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Vincristine liposome (Intravenous route)

Pronunciation:

vin-KRIS-teen SUL-fate LYE-poh-some

Brand Names:

  • Marqibo

Dosage Forms:

  • Solution
  • Suspension

Warnings:

Intravenous route(Suspension)

For intravenous use only. Fatalities have occurred when given by other routes, including intrathecal administration. VinCRIStine sulfate liposome injection has different dosage recommendations than vinCRIStine sulfate injection. Verify drug name and dose before preparation and administration to avoid overdosage .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Vincristine liposome injection is used to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in adult patients who have received at least 2 prior treatments that did not work well. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Vincristine liposome is an antineoplastic agent (cancer medicine).

This medicine is only administered by or under the 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 vincristine liposome injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

  • Boceprevir
  • Rotavirus 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.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Amiodarone
  • Aprepitant
  • Asparaginase
  • Atazanavir
  • Azithromycin
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Bosutinib
  • Captopril
  • Carbamazepine
  • Carvedilol
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Cyclosporine
  • Dexamethasone
  • Diltiazem
  • Dronedarone
  • Eliglustat
  • Erythromycin
  • Eslicarbazepine Acetate
  • Felodipine
  • Filgrastim
  • Fluconazole
  • Fosaprepitant
  • Fosphenytoin
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Lomitapide
  • Lopinavir
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Posaconazole
  • Primidone
  • Quercetin
  • Quinidine
  • Quinupristin
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rubella Virus Vaccine, Live
  • Saquinavir
  • Sargramostim
  • Simeprevir
  • Smallpox Vaccine
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Ticagrelor
  • Tocophersolan
  • Tolvaptan
  • Typhoid Vaccine
  • Ulipristal
  • Valspodar
  • Varicella Virus Vaccine
  • Verapamil
  • Voriconazole
  • Warfarin
  • Yellow Fever Vaccine
  • Zidovudine

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.

  • Nifedipine

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

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:

  • Anemia or
  • Intestinal or bowel problems (eg, constipation, blockage) or
  • Liver problems or
  • Nerve or muscle disorders (eg, numbness, weakness, tingling) or
  • Neutropenia (low white blood cells) or
  • Peripheral neuropathy (a nerve problem) or
  • Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.
  • Charcot-Marie-Tooth syndrome (a genetic nerve disorder)—Should not be used in patients with this condition.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in a vein.

This medicine usually comes with a patient information leaflet. Read and follow the information carefully. If you have any questions, talk to your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits while you are receiving this medicine to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are using this medicine to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

If vincristine liposome accidentally leaks out of the vein where it is injected, it may damage the skin and cause scars. Tell the doctor right away if you notice redness, pain, or swelling at the injection site.

Vincristine liposome 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 infections. 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 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 could occur.

This medicine may cause a serious reaction called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or feel tired.

This medicine may cause stomach pain, nausea, vomiting, or severe constipation. To prevent constipation, your doctor may direct you to take laxatives, drink fluids, or increase the fiber in your diet. Follow the directions carefully to prevent severe constipation.

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 tiredness, numbness, or a tingling sensation. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's Wort) or vitamin supplements.

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
Abdominal or stomach pain
black, tarry stools
bleeding gums
blood in the urine or stools
blurred vision
burning, tingling, numbness or pain in the hands, arms, feet, or legs
change in consciousness
change in muscle reflexes
chest pain
chills
confusion
cough
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fever
increased sensitivity to pain or touch
low blood pressure or pulse
lower back or side pain
nerve pain
painful or difficult urination
pale skin
pinpoint red spots on the skin
sensation of pins and needles
severe constipation
severe vomiting
shortness of breath
sneezing
sore throat
stabbing pain
sweating
tightness in the chest
troubled breathing
ulcers, sores, or white spots in the mouth
unsteadiness or awkwardness
unusual bleeding or bruising
unusual tiredness or weakness
Less common
Blue lips, fingernails, or skin
irregular, fast or slow, or shallow breathing
Incidence not known
Abdominal or stomach tenderness
clay colored stools
dark urine
decreased appetite
headache
itching
joint pain, stiffness, or swelling
loss of appetite
nausea and vomiting
skin rash
swelling of the feet or lower legs
yellow eyes or skin

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:

Less common
Lack or loss of strength
mental depression or anxiety
muscle weakness
nightmares or unusually vivid dreams
Incidence not known
Redness, pain, or swelling at the injection site

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.


Last Updated: 11/4/2014

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