(TOE si too MOE mab) Brand: Bexxar Dosimetric, BexxarTherapeutic
• You must not receive this medicine if you are allergic to mouse proteins, or if you have ever had an allergic reaction to a monoclonal antibody.
• Till you receive tositumomab, speak your doctor if you have kidney malady or severe bone marrow suppression.
• Tositumomab can reason hurt to the thyroid gland of an unborn child if the mother receives this medicine during pregnancy. You must not receive this medicine if you are pregnant.
• Tositumomab can be deleterious to an unborn child whether the father or the mother receives this medicine at the time of conception. Use effective birth control to prevent pregnancy during your treatment, whether you are a man or a woman. Continue using birth control for at least 12 months after you have received tositumomab.
• Tositumomab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being around people who are sick or have infections. Avoid activities that may magnify your risk of bleeding injury. Speak your doctor at once if you develop signs of infection.
• Do not receive a "live" vaccine just after you receive tositumomab.
• After you are treated with tositumomab, your body will retain radioactive material for different days. During this time you will be giving off a little amount of radiation to others near you. Your caregivers must give you instructions about how to avoid exposing another people to radiation before this effect wears off. Follow these instructions carefully.
• Take all medications your doctor prescribes to help protect your thyroid gland when you receive tositumomab. You may need to have blood trials to check your thyroid function at regular intervals for the rest of your life. Visit your doctor regularly.
• Tositumomab is a monoclonal antibody that is linked with radioactive iodine I-131. Monoclonal antibodies are made to target and destroy only determined cells in the body. This may help to protect healthy cells from damage.
• Tositumomab is used to treat determined forms of non-Hodgkin's lymphoma. It is generally given after another medications have been tried without successful treatment.
• Tositumomab may also be used for purposes not listed in this medicine guide.
• You must not receive this medicine if you are allergic to mouse proteins, or if you have ever had an allergic reaction to a monoclonal antibody.
• To create certain you can safely receive tositumomab, speak your doctor if you have any of these another conditions:
· kidney malady; or
· severe bone marrow suppression.
• FDA pregnancy category X. Tositumomab can reason hurt to the thyroid gland of an unborn child if the mother receives this medicine during pregnancy. You must not receive this medicine if you are pregnant.
• Tositumomab can be deleterious to an unborn child whether the father or the mother receives this medicine at the time of conception. Use effective birth control to prevent pregnancy during your treatment, whether you are a man or a woman. Continue using birth control for at least 12 months after you have received tositumomab.
• Tositumomab can pass into breast milk and may harm a nursing child. You must not breast-feed while you are using tositumomab.
• Some people treated with tositumomab later developed leukemia or another cancers. However, it has not been certain whether this medicine actually increases the risk of causing another cancers. Conversation with your doctor about your individual risk.
• Tositumomab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Tositumomab treatment consists of two various injections (tositumomab, and iodine I-131 tositumomab). These injections should be given one at a time and injected slowly through an IV infusion. The first injection is given over at least 60 minutes and the second injection is given over at least 20 minutes.
• Till and during your tositumomab treatment, you will be given another medications to protect your thyroid gland and to help prevent allergic reactions. You may need to hold taking some of these medications for up to 2 weeks after your treatment.
• The tositumomab treatment is generally given in two steps over a span of 7 days. In the first treatment step, you will receive the two injections just till you undergo an x-ray scan of your entire body. This scan will show your doctor how well the radioactive ingredients of the tositumomab injections are circulating throughout your body. You may receive at least 2 more scans over the following 6 or 7 days.
• Based on the results of your scans, your doctor will determine whether or not to give the second step of tositumomab treatment, and how big your doze must be.
• In step 2 of the treatment, you will again receive the two injections one at a time. These injections are considered your therapeutic doze. The 2-step tositumomab treatment is generally given only once, so you are not likely to receive a second rate of treatment with this medication.
