Select therapeutic use:

Leukemias, lymphomas, and other hematologic cancers:

Indications for RUXIENCE:

Relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin's lymphoma (NHL). Previously untreated follicular, CD20(+), B-cell NHL 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), low-grade, CD20(+), B-cell NHL as a single agent after first-line CVP chemotherapy. Previously untreated diffuse large B-cell, CD20(+) NHL (DLBCL) in combination with CHOP or other anthracycline-based chemotherapy regimens. CD20(+) chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.

Adult:

Give by IV infusion. Premedicate with an antihistamine and acetaminophen prior to each infusion. First infusion: initially at a rate of 50mg/hr; may increase by 50mg/hr increments every 30mins. Subsequent infusions: initially at a rate of 100mg/hr; may increase by 100mg/hr increments every 30mins. Both: max 400mg/hr if infusion reactions do not occur. Previously untreated follicular NHL and DLBCL patients: if no Grade 3 or 4 infusion related adverse events during Cycle 1, a 90-minute infusion may be given in Cycle 2 with a glucocorticoid-containing chemotherapy regimen (see full labeling). NHL: 375mg/m2 once weekly for 4 or 8 doses. Retreatment therapy: 375mg/m2 once weekly for 4 doses. Previously untreated, follicular, CD20(+), B-cell NHL: 375mg/m2 on Day 1 of each cycle of chemotherapy for up to 8 doses. In patients with complete or partial response, initiate Ruxience maintenance 8 weeks following completion of Ruxience in combination with chemotherapy. Administer Ruxience as a single-agent every 8 weeks for 12 doses. Non-progressing, low-grade, CD20(+), B-cell NHL after CVP chemotherapy: 375mg/m2 once weekly for 4 doses every 6 months for up to 16 doses. Diffuse large B-cell NHL: 375mg/m2 on Day 1 of each chemotherapy cycle for up to 8 infusions. CLL: 375mg/m2 the day prior to FC chemotherapy, then 500mg/m2 on Day 1 of Cycles 2–6 (every 28 days). Give PCP and antiherpetic viral prophylaxis during and up to 12 months after CLL therapy. As a component of Zevalin regimen: see full labeling.

Children:

Not established.

Boxed Warning:

Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.

Warnings/Precautions:

Discontinue if severe infusion-related or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Discontinue if SCr rises or oliguria occurs. Severe, active infections: not recommended. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiovascular or pulmonary disease, history of cardiopulmonary adverse reactions, circulating malignant cells (≥25000/mm3); monitor closely. Monitor CBCs, platelet counts prior to and during treatment, then as indicated. Update vaccination status prior to initiation. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥12 months after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥6 months after the last dose).

Pharmacologic Class:

CD20-directed cytolytic monoclonal antibody.

Interactions:

Concomitant live virus vaccines: not recommended. Give non-live vaccines at least 4 weeks prior to Ruxience. Concomitant biologics/DMARDs; monitor for infection. Concomitant immunosuppressants other than corticosteroids have not been studied. Renal toxicity with concomitant cisplatin.

Adverse Reactions:

Infusion-related reactions (may be fatal), fever, lymphopenia, chills, infections (may be serious), asthenia, neutropenia, upper RTI, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, UTI, bronchitis; mucocutaneous reactions (may be fatal), PML, tumor lysis syndrome, renal toxicity, HBV reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious). Also with concomitant chemotherapy: bowel obstruction and perforation; evaluate if abdominal pain or persistent vomiting occur.

Note:

Testing considerations: FCGR3A genotype testing

Generic Availability:

NO

How Supplied:

Single-dose vial (10mL, 50mL)—1

Pricing for RUXIENCE

10ml of 100mg/10ml vial (Qty: 1)
Appx. price $741
GoodRx

Miscellaneous immune disorders:

Indications for RUXIENCE:

For the treatment of granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis, in combination with glucocorticoids.

Adult:

Give by IV infusion. Premedicate with an antihistamine and acetaminophen prior to each infusion. First infusion: initially at a rate of 50mg/hr; may increase by 50mg/hr increments every 30mins. Subsequent infusions: initially at a rate of 100mg/hr; may increase by 100mg/hr increments every 30mins. Both: max 400mg/hr if infusion reactions do not occur. Induction: 375mg/m2 once weekly for 4 weeks. Begin glucocorticoids within 14 days prior to or with initiation of Ruxience and continue during and after the 4 week course (see full labeling). Follow-up treatment (in patients who achieved disease control with induction therapy): initiate within 24 weeks after last Ruxience induction dose or as clinically indicated, but no sooner than 16 weeks after last induction infusion; or within the 4 week period after disease controlled with other immunosuppressants. 500mg once, followed by second 500mg 2 weeks later, then 500mg every 6 months thereafter as clinically indicated. Give glucocorticoids 30mins before each infusion (see full labeling). PCP prophylaxis recommended during and for at least 6 months following last infusion.

Children:

Not established.

Boxed Warning:

Fatal infusion-related reactions. Severe mucocutaneous reactions. Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy.

Warnings/Precautions:

Discontinue if severe infusion-related or mucocutaneous reactions occur (eg, urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid or vesiculobullous dermatitis, toxic epidermal necrolysis). Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs). Discontinue if SCr rises or oliguria occurs. Severe, active infections: not recommended. Discontinue and treat if serious infections (eg, bacterial, fungal, viral) occur. Pre-existing cardiovascular or pulmonary disease, history of cardiopulmonary adverse reactions, circulating malignant cells (≥25000/mm3); monitor closely. Monitor CBCs, platelet counts prior to and during treatment, then as indicated. Update vaccination status prior to initiation. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥12 months after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥6 months after the last dose).

Pharmacologic Class:

CD20-directed cytolytic monoclonal antibody.

Interactions:

Concomitant live virus vaccines: not recommended. Give non-live vaccines at least 4 weeks prior to Ruxience. Concomitant biologics/DMARDs; monitor for infection. Concomitant immunosuppressants other than corticosteroids have not been studied. Renal toxicity with concomitant cisplatin.

Adverse Reactions:

Infusion-related reactions (may be fatal), fever, lymphopenia, chills, infections (may be serious), asthenia, neutropenia, upper RTI, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, UTI, bronchitis; mucocutaneous reactions (may be fatal), PML, tumor lysis syndrome, renal toxicity, HBV reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious). Also with concomitant chemotherapy: bowel obstruction and perforation; evaluate if abdominal pain or persistent vomiting occur.

Generic Availability:

NO

How Supplied:

Single-dose vial (10mL, 50mL)—1

Pricing for RUXIENCE

10ml of 100mg/10ml vial (Qty: 1)
Appx. price $741
GoodRx