • Corticosteroids may suppress reactions to allergy related skin tests
                  • Aspirin and NSAIDs
                    • Coadministration of aspirin (or other NSAIDs) and corticosteroids increases risk of gastrointestinal side effects Use this combination cautiously in hypoprothrombinemia
                    • Salicylate clearance may be increased if coadministered with corticosteroids
                  • CYP3A4 inducers/inhibitors
                    • Concomitant use with CYP3A4 inducers may enhance the metabolism of corticosteroids and may require an increase in the corticosteroid dose
                    • Ketoconazole, a strong CYP3A4 inhibitor, has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects

                  Vaccines

                  • Prolonged corticosteroid therapy may cause a diminished response to toxoids, live, or inactivated vaccines due to inhibition of antibody response; possibly potentiate the replication of some organisms contained in live attenuated vaccines
                  • If possible, defer routine administration of vaccines or toxoids until corticosteroid therapy is discontinued
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                  Pregnancy & Lactation

                  Pregnancy

                  There are no data regarding the use in pregnant women to inform a drug associated risk of adverse developmental outcomes

                  In animal reproductive studies from published literature, pregnant mice, rats, rabbits, or primates administered triamcinolone acetonide during organogenesis period at doses that produced exposures less than the maximum recommended human dose (MRHD) caused resorptions, decreased fetal body weight, craniofacial and/or other abnormalities such as omphalocele

                  Corticosteroids may result in menstrual pattern irregularities (eg, deviations in timing, duration of menses, increased/decreased blood loss)

                  Lactation

                  There are no available data on the presence of triamcinolone acetonide in either human or animal milk, the effects on the breastfed infant, or the effects on milk production

                  Corticosteroids have been detected in human milk and may suppress milk production

                  Caution should be exercised when corticosteroids are administered to breastfeeding women

                  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.

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                  Pharmacology

                  Mechanism of Action

                  Corticosteroid with anti-inflammatory and immunomodulating properties; it binds to and activates the glucocorticoid receptor, leading to activation of anti-inflammatory transcription factors (eg, lipocortins); it also inhibits inflammatory transduction pathways by blocking arachidonic acid release and preventing prostaglandin and leukotriene synthesis

                  Absorption

                  Peak plasma time: 7 hr

                  Peak plasma concentration: 1143.7 pg/mL

                  AUC: 21,219.2 pg·h/mL (0-24 hr); 842,149.2 pg·h/mL (0-inf hr)

                  Elimination

                  Half-life: 633.9 hr

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                  Administration

                  Intra-articular Preparation

                  Tap vial firmly on a padded surface to loosen up powder

                  Visually inspect vial to ensure powder is properly dislodged

                  Gently push vial adapter down onto powder vial until the adapter will snap into place

                  Withdraw 5 mL of supplied diluent with syringe and needle

                  Remove plastic holder from vial; remove needle from syringe containing diluent

                  Attach syringe onto vial adapter by pushing down and turning clockwise

                  Slowly and completely push down the plunger; slowly pull back on plunder to the 5 mL mark

                  Mix diluent and powder; tap bottom edge of the vial repeatedly and firmly

                  Swirl gently every five or six taps; tap for at least 1 minute until all powder is completely dispersed

                  Avoid vigorous shaking of the vial to minimize foaming

                  Inspect vial to ensure a uniform suspension has been achieved; properly mixed suspensions appear milky white, contain no clumps, and move freely down the vial wall

                  Intra-articular Administration

                  Intra-articular use only

                  Administered via a single dose device

                  Swirl the vial gently for at least 10 seconds to ensure the powder is fully suspended

                  Promptly inject after preparation to avoid settling of the suspension

                  If needed, the suspension can be stored in the vial for up to 4 hr at ambient conditions; gently swirl the vial to resuspend any of the settled microspheres prior to preparing the syringe for injection

                  Withdraw the full contents from vial into the syringe

                  Do not reuse

                  Discard any excess suspension in the vial immediately after the injection

                  Storage

                  Unopened kit

                  • Store refrigerated 36-46°F (2-8°C)
                  • Do not freeze
                  • If refrigeration is unavailable, may store at temperatures not exceeding 77°F (25°C) for up to 6 weeks and then discard
                  • Do not expose the single-dose kits to temperatures above 77°F (25°C)

                  Diluted suspension

                  • If needed, may store in the vial for up to 4 hr at ambient conditions
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                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.