Package leaflet: information for the user
Caelyx 2 mg/ml concentrate for solution for infusion
Pegylated liposomal doxorubicin hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
-Keep this leaflet. You may need to read it again.
-If you have any further questions, ask your doctor or pharmacist.
-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.What Caelyx is and what it is used for
2.What you need to know before you use Caelyx
3.How to use Caelyx
4.Possible side effects
5 How to store Caelyx
6.Contents of the pack and other information
1.What Caelyx is and what it is used for
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.
2. What you need to know before you use Caelyx
Do not use Caelyx
-if you are allergic to doxorubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
You should tell your doctor about any of the following:
-if you are receiving any treatment for heart disease or liver disease;
-if you are diabetic, because Caelyx contains sugar which may require an adjustment to the treatment of your diabetes;
-if you have Kaposi’s sarcoma and have had your spleen removed;
-if you notice sores, discolouration or any discomfort in your mouth.
Children and adolescents
Caelyx should not be used in children and adolescents, because it is not known how the medicine will affect them.
Other medicines and Caelyx
Tell your doctor or pharmacist
-if you are taking or have recently taken any other medicines, including medicines obtained without a prescription;
-about any other cancer treatments you are on or have been taking, as particular care needs to be taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells. If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.
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
Driving and using machines
Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx.
3.How to use Caelyx
Caelyx is a unique formulation. It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
How much Caelyx is given
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
How Caelyx is given
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 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.
4.Possible side effects
Like all medicines, this medicine 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 occurred. Stinging 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:
-you get reddening painful skin on your hands and feet;
- Myocet - doxorubicin hydrochloride
Prescription drugs listed. Substance: "Doxorubicin hydrochloride"
-you get painful reddening of the skin and/or blisters on the body or in the mouth;
-you get heart problems;
-you get mouth sores;
-you develop a fever or any other sign of an infection;
-you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing;
-you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk.
Other side effects
Between infusions, the following may occur:
Very common side effects (may affect more than 1 in 10 people)
-redness, swelling and sores on the palms of your hands and feet. These effects have been seen frequently, and are sometimes severe. In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely. The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat
-pain or sores in mouth or throat, nausea, vomiting, diarrhoea, constipation, loss of appetite, weight loss;
-decrease in the number of white blood cells, which can increase the chances of infections. Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding. In rare cases, having low white blood cells may lead to severe infection. It is because of the potential changes in your blood cells that you will have regular blood tests. From a clinical study in patients with
-general feeling of tiredness, weakness, feeling of pins and needles or pain in hands and feet;
Common side effects (may affect up to 1 in 10 people)
-oral thrush (a fungal infection in the mouth), sores in nose, bleeding from your nose, cold sores, and tongue inflammation;
-laboratory values related to the function of the liver may either increase or decrease while on Caelyx;
-sleepiness, dizziness, fainting, bone pain, breast pain, abnormal muscle tension, muscle pain, leg cramps or swelling, general swelling, inflammation of the retina (the
-inflammation of hair follicles, scaly skin, inflammation or rash, abnormal skin pigmentation (colouring), and nail disorder;
-heart problems, e.g., irregular heart beat, enlarged blood vessels;
-fever, increased temperature or any other sign of infection which may be related to your disease;
-respiratory problems, i.e., difficulty in breathing or coughing which may be linked to infections you have caught as a result of your disease;
-not enough water in the body (dehydration), severe weight loss and muscle wasting, low levels of calcium, magnesium, potassium or sodium in the blood, high levels of potassium in the blood;
-inflamed foodpipe, inflamed stomach lining, difficulty swallowing, dry mouth, passing wind, inflamed gums (gingivitis), change in sense of taste;
-inflammation of the vagina;
-pain when passing urine;
-if you have previously had skin reactions, i.e., pain, redness and dryness of skin, during treatment with radiotherapy, this may also happen with Caelyx;
-joint pain, decreased or abnormal sensation to stimulation, inflammation of the cornea, redness of the eye, redness of the scrotum may occur with a combination of Caelyx and bortezomib.
When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Uncommon side effects (may affect up to 1 in 100 people)
-inflammation of the veins and formation of blood clots in the veins which could lead to blockage of blood flow to your lungs causing difficulty breathing, chest pain and palpitations.
