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Caelyx (doxorubicin hydrochloride) – Package leaflet - L01DB

Updated on site: 05-Oct-2017

Medication nameCaelyx
ATC CodeL01DB
Substancedoxorubicin hydrochloride
ManufacturerJanssen-Cilag International N.V.

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.

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.

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 2-3 months, then as often as necessary to maintain an improvement in your condition.

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;

-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 hand-foot syndrome, below);

-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 AIDS-KS comparing Caelyx against another treatment (bleomycin/vincristine), there may be a higher chance of some infections with Caelyx. However, in contrast to the experience with patients with AIDS-KS, when Caelyx was compared to a standard treatment for advanced ovarian cancer (topotecan), the risk of infections was substantially lower in the Caelyx-treated patients. The risk of low blood counts and infections was similarly low in breast cancer studies. Some of these effects may be related to your disease and not to Caelyx;

-general feeling of tiredness, weakness, feeling of pins and needles or pain in hands and feet;

-hair loss.

Common side effects (may affect up to 1 in 10 people)

-stomach pain;

-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 light-detecting membrane of the eye), increased tear production, blurred vision, feeling of pins and needles or pain in hands and feet;

-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)

-confusion;

-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 (Stevens-Johnson syndrome/toxic epidermal necrolysis);

-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 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.

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.

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.

6. Contents of the pack and other information

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 -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)- - methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.

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-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

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:

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel.: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955 955

Eesti

UAB "JOHNSON & JOHNSON"Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

España

Janssen-Cilag, S.A.

E-28042 Madrid

Tel: +34 91 722 81 00

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: +32 14 64 94 11

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h

10010 Zagreb

Tel: +385 1 6610 700

Ireland

Janssen-Cilag Ltd.

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Tel: +44 1 494 567 444

Portugal

Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

România

Johnson & Johnson România SRL Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800

Slovenija

Johnson & Johnson d.o.o. Šmartinska cesta 53 SI-1000 Ljubljana

Tel: +386 1 401 18 30

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson, s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON"filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

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 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.

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 in-line filters.

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