Inotuzumab Ozogamicin Injection

IMPORTANT WARNING:

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.

WHY is this medicine prescribed?

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 in adults and children 1 year of age and older. Inotuzumab ozogamicin injection is in a class of medications called monoclonal antibodies. It works by activating the immune system to destroy cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Inotuzumab ozogamicin injection comes as powder to be mixed with liquid to be injected intravenously (into a vein) over 1 hour 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using inotuzumab ozogamicin injection,

• tell your doctor and pharmacist if you are allergic to inotuzumab ozogamicin, any other medications, or any of the ingredients in inotuzumab ozogamicin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also, tell your doctor if you have an infection or if you have or have ever had a low level of potassium or magnesium in your blood, heart problems, or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with inotuzumab ozogamicin injection. If you are a female, you should not become pregnant while you are receiving inotuzumab ozogamicin and for at least 8 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you are a male, you and your female partner should use birth control during your treatment and continue to use birth control for at least 5 months after your final dose. If you or your partner become pregnant while receiving inotuzumab ozogamicin, call your doctor. Inotuzumab ozogamicin may harm the fetus.

• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment with inotuzumab ozogamicin injection and for at least 2 months after your final dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of receiving inotuzumab ozogamicin injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Inotuzumab ozogamicin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• decreased appetite
• stomach pain
• diarrhea
• constipation
• mouth sores
• rash
• itching
• excessive sweating
• arm, leg, back, or neck pain
• muscle weakness
• anxiety

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:

• fever, chills, cough, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• pale skin
• fatigue
• dizziness, lightheadedness, or feeling faint
• slow, fast, or irregular heart beats

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

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.