mg / ml concentrate for solution for infusion solution 
doxorubicin (doxorubicin. Hydrochlorid.)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Caelyx pegylated liposomal is and what it is used for 
2. What you need to know before you use Caelyx pegylated liposomal 
3. How to use Caelyx pegylated liposomal 
4. Possible side effects 
5. How to take Caelyx pegylated liposomal must be stored 
6. Package contents and other information

What Caelyx pegylated liposomal is and what it is used for

Caelyx pegylated liposomal is a remedy for tumors.

Caelyx pegylated liposomal is used to treat breast cancer in patients at risk for heart problems. Caelyx pegylated liposomal is also used to treat ovarian cancer. It is used to kill cancer cells, reduce the size of tumor one, delay the growth of tumor one, and prolong survival.

Caelyx pegylated liposomal is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a type of cancer in the blood, in patients who have received at least one previous treatment regimen.

Caelyx pegylated liposomal is also used to improve your Kaposi’s sarcoma so that cancer flattens, brightens, and even shrinks. Other symptoms of Kaposi’s sarcoma, such as swelling around the tumor, may also improve or disappear.

Caelyx pegylated liposomal contains a drug that is able to interact with cells in such a way that it selectively kills cancer cells. The doxorubicin hydrochloride in Caelyx pegylated liposomal is encapsulated in small spheres called pegylated liposomes, which help deliver the drug from the bloodstream to the cancer tissue to a greater extent than to normal healthy tissue.

What you need to know before using Caelyx pegylated liposomal

Do not use Caelyx pegylated liposomal

  • if you are allergic to doxorubicin hydrochloride, peanuts or soy, or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to a doctor:

  • if you are receiving treatment for heart disease or liver disease;
  • if you have diabetes because Caelyx pegylated liposomal contains sugar, which may require an adjustment in the treatment of your diabetes;
  • if you have Kaposi’s sarcoma and have had surgery to remove your spleen;
  • if you get sores, discoloration, or any discomfort in your mouth.

Children and young people

Caelyx pegylated liposomal should not be used by children and adolescents as it is not known how the medicine will affect them.

Other drugs and Caelyx pegylated liposomal

Tell your doctor or pharmacist

  • if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription;
  • if you are receiving or have received other cancer treatments, special consideration needs to be given to treatments that reduce the number of white blood cells, as they may cause a further reduction in the number of white blood cells. If you are not sure what treatments you have received or what diseases you have had, discuss these with your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Because the active ingredient doxorubicin hydrochloride in Caelyx pegylated liposomal can cause birth defects, it is important that you tell your doctor if you think you may be pregnant. You should avoid becoming pregnant during the time you or your partner are being treated with Caelyx pegylated liposomal and for six months after stopping treatment with Caelyx pegylated liposomal.

Because doxorubicin hydrochloride may be harmful to breast-fed infants, women must discontinue breast-feeding before starting treatment with Caelyx pegylated liposomal. Experts recommend that HIV- infected women do not breast-feed their infants under any circumstances 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 pegylated liposomal.

Caelyx pegylated liposomal contains soybean oil and sodium

Caelyx pegylated liposomal contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

Caelyx pegylated liposomal contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.

3. How to use Caelyx pegylated liposomal

Caelyx pegylated liposomal is a unique form of the drug. It must not be replaced by other preparations of doxorubicin hydrochloride.

How much Caelyx pegylated liposomal is given

If you are being treated for breast or ovarian cancer, Caelyx pegylated liposomal will be given at a dose of 50 mg per square meter of your body surface area (based on your height and weight). Infusion one is repeated every 4 weeks as long as the disease does not worsen and you tolerate the treatment.

If you are being treated for multiple myeloma and have already received at least one previous treatment regimen, Caelyx pegylated liposomal will be given at a dose of 30 mg per square meter of your body surface area (based on your height and weight). Caelyx pegylated liposomal will be given as a one-hour intravenous infusion on day 4 of the bortezomib 3-week regimen, immediately following the bortezomib infusion. Dose one is repeated as long as you respond satisfactorily and tolerate treatment.

