Uceris

UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

• •The recommended dosage is 1 metered dose administered twice daily for 2 weeks followed by 1 metered dose administered once daily for 4 weeks.  
• •For rectal administration only. (
  2.2 Administration Instructions

  Advise patients:

  • •UCERIS rectal foam is only to be applied rectally. It is not for oral use.
  • •Before using UCERIS rectal foam, use the bathroom to empty your bowels.
  • •Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used.
  • •Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use.
  • •UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet).
  • •Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning.
  • •Avoid concomitant use of CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during treatment with UCERIS rectal foam.
  )
• •Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. (
  2.2 Administration Instructions

  Advise patients:

  • •UCERIS rectal foam is only to be applied rectally. It is not for oral use.
  • •Before using UCERIS rectal foam, use the bathroom to empty your bowels.
  • •Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used.
  • •Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use.
  • •UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet).
  • •Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning.
  • •Avoid concomitant use of CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during treatment with UCERIS rectal foam.
  )

UCERIS rectal foam is formulated as an emulsion which is filled into an aluminum canister with an aerosol propellant. It is available in 1 strength: 2 mg budesonide per metered dose.

• •
  Pregnancy:
  Based on animal data, may cause fetal harm.
• •
  Hepatic Impairment:
  Monitor patients for signs and/or symptoms of hypercorticism. (
  8.6 Hepatic Impairment

  No dosage adjustment is needed for patients with mild (Child-Pugh Class A) hepatic impairment. Patients with moderate to severe hepatic impairment (Child-Pugh Class B or C) should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS rectal foam should be considered in these patients if signs of hypercorticism are observed

  [see Warnings and Precautions (

  5.1

  )

  and

  Clinical Pharmacology ]

  .
  )

• •
  Hypercorticism and adrenal suppression:
  Follow general warnings concerning glucocorticosteroids.
• •
  Impaired Adrenal Function in Patients Transferred from Other Glucocorticoids:
  Taper slowly from glucocorticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema). (
  5.2 Impaired Adrenal Suppression in Patients Transferred from Other Glucocorticoids

  Monitor patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS rectal foam, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously.

  Replacement of systemic glucocorticosteroids with UCERIS rectal foam may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.
  )
• •
  Increased Risk of Infection, including serious and fatal chicken pox and measles:
  Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. (
  5.3 Increased Risk of Infection

  Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of glucocorticosteroids. In patients who have not had these diseases, particular care should be taken to avoid exposure.

  How the dose, route and duration of glucocorticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior glucocorticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see prescribing information for VZIG and IG). If chicken pox develops, treatment with antiviral agents may be considered.

  Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
  )
• •
  Other Glucocorticosteroid Effects:
  Monitor patients with other conditions where glucocorticoids may have unwanted effects. (
  5.4 Other Glucocorticosteroid Effects

  Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.
  )
• •
  Flammable Contents:
  The contents of UCERIS rectal foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration. (
  5.5 Flammable Contents

  The contents of UCERIS rectal foam include n-butane, isobutane and propane as propellants which are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following administration. Patients should temporarily discontinue use of UCERIS rectal foam before initiation of bowel preparation for colonoscopy and consult their healthcare provider before resuming therapy.
  )