vinorelbine 50 mg/5 mL intravenous solution

Generic name:
Vinorelbine - injection

Pronunciation
(vye-nor-ELL-bean)

Brand name(s)
Navelbine

This medication must be given only by injection into a vein by a trained healthcare professional. Deaths have occurred with medications similar to vinorelbine that were injected into the spine.

Vinorelbine can lower your blood cell counts (bone marrow suppression) and lower your ability to fight an infection. Your doctor will follow your blood counts closely. Tell your doctor right away if you develop any signs of an infection such as sore throat that doesn't go away, fever, or chills.

If this medication accidentally leaks out of your vein into surrounding tissue, the skin and/or muscle may be severely damaged. Tell your doctor right away if you have pain, redness, swelling, or discoloration at the injection site.

Vinorelbine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.

Vinorelbine is given by injection only into a vein by a healthcare professional. It is given as directed by your doctor, usually over 6-10 minutes, once a week. The dosage is based on your medical condition, response to treatment, and body size.

If this medication comes into contact with your skin, wash your skin right away and completely with soap and water. If vinorelbine gets into your eyes, flush them right away and completely with water, and contact the doctor.

See also Warning section.

Nausea, vomiting, tiredness, constipation, diarrhea, dizziness, muscle aches, joint pain, or irritation at the injection site may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. Your doctor may prescribe a laxative (such as a stool softener) to help prevent constipation. Ask your doctor or pharmacist which type of laxative is right for you.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• numbness/tingling/pain in the hands or feet
• decreased reflexes
• mouth sores
• easy bruising/bleeding
• weakness
• shortness of breath
• cough
• severe constipation
• blood in the urine
• mental/mood changes

Get medical help right away if you have any very serious side effects, including:

• chest pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• decreased bone marrow function/blood cell disorders (such as anemia, leukopenia, thrombocytopenia)
• liver disease
• numbness/tingling of the hands or feet
• blockage of the stomach/intestines (such as obstruction, paralytic ileus)
• heart disease

Vinorelbine can sometimes cause a serious skin reaction that looks like a severe sunburn when given after radiation treatment (radiation recall). The reaction usually develops on the skin area previously treated with radiation within days to months after vinorelbine treatment. Throat problems can also be part of radiation recall with vinorelbine. Tell your doctor right away if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. Your doctor may prescribe medication to treat your symptoms. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication can affect fertility in males. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using vinorelbine. Vinorelbine may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 9 days after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• mitomycin

Other medications can affect the removal of vinorelbine from your body, which may affect how vinorelbine works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.