Caelyx pegylated liposomal
doxorubicin
doxorubicin hydrochloride
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 Caelyx pegylated liposomal is and what it is used for
What you need to know before you use Caelyx pegylated liposomal
How to use Caelyx pegylated liposomal
Possible side effects
5 How to store Caelyx pegylated liposomal
6. Contents of the pack and other information
Caelyx pegylated liposomal is an antitumour agent.
Caelyx pegylated liposomal is used to treat cancer of the breast in patients at risk for heart problems. Caelyx pegylated liposomal 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 pegylated liposomal 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 pegylated liposomal 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 pegylated liposomal 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 pegylated liposomal 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.
if you are allergic to doxorubicin hydrochloride, peanut or soya, or any of the ingredients of this medicine (listed in section 6).
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 pegylated liposomal 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.
Caelyx pegylated liposomal should not be used in children and adolescents, because it is not known
how the medicine will affect them.
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 pegylated liposomal 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 pegylated liposomal and in the six months following discontinuation of Caelyx pegylated liposomal treatment.
Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx pegylated liposomal. Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx
pegylated liposomal.
Caelyx pegylated liposomal contains soya oil. If you are allergic to peanut or soya, do not use this medicine.
Caelyx pegylated liposomal contains less than 1 mmol sodium (23 mg) per dose, that is to say
‘essentially sodium-free’.
Caelyx pegylated liposomal is a unique formulation. It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
If you are being treated for breast cancer or ovarian cancer, Caelyx pegylated liposomal 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 pegylated liposomal 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 pegylated liposomal 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.
Caelyx pegylated liposomal 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).
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. During the infusion of Caelyx pegylated liposomal, the following reactions may occur:
severe allergic reaction that may include a swollen face, lips, mouth, tongue or throat; difficulty
swallowing or breathing; itchy rash (hives)
inflamed and narrowed airways in the lungs, causing coughing, wheezing and shortness of breath (asthma)
flushing, sweating, chills or a fever
chest pain or discomfort
back pain
high or low blood pressure
fast heart beat
fits (seizures)
Leaking of the injection fluid from the veins into the tissues under the skin may occur. If the drip stings or hurts while you are receiving a dose of Caelyx pegylated liposomal, tell your doctor immediately.
Your doctor should be contacted immediately if any of the following serious side effects are noticed:
you develop fever, feel tired, or if you have signs of bruising or bleeding (very common)
redness, swelling, peeling or tenderness, mainly on the hands or feet (‘hand-foot’ syndrome).
These effects have been seen very commonly 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 hand foot syndrome, below)
sores in mouth, severe diarrhoea or vomiting or nausea (very common)
infections (common), including lung infections (pneumonia) or infections that may affect your vision
being short of breath (common)
severe stomach pain (common)
severe weakness (common)
severe allergic reaction that may include a swollen face, lips, mouth, tongue or throat; difficulty swallowing or breathing; itchy rash (hives) (uncommon)
cardiac arrest (heart stops beating); heart failure, in which the heart does not pump enough
blood to the rest of the body, which makes you short of breath and may lead to swollen legs (uncommon)
blood clot that moves to the lungs, causes chest pain and makes you short of breath (uncommon)
swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets
worse when you stand or walk (rare)
severe or life-threatening rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or over most of the body (toxic epidermal
necrolysis) (rare)
Between infusions, the following may occur:
decrease in the number of white blood cells, which can increase the chances of infections. In rare cases, having low white blood cells may lead to severe infection. Anaemia (reduction in red
blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of
bleeding. It is because of the potential changes in your blood cells that you will have regular blood tests.
decreased appetite;
constipation;
skin rashes, including redness of the skin, allergic skin rash, red or raised rash on the skin
hair loss
pain including in the muscles and chest muscle, joint, arm, or leg
feeling very tired
infections, including severe infection throughout the body (sepsis), lung infections, herpes zoster virus infections (shingles), a type of bacterial infection (mycobacterium avium complex infection), urinary tract infection, fungal infections (including thrush and oral thrush in the mouth) infection of the hair roots, infected or irritated throat, infected nose, sinuses or throat (cold)
low number of a type of white blood cell (neutrophils), with a fever
severe weight loss and muscle wasting, not enough water in the body (dehydration), low level of potassium, sodium, or calcium in the blood
feeling confused, feeling anxious, depression, difficulty sleeping
nerve damage that may cause tingling, numbness, pain or loss of pain sensation, nerve pain, unusual feeling in the skin (such as tingling or a crawling feeling), decreased feeling or
sensitivity, especially in the skin
change in sense of taste, headache, feeling very sleepy with low energy, feeling dizzy;
inflamed eyes (conjunctivitis)
fast heart beat
high or low blood pressure, flushing
shortness of breath that may be brought on by physical activity, nose bleeds, cough
inflamed stomach lining or foodpipe, ulcers (sores) in the mouth, indigestion, difficulty swallowing, mouth pain, dry mouth
skin problems, including flaky or dry skin, redness of the skin, blister or ulcer (sore) on the skin,
itching, dark skin patches
excessive sweating
muscle spasms or aches
pain including in the muscles, bone, or back
pain when passing urine
allergic reaction to infusion of the medicine, flu-like illness, chills, inflamed lining of the cavities and passages in the body, such as the nose, mouth or windpipe, feeling weak, generally feeling unwell, swelling caused by fluid build up in the body, swollen hands, ankles or feet
weight loss
When Caelyx pegylated liposomal is used alone, some of these effects are less likely to occur, and some have not occurred at all.
