(rituximab-pvvr)

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

Administer only as an intravenous infusion [see Dosage and Administration (2.9)]. Do not administer as an intravenous push or bolus.

RUXIENCE should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur [see Warnings and Precautions (5.1)].

Premedicate before each infusion [see Dosage and Administration (2.8)].

Prior to First Infusion

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RUXIENCE [see Warnings and Precautions (5.3)]. Obtain complete blood counts (CBC) including platelets prior to the first dose.

During RUXIENCE Therapy

In patients with lymphoid malignancies, during treatment with RUXIENCE monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each RUXIENCE course. During treatment with RUXIENCE and chemotherapy, obtain CBC with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias [see Adverse Reactions (6.1)]. In patients with RA, GPA or MPA, obtain CBC with differential and platelet counts at two to four month intervals during RUXIENCE therapy. Continue to monitor for cytopenias after final dose and until resolution.

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First Infusion
Standard Infusion: Initiate infusion at a rate of 50 mg/hour. In the absence of infusion toxicity, increase infusion rate by 50 mg/hour increments every 30 minutes, to a maximum of 400 mg/hour.
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Subsequent Infusions
Standard Infusion: Initiate infusion at a rate of 100 mg/hour. In the absence of infusion toxicity, increase rate by 100 mg/hour increments at 30-minute intervals, to a maximum of 400 mg/hour.
For Previously Untreated Follicular NHL and DLBCL Adult Patients: If patients did not experience a Grade 3 or 4 infusion-related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen.
Initiate at a rate of 20% of the total dose given in the first 30 minutes and the remaining 80% of the total dose given over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used when administering the remainder of the treatment regimen (through Cycle 6 or 8).
Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count greater than or equal to 5,000/mm3 before Cycle 2 should not be administered the 90-minute infusion [see Clinical Studies (14.4)].
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Interrupt the infusion or slow the infusion rate for infusion-related reactions [see Boxed Warning, Warnings and Precautions (5.1)]. Continue the infusion at one-half the previous rate upon improvement of symptoms.

2.2 Recommended Dose for Non-Hodgkin's Lymphoma (NHL)

The recommended dose is 375 mg/m2 as an intravenous infusion according to the following schedules:

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Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 or 8 doses.
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Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 doses.
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Previously Untreated, Follicular, CD20-Positive, B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 doses. In patients with complete or partial response, initiate RUXIENCE maintenance eight weeks following completion of a rituximab product in combination with chemotherapy. Administer RUXIENCE as a single agent every 8 weeks for 12 doses.
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Non-progressing, Low-Grade, CD20-Positive, B-Cell NHL, after first-line CVP chemotherapy
Following completion of 6–8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
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Diffuse Large B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions.

2.3 Recommended Dose for Chronic Lymphocytic Leukemia (CLL)

The recommended dose is 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of Cycles 2–6 (every 28 days).

2.4 Recommended Dose as a Component of Zevalin® for Treatment of NHL

When used as part of the Zevalin therapeutic regimen, infuse 250 mg/m2 in accordance with the Zevalin package insert. Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.

2.5 Recommended Dose for Rheumatoid Arthritis (RA)

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Administer RUXIENCE as two-1,000 mg intravenous infusions separated by 2 weeks.
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Glucocorticoids administered as methylprednisolone 100 mg intravenous or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion-related reactions.
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Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.
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RUXIENCE is given in combination with methotrexate.

2.6 Recommended Dose for Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

     

Induction Treatment of Adult Patients with Active GPA/MPA

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Administer RUXIENCE as a 375 mg/m2 intravenous infusion once weekly for 4 weeks for patients with active GPA or MPA.
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Glucocorticoids administered as methylprednisolone 1,000 mg intravenously per day for 1 to 3 days followed by oral prednisone as per clinical practice. This regimen should begin within 14 days prior to or with the initiation of RUXIENCE and may continue during and after the 4 week induction course of RUXIENCE treatment.

Follow up Treatment of Adult Patients with GPA/MPA who have Achieved Disease Control with Induction Treatment

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Administer RUXIENCE as two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation.
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If induction treatment of active disease was with a rituximab product, initiate follow up treatment with RUXIENCE within 24 weeks after the last induction infusion with a rituximab product or based on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product.
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If induction treatment of active disease was with other standard of care immunosuppressants, initiate RUXIENCE follow up treatment within the 4 week period that follows achievement of disease control.

2.7 Recommended Dose for Pemphigus Vulgaris (PV)

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Administer RUXIENCE as two-1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids.
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Maintenance treatment
Administer RUXIENCE as a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation.
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Treatment of relapse
Administer RUXIENCE as a 1,000 mg intravenous infusion on relapse, and consider resuming or increasing the glucocorticoid dose based on clinical evaluation.

Subsequent infusions of RUXIENCE may be administered no sooner than 16 weeks following the previous infusion.

2.8 Recommended Dose for Premedication and Prophylactic Medications

Premedicate with acetaminophen and an antihistamine before each infusion of RUXIENCE. For adult patients administered RUXIENCE according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion [see Clinical Studies (14.4)].

For RA, GPA and MPA, and PV patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion.

Provide prophylaxis treatment for Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections for patients with CLL during treatment and for up to 12 months following treatment as appropriate [see Warnings and Precautions (5.6)].

PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last RUXIENCE infusion.

PCP prophylaxis should be considered for patients with PV during and following RUXIENCE treatment.

2.9 Administration and Storage

Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. RUXIENCE should be a clear to slightly opalescent, colorless to pale brownish-yellow liquid. Do not use vial if particulates or discoloration is present.

Administration

Use a sterile needle and syringe to prepare RUXIENCE. Withdraw the necessary amount of RUXIENCE and dilute to a final concentration of 1 mg/mL to 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Gently invert the bag to mix the solution. Do not mix or dilute with other drugs. Discard any unused portion left in the vial.

Storage

If not used immediately, store diluted RUXIENCE solutions as shown in the table below.

Diluted RUXIENCE Solution Storage Conditions

Diluent Used to Prepare Solution for Infusion

Diluted RUXIENCE Solution Storage Conditions

0.9% Sodium Chloride Injection, USP

Store RUXIENCE solution diluted in 0.9% Sodium Chloride Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 16 days after preparation.

5% Dextrose Injection, USP

Store RUXIENCE solution diluted in 5% Dextrose Injection, USP refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours after preparation.

No incompatibilities between RUXIENCE and polyvinylchloride bags have been observed.

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