Patient Medication Information: uses, side effects, how to take - Taro-Doxorubicin Liposomal
Serious Warnings and Precautions
|
|---|
What is Taro-DOXOrubicin Liposomal used for?
Taro-Doxorubicin Liposomal is used in adults to treat:
- Metastatic breast cancer, a form of cancer that has spread to other parts of the body. Taro-Doxorubicin Liposomal is used when the patient is at risk of developing heart problems if treated with doxorubicin;
- Advanced ovarian cancer. Taro-Doxorubicin Liposomal is used when standard first-line chemotherapy treatment does not work.
AIDS-related Kaposi’s sarcoma. Taro-Doxorubicin Liposomal is used in patients who have a low number of a specific type of white blood cell (CD4 lymphocytes) and:
- have large areas of the skin and mucous membrane impacted, or;
- have internal organ disease which has worsen even with therapy, or;
- who are not able to tolerate previous combination chemotherapy that targets the entire body.
How does Taro-DOXOrubicin Liposomal Work?
Taro-Doxorubicin Liposomal contains an ingredient which is able to interact with your body in such a way as to selectively kill cancer cells. Doxorubicin hydrochloride, the medicinal ingredient in Taro-Doxorubicin Liposomal, is surrounded in tiny spheres called pegylated liposomes. Pegylated liposomes help deliver the medicinal ingredient from the blood stream to the cancerous tissue in your body.
What are the ingredients in Taro-DOXOrubicin Liposomal?
Medicinal ingredient: Doxorubicin hydrochloride
Non-medicinal ingredients: ammonium sulphate, anhydrous ethanol, cholesterol, histidine, hydrochloric acid, hydrogenated soy phosphatidylcholine, MPEG-Distearoyl phosphatidylethanolamine, sodium hydroxide, sucrose, and water for injection.
Taro-DOXOrubicin Liposomal come in the following dosage forms:
Suspension: 2mg/mL
Do not be use Taro-DOXOrubicin Liposomal if:
- you are allergic to doxorubicin hydrochloride, any of the other ingredients of Taro-Doxorubicin Liposomal or components of the container.
you are breast-feeding.
- you think you are pregnant.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-DOXOrubicin Liposomal. Talk about any health conditions or problems you may have, including if you:
- have had previous treatment with anthracyclines, a class of drug used in cancer chemotherapy (e.g.doxorubicin, epirubicin, etc.)
- are undergoing chest radiation
- have heart and blood vessel problems
- have liver problems or disease
- are diabetic. Taro-Doxorubicin Liposomal contains sugar which may require an adjustment to the treatment of your diabetes.
- have a history of myelosuppression
Other warnings you should know about:
Monitoring and tests: Your healthcare professional will:
- complete blood tests to monitor your blood cell count during your treatment.
- monitor your heart function during your treatment
- monitor your liver function before administering Taro-Doxorubicin Liposomal
- examine your mouth for cancer during your treatment. You may develop oral cancer that can be fatal.
Hand-Foot Syndrome: Treatment with Taro-Doxorubicin Liposomal can increase your risk of developing Hand-Foot Syndrome. To prevent and treat this condition, considering the following:
- Soak hands and/or feet in basins of cold water when possible (e.g., while watching television, reading, or listening to the radio);
- Keep hands and feet uncovered (no gloves, socks, etc.);
- Stay in cool places (under tree shade, by a swimming area with shade etc.);
- Take cool baths or stay in the water during the summer;
- Avoid vigorous exercise that might cause trauma to the feet (e.g. jogging);
- Avoid exposure of skin to very hot water (e.g., jacuzzis, saunas);
- Avoid tight-fitting footwear or high-heeled shoes
Lung Problems: You may develop Interstitial Lung Disease (ILD) while taking Taro-Doxorubicin Liposomal. ILD is a lung disease that inflame or scar lung tissue. ILD can be fatal and your healthcare professional may end your treatment if you develop this condition.
Driving and using machines: Do not drive or operate any tools or machines if you feel tired or sleepy from treatment with Taro-Doxorubicin Liposomal.
Female Patients:
- If you are pregnant, or able to get pregnant there are specific risks you must discuss with your healthcare professional
- Do not take Taro-Doxorubicin Liposomal while pregnant as it may harm your unborn child. Use effective contraception while taking Taro-Doxorubicin Liposomal and for up to eight months after your last dose of Taro-Doxorubicin Liposomal.
- Taro-Doxorubicin Liposomal may pass into breast-milk. Do not breastfeed while you are taking Taro-Doxorubicin Liposomal.
