Patient Medication Information: uses, side effects, how to take - Pegylated Liposomal Doxorubicin Hydrochloride for Injection
Serious warnings and precautions box
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What Pegylated Liposomal Doxorubicin Hydrochloride for Injection is used for:
Pegylated Liposomal Doxorubicin Hydrochloride for Injection is used in adults to treat:
- Metastatic breast cancer, a form of cancer that has spread to other parts of the body. Pegylated Liposomal Doxorubicin Hydrochloride for Injection is used when the patient is at risk of developing heart problems if treated with doxorubicin;
- Advanced ovarian cancer. Pegylated Liposomal Doxorubicin Hydrochloride for Injection is used when standard first-line chemotherapy treatment does not work.
AIDS-related Kaposi’s sarcoma. Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection works:
Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection, 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.
The ingredients in Pegylated Liposomal Doxorubicin Hydrochloride for Injection are:
Medicinal ingredients: Doxorubicin hydrochloride
Non-medicinal ingredients: ammonium sulfate, cholesterol, histidine, hydrochloric acid, hydrogenated soy phosphatidylcholine (HSPC), N-(carbamoyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), sodium hydroxide, sucrose and water for injection.
Pegylated Liposomal Doxorubicin Hydrochloride for Injection comes in the following dosage forms:
suspension: 2 mg/mL
Do not use Pegylated Liposomal Doxorubicin Hydrochloride for Injection if:
- you are allergic to doxorubicin hydrochloride, any of the other ingredients in Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection. 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. Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection
- monitor your kidney function during your treatment; and
- examine your mouth for cancer during your treatment. You may develop oral cancer that can be fatal.
Hand-Foot Syndrome: Treatment with Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection. 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection.
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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection while pregnant as it may harm your unborn child. Use effective contraception while taking Pegylated Liposomal Doxorubicin Hydrochloride for Injection and for up to eight months after your last dose of Pegylated Liposomal Doxorubicin Hydrochloride for Injection.
- Doxorubicin may pass into breast-milk. Do not breastfeed while you are taking Pegylated Liposomal Doxorubicin Hydrochloride for Injection.
Male Patients:
Use effective contraception while taking Pegylated Liposomal Doxorubicin Hydrochloride for Injection and for six months after your last dose of Pegylated Liposomal Doxorubicin Hydrochloride for Injection.
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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection:
- other cancer treatments
- Drugs known to interact with the conventional formulation of doxorubicin hydrochloride.
How to take Pegylated Liposomal Doxorubicin Hydrochloride for Injection:
- Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection is different for everyone. Your healthcare professional will calculate how much Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection, 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 signs or symptoms. |
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Possible side effects from using Pegylated Liposomal Doxorubicin Hydrochloride for Injection:
These are not all the possible side effects you may have when taking Pegylated Liposomal Doxorubicin Hydrochloride for Injection. If you experience any side effects not listed here, tell your healthcare professional.
- Constipation
- Diarrhea
- Discomfort
- Loss of appetite
- Stomach pains/sickness (nausea or vomiting)
- Weight loss
Pegylated Liposomal Doxorubicin Hydrochloride for Injection 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
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Frequency/Side Effects/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effects/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effects/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| 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 Pegylated Liposomal Doxorubicin Hydrochloride for Injection, 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. | √ | ||
| Renal-limited thrombotic microangiopathy (damage to the small blood vessels in the kidneys): changes in urination, swelling, fatigue, bruising or bleeding easily. | √ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Keep Pegylated Liposomal Doxorubicin Hydrochloride for Injection out of reach and sight of children.
Do not use if Pegylated Liposomal Doxorubicin Hydrochloride for Injection dispersion is discolored or shows evidence of precipitation or particles.
Pegylated Liposomal Doxorubicin Hydrochloride for Injection should be stored in the refrigerator (2°C to 8°C). Do not freeze. Discard partially used vials.
Diluted Pegylated Liposomal Doxorubicin Hydrochloride for Injection should be refrigerated and used within 24 hours,
If you want more information about Pegylated Liposomal Doxorubicin Hydrochloride for Injection:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website www.drreddys.com, or by calling 1-855-845-1739.