Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Zevalin In-111
  2. Zevalin Y-90

Descriptions


Ibritumomab injection is a monoclonal antibody. It is used together with another monoclonal antibody (rituximab) and one radioactive medication (Y-90). Ibritumomab is used to treat a type of cancer called non-Hodgkin's lymphoma (NHL) in patients who have never received any treatment and for those who have received other cancer medicines.

This medicine is to be administered only by or under the immediate supervision of your doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibritumomab injection in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibritumomab injection in the elderly.

Pregnancy

Information about this ibritumomab-intravenous-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Acute myelogenous leukemia (AML) or
  • Myelodysplastic syndrome (MDS) or
  • Neutropenia (low white blood cells in the blood) or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it. Tell your doctor right away if you think you have become pregnant while using the medicine.

This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, chest tightness, swelling in your face or hands, lightheadedness, or if you feel like fainting within a few hours after you receive it.

If you have a severe skin reaction with this medicine, you should seek medical attention right away. Symptoms may include blistering or loosening of the skin; red, swollen, irritated, or scaly skin; fever; chills; headache; or diarrhea.

While you are being treated with ibritumomab, and after you stop treatment with it, do not have any immunizations (live vaccines) without your doctor's approval. Ibritumomab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Ibritumomab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid sports or other situations where bruising or injury could occur.

If ibritumomab accidentally seeps out of the vein where it is injected, it may damage the tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

This medicine contains albumin, which is derived from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bleeding gums
  3. blood in the urine or stools
  4. cough or hoarseness
  5. coughing up blood
  6. difficulty with breathing or swallowing
  7. dizziness
  8. fever or chills
  9. headache
  10. increased menstrual flow or vaginal bleeding
  11. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  12. lower back or side pain
  13. noisy breathing
  14. nosebleeds
  15. painful or difficult urination
  16. pale skin
  17. paralysis
  18. pinpoint red spots on the skin
  19. prolonged bleeding from cuts
  20. red or dark brown urine
  21. red stools
  22. shortness of breath
  23. sore throat
  24. sores, ulcers, or white spots on the lips or in the mouth
  25. swollen glands
  26. tightness in the chest
  27. troubled breathing with exertion
  28. unusual bleeding or bruising
  29. unusual tiredness or weakness
  30. wheezing

Less common

  1. Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes
  2. bluish lips or skin
  3. chest pain or discomfort
  4. confusion
  5. diarrhea
  6. fainting
  7. fast heartbeat
  8. hives
  9. itching
  10. lightheadedness
  11. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  12. rapid, shallow breathing
  13. skin rash
  14. small red or purple spots on the skin
  15. unusual vaginal bleeding
  16. vomiting blood or material that looks like coffee grounds

Rare

  1. Agitation
  2. anxiety
  3. back pain
  4. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
  5. blurred vision
  6. coma
  7. drowsiness
  8. fast, pounding, or irregular heartbeat or pulse
  9. hallucinations
  10. inability to speak
  11. irritability
  12. mood or mental changes
  13. nausea
  14. redness of the skin
  15. seizures
  16. severe headache
  17. slurred speech
  18. stiff neck
  19. temporary blindness
  20. vomiting
  21. weakness in the arm or leg on one side of the body, sudden and severe
  22. welts

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. cracks in the skin
  3. joint or muscle pain
  4. loss of heat from the body
  5. red skin lesions, often with a purple center
  6. red, irritated eyes
  7. red, swollen skin
  8. scaly skin
  9. skin blisters

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Abdominal or stomach pain
  2. bruising
  3. constipation
  4. difficult or labored breathing
  5. difficulty with moving
  6. faintness or lightheadedness when getting up from a lying or sitting position
  7. fear
  8. feeling of warmth
  9. full or bloated feeling or pressure in the stomach
  10. joint pain
  11. lack or loss of strength
  12. large, flat, blue or purplish patches in the skin
  13. loss of appetite
  14. muscle aching or cramping
  15. muscle pain or stiffness
  16. nervousness
  17. pain
  18. rash
  19. redness of the face, neck, arms and occasionally, upper chest
  20. runny nose
  21. sleeplessness
  22. sneezing
  23. stuffy nose
  24. sudden or increased sweating
  25. swelling of the abdominal or stomach area
  26. swelling of the hands, ankles, feet, or lower legs
  27. swollen joints
  28. throat irritation
  29. trouble with sleeping
  30. unable to sleep
  31. weight loss

Less common

  1. Acid or sour stomach
  2. belching
  3. heartburn
  4. indigestion
  5. stomach discomfort, upset, or pain
  6. swelling or redness in the joints

For several months after receiving this therapy, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following:

  1. Bleeding gums
  2. bone pain
  3. headache, sudden and severe
  4. inability to speak
  5. increased menstrual flow or vaginal bleeding
  6. red or black, tarry stools
  7. red or dark brown urine
  8. temporary blindness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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