Inotuzumab ozogamicin Medication Information

Discover comprehensive details about Inotuzumab ozogamicin, including its pronunciation, uses, dosage instructions, indications, and guidelines on how and when to take it or avoid it.

The updated prescription information covers potential side effects, precautions, warnings, and storage recommendations.

Additionally, explore the Inotuzumab ozogamicin brands available in India and internationally, along with pricing information. For personalized advice, consult your healthcare provider.

Generic Name : Inotuzumab ozogamicin

Pronunciation : IN-oh-TOOZ-ue-mab OH-zoe-ga-MYE-sin

Therapeutic Classification : Chemotherapy

Brand Names or Trade Names of Inotuzumab ozogamicin

India :

Besponsa

Overview of Inotuzumab ozogamicin

• Inotuzumab ozogamicin injection for intravenous use was approved by the US FDA in 2017 for treating adults with acute lymphoblastic leukemia (ALL).

Why is Inotuzumab ozogamicin Prescribed? (Indications)

Inotuzumab ozogamicin is a CD 22 - directed antibody-drug conjugate which is prescribed to treat adult patients suffering from relapsed or refractory B-cell precursor acute lymphoblastic leukemia, a type of blood cancer.

When should Inotuzumab ozogamicin not be taken? (Contraindications)

Inotuzumab ozogamicin should not be used in patients with

• Allergy to inotuzumab ozogamicin
• Pregnancy and breastfeeding
• Severe liver disorder
• Individuals predisposed to a type of cardiac rhythm problem called prolonged QTc interval
• Children below 18 years of age

What is the dosage of Inotuzumab ozogamicin?

• The maximum recommended dose of inotuzumab ozogamicin (1.8 mg/m²) for the first cycle is given over a maximum period of 3 to 4 weeks (21 or 28-day cycle) in three divided doses on day 1, 8 and 15 or as exactly advised by the physician.
• The subsequent cycles of Inotuzumab ozogamicin are for four weeks duration.
• The treatment should be discontinued in patients who do not respond to three cycles of treatment.
• Patients who proceed to hematopoietic stem cell transplant (HSCT) should receive only 2 cycles of treatment.
• Patients who do not proceed to hematopoietic stem cell transplant (HSCT) can receive a maximum of 6 cycles.

How should Inotuzumab ozogamicin be taken?

• Inotuzumab ozogamicin is available as a powder for reconstitution. It should be mixed with sterile water for injection and diluted with 0.9% sodium chloride with only gentle inversion without shaking.
• The diluted solution should be inspected for the presence of any visible particles or any discoloration before administration and should be discarded if present.
• The refrigerated diluted solution should be allowed to come at room temperature for about 1 hour before administration.
• The injection is given intravenously (directly into the vein) using a separate intravenous line by a healthcare provider in a hospital setting.
• Premedication with antipyretic (fever reducing), antihistamine (anti-allergy) and corticosteroids are recommended before starting the treatment to minimize or avoid infusion-related infusions.

What are the warnings and precautions for Inotuzumab ozogamicin?

• Patients should be advised to use effective contraceptive measures to avoid pregnancy. Women should continue the use of the contraceptive for at least 8 months after the last dose, while males should continue the use of the contraception for at least 5 months after the last dose.

• Do not breastfeed during and for at least two months after the last dose of inotuzumab ozogamicin therapy.

• Inotuzumab ozogamicin may affect fertility status both in men and women. Patients should therefore be advised to store their sperm or egg in a sperm or egg bank if they wish to plan a pregnancy after the completion of the treatment.

• Monitor liver functions during the treatment to avoid life-threatening liver problems such as veno-occlusive disease.

• The complete blood cell count and signs and symptoms of bleeding, infection (which may indicate low blood counts) should be monitored before, during and after treatment with inotuzumab ozogamicin. The dose can either be reduced or the treatment can be discontinued if blood counts reduce due to the treatment.

• Patients should be monitored closely during and for at least 1 hour after the infusion for serious or life-threatening infusion reactions such as fever, chills, breathing difficulties or rashes.

• Monitoring of ECG and electrolytes level is recommended while using inotuzumab ozogamicin particularly in patients with cardiac illness before and during the treatment.

What are the side effects of Inotuzumab ozogamicin?

Common: Nausea, stomach pain, headache, fever, chills, tiredness
Gastrointestinal: Vomiting, diarrhea, constipation, stomatitis, reduce appetite, liver damage ranging from increased liver enzymes and bilirubin levels to potentially fatal hepatic veno-occlusive disease
Cardiovascular: Abnormal heart rhythm (QT prolongation), bleeding
Respiratory: Cough, sore throat, difficulty in breathing, nosebleeds
Blood: Low blood counts
Others: Vaginal bleeding, infections, infusion-related reactions, increased risk of post-hematopoeitic stem cell transplant

What are the other precautions for Inotuzumab ozogamicin?

• Dose modifications are recommended, or the therapy can be discontinued depending on the occurrence of serious adverse reactions during inotuzumab ozogamicin therapy.
• Inotuzumab ozogamicin therapy should be initiated in women only when the pregnancy test shows a negative result.

What are the Drug Interactions of Inotuzumab ozogamicin?

Inotuzumab ozogamicin should not be used in combination with several drugs to avoid serious or life-threatening interactions including prolonged QTc interval of the heart. Some of these are as follows:

• Antiarrhythmic drugs (e.g. Amiodarone, quinidine, sotalol)
• Antibiotics (e.g. Gatifloxacin, grepafloxacin, moxifloxacin)
• Live vaccines (e.g. Typhoid vaccine, BCG vaccine, Yellow fever vaccine)
• Antipsychotics (e.g. Clozapine, thioridazine, ziprasidone)
• Antimalarials (e.g. Artemether)
• Cancer treating drugs (e.g. Carbozatinib, osimertinib, vandetanib)

What are the storage conditions for Inotuzumab ozogamicin?

• Store the inotuzumab ozogamicin vials in the original carton in a refrigerator at 2°C to 8°C.
• Reconstituted solution: Use immediately or up to 4 hours if stored at 2°C to 8°C.
• Diluted solution: Use immediately or up to 4 hours if kept at room temperature or 3 hours if kept at 2°C to 8°C. Bring the refrigerated solution to room temperature by keeping it outside the refrigerator for around an hour before use.
• Do not keep in a freezer.
• Protect from light and moisture.