ibritumomab tiuxetan (Rx)

Brand and Other Names:Zevalin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 3.2mg/2mL
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Non-Hodgkin Lymphoma

Day 1

  • Initiate the ibritumomab therapeutic regimen following recovery of platelet counts to ≥150,000/mm³ at least 6 weeks, but no more than 12 weeks, following the last dose of first-line chemotherapy
  • Administer acetaminophen 650 mg PO and diphenhydramine 50 mg PO to premedicate prior to rituximab infusion
  • Administer 250 mg/m² IV rituximab infusion at initial rate of 50 mg/hr; may increase rate by 50 mg/hr q30min to 400 mg/hr maximum; discontinue if severe reaction occurs 
  • Administer 5 mCi of In-111 ibritumomab tiuxetan over 10 minutes within 4 hr of rituximab infusion
  • Assess biodistribution by imaging 48-72 hr postadministration

Day 7, 8, or 9

  • Verify that expected biodistribution is present
  • Premedicate with acetaminophen 650 mg PO and diphenhydramine 50 mg PO prior to rituximab infusion
  • Administer 250 mg/m² rituximab at initial rate of 100 mg/hr; increase rate by 100 mg/hr q30min; not to exceed 400 mg/hr 
  • Platelet count >150,000 cells/mm³: Administer 0.4 mCi/kg of Y-90 ibritumomab tiuxetan as 10 minutes IVP within 4 hr of rituximab infusion; not to exceed 32 mCi Y-90 ibritumomab tiuxetan regardless of patient weight
  • Platelet count 100,000-149,000 cells/mm³: Administer 0.3 mCi/kg ibritumomab tiuxetan over 10 min; not to exceed 32 mCi Y-90 ibritumomab tiuxetan regardless of patient weight
  • Platelet count <100,000 cells/mm³: Do not administer

Monitor

qWeek CBC, platelet counts following therapeutic regimen until levels recover

Other Indications & Uses

Relapsed or refractory low-grade, follicular or transformed B-cell non-Hodgkin's lymphoma

Safety & efficacy not established

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Adverse Effects

>10%

Thrombocytopenia (95%)

Neutropenia (77%)

Anemia (61%)

Asthenia (43%)

Nausea (31%)

Infections (29%)

Chills (24%)

Fever (17%)

Abd pain (16%)

Pain (13%)

Vomiting (12%)

HA (12%)

1-10%

Cough (10%)

Dizziness (10%)

Diarrhea (9%)

Pruritus (9%)

Rash (8%)

Anorexia (8%)

Back pain (8%)

Edema (8%)

Arthralgia (7%)

Myalgia (7%)

Hypotension (6%)

Flushing (6%)

Constipation (5%)

Urticaria (4%)

Anxiety (4%)

Dyspepsia (4%)

Secondary malignancy (2%)

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Warnings

Black Box Warnings

The drug should be administered under the supervision of a cancer chemotherapy physician qualified by training and experienced in the safe use and handling of radionuclides

Fatal infusion reaction symptoms including hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock have occurred within 24 hr of rituximab infusion (~80% occurred in association with the first infusion); discontinue infusions and provide medical treatment to patients who experience infusion reactions

Y-90 ibritumomab tiuxetan administration results in severe and prolonged cytopenias in most patients

Do not administer to patients with greater than or equal to 25% lymphoma marrow involvement and/or impaired bone marrow reserve

Do not exceed absolute maximum allowable dose of 32.0 mCi (1184 MBq) for Y-90 ibritumomab tiuxetan

Do not administer Y-90 ibritumomab tiuxetan to patients with altered biodistribution as determined by imaging with In-111 ibritumomab tiuxetan

Severe cutaneous and mucocutaneous reactions, some with fatal outcome, may occur in association with the ibritumomab tiuxetan therapeutic regimen

Do not administer to patients experiencing a severe cutaneous or mucocutaneous reaction and provide prompt medical evaluation

Contraindications

Hypersensitivity to any component (incl rituximab, yttrium chloride, indium chloride), murine proteins or to another monoclonal antibody

Patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve

Platelets <100 K/mm³, ANC <1500/mm³

Do NOT administer Y-90 ibritumomab to patients with altered biodistribution as determined by In-111 ibritumomab imaging

Hypocellular bone marrow, failed stem cell collection history, myeloablative therapy history

Pregnancy

Cautions

Patients with prior treatment with murine proteins should be screened for human anti-mouse antibodies

Rituximab dose is lower when coadministered with ibritumomab than when use as a single agent

Effective contraception should be used during and for up to 12 months after treatment

Discontinue if patient develops infusion reaction symptom complex including hypoxia, pulmonary infiltrates, ARDS, MI, ventricular fibrillation, or cardiogenic shock

Risk of severe and prolonged cytopenias; some complicated by hemorrhage and severe infection

Risk of potentially fatal mucocutaneous reactions

Live viral vaccine use, murine protein exposure history

Drug not supplied radiolabeled, radiolabeling must be done in specialized facility

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Pregnancy & Lactation

Pregnancy Category: D

Lactation: excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Recombinant monoclonal antibody against CD20 (lymphocyte antigen) complexed with radiotherapeutic agent; promotes antibody-dependent lysis and free radical damage

Pharmacokinetics

Half-Life: 30 hr

Metabolism: unknown

Excretion: urine

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Administration

IV Preparation

Follow Mfr directions

IV Administration

Follow Mfr directions

Storage

Store at 2C-8C (36F-46F)

Protect from freezing

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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