• Tositumomab can lower blood cells that help your body fight infections. This can create it easier for you to bleed from an injury or get sick from being near others who are ill. Your blood may need to be tested often. Visit your doctor regularly.
• Wash your hands often to prevent infections.
• After you are treated with tositumomab, your body will retain radioactive material for different days. During this time you will be giving off a little amount of radiation to others near you. Your caregivers must give you instructions about how to avoid exposing another people to radiation before this effect wears off.
• Tositumomab can magnify your risk of developing hypothyroidism (underactive thyroid). Hypothyroidism can be treated with daily thyroid replacement medication.
• Take all medications your doctor prescribes to help protect your thyroid gland when you receive tositumomab. You may need to have blood trials to check your thyroid function at regular intervals for the rest of your life. Visit your doctor regularly.
• This medicine can reason unusual results with determined medical trials. You may also have an allergic reaction to diagnostic trials or treatments using mouse proteins or monoclonal antibodies. Tell any doctor who treats you that you have been treated with tositumomab.
• Because you will receive tositumomab in a clinical setting, you are not likely to miss a dose.
• Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
• Avoid being around people who are sick or have infections. Speak your doctor at once if you develop signs of infection.
• Do not receive a "live" vaccine while using tositumomab. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine. Ask your doctor how long after your treatment you must wait till receiving any vaccines.
• Avoid activities that may magnify your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
• Avoid handling any of your body fluids without wearing latex rubber gloves. If other face is handling your fluids (vomit, stools, or urine), they must wear gloves, eye protection, and a mask to cover the nose and mouth.
• When cleaning any spills of bodily fluid, use only disposable cleaning cloths that can be flushed down a toilet. Ask your doctor or health department how to dispose of any bodily fluid spills that can't be flushed down a toilet.
• To protect others from exposure to the radioactive matter in your body, try to remain at least 6 foots away from another people, especially children or pregnant women. Follow these steps for different days after your tositumomab treatment ends:
· Avoid crowds and popular places.
· Avoid traveling on long trips.
· Do not share a bed or bathroom with other person.
· Sit on the toilet while urinating and flush 3 times with the lid down after use.
· Always wash your hands after using the bathroom.
· Do not share a towel, wash dress, or toothbrush with other person.
· Do not share drinking glasses, plates, or silverware.
· Wait at least 1 week till washing any of the clothing and bed or bath linens you have used during the week after your treatment. Hold these items separate from the laundry of another people in your home.
· Wash your clothing and another items apart from another laundry in your home.
• Some people receiving a tositumomab injection have had a reaction to the infusion (when the medication is injected into the vein). Speak your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or short of breath, or if you have fever or chills during the injection.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.
• Call your doctor at once if you have a serious side effect such as:
· pale skin, feeling light-headed or short of breath, rapid heart course, trouble concentrating;
· light bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
· fever, chills, sore throat, body aches, flu symptoms;
· blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds; or
· stabbing chest pain, wheezing, cough with yellow or green mucus; feeling short of breath.
• Smaller serious side effects may include:
· decreased energy, feeling weak or irritable;
· weight gain;
· headache, joint or muscle pain;
· heighten thirst and hot, dry skin;
· nausea, vomiting, diarrhea, stomach pain, loss of appetite;
· mild itching or skin rash;
· runny or stuffy nose; or
· pain, itching, swelling, or redness near the IV needle.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Till receiving tositumomab, speak your doctor if you are using any type of blood thinner or medicine used to prevent blood clots, such as:
· aspirin;
· warfarin (Coumadin, Jantoven);
· abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), rivaroxaban (Xarelto), ticlopidine (Ticlid), tirofiban (Aggrastat);
· argatroban (Acova), dabigatran (Pradaxa), bivalirudin (Angiomax), lepirudin (Refludan);
· dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or
· alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase).
• This list is not complete and another drugs may interact with tositumomab. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.
• Your doctor or pharmacist can provide more information about tositumomab.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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