Ibritumomab tiuxetan

What is Ibritumomab tiuxetan?

• Ibritumomab tiuxetan (Zevalin) is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen used to treat certain types of B-cell non-Hodgkin lymphoma.

Ibritumomab tiuxetan structure

What are the uses of this medicine?

Ibritumomab tiuxetan (Zevalin) is used for the treatment of:

• Adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
• Previously untreated follicular NHL in adult patients who achieve a partial or complete response to first-line chemotherapy.

How does this medicine work?

• Ibritumomab tiuxetan contains a monoclonal antibody that binds to a protein called CD20, which is found on B cells and some types of lymphoma cells.
• It also contains the compound tiuxetan, which allows certain radioactive substances to be attached to the monoclonal antibody.
• This may help kill cancer cells.
• Ibritumomab tiuxetan is a type of monoclonal antibody and a type of immunoconjugate.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been performed with Zevalin.

Is this medicine FDA approved?

• Ibritumomab tiuxetan was the first radioimmunotherapy drug approved by the Food and Drug Administration (FDA) in 2002 to treat cancer.
• In September 2009, ibritumomab received approval from the FDA for an expanded label to include previously untreated patients with a chemotherapy response.

How should this medicine be used?

Recommended dosage:

• Day 1: Administer rituximab 250 mg/m2 intravenous infusion.
• Day 7, 8, or 9:

• Administer rituximab 250 mg/m2 intravenous infusion.

• If platelets at least 150,000/mm3: Within 4 hours after rituximab infusion, administer 0.4 mCi/kg (14.8 MBq per kg) Y-90 Zevalin intravenous infusion.
• If platelets 100,000 to 149,000/mm3 in relapsed or refractory patients: Within 4 hours after rituximab infusion, administer 0.3 mCi/kg (11.1 MBq per kg) Y-90 Zevalin intravenous infusion.

Administration:

• The treatment starts with an infusions of rituximab.
• This may be followed by an administration of indium-111 labelled ibritumomab tiuxetan (111In replaces the 90Y component) to allow the distribution of the drug to be imaged on a gamma camera, before the actual therapy is administered.
• Seven to nine days later, a second infusion of rituximab is given, followed by the 90Y-ibritumomab tiuxetan, by intravenous infusion over around 10 minutes.
• The radioactive activity is determined based on patient body weight and platelet count.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 3.2 mg per 2 mL in a single-dose vial.

This medicine is available in fallowing brand namesː

• Zevalin

What side effects can this medication cause?

The most common side effects of this medicine include:

• cytopenias
• fatigue
• nasopharyngitis
• nausea
• abdominal pain
• asthenia
• cough
• diarrhea
• pyrexia

What special precautions should I follow?

• Rituximab, alone or as a component of the Zevalin therapeutic regimen, can cause severe, including fatal, infusion reactions. Immediately discontinue rituximab and Y-90 Zevalin.
• Cytopenias with delayed onset and prolonged duration, some complicated by hemorrhage and severe infection, are the most common severe adverse reactions of the Zevalin therapeutic regimen. Do not administer Zevalin to patients with ≥ 25% lymphoma marrow involvement or impaired bone marrow reserve.
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis, some fatal, were reported. Discontinue rituximab and Zevalin infusions if patients develop severe cutaneous or mucocutaneous reactions.
• The radiation dose resulting from therapeutic exposure to Y-90 radiolabeled Zevalin may result in secondary malignancies. Monitor patients for hematological toxicity including secondary malignancies.
• Monitor patients closely for evidence of extravasation during Zevalin infusion. Monitor for extravasation and terminate infusion if it occurs. Resume infusion in another limb.
• The safety of immunization with live viral vaccines following the Zevalin therapeutic regimen has not been studied. Do not administer live viral vaccines to patients who recently received Zevalin.
• Zevalin may cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
• During and after radiolabeling Zevalin with Y-90, minimize radiation exposure to patients and to medical personnel, consistent with institutional good radiation safety practices and patient management procedures.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Severe cytopenias

Management of overdosage:

• Severe cytopenias may require stem cell support.

Can this medicine be used in pregnancy?

• Based on its radioactivity, Y-90 Zevalin may cause fetal harm when administered to a pregnant woman.
• There are no available data on Zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
• 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• IBRITUMOMAB TIUXETAN

Inactive Ingredients:

• SODIUM CHLORIDE
• WATER

Inactive Ingredients in formulation buffer:

• ALBUMIN HUMAN
• SODIUM CHLORIDE
• SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
• PENTETIC ACID
• POTASSIUM PHOSPHATE, MONOBASIC
• POTASSIUM CHLORIDE
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID
• WATER

Inactive Ingredients in SODIUM ACETATE:

• SODIUM ACETATE
• WATER

Who manufactures and distributes this medicine?

Manufactured for:

• Acrotech Biopharma LLC
• East Windsor, NJ
• Zevalin® is a registered trademark of Acrotech Biopharma LLC and its subsidiaries.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Ibritumomab tiuxetan
• FDA Ibritumomab tiuxetan

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