herpes simplex virus infections (cold sores or genital herpes), fungal infection
low number of all types of blood cells, increased number of ‘platelets’ (cells that help blood to clot)
allergic reaction
high level of potassium in the blood, low level of magnesium in the blood
nerve damage affecting more than one area of the body
fits (seizures), fainting
unpleasant or painful sensation, especially to touch, feeling sleepy
blurred vision, watery eyes
heart beat feels fast or uneven (palpitations), heart muscle disease, heart damage
tissue damage (necrosis) where the injection is given, inflamed veins that cause swelling and pain, feeling dizzy upon sitting up or standing up
chest discomfort
passing wind, inflamed gums (gingivitis)
skin problems or rashes, including flaky or peeling skin, allergic skin rash, ulcer (sore) or hives on the skin, discoloured skin, change in the natural colour (pigment) of the skin, small red or
purple spots caused by bleeding under the skin, nail problems, acne
muscle weakness
breast pain
irritation or pain where the injection is given
swollen face, high body temperature
symptoms (such as inflammation, redness or pain) come back at a part of the body that previously received radiation therapy or was previously damaged by a chemotherapy injection into a vein
infection that occurs in people with a weak immune system
low number of blood cells made in the bone marrow
inflamed retina, which may cause changes in vision or blindness
abnormal heart rhythm, abnormal heart tracing on an ECG (electrocardiogram) and may be with a slow heart beat, problem with the heart that affects the heart beat and rhythm, blue colour to
the skin and mucosa caused by low oxygen in the blood
widening of blood vessels
tight feeling in the throat
sore and swollen tongue, ulcer (sore) on the lip
skin rash with fluid-filled blisters
vaginal infection, redness of the scrotum
problems with the lining of the cavities and passages in the body, such as the nose, mouth or windpipe
abnormal liver blood test results, increased level of ‘creatinine’ in the blood
cancer of the blood that develops quickly and affects the blood cells (acute myeloid leukaemia), bone marrow disease that affects the blood cells (myelodysplastic syndrome), cancer of the
mouth or lip
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 hand-foot syndrome include:
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 high-heeled shoes.
Pyridoxine (Vitamin B6):
vitamin B6 is available without prescription;
take 50-150 mg daily beginning at the first signs of redness or tingling.
Keep this medicine out of the sight and reach 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 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.
The active substance is doxorubicin hydrochloride. One ml of Caelyx pegylated liposomal
contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
The other ingredients are α-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω- methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment). See section 2.
Caelyx pegylated liposomal concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg).
Caelyx pegylated liposomal is sterile, translucent and red. Caelyx pegylated liposomal is available in glass vials as a single pack or packs of ten vials.
Not all pack sizes may be marketed.
Baxter Holding B.V. Kobaltweg 49,
3542 CE Utrecht, Netherlands
Janssen Pharmaceutica NV
Turnhoutseweg 30 B-2340 Beerse Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB „Baxter Lithuania“
Tel: +37052527100
Baxter Holding B.V.
Teл.: +31 (0)30 2488 911
BAXTER CZECH spol. s r.o.
Tel: +420 225 774 111
Baxter A/S
Tlf: +45 4816 6400
Baxter Holding B.V. Tel: +44 (0)1635 206345
Baxter Deutschland GmbH
Tel: +49 (0)89 31701-0
Baxter B.V.
Tel: +31 (0)30 2488 911
OÜ Baxter Estonia
Tel: +372 651 5120
Baxter AS
Tlf: +47 22 58 48 00
Baxter (Hellas) Ε.Π.Ε.,
Τηλ: +30 210 28 80 000
Baxter S.L.
Tel: +34 91 678 93 00
Baxter Healthcare GmbH
Tel: +43 1 71120 0
austria_office_healthcare@baxter.com
Baxter Polska Sp. z o.o. Tel: +48 22 488 37 77
Baxter SAS
Tél: +33 1 34 61 50 50
Baxter Médico Farmacêutica, Lda.
Tel: +351 21 925 25 00
Baxter Healthcare d.o.o. Tel: +385 1 6610314
BAXTER HEALTHCARE SRL Tel: +40 372 302 053
Baxter Holding B.V. Tel: +44 (0)1635 206345
Baxter d.o.o.
Tel: +386 1 420 16 80
Baxter Medical AB Sími: +46 8 632 64 00
Baxter S.p.A.
Tel: +390632491233
Baxter Oy
Puh/Tel: +358 (09) 862 111
Baxter Holding B.V.
Τηλ: +31 (0)30 2488 911
Baxter Medical AB
Tel: +46 (0)8 632 64 00
Baxter Latvia SIA Tel: +371 677 84784
Baxter Holding B.V. Tel: +44 (0)1635 206345
The following information is intended for medical or healthcare professionals only (see section 3):
Caution must be exercised in handling Caelyx pegylated liposomal dispersion. The use of gloves is required. If Caelyx pegylated liposomal comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water. Caelyx pegylated liposomal must be handled and disposed of in a manner consistent with that of other anticancer medicinal products.
Determine the dose of Caelyx pegylated liposomal to be administered (based upon the recommended dose and the patient's body surface area). Take the appropriate volume of Caelyx pegylated liposomal up into a sterile syringe. Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx pegylated liposomal. The appropriate dose of Caelyx pegylated liposomal must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration. For doses < 90 mg, dilute Caelyx pegylated liposomal in 250 ml, and for doses
≥ 90 mg, dilute Caelyx pegylated liposomal 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 pegylated liposomal infusions may be administered over a 60-minute period.
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 pegylated liposomal.
It is recommended that the Caelyx pegylated liposomal 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 in-line filters.