Inotuzumab ozogamicin

Inotuzumab ozogamicin is injected into a vein through an IV. A healthcare provider will give you this injection.

You may be given other medicines to help prevent certain side effects of inotuzumab ozogamicin. Take these medicines for the full prescribed length of time.

Inotuzumab ozogamicin is given in a 21-day or 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 this medicine.

Inotuzumab ozogamicin may cause serious or life-threatening liver problems, including veno-occlusive disease (blocked blood vessels in the liver that can lead to liver damage). You will need frequent blood tests to check your liver function.

Inotuzumab ozogamicin can also lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your inotuzumab ozogamicin injection.

Inotuzumab ozogamicin is a monoclonal antibody linked to a chemotherapy drug. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Inotuzumab ozogamicin is used to treat a certain type of acute lymphocytic leukemia that has come back or has not responded after prior chemotherapy.

Inotuzumab ozogamicin may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss an appointment for your inotuzumab ozogamicin injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

• If you have an allergy to inotuzumab ozogamicin or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take inotuzumab ozogamicin or for 2 months after your last dose.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take inotuzumab ozogamicin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Antineoplastic Agent, Anti-CD22
• Antineoplastic Agent, Antibody Drug Conjugate
• Antineoplastic Agent, Monoclonal Antibody

Inotuzumab ozogamicin is a humanized CD22-directed monoclonal antibody-drug conjugate which is composed of the IgG4 kappa antibody inotuzumab (which is specific for human CD22), a calicheamicin component (a cytotoxic agent that causes double-stranded DNA breaks), and an acid-cleavable linker that covalently binds the calicheamicin to inotuzumab. After the antibody-drug conjugate binds to CD22, the CD22-conjugate complex is internalized, and releases calicheamicin. Calicheamicin binds to the minor groove of DNA to induce double strand cleavage and subsequent cell cycle arrest and apoptosis (Kantarjian 2016).

Distribution

~12 L.

Metabolism

Calicheamicin: Primarily via nonenzymatic reduction

Excretion

Clearance (steady state): 0.0333 L/hour

Half-Life Elimination

12.3 days

Protein Binding

Calicheamicin: ~97% bound to human plasma proteins.

Hepatic impairment prior to treatment initiation:

Total bilirubin ≤1.5 times ULN and AST/ALT ≤2.5 times ULN: No initial dosage adjustment necessary.

Total bilirubin >1.5 times ULN and/or AST/ALT >2.5 times ULN: There are no dosage adjustments provided in the manufacturer's labeling.

Hepatotoxicity during treatment:

Sinusoidal obstruction syndrome (also known as veno-occlusive disease) or other severe liver toxicity: Discontinue permanently.

Total bilirubin >1.5 times ULN and AST/ALT >2.5 times ULN: Interrupt treatment until recovery of total bilirubin to ≤1.5 times ULN and AST/ALT to ≤2.5 times ULN prior to each dose unless due to Gilbert syndrome or hemolysis. Permanently discontinue treatment if total bilirubin does not recover to ≤1.5 times ULN or AST/ALT does not recover to ≤2.5 times ULN. Refer to Dosing: Adjustment for Toxicity for dose modifications depending on duration of treatment interruption.