• 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 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
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