Daunorubicin citrate liposome (Intravenous)

Liposomal daunorubicin is part of a group of medicines called antineoplastics. It is used to treat advanced acquired immunodeficiency syndrome (AIDS)–associated Kaposi's sarcoma (KS), which is a type of skin cancer.

Liposomal daunorubicin appears to block the growth of cancer cells, leading to their destruction. However, it may also affect the growth of normal body cells, leading to other effects. Some of these effects can be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but could be concerning. Some effects may not show up until months or years after using the medicine.

Before starting treatment with liposomal daunorubicin, you should discuss with your doctor the benefits of this medicine as well as the risks involved.

Liposomal daunorubicin should only be given by your doctor or under their immediate supervision.

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly and to monitor for any unwanted effects.

While you are receiving treatment with liposomal daunorubicin, and after you finish treatment, do not get any immunizations (vaccinations) without your doctor's approval. Liposomal daunorubicin may weaken your body's resistance, and you might get the infection that the immunization is supposed to prevent. Additionally, people in your household should not take the oral poliovirus vaccine because they could pass the poliovirus to you. Avoid close contact with anyone who has received the oral poliovirus vaccine. Do not stay in the same room with them for long periods. If you cannot avoid these situations, consider wearing a protective face mask that covers your nose and mouth.

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

• If possible, avoid people who have infections. Contact your doctor immediately if you think you may have an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult your 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 cautious when using sharp objects, such as safety razors or fingernail or toenail clippers, to avoid cutting yourself.
• Avoid contact sports or other activities where bruising or injury may happen.

In deciding to use a medicine, you and your doctor must consider the risks of the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

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

Pediatric

There is no specific information comparing the use of liposomal daunorubicin in children to its use in other age groups. The safety and effectiveness of liposomal daunorubicin in children have not been established.

Geriatric

There is no specific information comparing the use of liposomal daunorubicin in elderly patients to its use in other age groups. The safety and effectiveness of liposomal daunorubicin in the elderly have not been established.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction may occur. In these cases, your doctor may adjust the dose, or other precautions may be needed. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions have been chosen based on 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
• Tasonermin
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Margetuximab
• Pertuzumab
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Trastuzumab
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used near the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or
• Kidney stones—Liposomal daunorubicin may increase uric acid in the body, which can cause gout or kidney stones

• Heart disease—Risk of heart problems caused by liposomal daunorubicin may be increased

• Infection—Liposomal daunorubicin can reduce your body's ability to fight infections

• Kidney disease or
• Liver disease—Effects of liposomal daunorubicin may be increased due to slower removal from the body

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

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Cough or hoarseness
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Shortness of breath
• Sore throat
• Troubled breathing
• Weakness or numbness in arms or legs

Less common

• Black, tarry stools
• Blood in urine or stools
• Bloody vomit
• Chest pain
• Coughing up blood
• Fainting
• Fast heartbeat
• Irregular heartbeat
• Pinpoint red spots on skin
• Producing large amounts of pale, dilute urine
• Sores in mouth and on lips
• Swelling of abdomen, face, fingers, hands, feet, or lower legs
• Unusual bleeding or bruising
• Unusual nighttime urination
• Unusual tiredness or weakness
• Weight gain

Some side effects may happen 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 suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Abdominal pain
• Back pain
• Chest tightness
• Diarrhea
• Feeling unusually cold
• Flushing
• Headache
• Nausea and vomiting
• Shivering
• Skin rash or itching

Less common

• Bleeding after defecation
• Bleeding gums
• Constipation
• Difficulty swallowing
• Dizziness
• Dry mouth
• Dry, irritated, itching, or red eyes
• Extreme feeling of sleepiness
• Eye pain
• Frequent urge to defecate
• Pain in joints or muscles
• Pain at site of injection
• Painful, red, hot, or irritated hair follicles
• Red, hot, or irritated skin at site of injection
• Ringing sound in ears
• Sleeplessness
• Swelling or lump under skin at site of injection
• Tooth pain
• Uncomfortable swelling around anus
• Uncontrollable movement of body

Symptoms of overdose

• Black, tarry stools
• Blood in urine or stools
• Cough or hoarseness
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Pinpoint red spots on skin
• Sore throat
• Sores in mouth and on lips
• Unusual bleeding or bruising

Liposomal daunorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is expected and only lasts for 1 or 2 days after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with liposomal daunorubicin has ended, normal hair growth should return.

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.

In the U.S.

• Daunoxome

Chemical Class: Anthracycline

Liposomal daunorubicin 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.

While you are receiving liposomal daunorubicin, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.