Lipodox

Name: Lipodox

How is Lipodox (doxorubicin liposomal)given?

Doxorubicin liposomal is injected into a vein through an IV. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when doxorubicin liposomal is injected.

If this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water.

Doxorubicin liposomal can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while using Lipodox (doxorubicin liposomal)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while using doxorubicin liposomal. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Lipodox (doxorubicin liposomal) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

  • pain, redness, swelling, blistering, or peeling skin on your hands or feet;

  • feeling short of breath (even with mild exertion), swelling, rapid weight gain;

  • fever, chills, body aches, flu symptoms;

  • white patches or sores inside your mouth or on your lips;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Doxorubicin liposomal may cause your urine to turn a reddish-orange color. This side effect by itself is usually not harmful. However, call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • tired feeling;

  • loss of appetite, nausea, vomiting;

  • constipation, diarrhea; or

  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses For Lipodox

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.

Uses of Lipodox

  • It is used to treat cancer.

If OVERDOSE is suspected

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.

Consumer Information Use and Disclaimer

  • 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 Lipodox, 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 Lipodox. 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 Lipodox.

Review Date: October 4, 2017

Pregnancy & Lactation


Liposomal doxorubicin is embryotoxic at doses of 1 mg/kg/day in rats and embryotoxic and abortifacient at 0.5 mg/kg/day in rabbits (both doses are about one eighth the 50 mg/m2 human dose on a mg/m2 basis).

There are no adequate and well controlled studies in pregnant women. If Lipodox is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. If pregnancy occurs during the first few months following treatment with Lipodox, the prolonged half life of the drug must be considered. Women of child bearing potential should be advised to avoid pregnancy.

It is not known whether this drug is excreted in human milk. Because many drugs, including anthracyclines, are excreted in breast milk and because of the potential of serious adverse effects in nursing infants from Lipodox, mothers should discontinue nursing prior to taking this drug.

Presentation

Lipodox is available as 2 mg/ml concentrate solution for infusion in 5 ml and 10 ml vials.


Lipodox 50 is available as 2 mg/ml concentrate solution for infusion in 30 ml vial containing 25 ml concentrate solution for infusion.

NDC:

Lipodox (10 ml):                      NDC 47335-082-50
Lipodox 50 (25 ml):                 NDC 47335-083-50
 
For further details, please write to:
sun pharmaceutical ind. ltd.
Acme Plaza, Andheri-Kurla Road,
Andheri (E), Mumbai-400 059, INDIA.
 
PJPI0383
D140/032010/V6
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