If you are being treated for Kaposi’s sarcoma, Caelyx pegylated liposomal will be given at a dose of 20 mg per square meter of your body surface area (based on your height and weight). Infusion one is repeated every two to three weeks for two to three months, then as often as needed to maintain an improvement in your condition.

How Caelyx pegylated liposomal is given

Caelyx pegylated liposomal will be given by your doctor as a drip ( infusion ) into a vein. Depending on the dose one and what it is used for, it can take from 30 minutes to more than an hour (ie 90 minutes).

If you use more Caelyx pegylated liposomal than you should

Acute overdose aggravates side effects such as sores in the mouth or a decreased number of white blood cells and platelets in the blood. Treatment will include administration of antibiotics, transfusion of platelets, use of factors that stimulate the production of white blood cells, and symptomatic treatment of ulcers in the mouth.

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 infusion one of Caelyx pegylated liposomal, the following reactions may occur: swelling of the face, shortness of breath, headache, chills, back pain, heaviness in the chest and/or throat, sore throat, decreased or elevated blood pressure, rapid heartbeat, dizziness, fever, dizziness, nausea, indigestion, itching , rash, and sweating. In very rare cases, seizures have occurred. Burning or swelling of the skin around the injection may also occur. If the drop stings or hurts when you receive a dose of Caelyx pegylated liposomal, tell your doctor immediately.

Contact your doctor immediately if:

  • the skin on your hands and feet blushes and aches;
  • you get a painful reddening of the skin and/or blisters on the body or in the mouth;
  • you get heart problems;
  • you get cold sores;
  • you develop a fever or other signs of infection;
  • you experience sudden shortness of breath or marked chest pain that may worsen with deep breathing or coughing;
  • you become swollen, hot, or sore in the soft parts of the legs, sometimes with pain that gets worse when you stand or walk.

Other side effects are

Between infusions, the following may occur:

Very common side effect are (can occur in more than 1 in 10):

  • redness, swelling, and sores on the palms and soles of the feet. These side effectshave has been seen frequently and are sometimes severe. In severe cases, these side effects can affect certain daily activities and may persist for 4 weeks or longer before complete healing. Your doctor may want to postpone and/or reduce your dose for the next treatment (see below, Strategies for Preventing and Treating Foot Syndrome);
  • pain or sores in the mouth or throat, nausea, vomiting, diarrhea, constipation, loss of appetite, weight loss;
  • reduction in the number of white blood cells, which may increase the risk of infection. Anemia (reduction of red blood cells ) can cause fatigue, and reduced platelet count may increase the risk of bleeding. In rare cases, a low number of white blood cells can lead to severe infection. Because blood can be affected, you need to take blood samples regularly. The results of a clinical study in patients with AIDS -KS who compared Caelyx pegylated liposomal with another treatment (bleomycin/vincristine), showed that there may be a higher risk of certain infections with Caelyx pegylated liposomal. In contrast to the experience in patients with AIDS -KS, however, was the risk of infection s, Caelyx pegylated liposomal when compared to the standard treatment for advanced ovarian cancer (topotecan), significantly lower in patients treated with pegylated liposomal Caelyx. The risk of low blood levels and infection was just as low in breast cancer studies. Some of these effects are due to your disease and not to Caelyx pegylated liposomal;
  • the general feeling of tiredness, feeling of weakness, a stinging or crawling sensation or pain in the hands and feet;
  • hair loss.