Very rare side effects (may affect up to 1 in 10,000 people)
-serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion
-oral cancer may occur when Caelyx is taken for a long time (more than one year).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Strategies to prevent and treat
-soaking hands and/or feet in basins of cold water when possible (e.g., while watching television, reading, or listening to the radio);
-keeping hands and feet uncovered (no gloves, socks, etc.);
-staying in cool places;
-taking cool baths during hot weather;
-avoiding vigorous exercise that might cause trauma to the feet (e.g., jogging);
-avoiding exposure of skin to very hot water (e.g., jacuzzis, saunas);
-avoiding tight fitting footwear or
Pyridoxine (Vitamin B6):
-vitamin B6 is available without prescription;
5.How to store Caelyx
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 C – 8 C). Do not freeze.
Chemical and physical
Do not use this medicine after the expiry date which is stated on the label and carton.
Do not use this medicine if you notice that it shows evidence of precipitation or any other particulate matter.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
- Darzalex - Janssen-Cilag International N.V.
- Invokana - Janssen-Cilag International N.V.
- Xeplion - Janssen-Cilag International N.V.
- Incivo - Janssen-Cilag International N.V.
- Rezolsta - Janssen-Cilag International N.V.
- Edurant - Janssen-Cilag International N.V.
Prescription drugs listed. Manufacturer: "Janssen-Cilag International N.V."
What Caelyx contains
-The active substance is doxorubicin hydrochloride. One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
-The other ingredients are
Caelyx concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg).
What Caelyx looks like and contents of the pack
The solution for infusion is sterile, translucent and red. Caelyx is available in glass vials as a single pack or packs of ten vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen Pharmaceutica NV
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tel/Tél: +32 14 64 94 11
„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766
Тел.: +359 2 489 94 00
Tlf: +45 45 94 82 82
Johnson & Johnson Platz 1
Tel: +49 2137 955 955
UAB "JOHNSON & JOHNSON"Eesti filiaal Lõõtsa 2
Tel: +372 617 7410
Tel: +34 91 722 81 00
UAB "JOHNSON & JOHNSON"
Geležinio Vilko g. 18A
Tel: +370 5 278 68 88
Tél/Tel: +32 14 64 94 11
Tel.: +36 1 884 2858
AM MANGION LTD.
Mangion Building, Triq Ġdida fi Triq Valletta
Tel: +356 2397 6000
Graaf Engelbertlaan 75
Tel: +31 76 711 1111
Tlf: +47 24 12 65 00
Tel: +43 1 610 300
Tel.: +48 22 237 60 00
1, rue Camille Desmoulins, TSA 91003
Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h
Tel: +385 1 6610 700
Buckinghamshire HP12 4EG
Tel: +44 1 494 567 444
Tel: +351 21 43 68 835
Johnson & Johnson România SRL Str. Tipografilor nr.
Tel: +40 21 207 1800
Johnson & Johnson d.o.o. Šmartinska cesta 53
Tel: +386 1 401 18 30
Johnson & Johnson, s.r.o.
c/o Vistor hf.
CBC III, Karadžičova 12
Tel: +421 232 408 400
Sími: +354 535 7000
Via M.Buonarroti, 23
Tel: +39 02 2510 1
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ
Λεωφόρος Γιάννου Κρανιδιώτη 226
Tel: +46 8 626 50 00
Τηλ: +357 22 207 700
UAB "JOHNSON & JOHNSON"filiāle Latvijā
Mūkusalas iela 101
Tel: +371 678 93561
Buckinghamshire HP12 4EG - UK
Tel: +44 1 494 567 444
This leaflet was last approved on
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
The following information is intended for medical or healthcare professionals only (see section 3):
Caution must be exercised in handling Caelyx solution. The use of gloves is required. If Caelyx comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water. Caelyx must be handled and disposed of in a manner consistent with that of other anticancer medicinal products.
Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient's body surface area). Take the appropriate volume of Caelyx up into a sterile syringe. Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx. The appropriate dose of Caelyx must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration. For doses < 90 mg, dilute Caelyx in 250 ml, and for doses 90 mg, dilute Caelyx in 500 ml.
To minimise the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute. If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a
In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows: 5% of the total dose was infused slowly over the first 15 minutes. If tolerated without reaction, the infusion rate was doubled for the next 15 minutes. If tolerated, the infusion was completed over the next hour for a total infusion time of 90 minutes.
If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
The use of any diluent other than 5% (50 mg/ml) glucose solution for infusion, or the presence of any bacteriostatic agent such as benzyl alcohol may cause precipitation of Caelyx.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ml) glucose. Infusion may be given through a peripheral vein. Do not use with