What is it and how is it used?
Caelyx is an antitumour agent.
Caelyx is used to treat cancer of the breast in patients at risk for heart problems. Caelyx is also used to treat cancer of the ovary. It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.
Caelyx is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a cancer of the blood in patients who have received at least 1 prior therapy.
Caelyx is also used to produce an improvement in your Kaposi’s sarcoma including flattening, lightening and even shrinkage of the cancer. Other symptoms of Kaposi’s sarcoma, such as swelling around the tumour, may also improve or disappear.
Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells. The doxorubicin hydrochloride in Caelyx is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.
What do you have to consider before using it?
Do not use Caelyx
Take special care with Caelyx
Taking other medicines
Please tell your doctor or pharmacist
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Because the active ingredient doxorubicin hydrochloride in Caelyx may cause birth defects, it is important to tell your doctor if you think you are pregnant. Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx. Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Driving and using machines
Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx.
How is it used?
Caelyx is a unique formulation. It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Caelyx will be given to you by your doctor in a drip (infusion) into a vein. Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).
If you are being treated for breast cancer or ovarian cancer, Caelyx will be administered at a dose of 50 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.
If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on Day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion. The dose is repeated as long as you respond satisfactorily and tolerate treatment.
If you are being treated for Kaposi’sarcoma, Caelyx will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 2 to 3 weeks for 2 - 3 months, then as often as necessary to maintain an improvement in your condition.
If you use more Caelyx than you should
Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood. Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Caelyx can cause side effects, although not everybody gets them.
During the infusion of Caelyx, the following reactions may occur: flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/or throat, sore throat, low or increase in blood pressure, rapid heart beat, puffing of the face, fever, dizziness, nausea, indigestion, itching, rash and sweating. In very rare cases, seizures (convulsions) have occurredStinging or swelling of the skin at the site of injection may also occur. If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.
Contact your doctor immediately if:
Between infusions, the following may occur:
Other side effects that may occur with a combination of Caelyx and bortezomib include:
When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Strategies to prevent and treat hand-foot syndrome:
Every day for 4-7 days beginning immediately after you have received Caelyx:
Pyridoxine (Vitamin B6):
How should it be stored?
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
After dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C. Partially used vials must be discarded.
Do not use Caelyx after the expiry date which is stated on the label and carton.
Do not use Caelyx if you notice that it shows evidence of precipitation or any other particulate matter.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
