Inotuzumab ozogamicin injection may cause severe or life-threatening liver damage, including hepatic veno-occlusive disease (VOD; blocked blood vessels inside the liver). Tell your doctor if you have or have ever had liver disease or have had a hematopoietic stem-cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body). If you experience any of the following symptoms, call your doctor immediately: rapid weight gain, pain or swelling in the upper right part of the stomach, yellowing of the skin or eyes, nausea, vomiting, dark colored urine, or extreme tiredness.
Inotuzumab ozogamicin injection may cause an increased risk of death, not due to return of leukemia, after receiving a HSCT. If you experience any of the following symptoms after a HSCT while receiving inotuzumab ozogamicin injection, call your doctor immediately: fever, cough, sore throat, chills, or other signs of infection; rapid weight gain, or pain or swelling in the upper right part of the stomach.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and after your treatment to check your body's response to inotuzumab ozogamicin.
Inotuzumab ozogamicin injection is used to treat certain acute lymphoblastic leukemia (ALL; a type of cancer that begins in the white blood cells) in adults who have not responded to previous cancer treatments. Inotuzumab ozogamicin injection is in a class of medications called monoclonal antibodies. It works by activating the immune system to destroy cancer cells.
Inotuzumab ozogamicin injection comes as powder to be mixed with liquid to be injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility. It is usually injected on days 1, 8, and 15 of a 3- to 4-week cycle. The cycle may be repeated every 4 weeks as recommended by your doctor. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.
Your doctor may need to interrupt or stop your treatment, lower your dose, or treat you with additional medications, depending on your response to inotuzumab ozogamicin and any side effects that you experience. You will receive certain medications to help prevent a reaction before you receive each dose of inotuzumab ozogamicin. Tell your doctor or nurse if you experience any of the following symptoms during and for at least one hour after the end of infusion: fever, chills, rash, shortness of breath, or difficulty breathing. Talk to your doctor about how you are feeling during and after your treatment.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before using inotuzumab ozogamicin injection,
Unless your doctor tells you otherwise, continue your normal diet.
Inotuzumab ozogamicin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or HOW sections, call your doctor immediately or get emergency medical treatment:
Inotuzumab ozogamicin injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).
Ask your pharmacist any questions you have about inotuzumab ozogamicin injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.