Zevalin

Zevalin is a prescription medication used in patients with cancer who have been treated with chemotherapy or with rituximab and have not gotten better or have had a relapse. Zevalin belongs to a group of drugs called monoclonal antibodies. When combined with a radioactive substance and given with rituximab, it works as a type of radioimmunotherapy to destroy cancer cells.

This medication comes as an injectable form to be given directly into the vein (IV) by a healthcare professional.

Common side effects include fatigue, nose and throat infection, and nausea. Do not drive or operate heavy machinery until you know how this medicaiton affects you.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 0.3 or 0.4 mCi/kg (14.8 MBq per kg) Y-90 Zevalin injection.

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and the laboratory.Your doctor will order certain tests during your treatment and for up to 3 months after your treatment to check your body's response to Zevalin.

Storage

Parenteral

Ibritumomab tiuxetan kit: 2–8°C; do not freeze.1

Yttrium Y 90 ibritumomab tiuxetan: 2–8°C until use.1 Administer within 8 hours of radiolabeling.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution is restricted to qualified and appropriately licensed clinicians and facilities equipped to handle radionuclides (e.g., nuclear pharmacies); the regimen is not available through community pharmacies.2

Ibritumomab tiuxetan is commercially available as a kit that contains all of the nonradioactive ingredients necessary to prepare a single dose of yttrium Y 90 ibritumomab tiuxetan.1 Yttrium 90 chloride sterile solution is shipped directly from the supplier when the yttrium Y 90 ibritumomab tiuxetan (Y-90 Zevalin) kit is ordered.1 Rituximab must be ordered separately.1

Pregnancy

Pregnancy Category D [see Warnings and Precautions (5.9)]

Risk Summary

Based on its radioactivity, Y-90 Zevalin may cause fetal harm when administered to a pregnant woman. Immunoglobulins are known to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Animal reproductive toxicology studies of Zevalin have not been conducted.

Advise women of childbearing potential to use adequate contraception for a minimum of twelve months. Inform women who become pregnant while receiving Zevalin of the potential fetal risks.

Nursing Mothers

Because human IgG is excreted in human milk, it is expected that Zevalin would be present in human milk. Because of the potential for adverse reactions in nursing infants from Y-90 Zevalin, a decision should be made to discontinue nursing or not administer the Zevalin therapeutic regimen, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of Zevalin have not been established in pediatric patients.

Geriatric Use

Of 349 patients with relapsed/refractory NHL treated with the Zevalin therapeutic regimen in clinical studies, 38% (132 patients) were age 65 years and over, while 12% (41 patients) were age 75 years and over.

Of 414 patients enrolled in Study 4 (Zevalin following first-line chemotherapy) 206 patients received Zevalin. Of these patients 14% (29 patients) were 65 years and over, while 2% (4 patients) were 75 years and older. In the control arm, 10% (21 patients) were 65 years or over and 0% (0 patients) were 75 years or older.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 68152-103-03). 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:

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

Rituximab (Rituxan®, Biogen Idec and Genentech USA) must be ordered separately.

Storage

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

Zevalin® (ibritumomab tiuxetan)

Manufactured for:

Spectrum Pharmaceuticals, Inc.

157 Technology Drive

Irvine, CA 92618

U.S. License No. 1832

Zevalin® is a registered trademark of Spectrum Pharmaceuticals, Inc. 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.