Lipodox 50 (Intravenous)

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

Doxorubicin liposome affects the growth of cancer cells, which are eventually destroyed by the body. It may also affect the growth of normal body cells, leading to other unwanted side effects. Some of these side effects can be serious and should be reported to your doctor.

This medicine must be given only by or under the direct supervision of your doctor.

It is very important for your doctor to check you regularly while you are receiving this medicine to ensure it is working properly. Blood tests may be needed to look 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 prevent pregnancy. If you think you or your partner might be 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 immediately if you experience chest pain or discomfort, a fast or irregular heartbeat, swelling in your feet and lower legs, or trouble breathing. These could be signs 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 receiving this medicine.

This medicine may cause hand-foot syndrome. Check with your doctor immediately 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 reduce the number of white blood cells in your blood, increasing the risk of 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 possible, 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 your 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 suggest 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 cautious when using sharp objects like a safety razor or fingernail or toenail clippers to avoid cuts.
• Avoid contact sports or other situations where bruising or injury could happen.

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 signs of oral cancer.

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

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

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it will provide. Here are some important things to consider for this medicine:

Allergies

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

Pediatric

Studies have not been done to determine how age affects the use of doxorubicin liposome injection in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of doxorubicin liposome injection.

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 against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When you receive this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected for 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 necessary 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
• Escitalopram
• 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
• Sertraline
• 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 increase the 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used during meals or with specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected for 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 provide special instructions about using food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform 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 worsen these conditions.

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

• Liver disease—Use with caution. Effects may be stronger due to slower elimination of the medicine 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, 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.

In the U.S.

• Doxil
• Lipodox
• Lipodox 50

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

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.

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