INOTUZUMAB OZOGAMICIN
Background and Date of Approval
The U.S. FDA approved inotuzumab ozogamicin for the treatment of acute lymphoblastic leukaemia on August 17, 2017.
Uses
Inotuzumab ozogamicin is used to treat acute lymphoblastic leukemia in adults. It is intended when patients have failed to respond to other treatments.
How is it administered?
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.
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.
Warnings
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.
Precautions
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.
Word of Advice
Store inotuzumab ozogamicin in the refrigerator between 2°C and 8°C. Keep the medication in a cool, dry place, protected from direct heat and light. Do not freeze. If you have missed a dosing appointment, inform your doctor to reschedule promptly. Inotuzumab ozogamicin is not recommended for use in children and adolescents.
References
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 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 H.G. Watson, J.I.O. Craig, L.M. Manson, Blood disease, Davidson's Principles and Practice of Medicine, 22nd Edition, 2014, 989-1056. D. Bhojwani et al., Inotuzumab ozogamicin in pediatric patients with relapsed/refractory acute lymphoblastic Leukemia, Leukemia (2019) 33:884â892, https://www.nature.com/articles/s41375-018-0265-z.pdf
Frequently Asked Questions
Why is liver enzyme getting elevated during treatment with Inotuzumab ozogamicin?
The reason for this elevation is not completely understood, but it is thought to be related to the drug's effects on certain enzymes involved in liver function.
Do we have to use contraception even after the treatment with Inotuzumab ozogamicin?
Yes, it is advised to use effective contraception even after the last dose of Inotuzumab; eight months for women and five months for men.
What should I inform the doctor about before starting the Inotuzumab ozogamicin?
Inform about underlying medical conditions, especially the history of blood clots and liver-related conditions, before starting Inotuzumab ozogamicin.
Can I Inotuzumab ozogamicin in children?
No, Only limited information is available about Inotuzumab ozogamicin usage in children. So it is advised not to use it in children. Talk to your doctor for more information.
Do we have to take any tests during Inotuzumab ozogamicin treatment?
Yes, your physician might regularly take blood tests to monitor your blood count and liver enzymes. Additionally, with an electrocardiogram, your electrolyte will also be monitored during the treatment with Inotuzumab ozogamicin.