Daunoxome (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 stop cancer cells from growing, leading to their destruction. Since it can also affect the growth of normal body cells, other side effects may occur. Some of these side effects can be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but can be concerning. Some side effects may not appear until months or years after using the medicine.

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

Liposomal daunorubicin must be given only by or under the direct supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and to look for any unwanted effects.

While you are being treated with liposomal daunorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Liposomal daunorubicin may lower your body's resistance, and there is a chance you might get the infection that the immunization is meant to prevent. Additionally, other people in your household should not take oral poliovirus vaccine because there is a chance they could pass the poliovirus on to you. Also, avoid people who have taken oral poliovirus vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers your nose and mouth.

Liposomal daunorubicin 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 happens, 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 have 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 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against its benefits. Here are some important factors to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

There is no specific information available that compares the use of liposomal daunorubicin in elderly patients to 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 while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor might adjust the dose, or other precautions may be needed. When receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

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

• 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 it may be necessary in some cases. If both medicines are prescribed together, your doctor may alter the dose or frequency of use for 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

Some medicines should not be used around the time of eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical conditions, especially:

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

• Gout (history of) or
• Kidney stones—Liposomal daunorubicin may raise uric acid levels in the body, potentially causing gout or kidney stones

• Heart disease—there may be an increased risk of heart problems caused by liposomal daunorubicin

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

• Kidney disease or
• Liver disease—effects of liposomal daunorubicin may be heightened 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 occur, if they do occur they may 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 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

• 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 to be 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.