Doxil

Doxil is a prescription medication used in combination with other medications to treat:

• Ovarian cancer - After failure of platinum-based chemotherapy.
• AIDS-related Kaposi's Sarcoma - After failure of prior systemic chemotherapy or intolerance to such therapy.
• Multiple Myeloma - In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Doxil is part of the drug class:

• Anthracyclines and related substances

Doxil is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Call your doctor for instructions if you miss an appointment for your doxorubicin liposomal injection.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with doxorubicin liposomal, especially:

• cyclophosphamide; or

• mercaptopurine.

This list is not complete. Other drugs may interact with doxorubicin liposomal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Doxil
• Lipodox
• Lipodox 50

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

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.

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:

• 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

• Pain at the injection site
• skin rash or itching

• 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:

• Creamy white, curd-like patches in mouth or throat
• diarrhea
• loss of appetite
• nausea
• pain when eating or swallowing
• sore throat
• swallowing problems
• vomiting

• 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

• 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Doxil, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Doxil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Doxil.

Review Date: October 4, 2017

No formal drug interaction studies have been conducted with Doxil.

Common side effects of Doxil include: severe anemia, severe erythrodysesthesia syndrome, nausea, vomiting, diarrhea, stomatitis, erythrodysesthesia syndrome, alopecia, anemia, asthenia, bone marrow depression, neutropenia, thrombocytopenia, and anorexia. Other side effects include: asthma, syncope, severe neutropenia, back pain, chest pain, dyspnea, facial edema, fever, headache, hypotension, pruritus, skin rash, tachycardia, pharyngitis, and chills. See below for a comprehensive list of adverse effects.

Applies to doxorubicin liposomal: intravenous solution

Along with its needed effects, doxorubicin liposomal (the active ingredient contained in Doxil) 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 while taking doxorubicin liposomal:

• 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

• Pain at the injection site
• skin rash or itching

• 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 of doxorubicin liposomal 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:

• Creamy white, curd-like patches in mouth or throat
• diarrhea
• loss of appetite
• nausea
• pain when eating or swallowing
• sore throat
• swallowing problems
• vomiting

• 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

• 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

20 mg/m2 IV over 30 minutes. The dose should be repeated once every 3 weeks according to patient response.

The following information regarding doxorubicin in pregnancy was not from use of the liposomal form. Doxorubicin crosses the human placenta. Several cases of birth defects have been associated with the use of doxorubicin during pregnancy. These birth defects have included imperforate anus, rectovaginal fistula, brachycephaly, hypoplasia of the anterior cranial base and face, synostoses of cranial sutures, hypoplastic digits, and fetal maceration. Fetal death has been reported 36 hours after treatment with doxorubicin and other neoplastic agents. Doxorubicin may cause reversible testicular and ovarian dysfunction or menstrual abnormalities. Most men who have received doxorubicin regain spermatogenesis and sperm motility. Some women who were previously treated with doxorubicin have subsequently had normal pregnancies. Development of sterility may depend on the dose, duration of therapy, and the pretreatment state of gonadal function. Pregnancy outcome in women who received doxorubicin for malignancy in childhood has been reported to generally be favorable. Those with baseline left ventricular dysfunction should be considered at increased risk for worse pregnancy outcome and further deterioration in myocardial function. Peripartum heart failure has been reported years after doxorubicin therapy. Pregnancy, preeclampsia, anemia, or overhydration are possible precipitating factors in the emergence of heart failure in patients who have received doxorubicin.

Doxorubicin liposomal has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and abortifacient activity. Several cases of birth defects have been associated with the use of doxorubicin. There are no controlled data in human pregnancy. Women should be advised to avoid pregnancy. The prolonged half-life of doxorubicin liposomal should be considered if a woman becomes pregnant in the first few months following treatment.