Zevalin (Page 6 of 6)

14.2 Follicular, B-Cell NHL Upon Completion of First-Line Chemotherapy

The FIT (First-line Indolent Trial) study (NCT00185393) was a multi-center, randomized, open-label study conducted in patients with follicular NHL with a partial (PR) or complete response (CR/CRu) upon completion of first-line chemotherapy. Randomization was stratified by center and response to first-line therapy (CR or PR). Key eligibility criteria were <25% bone marrow involvement, no prior external beam radiation or myeloablative therapy, and recovery of platelets to normal levels. Patients were randomized to receive Zevalin (n=208) or no further therapy (n=206). Y-90 Zevalin was administered at least 6 weeks but no more than 12 weeks following the last dose of chemotherapy. The main efficacy outcome measure was progression-free survival (PFS) assessed by study investigators using the International Workshop to Standardize Response Criteria for non-Hodgkin’s Lymphoma (1999).

Among the 414 patients, 49% were male, 99% were Caucasian, 12% were ≥65 years old, 83% had a WHO performance status of 0, and 65% had Stage IV disease. Thirty-nine (9.5%) patients received single agent chlorambucil, 22 (5%) patients received fludarabine or a fludarabine-containing regimen, 294 (71%) patients received cyclophosphamide-containing combination chemotherapy [CHOP (31%); CHOP-like (15%); CVP/COP (26%)] and 59 (14%) patients received rituximab-containing combination chemotherapy as first-line treatment.

Progression-free survival was significantly prolonged among Zevalin-treated patients compared to those receiving no further treatment [median PFS 38 months vs. 18 months; HR 0.46 (95% CI: 0.35, 0.60) p<0.0001 Cox model stratified by response to first-line therapy and initial treatment strategy (immediate vs. watch-and-wait)]. The number of patients who died was too small to permit a reliable comparison on survival.

The results for PFS are presented in Figure 1.

Study 4: Kaplan-Meier Estimator for Investigator-Assessed Progression Free Survival Time
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 72893-007-04). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials:

1.
One (1) Zevalin vial containing 3.2 mg ibritumomab tiuxetan in 2 mL 0.9% Sodium Chloride as a clear, colorless solution.
2.
One (1) 50 mM Sodium Acetate Vial containing 13.6 mg Sodium Acetate trihydrate in 2 mL Water for Injection, USP as a clear, colorless solution.
3.
One (1) Formulation Buffer Vial containing 750 mg Albumin (Human), 76 mg Sodium Chloride, 28 mg Sodium Phosphate Dibasic Dodecahydrate, 4 mg Pentetic Acid, 2 mg Potassium Phosphate Monobasic and 2 mg Potassium Chloride in 10 mL Water for Injection, pH 7.1 as a clear yellow to amber colored solution.
4.
One (1) empty Reaction Vial.

Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit.

Rituximab must be ordered separately.

Storage

Store the kit at 2-8°C (36-46°F). Do not freeze.

17 PATIENT COUNSELING INFORMATION

Advise patients:

To contact a healthcare professional for severe signs and symptoms of infusion reactions.
To take premedications as prescribed [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ].
To report any signs or symptoms of cytopenias (bleeding, easy bruising, petechiae or purpura, pallor, weakness or fatigue) [see Warnings and Precautions (5.2) ].
To avoid medications that interfere with platelet function, except as directed by a healthcare professional [see Warnings and Precautions (5.2) ].
To seek prompt medical evaluation for diffuse rash, bullae, or desquamation of the skin or oral mucosa [see Warnings and Precautions (5.3) ].
To immediately report symptoms of infection (e.g. pyrexia) [see Adverse Reactions (6.2) ].
That immunization with live viral vaccines is not recommended for 12 months following the Zevalin therapeutic regimen [see Warnings and Precautions (5.6) ].
To use effective contraceptive methods during treatment and for a minimum of 12 months following Zevalin therapy [see Warnings and Precautions (5.8) ], Use in Specific Populations (8.1, 8.3)and Nonclinical Toxicology (13.1)].
To discontinue breastfeeding during and for 6 months after the last dose of Zevalin treatment [see Use In Specific Populations (8.2) ].

Zevalin® (ibritumomab tiuxetan)
Manufactured for:
Acrotech Biopharma LLC East Windsor, NJ 08520

U.S. License No. 2159

Zevalin® is a registered trademark of Acrotech Biopharma LLC and its subsidiaries.

Protected by U.S. Patent Nos. 5,736,137, 5,776,456, 5,843,439, 6,207,858, 6,399,061, 6,682,734, 6,994,840, 7,229,620, 7,381,560, 7,422,739 and other patents and patents pending

18. PRINCIPAL DISPLAY PANEL

image-04
(click image for full-size original)
Sodium Acetate
(click image for full-size original)
Ibritumomab Tiuxetan
(click image for full-size original)
Reaction Vial for Zevalin
(click image for full-size original)
90Y-Ibritumomab Tiuxetan
(click image for full-size original)
Carton -- Zevalin (Ibritumomab Tiuxetan)
(click image for full-size original)

ZEVALIN ibritumomab tiuxetan kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72893-007
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72893-007-04 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 2 mL
Part 2 1 VIAL 10 mL
Part 3 1 VIAL 2 mL
Part 1 of 3
ZEVALIN ibritumomab tiuxetan injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBRITUMOMAB TIUXETAN (IBRITUMOMAB TIUXETAN) IBRITUMOMAB TIUXETAN 1.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.8 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Part 2 of 3
FORMULATION BUFFER ibritumomab tiuxetan injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN 75 mg in 1 mL
SODIUM CHLORIDE 7.6 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 2.8 mg in 1 mL
PENTETIC ACID 0.4 mg in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.2 mg in 1 mL
POTASSIUM CHLORIDE 0.2 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 10 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Part 3 of 3
SODIUM ACETATE ibritumomab tiuxetan injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE 6.8 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Labeler — Acrotech Biopharma LLC (116965616)
Registrant — Acrotech Biopharma LLC (116965616)
Establishment
Name Address ID/FEI Operations
Ajinomoto Bio-Pharma Services 023050730 MANUFACTURE (72893-007)

Revised: 09/2019 Acrotech Biopharma LLC

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