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Zevalin (In-111) intravenous

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Zevalin (In-111) intravenous Warnings

Rituximab, a medication that is used along with ibritumomab tiuxetan, may infrequently cause serious (sometimes fatal) side effects, including severe breathing problems (e.g., hypoxia, pulmonary infiltrates, acute respiratory distress syndrome) or heart problems (e.g., heart attack, irregular heartbeat, low blood pressure). These effects usually occur within 30 minutes to 2 hours of receiving rituximab. The risk of these effects is greater during your first treatment. Seek immediate medical attention if you have any of the following signs: trouble breathing (e.g., shortness of breath, wheezing), itching, swelling (especially of the throat/lips), severe dizziness, fast/slow/irregular heartbeat, chest pain.

This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

Rarely, serious (sometimes fatal) skin reactions (e.g., Stevens-Johnson syndrome) have occurred in patients receiving this treatment program. These reactions can occur during treatment or days to months after treatment is finished. Seek immediate medical attention if you develop a rash or pain/swelling of the mouth/tongue/throat/eyes. If you have previously had a severe skin reaction due to ibritumomab tiuxetan or the other medication(s) used in the treatment program (e.g., rituximab, indium, yttrium), do not start this treatment program again. Consult your doctor or pharmacist for more details.

Zevalin (In-111) intravenous Uses

This medication is combined with certain radioactive substances (Indium-111, Yttrium-90) and used along with rituximab to treat a certain type of cancer (B-cell non-Hodgkin's lymphoma) in patients whose cancer has returned or has not responded to other treatments. Ibritumomab tiuxetan and rituximab are known as monoclonal antibodies. They work by killing certain blood and cancer cells from your immune system (B cells). Yttrium-90 helps kill the cancer cells, and Indium-111 helps to show how the medication is spread throughout the body (imaging studies).

How to use Zevalin (In-111) intravenous

This medication is given by injection into a vein by a health care professional.

Dosage is based on your medical condition, weight, and response to treatment. This medication is usually given as 2 doses. It is always given within 4 hours after rituximab. The first dose of this medication is combined with Indium-111. A test is done usually 48 to 72 hours after your dose to determine how the medication has spread throughout the body. If the test shows that the medication has spread properly, another dose of this medication (combined with Yttrium-90) is given 7 to 9 days after the first dose.

Zevalin (In-111) intravenous Side Effects

See also Warning section.

Nausea, vomiting, diarrhea, abdominal/stomach pain, cough, dizziness, headache, flushing, or loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: pain/swelling at injection site, swelling ankles/feet, mental/mood changes (e.g., anxiety), black stools, vomit that looks like coffee grounds, vaginal bleeding.

Get medical help right away if any of these rare but very serious side effects occur: weakness on one side of the body, vision problems, confusion, slurred speech.

This medication is made from human blood. Even though donors are carefully screened and this medication goes through a special manufacturing process, there is a very small chance that you may get infections from the medication (e.g., viruses). Tell the doctor immediately if you develop any signs of infection, including fever or persistent sore throat.

This medication has infrequently caused other types of cancer (including myelodysplastic syndrome-MDS, acute myelogenous leukemia-AML). This condition can lead to very serious blood disorders. See also Warning section for symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Zevalin (In-111) intravenous Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; or to other medications in the treatment plan (rituximab, Yttrium-90, Indium-111); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (e.g., neutropenia, thrombocytopenia), recent/current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 12 months afterwards. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Zevalin (In-111) intravenous Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs that affect the immune system (e.g., azathioprine, cyclosporine, corticosteroids such as prednisone), drugs that can cause bleeding/bruising (e.g., "blood thinners" such as warfarin/heparin, anti-platelet drugs including NSAIDs such as ibuprofen/aspirin).

Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Ask your doctor or pharmacist for more details.

Zevalin (In-111) intravenous Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

NOTES:

Laboratory and/or medical tests (e.g., complete blood count, platelets, blood pressure, imaging studies) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

STORAGE:

Not applicable. This medication is given in a clinic and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised September 2013. Copyright(c) 2013 First Databank, Inc.

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