KENALOG-40 SUMMARY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intramuscular or Intra-articular Use
NOT FOR INTRAVENOUS, INTRADERMAL, OR INTRAOCULAR USE
Kenalog®-40 Injection (triamcinolone acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRA-DERMAL INJECTION.
Kenalog®-40 Injection is indicated for the following
Intramuscular
Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows:
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic diseases: For the palliative management of leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Intra-Articular
The intra-articular or soft tissue administration of Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
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NEWS HIGHLIGHTSMedia Articles Related to Kenalog-40 (Triamcinolone)
triamcinolone acetonide inhaler, Azmacort
Source: MedicineNet budesonide inhaler Specialty [2009.07.31]
Title: triamcinolone acetonide inhaler, Azmacort
Category: Medications
Created: 12/31/1997
Last Editorial Review: 7/31/2009
Published Studies Related to Kenalog-40 (Triamcinolone)
A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6. [2009.09]
OBJECTIVE: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with standard care (grid photocoagulation in eyes without dense macular hemorrhage and deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage) for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO)... CONCLUSIONS: There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group. Application to Clinical Practice Grid photocoagulation as applied in the SCORE Study remains the standard care for patients with vision loss associated with macular edema secondary to BRVO who have characteristics similar to participants in the SCORE-BRVO trial. Grid photocoagulation should remain the benchmark against which other treatments are compared in clinical trials for eyes with vision loss associated with macular edema secondary to BRVO. Trial Registration clinicaltrials.gov Identifier: NCT00105027.
A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. [2009.09]
OBJECTIVE: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO)... CONCLUSIONS: Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.
Factors associated with variability in response of diabetic macular oedema after intravitreal triamcinolone. [2009.08]
PURPOSE: To identify factors associated with variability in anatomical and functional response of diabetic macular oedema (DMO) after 4 mg of intravitreal triamcinolone acetonide (ivTA), and for recurrence of macular oedema. Design: Pooled analysis of individual data from two randomized controlled trials... CONCLUSION: Baseline OCT-measured retinal thickening and BCVA are important predictors of maximal anatomical and functional response of DMO to ivTA, respectively. Combination treatment strategy using sequential laser therapy may have a role in delaying recurrence of oedema after triamcinolone.
Periocular triamcinolone for prevention of macular edema after plaque radiotherapy of uveal melanoma: a randomized controlled trial. [2009.07]
OBJECTIVE: To determine the efficacy and safety of periocular triamcinolone acetonide (40 mg) for the prevention of macular edema in patients undergoing plaque radiotherapy for uveal melanoma... CONCLUSIONS: Periocular triamcinolone is beneficial in reducing the risk of macular edema up to 18 months after plaque radiotherapy for uveal melanoma and significantly reduces the risk of moderate vision loss and poor visual acuity in these patients.
A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. [2009.07]
PURPOSE: To compare intraoperative injection of triamcinolone and ciprofloxacin in a controlled-release system (DuoCat) with prednisolone and ciprofloxacin eye drops after cataract surgery... CONCLUSIONS: One injection of DuoCat had a therapeutic response and ocular tolerance that were equivalent to conventional eye drops in controlling inflammation after cataract surgery. (ClinicalTrials.gov number, NCT00431028.).
Clinical Trials Related to Kenalog-40 (Triamcinolone)
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema involving the center of the macula who have not already been given maximal laser
treatment.
Patients with one study eye will be randomly assigned (stratified by prior laser) with equal
probability to one of five treatment groups:
1. Focal laser photocoagulation (modified ETDRS technique)
2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
3. Anterior peribulbar injection of 20 mg triamcinolone
4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
For patients with two study eyes (both eyes eligible at the time of randomization), the right
eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of
the five treatment groups listed above. If the right eye was assigned to laser only, then the
left eye will be assigned to one of the four triamcinolone groups above with equal
probability (stratified by prior laser). If the right eye was assigned to receive
triamcinolone, then the left eye will receive laser only.
Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone
acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb
and is approved by the Food and Drug Administration for intramuscular use for a variety of
indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular
conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many
years.
Two different triamcinolone regimens will be assessed in the study: 40 mg injected
posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen
will be better. Although the injection behind the eye is more common than the injection near
the front of the eye, the injection near the front of the eye has less risk of injuring the
eye. However, it is possible that the injection near the front of the eye may increase eye
pressure more frequently. Little is known about which of the two injections decreases macular
edema and improves vision more often.
Patients enrolled into the study will be followed for three years and will have study visits
1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study
treatment. For the first 8 months of the study, patients should only be retreated with their
randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or
more, then any treatment may be given at the investigator's discretion. After completion of
the 8-month visit, treatment is at investigator discretion.
The primary objective of this study is to obtain estimates of efficacy and safety outcomes
for each of the treatment groups. These estimates will provide a basis for the sample size
estimation and hypothesis generation in a phase III trial.
Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration [Completed]
To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone
will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared
with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult
subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal
triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the
safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim
statistical readout will be performed when the first 60 patients have completed 6 months of
follow-up evaluation.
Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema [Active, not recruiting]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema. Patients with one study eye will be randomly assigned (stratified by visual acuity and
prior laser) with equal probability to one of the three treatment groups:
1. Laser photocoagulation
2. 1mg intravitreal triamcinolone acetonide injection
3. 4mg intravitreal triamcinolone acetonide injection
For patients with two study eyes (both eyes eligible at the time of randomization), the right
eye (stratified by visual acuity and prior laser) will be randomly assigned with equal
probabilities to one of the three treatment groups listed above. The left eye will be
assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned
to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with
equal probability (stratified by visual acuity and prior laser).
The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal
injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will
receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will
be better.
Patients enrolled into the study will be followed for three years and will have study visits
every 4 months after receiving their assigned study treatment. In addition, standard of care
post-treatment visits will be performed at 4 weeks after each intravitreal injection.
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema [Completed]
Melanoma is the most common primary tumour which occurs inside the eye. For over 20-years,
it has been possible, in many cases, to use local delivery of radiation to the eye to treat
this type of tumour, avoiding the need to surgically remove the affected eye. This
treatment, however, is often complicated by radiation-induced loss of vision, months or years
after treatment.
The aim of this research project is to investigate the potential prevention of radiation
complications in the eye by giving anti-inflammatory medication (a long-acting steroid) in
the form of a local injection around the eye at the time of treatment, and at 4-months and
8-months following treatment. This medication (named ‘triamcinolone’) has been successfully
used to treat similar complications of diabetic eye disease, for example, and has a good
safety profile.
The rationale of this study is to attempt to preserve vision, in addition to preserving the
eye, in patients affected by this eye tumour, and therefore preserve quality of life for
these patients.
Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study [Active, not recruiting]
This open label extension will treat all the eyes of study participants with active study
medication (intravitreal triamcinolone) as well as standard laser treatment where
appropriate.
The specific aims will be to test the following hypotheses:
- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs
after laser treatment remains efficacious over five years
- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs
after laser treatment retains a manageable and acceptable safety profile over five
years
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