RECOMMENDED PREMEDICATION AND PROPHYLACTIC MEDICATIONS 1

  • Provide prophylaxis for Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections for patients with CLL during treatment and for up to 12 months following treatment as appropriate

RITUXAN HYCELA ADMINISTRATION 1

RITUXAN HYCELA is for subcutaneous use only

Inject RITUXAN HYCELA into the subcutaneous tissue of the abdomen over approximately 5-7 minutes

  • RITUXAN HYCELA should only be administered by a healthcare professional with appropriate medical support to manage severe reactions that can be fatal if they occur
  • Never inject RITUXAN HYCELA into areas where the skin is red, bruised, tender, hard, or areas where there are moles or scars
  • No data are available on performing the injection at other sites of the body
  • If administration of RITUXAN HYCELA is interrupted, continue administering at the same site or at a different site, but restricted to the abdomen
  • During treatment with RITUXAN HYCELA, do not administer other medications for subcutaneous use at the same sites as RITUXAN HYCELA
  • The injection should be interrupted immediately when observing signs of a severe reaction and aggressive symptomatic treatment should be initiated

RITUXAN HYCELA is supplied in a ready-to-use vial and is administered as a fixed dose

  • FL & DLBCL Volume of 11.7 mL:
    • 1,400 mg rituximab and 23,400 Units hyaluronidase human in a single-dose vial
  • CLL Volume of 13.4 mL:
    • 1,600 mg rituximab and 26,800 Units hyaluronidase human in a single-dose vial
  • Dose reductions of RITUXAN HYCELA are not recommended
  • When RITUXAN HYCELA is given in combination with chemotherapy dose, reduce the chemotherapeutic drugs to manage adverse reactions

Observe patients for at least 15 minutes following RITUXAN HYCELA administration

  • Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3)
  • A longer observation period may be appropriate in patients with an increased risk of hypersensitivity reactions

Local cutaneous reactions, including injection site reactions, have been reported in patients receiving RITUXAN HYCELA

  • Symptoms included pain, swelling, induration, hemorrhage, erythema, pruritus, and rash
  • Some local cutaneous reactions occurred more than 24 hours after RITUXAN HYCELA administration
  • The incidence of local cutaneous reactions following administration of RITUXAN HYCELA was 16%. Reactions were mild or moderate and resolved without any specific treatment
  • Local cutaneous reactions of any grade were most common during the first RITUXAN HYCELA cycle (Cycle 2; 5%), with the incidence decreasing with subsequent injections
Watch the Dosing & Administration Video
Download the RITUXAN HYCELA Dosing & Administration Brochure