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The following serious adverse reactions are discussed elsewhere in the label:
- Infections [see WARNINGS AND PRECAUTIONS]
- Malignancies [see WARNINGS AND PRECAUTIONS]
- Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Psoriasis Clinical Studies
The safety data reflect exposure to STELARA® in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years.
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies].
Table 1: Adverse reactions reported by ≥ 1% of
subjects through Week 12 in Ps STUDY 1 and Ps STUDY 2
|45 mg||90 mg|
|Nasopharyngitis||51 (8%)||56 (8%)||49 (7%)|
|Upper respiratory tract infection||30 (5%)||36 (5%)||28 (4%)|
|Headache||23 (3%)||33 (5%)||32 (5%)|
|Fatigue||14 (2%)||18 (3%)||17 (3%)|
|Diarrhea||12 (2%)||13 (2%)||13 (2%)|
|Back pain||8 (1%)||9 (1%)||14 (2%)|
|Dizziness||8 (1%)||8 (1%)||14 (2%)|
|Pharyngolaryngeal pain||7 (1%)||9 (1%)||12 (2%)|
|Pruritus||9 (1%)||10 (2%)||9 (1%)|
|Injection site erythema||3 ( < 1%)||6 (1%)||13 (2%)|
|Myalgia||4 (1%)||7 (1%)||8 (1%)|
|Depression||3 ( < 1%)||8 (1%)||4 (1%)|
Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).
One case of RPLS occurred during clinical trials [see WARNINGS AND PRECAUTIONS].
In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA® -treated subjects), 27% of STELARA® -treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA® -treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of follow-up) [see WARNINGS AND PRECAUTIONS].
In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 3.2 years), representing 8998 subject-years of exposure, 72.3% of STELARA® -treated subjects reported infections (0.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up).
In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 3.2 years, representing 8998 subject-years of exposure), 1.7% of STELARA® -treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred subject-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of STELARA® -treated subjects (0.52 per hundred subject-years of follow-up) [see WARNINGS AND PRECAUTIONS]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, melanoma, colorectal and breast. Malignancies other than non-melanoma skin cancer in STELARA® -treated patients during the controlled and uncontrolled portions of studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).1
Psoriatic Arthritis Clinical Studies
The safety of STELARA® was assessed in 927 patients in two randomized, double-blind, placebo-controlled studies in adult patients with active psoriatic arthritis (PsA). The overall safety profile of STELARA® in patients with PsA was consistent with the safety profile seen in psoriasis clinical studies. A higher incidence of arthralgia, nausea, and dental infections was observed in STELARA® -treated patients when compared with placebo-treated patients (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical trials.
Approximately 6% of patients treated with STELARA® in psoriasis and psoriatic arthritis clinical studies developed antibodies to ustekinumab, which were generally low-titer. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. No ustekinumab-related serious hypersensitivity reactions were observed in psoriasis and psoriatic arthritis clinical trials. In psoriasis studies, the majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies.
The data above reflect the percentage of subjects whose test results were positive for antibodies to ustekinumab and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ustekinumab with the incidence of antibodies to other products may be misleading.
Adverse reactions have been reported during post-approval use with STELARA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to STELARA® exposure.
Skin reactions: Pustular psoriasis, erythrodermic psoriasis.
1Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 6.6.2 Regs Research Data, Nov 2009 Sub (1973-2007) - Linked To County Attributes - Total U.S., 1969-2007 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2010, based on the November 2009 submission.
Read the Stelara Injection (ustekinumab) Side Effects Center for a complete guide to possible side effects
Drug interaction studies have not been conducted with STELARA®.
In psoriasis studies the safety of STELARA® in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA® [see WARNINGS AND PRECAUTIONS].
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, STELARA® , an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation of STELARA® in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, monitoring for therapeutic effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) should be considered and the individual dose of the drug adjusted as needed [see CLINICAL PHARMACOLOGY].
STELARA® has not been evaluated in patients who have undergone allergy immunotherapy. STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Read the Stelara Injection Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/18/2014
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