Pronunciation:

vin-OR-el-been

Brand Names:

• Navelbine

Dosage Forms:

• Solution

Warnings:

Myelosuppression: Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Vinorelbine injection is used to treat metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). It is also used together with other medicines (eg, cisplatin) for the first-line treatment of advanced or metastatic NSCLC.

Vinorelbine belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells also may be affected by vinorelbine, other effects can occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Vinorelbine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of vinorelbine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vinorelbine injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adenovirus Vaccine, Live
• Aprepitant
• Bacillus of Calmette and Guerin Vaccine, Live
• Carbamazepine
• Cholera Vaccine, Live
• Cisplatin
• Clarithromycin
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosaprepitant
• Fosnetupitant
• Gefitinib
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Mavacamten
• Netupitant
• Omaveloxolone
• Phenobarbital
• Poliovirus Vaccine, Live
• Posaconazole
• Primidone
• Quinupristin
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Voriconazole
• Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain or nerve problems or
• Lung disease or breathing problems or
• Stomach or bowel problems (eg, blockage, perforation)—Use with caution. May make these conditions worse.

• Infection—Use with caution. This medicine may decrease your body's ability to fight infections.

• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Vinorelbine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

Your doctor may want you to drink plenty of fluids, eat meals rich in fiber, or use stool softeners (laxatives) to prevent constipation.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive it, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Vinorelbine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infection. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose, unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury can occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause severe constipation, stomach or bowel blockage, or perforation, which can be life-threatening. Check with your doctor right away if you have stomach cramps or pain, black, tarry stools, diarrhea, fever, or severe vomiting, sometimes with blood.

If vinorelbine accidentally leaks out of the vein into which it is injected, it may damage the skin tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

Check with your doctor right away if you have burning, tingling, numbness, or pain in the hands, arms, feet, or legs ,sensation of pins and needles, stabbing pain, or muscle weakness. These may be signs of a brain or nerve problem.

Serious lung or breathing problems (eg, bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome) may occur after you get a shot of this medicine into one of your muscles. Call your doctor right away if have any changes in your breathing after you receive this medicine.

If you plan to have children, talk with your doctor before receiving this medicine. Some men receiving this medicine have become infertile (unable to have children).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blood in the urine or stools

bluish color of the skin

burning, numbness, tingling, or painful sensations

changes in skin color

chest pain

chills

clay-colored stools

constipation

cough

dark urine

decreased appetite

dizziness

feeling of fullness in the ears

fever

headache

hoarseness

itching, skin rash

loss of appetite

loss of balance

loss of hearing

lower back or side pain

muscle pains, cramps, or stiffness

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

ringing or buzzing in the ears

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain or tenderness

swelling of the feet or lower legs

swollen glands

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

trouble in hearing

troubled breathing with exertion

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Less common

Chest tightness

increased sensitivity to pain or touch

overactive reflexes, followed by underactive reflexes

trouble breathing

Rare

Agitation

chest discomfort

confusion

decreased awareness or responsiveness

decreased urine output

depression

frequent urination

hostility

irritability

loss of consciousness

lower abdominal cramping

muscle twitching

pain or discomfort in the arms, jaw, back, or neck

rapid weight gain

seizures

severe sleepiness

swelling of the face, ankles, or hands

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

Incidence not known

Anxiety

blistering or sloughing of the skin

bloating

blurred vision

change in walking and balance

clumsiness or unsteadiness

coughing that sometimes produces a pink frothy sputum

difficult, fast, noisy breathing

difficulty in swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, pounding, or irregular heartbeat or pulse

heartburn

hives or welts

increased sweating

increased thirst

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lightheadedness

nervousness

pain or burning in the throat

pain, redness, or swelling in the arm or leg

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

slow heartbeat

ulceration of the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Chest pain

chills

confusion

fainting

fast heartbeat

fever

lightheadedness

lower back or side pain

painful or difficult urination

partial or slight paralysis

rapid, shallow breathing

severe constipation

severe stomach pain

severe vomiting

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in taste

diarrhea

difficulty in moving

impaired hearing

joint pain or swelling

lack or loss of strength

thinning or loss of hair

Incidence not known

Back pain

cracked, dry, scaly skin

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

jaw pain

pain and redness of the skin at the place of earlier radiation treatment

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.