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

  • abdominal pain;
  • cold sores (fungal infection of the oral cavity), sores in the nose, nosebleeds, cold sores, and inflammation of the tongue;
  • laboratory values ​​related to hepatic function may either increase or decrease during treatment with Caelyx pegylated liposomal;
  • drowsiness, dizziness, fainting, skeletal pain, chest pain, abnormal muscle tension, muscle aches, leg cramps or swollen legs, general swelling, inflammation of the retina (the photosensitive membrane of the eye), increased tear production, blurred vision, a stinging or tingling sensation or pain in hands and feet ;
  • inflammation of hair follicles, scaly skin, inflammation or rash, abnormal pigmentation (coloring) of the skin, and nail problems;
  • heart problems, e.g. irregular heartbeat, enlarged blood vessels;
  • fever, fever or other signs of infection that may be related to your illness;
  • respiratory problems, ie. difficulty breathing or coughing that may be due to infection that you got as a result of your illness;
  • dehydration ( dehydration ), severe weight loss and muscle wasting, low calcium – magnesium -, potassium – or sodium levels, high potassium levels in the blood;
  • inflammation of the esophagus, inflammation of the gastric mucosa, difficulty swallowing, dry mouth, bloating, gingivitis ( gingivitis ), altered sense of taste;
  • inflammation of the vagina;
  • pain when urinating;
  • if you have previously had skin reactions, ie. pain, redness, and dry skin during radiation therapy, this can also occur with Caelyx pegylated liposomal;
  • joint pain, decreased or abnormal perception of stimulation, corneal inflammation, red eyes, redness of the scrotum may occur with a combination of Caelyx pegylated liposomal and bortezomib.

When Caelyx pegylated liposomal alone is used, some of these side effects are less likely to occur and some have not occurred at all.

Less common side effects are (may affect up to 1 in 100):

  • confusion;
  • inflammation of the veins and the formation of blood clots in the veins which can lead to the blood flow to your lungs being blocked and causing breathing problems, chest pain, and palpitations;
  • abnormal heart rhythm, heartbeat feels fast or uneven (palpitations), heart failurethat gives you shortness of breath and can lead to swollen legs, cardiac arrest.

Rare side effects are (may affect up to 1 in 1000 people):

  • blue skin and mucous membranes caused by lack of oxygen in the blood;
  • patchy skin calluses.

Very rare side effects are (may affect up to 1 in 10 000 users):

  • severe skin side effects such as widespread, flaky skin, blisters, and ulcers on the mucous membranes (Stevens-Johnson syndrome / toxic epidermal necrolysis );
  • Oral cancer can occur when Caelyx pegylated liposomal is taken for a long time (more than a year).

Strategies for preventing and treating ankle syndrome include:

  • to keep your hands and / or feet in a tub of cold water whenever possible (eg when watching TV, reading, or listening to the radio);
  • to hold hands and feet only (no gloves, socks, etc.);
  • to stay in cool places;
  • to take cool baths in hot weather;
  • to avoid strenuous exertion that may cause foot problems (eg jogging);
  • to avoid exposing the skin to very hot water (eg jacuzzi, sauna);
  • to avoid tight and/or high-heeled shoes.

Pyridoxine ( vitamin B6):

  • Vitamin B6 is available without a prescription.
  • take 50-150 mg daily at the first symptoms of redness or stinging sensation.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Caelyx pegylated liposomal

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

After preparation:

Chemical and physical in-use stability has been demonstrated for 24 hours at 2 ° C – 8 ° C. For microbiological reasons, 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 would not be longer than 24 hours at 2 ° C – 8 ° C. Partially used vials should be disposed of.

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 any signs of precipitation or other particle formation.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is doxorubicin hydrochloride. One ml of Caelyx pegylated liposomal contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal preparation.
  • The other ingredients are α- (2- [1,2-distearoyl- sn -glycerol (3) phosphooxy] ethylcarbamoyl) -ω-methoxy poly (oxyethylene) -40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulfate, 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 : 10 ml (20 mg) or 25 ml (50 mg) vials.

What the medicine looks like and the contents of the pack

The infusion solution is sterile, translucent, and red. Caelyx pegylated liposomal is supplied in glass vials as a single pack or pack 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

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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