Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Serious Infusion Reactions [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] .
Prolonged and Severe Cytopenias [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ].
Severe Cutaneous and Mucocutaneous Reactions [ see Boxed Warning and Warnings and Precautions ( 5.3 ) ].
Leukemia and Myelodysplastic Syndrome [ see Warnings and Precautions ( 5.4 ) ].
Common adverse reactions ( > 10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc.
at 1-866-298-8433 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The reported safety data reflects exposure to Zevalin in 349 patients with relapsed or refractory, low-grade, follicular or transformed NHL across 5 trials (4 single arm and 1 randomized) and in 206 patients with previously untreated follicular NHL in a randomized trial (FIT study) who received any portion of the Zevalin therapeutic regimen.
The safety data reflect exposure to Zevalin in 270 patients with relapsed or refractory NHL with platelet counts ≥150,000/ mm 3 who received 0.4 mCi/kg (14.8 MBq/kg) of Y-90 Zevalin (Group 1 in Table 4 ), 65 patients with relapsed or refractory NHL with platelet counts of ≥ 100,000 but ≤ 149,000 /mm 3 who received 0.3 mCi/kg (11.1 MBq/kg) of Y-90 Zevalin (Group 2 in Table 4 ), and 204 patients with previously untreated NHL with platelet counts ≥150,000/ mm 3 who received 0.4 mCi/kg (14.8 MBq/kg) of Y-90 Zevalin;
all patients received a single course of Zevalin.
5 WARNINGS AND PRECAUTIONS Serious Infusion Reactions: Immediately discontinue rituximab and Y-90 Zevalin.
( 5.1 , 6.1 ) Prolonged and Severe Cytopenias: Do not administer Zevalin to patients with ≥ 25% lymphoma marrow involvement or impaired bone marrow reserve.
( 5.2 , 6.1 ) Severe Cutaneous and Mucocutaneous Reactions: Discontinue rituximab and Zevalin infusions if patients develop severe cutaneous or mucocutaneous reactions.
( 5.3 , 6.2 ) Development of Leukemia and Myelodysplastic Syndrome: Monitor patients for hematological toxicity including secondary malignancies.
( 5.4 , 6.1 ) Extravasation: Monitor for extravasation and terminate infusion if it occurs.
Like all medications, Zevalin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: