Usual Adult Dose for Follicular Lymphoma

Relapsed or Refractory, Follicular Lymphoma: 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously once a week for 3 or 7 weeks following a full dose of a rituximab product by IV infusion at week 1 (4 or 8 weeks total)

Retreatment for Relapsed or Refractory, Follicular Lymphoma: 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously once a week for 3 weeks following a full dose of a rituximab product by IV infusion at week 1 (4 weeks total)

Previously Untreated, Follicular Lymphoma: 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously on Day 1 of Cycles 2 through 8 of chemotherapy (every 21 days), for up to 7 cycles following a full dose of a rituximab product by IV infusion on Day 1 of Cycle 1 of chemotherapy (up to 8 cycles total); in patients with complete or partial response, initiate maintenance treatment 8 weeks following completion of hyaluronidase-rituximab in combination with chemotherapy; administer 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously as a single agent every 8 weeks for 12 doses

Non-progressing, Follicular Lymphoma after first line CVP chemotherapy: Following completion of 6 to 8 cycles of CVP chemotherapy and a full dose of a rituximab product by IV infusion at week 1, administer 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously once a week for 3 weeks (4 weeks total) at 6 month intervals to a maximum of 16 doses

Comments:

• All patients must receive at least one full dose of a rituximab product by IV infusion before starting therapy with hyaluronidase-rituximab.
• Premedicate before each dose with acetaminophen and an antihistamine. Premedication with a glucocorticoid should also be considered.

Use: For the treatment of adult patients with:

• Relapsed or refractory, follicular lymphoma as a single agent
• Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy
• Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy

Usual Adult Dose for Lymphoma

23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously on Day 1 of Cycles 2 through 8 of CHOP chemotherapy for up to 7 cycles following a full dose of a rituximab product by IV infusion at Day 1, Cycle 1 of CHOP chemotherapy (up to 6 to 8 cycles total)

Comments:

• All patients must receive at least one full dose of a rituximab product by IV infusion in combination with CHOP chemotherapy before starting therapy with hyaluronidase-rituximab.
• Premedicate before each dose with acetaminophen and an antihistamine. Premedication with a glucocorticoid should also be considered.

Use: For the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens

Usual Adult Dose for Chronic Lymphocytic Leukemia

26,800 Units hyaluronidase human and 1600 mg rituximab subcutaneously on Day 1 of Cycles 2 through 6 (every 28 days) for a total of 5 cycles following a full IV dose at Day 1, Cycle 1 (6 cycles total) in combination with fludarabine and cyclophosphamide (FC) chemotherapy

Comments:

• All patients must receive at least one full dose of a rituximab product by IV infusion in combination with CHOP chemotherapy before starting therapy with hyaluronidase-rituximab.
• Premedicate before each dose with acetaminophen and an antihistamine. Premedication with a glucocorticoid should also be considered.

Use: In combination with fludarabine and cyclophosphamide (FC) for the treatment of adult patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products.
• Hepatitis B Virus (HBV) reactivation can occur in patients treated with rituximab-containing products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before therapy initiation, and monitor patients during and after discontinuation of therapy. Discontinue this combination drug and concomitant medications in the event of HBV reactivation.
• Progressive Multifocal Leukoencephalopathy (PML), sometimes fatal, can occur in patients receiving rituximab-containing products.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Premedicate with acetaminophen and an antihistamine before each dose. Premedication with a glucocorticoid should also be considered.
• 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.
• This drug product is ready to use. To avoid needle clogging, attach the hypodermic injection needle to the syringe immediately prior to administration.
• Inject into the subcutaneous tissue of the abdomen over approximately 5 to 7 minutes and do not inject into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars.
• If administration is interrupted, continue administering at the same site, or at a different site, but restricted to the abdomen.
• Observe patients for at least 15 minutes following administration.
• Do not administer other medications for subcutaneous use at the same sites as this drug.