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Uceris

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Uceris

Side Effects
Interactions

SIDE EFFECTS

Serious and important adverse reactions include:

  • Hypercorticism and adrenal axis suppression [see WARNINGS AND PRECAUTIONS]
  • Symptoms of steroid withdrawal in those patients transferring from systemic glucocorticosteroid therapy [see WARNINGS AND PRECAUTIONS]
  • Increased susceptibility to infection [see WARNINGS AND PRECAUTIONS]
  • Other glucocorticosteroid effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to UCERIS rectal foam in 332 patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The median duration of exposure was 42 days. This included 14 patients exposed for at least 6 months.

UCERIS rectal foam was studied primarily in 2 placebo-controlled, 6-week trials in patients with active disease (Study 1 and Study 2). In these trials, 268 patients received UCERIS rectal foam 2 mg twice a day for 2 weeks followed by 2 mg once a day for 4 weeks [see Clinical Studies].

The most common adverse reactions ( ≥ 2% of the UCERIS rectal foam or Placebo group and at higher frequency in the UCERIS rectal foam group) were decreased blood cortisol, adrenal insufficiency, and nausea (Table 1). Decreased blood cortisol was defined as a morning cortisol level of < 5 mcg/dL. Adrenal insufficiency was defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with adrenocorticotropic hormone (ACTH).

A total of 10% of UCERIS rectal foam-treated patients discontinued treatment due to an adverse reaction compared with 4% of placebo-treated patients.

Table 1: Summary of Adverse Reactions in 2 Placebo Controlled Trials* (Studies 1 and 2)

Adverse Reaction UCERIS Rectal Foam 2 mg/25 mL
N = 268
n (%)
Placebo
N = 278
n (%)
Decreased blood cortisol# 46 (17) 6 (2)
Adrenal insufficiency† 10 (4) 2 (1)
Nausea 6 (2) 2 (1)
*Experienced by ≥ 2% of the UCERIS rectal foam or Placebo group and at higher frequency in the UCERIS rectal foam group
#Decreased blood cortisol was defined as a morning cortisol level of < 5 mcg/dL
†Adrenal insufficiency was defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with ACTH.

Of the 46 UCERIS rectal foam treated patients with decreased blood cortisol (defined as a morning cortisol level of < 5 mcg/dL) reported as an adverse event, none had adrenal insufficiency (defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with ACTH) (see Table 2). All cases of adrenal insufficiency resolved.

Table 2 summarizes the percentages of patients reporting glucocorticoid related effects in the 2 placebo-controlled trials (Studies 1 and 2).

Table 2: Summary of Glucocorticoid Related Effects in Two Placebo-Controlled Trials (Studies 1 and 2)

Adverse Reaction UCERIS Rectal Foam 2 mg/25 mL
N = 268
n (%)
Placebo
N = 278
n (%)
Overall 60 (22) 10 (4)
Blood cortisol decreased 46 (17)* 6 (2)
Adrenal insufficiency 10 (4) 2 (1)
Insomnia 1 (0.4) 1 (0.4)
Sleep disorder 1 (0.4) 0
Acne 1 (0.4) 0
Depression 1 (0.4) 1 (0.4)
Hyperglycemia 1 (0.4) 0
* Decreases in serum cortisol levels associated with budesonide treatment were seen at Weeks 1 and 2 (twice-daily treatment) in the UCERIS rectal foam group, but gradually returned to baseline levels during the 4 weeks of once daily treatment.

No clinically significant differences were observed with respect to the overall percentages of patients with any glucocorticoid related effects between UCERIS rectal foam and placebo after 6 weeks of therapy.

For additional details on morning cortisol levels and the response to the ACTH stimulation test, see CLINICAL PHARMACOLOGY.

Post-Marketing Experience

In addition to adverse reactions reported from clinical trials for UCERIS rectal foam, the following adverse reactions have been identified during post-approval use of other oral and rectal formulations of budesonide. 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 drug exposure.

Cardiac disorders: hypertension

Gastrointestinal disorders: pancreatitis

General disorders and administration site conditions: pyrexia, peripheral edema

Immune System Disorders: anaphylactic reactions

Nervous System Disorders: dizziness, benign intracranial hypertension

Psychiatric Disorders: mood swings

Skin and subcutaneous tissue disorders: pruritus, maculo-papular rash, allergic dermatitis

Read the Uceris (budesonide extended-release tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

CYP3A4 Inhibitors

The active ingredient of UCERIS rectal foam, budesonide, is metabolized by CYP3A4. Inhibitors of CYP3A4 activity (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) can increase systemic budesonide concentrations. Avoid concomitant use of CYP3A4 inhibitors with UCERIS rectal foam [see CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 11/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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