What is the most important information I should know about obinutuzumab?
If you've ever had hepatitis B, using obinutuzumab can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.
Obinutuzumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.
What is obinutuzumab?
Obinutuzumab is used in combination with another cancer medicine called chlorambucil to treat chronic lymphocytic leukemia.
Obinutuzumab is also used in combination with other cancer medicines to treat follicular lymphoma (a type of non-Hodgkin lymphoma), or to help delay the progression of this disease.
Obinutuzumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving obinutuzumab?
You should not receive this medicine if you have ever had a severe allergic reaction to obinutuzumab, including a condition called serum sickness.
Tell your doctor if you have ever had:
- high blood pressure;
- hepatitis B or other liver problems;
- kidney disease;
- an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
- if you have an active infection.
Do not use obinutuzumab if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
Do not breastfeed while using this medicine, and for at least 6 months after your last dose.
How is obinutuzumab given?
Obinutuzumab is given as an infusion into a vein. A healthcare provider will give you this injection.
Obinutuzumab is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with obinutuzumab.
On the days you receive this medicine, plan to spend most of the day at the hospital or infusion clinic.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep using these medicines for as long as your doctor has prescribed.
Obinutuzumab can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.
If you've ever had hepatitis B, using obinutuzumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your obinutuzumab injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving obinutuzumab?
Do not receive a "live" vaccine while receiving obinutuzumab. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).
What are the possible side effects of obinutuzumab?
Get emergency medical help if you have signs of an allergic reaction: hives, rash; fever, joint pain; fast heartbeats, chest pain, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Obinutuzumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Some side effects may occur during the injection, or within 24 hours afterward. Tell your caregiver if you feel sudden warmth, redness, tingly feeling, feverish, chilled, light-headed, nauseated, or if you have headache, pounding in your neck or ears, tiredness, rash, dizziness, diarrhea, vomiting, chest discomfort, or trouble breathing.
Call your doctor at once if you have other side effects such as:
- easy bruising, unusual bleeding, purple or red spots under your skin;
- weakness, cough, diarrhea, burning when you urinate;
- right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes;
- dizziness, loss of balance or coordination;
- confusion, vision problems, problems with speech or walking;
- low white blood cell counts --fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
- signs of tumor cell breakdown --tiredness, muscle cramps, nausea, vomiting, fast or slow heart rate, tingling in your hands and feet or around your mouth.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- a reaction during or shortly after the injection;
- low white blood cell counts;
- diarrhea, constipation;
- muscle or joint pain; or
- cold symptoms such as stuffy nose, sneezing, cough, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect obinutuzumab?
Tell your doctor about all your other medicines, especially:
- a blood thinner --warfarin, Coumadin, Jantoven; or
- medicine to treat or prevent blood clots --cilostazol, clopidogrel, dipyridamole, ticagrelor, ticlopidine, and others.
This list is not complete. Other drugs may affect obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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