Teniposide Injection

IMPORTANT WARNING:

Teniposide injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Teniposide can cause a severe decrease in the number of blood cells in your bone marrow. This increases the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; black and tarry stools; red blood in stools; bloody vomit; vomited material that looks like coffee grounds.

Teniposide may cause severe or life-threatening allergic reactions. If you experience an allergic reaction to teniposide injection, it may begin during or after your infusion ends, and you may experience the following symptoms: hives; rash; itching; swelling of the eyes, face, throat, lips, tongue, hands, arms, feet, or ankles; difficulty breathing or swallowing; flushing; dizziness; faintness; or fast heartbeat. Your doctor or nurse will watch you carefully while you receive each dose of teniposide and for a period of time afterwards. Tell your doctor immediately if you experience any of these symptoms. You will receive certain medications to help prevent an allergic reaction before you receive each dose of teniposide if you have experienced an allergic reaction to teniposide.

WHY is this medicine prescribed?

Teniposide is used with other chemotherapy drugs to treat acute lymphocytic leukemia (ALL; a type of cancer of the white blood cells) in children that has not improved or that has worsened after treatment with other medications. Teniposide is in a class of medications known as podophyllotoxin derivatives. It works by slowing or stopping the growth of cancer cells in your body.

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?

Teniposide comes as a solution (liquid) to be injected over at least 30 to 60 minutes intravenously (into a vein) by a doctor or nurse in a medical facility. Your doctor will tell you how often you will receive teniposide. The schedule depends on how your body responds to the medication.

What SPECIAL PRECAUTIONS should I follow?

Before receiving teniposide,

• tell your doctor and pharmacist if you are allergic to teniposide, any other medications, polyoxyethylated castor oil (Cremophor EL), or any of the ingredients in teniposide 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. Be sure to mention any of the following: medications for nausea and vomiting, methotrexate (Abitrexate, Folex, Rheumatrex, Trexall), or tolbutamide (Orinase). Other medications may also interact with teniposide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had kidney or liver disease or if you have Down syndrome (an inherited condition causing a range of developmental and physical problems).

• tell your doctor if you are pregnant, plan to become pregnant, if you are breast-feeding, or if you plan to father a child. You should know that teniposide may stop sperm production in men. You should not become pregnant or breast-feed while you are receiving teniposide injection. If you or your partner become pregnant while receiving teniposide injection, call your doctor. Teniposide may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• sores in the mouth or tongue
• diarrhea
• hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• blurred vision
• pale skin
• excessive tiredness
• headache
• confusion
• pain, numbness, burning, or tingling in the hands or feet
• slow or irregular heartbeat

Teniposide may increase the risk that you will develop other cancers. Talk to your doctor about the risks of receiving teniposide injection.

Teniposide may cause other side effects. Call your doctor if you have any unusual problems while taking 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 should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• slowed breathing
• excessive tiredness
• slow or irregular heartbeat
• confusion
• fainting
• dizziness
• blurred vision
• fever, sore throat, chills, ongoing cough and congestion, or other signs of infection
• unusual bleeding or bruising

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to teniposide.

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.