triamcinolone (Rx)

Brand and Other Names:Zilretta, Kenalog-10, more...Kenalog-40
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable suspension (triamcinolone acetonide)

  • 10mg/mL (Kenalog-10; intralesional or intra-articular administration)
  • 40mg/mL (Kenalog-40; IM or intra-articular administration)

injectable, powder for reconstitution (triamcinolone acetonide)

  • 32mg/single-dose vial (Zilretta; intraarticular administration)
  • When reconstituted, forms an extended-release suspension
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Rheumatic or Arthritic Disorders

Treatment of rheumatic or arthritic disorders

60 mg IM every 6 weeks; may be supplemented by additional 20-100 mg IM PRN

Intralesional injection (Kenalog-10): 1 mg per injection site 1 or more times weekly; not to exceed 30 mg/day

Intra-articular/intrasynovial/soft-tissue injection (Kenalog-40): Large joints, 15-40 mg; small joints/tendon sheath inflammation, 2.5-10 mg

Osteoarthritis of the knee (Zilretta)

  • 32 mg administered as a single intra-articular injection in the knee
  • Also, see Dosing Considerations and Administration

Dermatoses

Indicated for treatment of steroid-responsive dermatoses

Kenalog-10: Initial dose varies intralesional injection depending on specific disease and lesion being treated; may be repeated at weekly or less frequent intervals; multiple sites may be injected if they are ≥1 cm apart

Inflammatory & Allergic Systemic Conditions

Kenalog-40: 60 mg IM single injection; adjust dose to a range of 40-80 mg

For patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy, a single injection of 40-100 mg per season may be given

Multiple Sclerosis

Kenalog-40: 160 mg IM qDay for 1 week, followed by 64 mg every other day for 1 month

Dosing Considerations

Zilretta is not interchangeable with other formulations of injectable triamcinolone acetonide

Limitation of Use

  • Zilretta is not intended for repeat administration

Dosage Forms & Strengths

injectable suspension (triamcinolone acetonide)

  • 10mg/mL (Kenalog-10; intralesional or intra-articular administration)
  • 40mg/mL (Kenalog-40; IM or intra-articular administration)
more...

Rheumatic or Arthritic Disorders

Treatment of rheumatic or arthritic disorders

Neonates: Not for use in neonates (contains benzyl alcohol); see Cautions

6-12 years: 0.03-0.2 mg/kg IM every 1-7 days

>12 years: 60 mg IM every 6 weeks; may be supplemented by additional 20-100 mg IM PRN

>12 years, intralesional injection (10 mg/mL suspension): 1 mg per injection site 1 or more times weekly; not to exceed 30 mg/day

Inflammatory & Allergic Systemic Conditions

Initial dose of triamcinolone may vary depending on specific disease entity being treated

0.11-1.6 mg/kg/day IM divided q3-4hr 

Also, see Cautions and Administration

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Interactions

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            Adverse Effects

            1-10%

            Joint swelling (3%)

            Contusions (2%)

            Sinusitis (2%)

            Cough (2%)

            Frequency Not Defined

            Acne

            Arrhythmia

            Cardiac enlargement

            Circulatory collapse

            Adrenal suppression

            Anaphylaxis

            Vasculitis

            Increased intracranial pressure

            Thromboembolism

            Euphoria

            Arthragia

            Stroke

            Fracture

            Joint tissues damage

            Lupus erythematosus-like lesions

            Hypertrichosis

            Cataract

            Delayed wound healing

            Diabetes mellitus

            Epistaxis

            Neuritis

            Hirsutism

            Increased appetite

            Indigestion

            Tendon rupture

            Insomnia

            Myopathy

            Osteoporosis

            Pseudotumor cerebri (on withdrawal)

            Psychosis

            Vertigo

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            Warnings

            Contraindications

            Systemic fungal infection, except as intra-articular injection for localized joint conditions

            Documented hypersensitivity to corticosteroids or any components of the product

            IM corticosteroids contraindicated for idiopathic thrombocytopenic purpura (ITP)

            Triamcinolone diacetate injectable suspension contraindicated for intrathecal administration

            Cerebral malaria

            Benzyl alcohol-containing formulations associated with potentially fatal "gasping syndrome" in premature newborns

            Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids

            Cautions

            Triamcinolone acetonide injectable suspension is for intra-articular or intralesional use only, not for IV, IM, SC, intraocular, epidural, or IT use

            Triamcinolone acetonide suspensions contain benzyl alcohol; exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants

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

            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 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

            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

            Epidural injection

            • Serious neurologic events, some resulting in death, have been reported with epidural 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 interactions 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
            • Cholestyramine may increase the clearance of corticosteroids Increased activity of both cyclosporine and corticosteroids may occur when the two 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
              • Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects
              • Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia
              • Clearance of salicylates may be increased with concurrent use of 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 of triamcinolone acetonide 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)

            Lactaction

            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 a nursing woman

            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

            Potent glucocorticoid with minimal to no mineralocorticoid activity

            Controls or prevents inflammation by suppressing migration of polymorphonuclear leukocytes and fibroblasts and reversing capillary permeability

            Suppresses immune system by reducing volume and activity of lymphatic system

            Absorption

            Bioavailability: Complete with intra-articular injection

            Duration: 8-12 hr (PO)

            Peak plasma time: 8-10 hr (IM); 7 hr (Zilretta)

            Peak plasma concentration: 1143.7 pg/mL (Zilretta)

            Distribution

            Protein bound: 68%

            Vd: 99.5 L

            Metabolism

            Metabolized in liver

            Elimination

            Half-life: Plasma, 2-3 hr; biologic, 18-36 hr; 633.9 (Zilretta)

            Renal clearance: 9.5 mL/min

            Excretion: Urine (40%), feces (60%)

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            Administration

            Inspect all kit components to confirm they have not expired and the seals are intact

            Preparation (Zilretta)

            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 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 one 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

            IM, Intralesional, or Intra-articular Administration

            Kenalog injection

            • Systemic: Deep IM administration into the gluteal muscle
            • Local: Intra-articular or intralesional administration only
            • With intra-articular administration, prior use of a local anesthetic may often be desirable
            • When administered intralesionally, inject directly into the lesion (ie, intradermally or subcutaneously); one mL syringes with a 23- to 25-gauge needle are preferable for intralesional injections

            Zilretta

            • Intra-articular use only
            • Single dose-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 hours 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

            Kenalog-10 and Kenalog 40: Store at 20-25°C (68-77°F); avoid freezing

            Single-dose triamcinolone acetonide kits (Zilretta)

            • Unused kits: Store in refrigerator 36-46°F (2°-8°C); do not freeze
            • If refrigeration is unavailable, store temperatures ≥77°F (25°C) for up to six weeks and then discard
            • Do not expose the single-dose kits to temperatures above 77°F (25°C)
            • Diluted suspensions: Stored in the vial for up to 4 hours at ambient conditions
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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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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