The U.S. FDA-approved Inotuzumab ozogamicin to treat people with acute lymphoblastic leukemia conditions on August 17, 2017. 

Inotuzumab ozogamicin is used to treat acute lymphoblastic leukemia in adults. It is intended when patients have failed to respond to other treatments. 

A trained doctor or nurse should only administer it. Do not self-administer the Inotuzumab  injection. Your doctor will decide the dose and duration of your treatment based on the disease severity and other factors. It will be given as an intravenous infusion, and you will be monitored carefully for unwanted side effects. 

The most common side effects of inotuzumab ozogamicin are anemia, tiredness, infection bleeding, fever, nausea, headache, abnormal blood values, stomach pain, high bilirubin value, low appetite, mouth inflammation, constipation, diarrhea, swelling of the abdomen.

Serious side effects while taking Inotuzumab ozogamicin are infusion reactions breathing trouble, chills, rapid weight gain, abnormal liver function values, frequent bleeding and bruising, infusion-related reaction (fever, chill, breathing trouble), venoocclusive liver disease (rapid weight gain, right upper abdomen pain, swelling of the liver), lower number of blood cells, tumor lysis syndrome, changes in the electrical activity of the heart. 

Do not take Inotuzumab injection if you are allergic to Inotuzumab or any other ingredients of this medicine, if you have or have any history with any liver disease, such as venoocculusive disease (damaged liver blood vessels), cirrhosis, nodular regenerative hyperplasia (signs and symptoms of portal hypertension due to chronic use of medicine), or active hepatitis (inflammation of the liver) and blood clot. Before starting the Inotuzumab treatment, inform your doctor if you have signs and symptoms of tumor lysis syndrome, a low number of blood cells (neutrophils), elevations in amylase or lipase enzymes, or a history of QT interval prolongation. 

Notify your doctor if you are pregnant or planning to get pregnant during and after the treatment for up to 8 months. Use effective contraception during and after eight months of treatment for women and five months for men. Discuss with your doctor for more fertility concerns. Certain tests will be taken to monitor the blood cell count, liver enzyme, and QT interval. There is limited information on the safety of Inotuzumab in renal failure patients; inform your physician if you have kidney disease. Notify your doctor if you experience any side effect symptoms, as your doctor may change the dosage of this medicine or give additional medicine to reduce the effect of the side effects.

Store in a cool, dry place, away from direct heat and light.  Store Inotuzumab ozogamicin in the refrigerator (2°C to 8°C). Do not refrigerate or freeze. Contact your doctor for more concerns. If you have missed any dosing appointments, inform your doctor and schedule immediately. It is not advised to use in children and adolescents.

1. Pfizer Limited, Electronic Medicines Compendium (EMC), [Revised on Jan 2021] [Accessed on 04 May 2023], https://www.medicines.org.uk/emc/files/pil.650.pdf
2. Wyeth Pharmaceuticals Inc., US Food & Drug Administration, [Revised on Aug 2017] [Accessed on 04 May 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf
3. H.G. Watson, J.I.O. Craig, L.M. Manson, Blood disease, Davidson's Principles and Practice of Medicine, 22nd Edition, 2014, 989-1056.
4. D. Bhojwani et al., Inotuzumab ozogamicin in pediatric patients with relapsed/refractory acute lymphoblastic Leukemia, Leukemia (2019) 33:884–892, https://www.nature.com/articles/s41375-018-0265-z.pdf

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you are eligible to receive this treatment.