Vincristine Injection

IMPORTANT WARNING:

Vincristine should be administered only into a vein. However, it may leak into surrounding tissue causing severe irritation or damage. Your doctor or nurse will monitor your administration site for this reaction. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected.

Vincristine should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.

WHY is this medicine prescribed?

Vincristine is used in combination with other chemotherapy drugs to treat certain types of leukemia (cancer of the white blood cells), including acute myeloid leukemia (AML, ANLL) and acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma (Hodgkin's disease), and non-Hodgkin's lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection). Vincristine is also used in combination with other chemotherapy drugs to treat Wilms tumor (a type of kidney cancer that occurs in children), neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children), and rhabdomyosarcoma (cancer that forms in muscles in children). Vincristine is in a class of medications called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

Vincristine is also sometimes used to treat certain types of brain tumors, certain types of lung cancer, multiple myeloma (a type of cancer of the bone marrow), chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells), Kaposi's sarcoma (a type of cancer that causes abnormal tissue to grow on different parts of the body) related to acquired immunodeficiency syndrome (AIDS), Ewings sarcoma (a type of cancer in bones or muscle), and gestational trophoblastic tumors (a type of tumor that forms inside a woman's uterus while she is pregnant). Vincristine is also sometimes used to treat thrombotic thrombocytopenic purpura (TPP; a blood disorder that causes blood clots to form in small blood vessels in the body). Talk to your doctor about the risks of using this medication for your condition.

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

HOW should this medicine be used?

Vincristine comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually given once a week. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.

Your doctor may need to delay your treatment or change your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with vincristine injection.

Your doctor may tell you to take a stool softener or laxative to help prevent constipation during your treatment with vincristine injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving vincristine,

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

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: aprepitant (Emend); carbamazepine (Tegretol); certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend), and posaconazole (Noxafil); clarithromycin (Biaxin, in Prevpac); darifenacin (Enablex); dexamethasone (Decadron); fesoterodine (Toviaz); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); nefazodone; oxybutynin (Ditropan, Ditropan XL, Oxytrol); phenobarbital; phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); rifapentine (Priftin); solifenacin (Vesicare); telithromycin (Ketek); trospium (Sanctura); or tolterodine (Detrol, Detrol LA). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had a disorder that affects your nerves. Your doctor may not want you to receive vincristine injection.

• tell your doctor if you are having or have ever had radiation (x-ray) therapy, if you have an infection, or if you have or have ever had lung or liver disease.

• you should know that vincristine may interfere with the normal menstrual cycle (period) in women and may temporarily or permanently stop sperm production in men. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breastfeed while you are receiving vincristine injection. If you become pregnant while receiving vincristine injection, call your doctor. Vincristine 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?

Vincristine 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 and throat
• loss of appetite or weight
• stomach pain
• diarrhea
• headache
• hair loss

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

• hives
• rash
• itching
• difficulty breathing or swallowing
• constipation
• increased or decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• unusual bleeding or bruising
• unusual tiredness or weakness
• pain, numbness, burning, or tingling in the hands or feet
• difficulty walking or unsteady walking
• muscle or joint pain
• sudden changes in vision, including loss of vision
• hearing loss
• dizziness
• loss of the ability to move muscles and to feel a part of the body
• hoarseness or loss of ability to speak loudly
• seizures
• jaw pain
• fever, sore throat, chills, or other signs of infection

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

Vincristine 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 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:

• seizures
• severe constipation
• stomach pain
• unusual bleeding or bruising

What OTHER INFORMATION should I know?

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

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.

^¶ This branded product is no longer on the market. Generic alternatives may be available.