Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vinorelbine injection in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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 Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Aprepitant
- Avacopan
- Carbamazepine
- Cholera Vaccine
- Cisplatin
- Clarithromycin
- Conivaptan
- Ebola Zaire Vaccine, Live
- Fedratinib
- Fexinidazole
- Fluconazole
- Fosaprepitant
- Fosnetupitant
- Gefitinib
- Influenza Virus Vaccine, Live
- Itraconazole
- Ketoconazole
- Letermovir
- Netupitant
- Omaveloxolone
- Phenobarbital
- Posaconazole
- Primidone
- Quinupristin
- Rotavirus Vaccine, Live
- Tazemetostat
- Voriconazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
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
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
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
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.
CON-XXXXXXXX
