Vinorelbine Injection

IMPORTANT WARNING:

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

Vinorelbine can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood. Your doctor may decrease your dose, or delay, interrupt, or stop your treatment if the number of white blood cells is too low. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection.

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

WHY is this medicine prescribed?

Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. Vinorelbine 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?

Vinorelbine is also sometimes used to treat breast cancer, cancer of the esophagus (tube that connects the mouth and stomach), and soft tissue sarcomas (cancer that forms in muscles). 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?

Vinorelbine 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 how well your body responds to treatment with vinorelbine.

You should know that vinorelbine 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 the area near where the medication was injected. If you experience any of the following symptoms, tell your doctor immediately: pain, itching, redness, swelling, blisters, or sores near the place where the medication was injected.

What SPECIAL PRECAUTIONS should I follow?

Before receiving vinorelbine,

• tell your doctor and pharmacist if you are allergic to vinorelbine, any other medications, or any of the ingredients in vinorelbine 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: certain antifungals such as itraconazole (Onmel, Sporanox, Tolsura) and ketoconazole; clarithromycin ; HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Technivie, Viekira), and saquinavir (Invirase); or nefazodone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had liver disease.

• Tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You or your partner should not become pregnant while you are receiving vinorelbine injection. You must take a pregnancy test before you start treatment to be sure you are not pregnant. If you are a female, use effective birth control during your treatment and for 6 months after your final dose. If you are a male, use effective birth control during your treatment and for 3 months after your final dose. If you or your partner become pregnant while you're receiving vinorelbine injection, call your doctor. Vinorelbine may harm the fetus.

• tell your doctor if you are breast-feeding. Your doctor will probably tell you not to breastfeed during your treatment and for 9 days after your final dose.

• you should know that vinorelbine may cause constipation. Talk to your doctor about changing your diet and using other medications to prevent or treat constipation while you are taking vinorelbine.

What SPECIAL DIETARY instructions should I follow?

Your doctor may tell you to be sure to drink enough of water, and eat high fiber foods such as lettuce, spinach, broccoli, squashes, beans, nuts, seeds, fruit, whole wheat bread, whole wheat pasta, or brown rice. Be sure to follow the instructions carefully.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• diarrhea
• loss of appetite
• weight loss
• change in ability to taste food
• sores in the mouth and throat
• hearing loss
• muscle, or joint pain
• hair loss
• lack of energy, not feeling well, tiredness

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 or get emergency medical treatment:

• shortness of breath or difficulty breathing, cough
• constipation, stomach pain, nausea, vomiting
• unusual bleeding or bruising
• hives, itching, rash, difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, and eyes
• blistering or peeling skin
• yellowing of skin or eyes, dark colored urine, light colored stool
• numbness, tingling feeling on skin, sensitive skin, decreased sense of touch, or muscle weakness
• fever, chills, sore throat or other signs of infection
• chest pain, shortness of breath, coughing up blood
• red, swollen, tender, or warm arm or leg

Talk to your doctor about the risks of receiving vinorelbine injection.

Vinorelbine 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:

• sores in the mouth and throat
• stomach pain
• constipation
• fever, sore throat, chills, or other signs of infection
• loss of the ability to move muscles and to feel a part of the body

What OTHER INFORMATION should I know?

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.