Pronunciation:

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

Brand Names:

• Marqibo

Dosage Forms:

• Suspension

Warnings:

VinCRIStine sulfate liposome is for IV use only and is fatal if given by other routes. Death has occurred with intrathecal use. 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) that has worsen or come back or in patients who have received at least 2 previous cancer treatments that did not work well.

Vincristine liposome is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine 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 vincristine liposome 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 vincristine liposome injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution for patients receiving this medicine.

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

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
• Amiodarone
• Apalutamide
• Asparaginase
• Atazanavir
• Carbamazepine
• Carvedilol
• Clarithromycin
• Cobicistat
• Conivaptan
• Cyclosporine
• Dexamethasone
• Dronedarone
• Enzalutamide
• Erythromycin
• Fedratinib
• Fexinidazole
• Filgrastim
• Flibanserin
• Fluconazole
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lapatinib
• Lopinavir
• Lumacaftor
• Mavacamten
• Mitotane
• Nefazodone
• Nelfinavir
• Nilotinib
• Nirmatrelvir
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Quinidine
• Quinupristin
• Ranolazine
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Sargramostim
• Simeprevir
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Valspodar
• Vemurafenib
• Verapamil
• Voriconazole
• Warfarin
• 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 (low red blood cells) or
• Liver disease or
• Nerve or muscle problem (eg, neuropathy) or
• Neutropenia (low white blood cells) or
• Stomach or bowel problems (eg, blockage, ileus) or
• Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.

• Nerve problem (eg, Charcot-Marie-Tooth syndrome)—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 medical facility. It is given through a needle placed into one of your veins.

This medicine must be given slowly, so the needle will have to stay in place for at least 1 hour. It is usually given every 7 days.

Precautions While Using This Medicine:

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

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant or your partner has become pregnant while receiving this 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 nerve problem called peripheral neuropathy.

If vincristine liposome accidentally leaks out of the vein where it is injected, it may damage the skin and cause tissue injury. 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal 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

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

chest pain or tightness

chills

confusion

cough

diarrhea

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

fever

lack or loss of strength

lower back or side pain

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid breathing

severe constipation

severe vomiting

sneezing

sore throat

stomach pain

sweating

trouble 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

bone pain

change in muscle reflexes

coughing up blood

dark urine

headache

irregular, fast or slow, or shallow breathing

joint pain, stiffness, or swelling

light-colored stools

muscle pain or weakness

stomach pain, continuing

swelling of the feet or lower legs

vomiting

weakness of the muscles in your face

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

Anxiety

mental depression

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.