Male Patients:
Use effective contraception while taking Taro-Doxorubicin Liposomal and for six months after your last dose of Taro-Doxorubicin Liposomal.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Taro-DOXOrubicin Liposomal:
- other cancer treatments
- Drugs known to interact with the conventional formulation of doxorubicin hydrochloride
How to take Taro-DOXOrubicin Liposomal:
- Taro-Doxorubicin Liposomal will be given to you by your healthcare professional in a drip (infusion) into a vein. This may take from 30 minutes to more than one hour (i.e., 90 minutes)
Usual dose:
The usual dose of Taro-Doxorubicin Liposomal is different for everyone. Your healthcare professional
will calculate how much Taro-Doxorubicin Liposomal to give you. Your dose will depend on the
condition you are being treated for, your height and weight.
Overdose:
Overdosing worsens side effects like sores in the mouth.
| If you think you, or a person you are caring for, have taken too much Taro-Doxorubicin Liposomal, contact a healthcare professional, hospital emergency department, or regional Poison Control Centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms. |
|---|
What are possible side effects from using Taro-DOXOrubicin Liposomal?
These are not all the possible side effects you may have when taking Taro-Doxorubicin Liposomal.
If you experience any side effects not listed here, tell your healthcare professional.
- Constipation
- Diarrhea
- Discomfort
- Loss of appetite
- Stomach pains/sickness (neausea or vomiting)
- Weight loss
Taro-DOXOrubicin Liposomal can cause abnormal blood test results. Your healthcare professional
will decide when to perform blood tests and will interpret the results
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
Allergic reactions: Flushing of the face, shortness of breath, headache, chills, chest pain, back pain, fever, sweating, tightness in the chest and/or throat, low or high blood pressure, dizziness and puffing of the face, stinging or swelling of the skin at the site of injection, tongue inflammation, general swelling, inflammation or eruption of skin. | √ | ||
| Fungal Infections: Oral thrush (creamy white, sore patches in your mouth or on your tongue); aching muscles with high temperature, sore throat, and swollen glands. | √ | ||
| Injection site reactions: rash, the drip stings or hurts while you are receiving a dose of Taro-Doxorubicin Liposomal, uncontrolled shaking. | √ | ||
| Hand-foot syndrome: swelling, reddening painful skin and sores on the palms of your hands and feet. | √ | ||
Heart problems: Irregular heartbeat, weakening of the heart muscle and/or swelling of feet or hands. | √ | ||
Lung problems: Coughing, shortness of breath or difficulty in breathing which may be linked to infections you have caught as a result of your disease. | √ | ||
| Blood cancers: Fever (increased temperature) or any other sign of an infection, bruising more easily than normal, signs of anemia (reduction in red blood cells) such as tiredness, being short of breath, and looking pale; decrease in the number of white blood cells, which can increase the chances of infections. | √ | ||
| Stomatitis (sore or inflammation inside of the mouth): Mouth sores/cold sores, pain in mouth. | √ | ||
| Eye and Nose problems: Blurred vision, tearing of the eye, sores in nose, bleeding from your nose. | √ | ||
General feeling of tiredness, weakness, bone pain, breast pain, muscle pain, leg cramps or swelling. | √ | ||
| Skin reactions: Hair loss, inflammation of hair follicles, scaly skin, abnormal skin pigmentation, nail problems, pain, redness and dryness of skin. | √ | ||
Nervous system problems: Feeling of pins and needles or pain in hands and feet; sleepiness, confusion. | √ | ||
| UNCOMMON | |||
| Cellulitis (bacterial skin infection): Swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk. | √ | ||
| RARE | |||
| Leukemia (Cancer of the blood): Fatigue, breathlessness, infections, and bruising or bleeding more easily. | √ | ||
| Myelodysplastic Syndrome (Bone marrow disease affecting blood cells): Light-headedness, easy bruising or bleeding, fever, frequent infections and bone pain. | √ | ||
| UNKNOWN | |||
| Oral cancer: Mouth lining discolouration. | √ | ||
| Interstitial lung disease: Coughing and shortness of breath, possibly accompanied by fever, that is not brought on by physical activity. | √ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
Keep Taro-Doxorubicin Liposomal out of reach and sight of children.
Do not use if Taro-Doxorubicin Liposomal solution is discolored or shows evidence of precipitation or particles.
Taro-Doxorubicin Liposomal should be stored in the refrigerator (2 ºC – 8 ºC). Do not freeze. Discard partially used vials.
Diluted Taro-Doxorubicin Liposomal should be refrigerated and used within 24 hours
If you want more information about Taro-DOXOrubicin Liposomal:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.
130 East Drive Brampton, Ontario L6T 1C1
TARO is a registered trademark of Taro Pharmaceuticals Inc.