Pronunciation:

dox-oh-ROO-bi-sin hye-droe-KLOR-ide LYE-poh-some

Brand Names:

• Doxil
• Lipodox
• Lipodox 50

Dosage Forms:

• Solution

Warnings:

DOXOrubicin hydrochloride (HCl) liposome injection can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 to 550 mg/m(2). Assess left ventricular cardiac function prior to initiation of DOXOrubicin HCl liposome and during and after treatment. Serious, life-threatening and fatal infusion-related reactions can occur with DOXOrubicin HCl liposome. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXOrubicin HCl liposome for infusion-related reactions and resume at a reduced rate. Discontinue DOXOrubicin HCl liposome for serious or life-threatening infusion-related reactions .

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

Anthracycline

Uses of This Medicine:

Doxorubicin liposome injection is used to treat ovarian cancer and Kaposi sarcoma (AIDS patients). It is also used together with bortezomib to treat multiple myeloma. Doxorubicin liposome is an antineoplastic agent (cancer medicine).

Doxorubicin liposome interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by doxorubicin liposome, other unwanted side effects will also occur. Some of these may be serious and must be reported to your doctor.

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 doxorubicin 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 doxorubicin liposome injection in the elderly.

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.

• Atazanavir
• Boceprevir
• Cobicistat
• Lopinavir
• Nelfinavir
• Saquinavir
• Telaprevir

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.

• Abiraterone Acetate
• Adagrasib
• Amiodarone
• Amitriptyline
• Amobarbital
• Amprenavir
• Aprepitant
• Aprobarbital
• Azathioprine
• Azithromycin
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Capmatinib
• Captopril
• Carbamazepine
• Carvedilol
• Ceritinib
• Chlorpromazine
• Cinacalcet
• Ciprofloxacin
• Cisplatin
• Clarithromycin
• Clobazam
• Clozapine
• Conivaptan
• Crizotinib
• Cyclophosphamide
• Cyclosporine
• Darunavir
• Delavirdine
• Desipramine
• Desvenlafaxine
• Dexamethasone
• Diltiazem
• Dronedarone
• Duloxetine
• Efavirenz
• Enzalutamide
• Erythromycin
• Etravirine
• Felodipine
• Fluconazole
• Fluoxetine
• Fluphenazine
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Mephobarbital
• Mercaptopurine
• Methohexital
• Miconazole
• Mifepristone
• Modafinil
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nefazodone
• Nevirapine
• Oxcarbazepine
• Paclitaxel
• Paroxetine
• Pentobarbital
• Phenobarbital
• Phenytoin
• Piperaquine
• Posaconazole
• Quercetin
• Quinidine
• Ranolazine
• Regorafenib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Secobarbital
• Simeprevir
• Stavudine
• St John's Wort
• Telithromycin
• Terbinafine
• Thiopental
• Thioridazine
• Ticagrelor
• Tipranavir
• Tocophersolan
• Trastuzumab
• Valspodar
• Venetoclax
• Verapamil
• Vinflunine
• 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.

• Rolapitant
• Sorafenib

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:

• Congestive heart failure or
• Heart or blood vessel disease, history of—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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 your vein.

Do not substitute Doxil® for doxorubicin HCl injection.

This medicine often causes nausea and vomiting. Your doctor may give you medicine to prevent this. Talk to your doctor if you continue to have nausea and vomiting after you receive the medicine.

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 it 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 receiving this medicine and for 6 months after treatment to keep from getting pregnant. If you think you or your partner have become pregnant, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Check with your doctor right away if you have chest pain or discomfort, a fast or irregular heartbeat, swelling of the feet and lower legs, or troubled breathing. These could be symptoms of a serious heart problem.

This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest tightness, a cough, dizziness, a fast heartbeat, trouble breathing, trouble swallowing, swelling in your face or hands, a fever or chills, or lightheadedness or faintness while you are receiving this medicine.

This medicine may cause hand-foot syndrome. Check with your doctor right away if you have tingling or burning, redness, swelling, blistering, or small sores on the palms of your hands or soles of your feet.

Doxorubicin 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 can occur.

If you continue to receive this medicine for a full year, tell your doctor right away if you have any discomfort, pain, sores or ulcers in your mouth. These could be symptoms of oral cancer.

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

This medicine may cause your urine color to be red or orange for 1 or 2 days after you receive the injection. This is normal.

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

blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet

blood in the urine or stools

chills

cough or hoarseness

facial swelling

fever

headache

loss of strength and energy

lower back or side pain

numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet

painful or difficult urination

pinpoint red spots on the skin

shortness of breath

sore throat

sores in the mouth and on the lips

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Pain at the injection site

skin rash or itching

Rare

Chest pain

decreased urine output

dilated neck veins

extreme fatigue

irregular breathing

irregular heartbeat

swelling of the face, fingers, feet, or lower legs

tightness in the chest

weight gain

yellowing of the eyes and 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:

More common

Creamy white, curd-like patches in mouth or throat

diarrhea

loss of appetite

nausea

pain when eating or swallowing

sore throat

swallowing problems

vomiting

Less common

Anxiety

back pain

bad, unusual, or unpleasant aftertaste

burning, dry, or itching eyes

change in skin color

constipation

dizziness

excessive tearing

itching

joint pain

muscle aches

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

trouble sleeping

Rare

Abnormal thinking

change in sense of smell

chills

clumsiness, unsteadiness, trembling, or problems with muscle coordination

cough

fever

general feeling of discomfort or illness

shivering

sweating

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.