• Relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (including rituximab-resistant).
• Previously untreated follicular non-Hodgkin's lymphoma in patients who achieve a partial or complete response to first-line chemotherapy.

Contraindicated in:

• Hypersensitivity to ibritumomab, indium-111, yttrium-90, or murine proteins
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Thrombocytopenia (step 2 dose of yttrium-90 ibritumomab should be ↓)
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

Derm: ecchymoses, pruritus.

EENT: rhinitis.

GI: abdominal pain, anorexia, diarrhea, nausea, vomiting.

GU: ↓ fertility.

Hemat: anemia, leukopenia, thrombocytopenia.

MS: arthralgia.

Neuro: anxiety, dizziness.

Resp: cough, dyspnea, bronchospasm.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) , INFECTIONS, INFUSION REACTIONS, SECONDARY MALIGNANCIES.

Drug-Drug:

• May ↓ antibody response to, and ↑ risk of adverse reactions from, live-virus vaccines.
• ↑ risk of bleeding with anticoagulants, antiplatelet agents, and other agents that may affect hemostasis.
• Growth factor should be avoided for 2 wk before and two wk following treatment.

• Yttrium-90 (Y-90) Zevalin kit: contains one 2-mL vial of 3.2 mg ibritumomab in solution, one 50 mM sodium acetate vial, one formulation buffer vial, and one empty reaction vial with four identification labels (yttrium-90 is shipped directly);

Day 1

• IV (Adults): Administer rituximab 250 mg/m².

Days 7, 8, or 9

• IV (Adults): Administer rituximab 250 mg/m²; within 4 hr after rituximab infusion, administer Y–90 ibritumomab at dose based on platelet level: If platelets ≥150,000/mm³: Administer 0.4 mCi/kg (14.8 MBq per kg) Y-90 ibritumomab; If platelets 100,000–149,000/mm³: Administer 0.3 mCi/kg (11.1 MBq per kg) Y-90 ibritumomab.

Zevalin

• Ibritumomab is a monoclonal antibody linked to a radioisotope that targets white blood cells, including malignant ones. Used in combination with rituxumab as part of a two-step process using indium-111 (step 1) and yttrium-90 (step 2) ibritumomab.

• Decreased spread of lymphoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, radioisotopes

Absorption: IV administration results in complete bioavailability.

Distribution: Distributes to lymphoid tissue in bone marrow, lymph nodes, thymus, spleen, tonsils, and lymphoid nodules in the intestinal tract.

Metabolism/Excretion: Over 7 days, 7.2% of injected radioactivity was excreted in urine.

Half-life: Mean half-life of yttrium-90–ibritumomab activity in blood is 30 hr.

• Inform patient of the purpose and procedure for ibritumomab.
• Instruct patient to notify health care professional if rash; fever; chills; sore throat; signs of infection; bleeding gums; bruising; purpura; petechiae; pallor; weakness; fatigue; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patients should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs; may increase GI irritation.
• Caution patient not to receive live vaccines during and for 12 mo following therapy.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Caution female patients of reproductive potential and male patients with female partners of reproductive potential to use contraception during and for at least 12 mo following therapy and to avoid breastfeeding. Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

i-bri-TOO-mo-mab

NDC Code^*

• 68152- Spectrum Pharmaceuticals, Inc.
  • 68152-103- Zevalin
    • 68152-103-03- 1 KIT in 1 CARTON (68152-103-03) * 2 mL in 1 VIAL * 2 mL in 1 VIAL * 10 mL in 1 VIAL

• 72893- Acrotech Biopharma LLC
  • 72893-007- Zevalin
    • 72893-007-04- 1 KIT in 1 CARTON (72893-007-04) * 10 mL in 1 VIAL * 2 mL in 1 VIAL * 2 mL in 1 VIAL