Serious infusion reactions, including fatalities, have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. Most fatal infusion reactions (80%) occurred with the first rituximab infusion. Administration also results in severe and prolonged cytopenias in most patients. The ibritumomab tiuxetan therapeutic regimen should not be administered to patients with 25% or greater lymphoma marrow involvement and/or impaired bone marrow reserve. Severe cutaneous and mucocutaneous reactions, some with fatal outcome, can occur with therapy. The dose of Y-90 ibritumomab tiuxetan should not exceed the absolute maximum allowable dose of 32 millicurie (1184 megabecquerels) .
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.
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibritumomab injection in the elderly.
|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.|
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.
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.
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:
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.
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:
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.
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:
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:
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:
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.