Vincristine Lipid Complex Injection

IMPORTANT WARNING:

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

WHY is this medicine prescribed?

Vincristine lipid complex is used to treat a certain type of acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) that has not improved or that has worsened after at least two different treatments with other medications. Vincristine lipid complex 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?

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

HOW should this medicine be used?

Vincristine lipid complex comes as a liquid to be injected intravenously (into a vein) over 1 hour by a doctor or nurse in a medical facility. It is usually given once every 7 days. The length of treatment depends on the types of drugs you are taking, how well your body responds to them.

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 lipid complex.

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

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

What SPECIAL PRECAUTIONS should I follow?

Before receiving vincristine lipid complex,

• tell your doctor and pharmacist if you are allergic to vincristine, any other medications, or any of the ingredients in vincristine lipid complex 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); dexamethasone (Decadron); HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; phenobarbital; phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); rifapentine (Priftin);or telithromycin (Ketek). 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 lipid complex or may need to change your dose of vincristine lipid complex injection.

• 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 lipid complex. If you become pregnant while receiving vincristine lipid complex, call your doctor. Vincristine may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

You should eat plenty of fiber, including fruits and vegetables, and drink plenty of fluids during your treatment to help prevent constipation.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• loss of appetite
• stomach pain
• diarrhea
• trouble falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected
• constipation
• fever, sore throat, ongoing cough and congestion, or other signs of infection
• unusual bleeding or bruising
• bloody or black, tarry stools
• unusual tiredness or weakness
• dizziness
• pale skin
• fast heartbeat
• pain, burning, tingling, weakness in the hands or feet
• difficulty walking
• increased or decreased feeling or sensitivity to touch
• decreased or absent reflexes
• muscle or joint pain
• jaw pain
• sudden changes in vision
• sudden decrease or loss of hearing
• confusion or memory loss
• sudden weakness on one side of the face

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

Vincristine lipid injection 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:

• seizures
• weakness in the hands or feet
• difficulty walking

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 lipid complex.

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.