IMPORTANT SAFETY
INFORMATION FOR KENALOG-10, KENALOG-40, AND
KENALOG-80 INJECTIONS

KENALOG Injection is not for use in neonates. Contains benzyl alcohol.

KENALOG is not for intravenous, intraocular, epidural, or intrathecal use due to the potential for serious adverse events that could be life threatening or lead to death. Please see full Prescribing Information for additional information on potential adverse events associated with these routes of administration. Additionally, KENALOG-10 is not for intramuscular use; and KENALOG-40 and KENALOG-80 are not for intradermal use.

Contraindications

• Use in patients who are hypersensitive to any components of this product
• For intramuscular administration for idiopathic thrombocytopenic purpura

Warnings and Precautions

General:

• Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus and also rare reports of death, particularly in preterm infants. The amount of benzyl alcohol at which toxicity occurs is unknown; consider the daily metabolic load from combined sources
• Cases of serious anaphylaxis, including death, have been reported in patients receiving triamcinolone injection, regardless of route of administration
• Should not be used in acute stress situations due to long-acting formulation
• High doses should not be used for the treatment of traumatic brain injury due to an increase in early and late mortality in patients with cranial trauma
• Treatment complications with glucocorticoids are dose and duration dependent; use the lowest possible dose to control the condition
• Kaposi’s sarcoma has been reported in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation may lead to improvement
• Additional KENALOG-40 and KENALOG-80 Warning:
  • Local atrophy is likely to occur unless a deep intramuscular injection is given
  • To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress during treatment and for a year afterward

Cardio-Renal:

• Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary
• Use with great caution in patients with left ventricular free wall rupture after a recent myocardial infarction, and with caution in patients with congestive heart failure, hypertension, or renal insufficiency

Endocrine:

• Reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency can occur after treatment withdrawal
• Changes in thyroid status may necessitate dosage adjustment
• Drug-induced secondary adrenocortical insufficiency may be minimized by gradual dosage reduction

Infections:

• Corticosteroids may increase susceptibility to a new infection, decrease resistance, cause inability to localize infection, mask some signs of current infection, and increase the risk of exacerbation of systemic fungal infections or reactivation/exacerbation of infections caused by special pathogens or latent tuberculosis; the rate of infectious complications increases with increasing dose
• Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids
• Vaccination: administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted

Ophthalmic:

• Corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections
• Use is not recommended in the treatment of optic neuritis and active ocular herpes simplex
• Monitor intraocular pressure when used for more than 6 weeks
• Nasal turbinate use is not recommended

Gastrointestinal:

• Use with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, due to increased risk of a perforation. Signs of perforation may be minimal or absent
• There is an enhanced effect of corticosteroids in patients with cirrhosis

Intra-Articular and Soft Tissue Administration:

• Intra-articularly injected corticosteroids may be systemically absorbed
• Examine any joint fluid present to exclude a septic process. If needed, institute antimicrobial therapy
• Avoid injection into an infected site. Local injection into a previously infected joint or into unstable joints is not usually recommended. Intra-articular injection may damage joint tissues

Musculoskeletal:

• Corticosteroids may lead to inhibition of bone growth in pediatric patients and osteoporosis at any age
• Use caution in patients at increased risk of osteoporosis

Neuro-Psychiatric:

• Although corticosteroids may be effective in acute exacerbations of multiple sclerosis, it is unknown if they affect the outcome or history of the disease
• Acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with neuromuscular transmission disorders or receiving concomitant therapy with neuromuscular blocking drugs. The acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Improvement after discontinuation may take weeks to years
• Psychiatric episodes may appear with corticosteroid use. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids

Adverse Reactions

From a BMS analysis of 14 published prospective randomized clinical trials or observational studies (N=1362), the most common adverse reactions (1-10%) in adults and pediatrics were: arthralgia (3.1%), infection (2.2%), headache (1.4%), and injection site reaction (1.1%).*

Drug Interactions

• Coadministration with amphotericin B, potassium-depleting diuretics, or digitalis may increase risk of hypokalemia
• Macrolide antibiotics and estrogens, including oral contraceptives, may decrease corticosteroid clearance and/or metabolism
• Coadministration with warfarin may result in inhibition of response to warfarin
• Corticosteroids may increase blood glucose concentrations; antidiabetic agent dose may require adjustment
• KENALOG is a substrate of CYP3A4. Consider the benefit-risk of concomitant use and monitor for systemic corticosteroid side effects when coadministering with strong CYP3A4 inhibitors. Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%. There have been post-marketing reports of clinically significant drug interactions with strong CYP3A4 inhibitors such as ritonavir
• Hepatic enzyme inducers may enhance metabolism and require dose increase of corticosteroids
• Coadministration with aspirin or nonsteroidal anti-inflammatory drugs increases risk of gastrointestinal side effects; use caution with aspirin in patients with hypoprothrombinemia

Pregnancy

• There are no adequate and well-controlled studies with corticosteroids in pregnant women. Corticosteroids are teratogenic in many species when given in doses equivalent to human doses. Animal studies have shown an increased incidence of cleft palate in the offspring; use only if the potential benefit justifies the potential risk
• Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism

Lactation

• Use with caution in nursing mothers; corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects



Please see full Prescribing Information for KENALOG-10 Injection.

Please see full Prescribing Information for KENALOG-40 and KENALOG-80 Injection.

^*Data on File. TRIA001. Bristol-Myers Squibb Company, Princeton, NJ.

Reference:

Reference:

1. KENALOG-10 (triamcinolone acetonide injectable suspension, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb.
2. KENALOG-40 and KENALOG-80 (triamcinolone acetonide injectable suspension, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb.
3. KENALOG-40 and KENALOG-80 (triamcinolone acetonide injectable suspension, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb.