DAUNOXOME INJECTION 2MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Active substance: DAUNORUBICIN HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
DaunoXome for Injection 2mg/ml concentrate
solution for infusion Daunorubicin
Read all of this leaflet carefully before you start using this medicine.
1. What DaunoXome is and what it is used for
What DaunoXome is
DaunoXome is an anti-cancer medicine (a cytotoxic agent) which reduces tumour cell growth. The active substance of DaunoXome is daunorubicin. DaunoXome is a special formulation of daunorubicin (in liposome form), which is used to treat a type of cancer known as Kaposis sarcoma. Kaposis sarcoma is a form of cancer that mainly affects the skin, but which can also affect the lungs and intestines.
2. Before you are given DaunoXome
DaunoXome is not to be used:
if you are allergic (hypersensitive) to daunorubicin or any of the other ingredients of DaunoXome, or any other medicines belonging to the same group (these are called anthracyclines or anthracenediones). if you are pregnant or breastfeeding. If any of these applies to you, you must not be given DaunoXome. If in doubt, ask your doctor or pharmacist for advice.
DaunoXome can suppress bone marrow activity, which can cause fever; infections, including infection in the blood (sepsis); bleeding problems and reduced red blood cells (anaemia). Your doctor will carry out regular blood monitoring. The risk of bone marrow problems with DaunoXome is higher if you already have a weakened immune system. DaunoXome may also cause tissue damage such as redness, swelling or pain at the site of infusion if the product leaks from the vein. This damage usually resolves within 6 months. Tell your doctor if you notice a stinging pain, redness or leakage of fluid in the area of the infusion site. DaunoXome is not usually recommended for children or older people. Its safety and efficacy has not yet been studied in these two groups.
Pregnancy and breast-feeding
DaunoXome can cause serious birth defects if it is used during pregnancy. It may also pass into breast milk and cause problems if you are breastfeeding. Tell your doctor before receiving DaunoXome if you are planning to become pregnant, or if you are already pregnant or breast-feeding. You might not be treated with DaunoXome in this situation. Male and female patients should use contraception to avoid pregnancy during and after treatment with DaunoXome. Contraception should still be used for 24 weeks after the end of treatment.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
What DaunoXome is used for
DaunoXome is used for the treatment of a severe form of Kaposis sarcoma in patients with AIDS.
Take special care with DaunoXome
This medicine can cause heart problems (cardiac failure) because of its effects on heart muscle. Rarely, these heart problems can be fatal. Heart problems can develop suddenly and may occur weeks or months after the end of treatment. Damage to the heart may be irreversible. As a precaution, your doctor will carry out tests to monitor your hearts performance, before and during the treatment. Make sure your doctor knows about any heart problems you have had Tell your doctor if you have been treated before with any medicines in the same class as DaunoXome (anthracyclines or anthracenediones). The risk of heart problems is higher in some situations: if you have existing heart problems if you are over 65 years old if you have been given high doses of DaunoXome, or high total doses of other anthracycline medicines as well as DaunoXome if you have been treated with other medicines that may damage the heart if you have received radiation therapy to the chest.
Driving and using machines
Do not drive a car, or use any tools or machines immediately after treatment with DaunoXome, because the side effects of this medicine could stop you doing this safely. In particular, the medicine can cause dizziness, nausea or sickness (see also section 4, Possible side effects).
In this leaflet:
Other medicines and DaunoXome
Tell your doctor if you are taking any other medicines, or have recently taken any. This includes medicines and herbal products you bought without a prescription.
1. What DaunoXome is and what it is used for 2. Before you use DaunoXome 3. How DaunoXome is used 4. Possible side effects 5. How to store DaunoXome
83034406
Other medicines that affect the heart or bone marrow
Your doctor will be especially careful if DaunoXome is given at the same time as any medicine which reduces the function of the heart or of the bone marrow, and with medicines that suppress the immune system. This includes medicines in the same class as DaunoXome (anthracyclines or anthracenediones).
Anti-viral medicines for HIV
There is a possibility that DaunoXome may interact with two groups of anti-HIV medicines, protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NRTIs). Tell your doctor if you are taking or have recently taken any of these.
6. Further information
16/06/11
1
3. How DaunoXome is used
DaunoXome is always given to you by a doctor or nurse. It is given as an infusion into a vein (a drip). DaunoXome must not be given by any other method. Before use, DaunoXome will first be diluted with a solution of glucose (5%), and it will then be administered as an infusion into a vein (intravenously). Normally, DaunoXome should be used straight after it has been diluted. However, your doctor or pharmacist may decide to store the diluted DaunoXome for a maximum of 24 hours before use, depending on the solution. The infusion will usually take 30 to 60 minutes.
4. Possible side effects
Like all medicines, DaunoXome can cause side effects, although not everybody gets them. Tell your doctor at once if you notice any of these side effects, or any others not listed in this leaflet.
Uncommon side effects
(may affect up to 1 in every 100 people treated) an infection in the blood (sepsis) which can cause fever or chills, rapid heartbeat or rapid breathing; and/ or septic shock (a life-threatening form of sepsis) which also causes low blood pressure. disease of the heart muscle and heart failure. Your doctor may order some special heart function tests, both before and during your treatment.
5. How to store DaunoXome
Keep out of the reach and sight of children. Do not use DaunoXome after the expiry date which is stated on the label {Expiry Date}. The product must be used within 24 hours after dilution with 5% glucose. Store at 2C to 8C (in a refrigerator). Do not freeze. Keep the vial in the outer carton. Vials are for single use only. 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. Further information
What DaunoXome contains
The active substance is daunorubicin (as citrate salt) equivalent to 2 mg/ mL (total 50 mg) daunorubicin base, encapsulated in liposomes. The other ingredients in the liposome are distearoylphosphatidylcholine, cholesterol, citric acid (E330). The other ingredients in the buffer are sucrose, glycine (E640), calcium chloride (E509), water for injection.
Very common side effects
(may affect more than 1 in 10 people treated) damage to the bone marrow. Signs include frequent infections and bleeding, reduced levels of red blood cells (anaemia) infusion reactions. Signs include back pain, flushing, a tight feeling in the chest and shortness of breath. These reactions generally occur within the first 10 minutes of the infusion and subside when the infusion is slowed or stopped allergic reactions. These may include rash or wheezing headaches tiredness difficulty breathing chills, fever nausea, vomiting, diarrhoea, tummy ache hair loss inflammation of the mucous membranes (such as the lining of the mouth, throat, nose, rectum and vagina).
Rare side effects
(may affect up to 1 in every 1,000 people treated) anaphylactic reactions (lifethreatening type of allergic reaction). Signs include flushing, itching, wheezing, and swelling of the mouth, tongue or throat that can prevent breathing. heart attack; abnormal rhythm of the heart (atrial fibrillation) hand-foot syndrome, which is also known as Palmar-Plantar Erythrodysaesthesia (PPE). Signs are swelling, redness, pain, and tingling of the hands and feet, which may lead to peeling of the skin. Tell your doctor at once if you notice any of these side effects, or any others not listed in this leaflet.
What DaunoXome looks like and contents of the pack
DaunoXome is a red, clear or slightly cloudy solution in a 50 ml glass vial containing 25 ml of concentrate. Each vial contains daunorubicin hydrochloride, corresponding to 50 mg of daunorubicin.
Dosage for adults
The dose of DaunoXome is calculated on the basis of your body surface area (which is related to your height and weight). The starting dose is 40 milligrams per m2, given every two weeks. During your treatment, your doctor may also decide to raise or lower the amount you are given. Normally, he or she will treat you with DaunoXome for as long as it has a positive effect.
Marketing Authorisation Holder
Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK
Manufacturer
Gilead Sciences Ltd. IDA Business and Technology Park Carrigtohill Co. Cork Ireland DaunoXome is registered under the number PL 27827/0007 This leaflet was last approved in 10/2011.
If you are given too much DaunoXome
As your infusion is administered by a doctor or nurse, it is very unusual to be given too much of this medicine. Tell your doctor at once if you suspect that you have been given too much DaunoXome. In the event of an overdose, the side effects listed in section 4 may appear more pronounced. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Common side effects
(may affect up to 1 in 10 people treated) dehydration depression dizziness decreased ability of the left chamber of the heart to pump blood redness of the skin, pain and swelling around the infusion site, caused by leakage from a vein into surrounding tissue.
83034406
16/06/11
2
DaunoXome for Injection 2mg/ml concentrate
solution for infusion Daunorubicin
Read all of this leaflet carefully before you start using this medicine.
1. What DaunoXome is and what it is used for
What DaunoXome is
DaunoXome is an anti-cancer medicine (a cytotoxic agent) which reduces tumour cell growth. The active substance of DaunoXome is daunorubicin. DaunoXome is a special formulation of daunorubicin (in liposome form), which is used to treat a type of cancer known as Kaposis sarcoma. Kaposis sarcoma is a form of cancer that mainly affects the skin, but which can also affect the lungs and intestines.
2. Before you are given DaunoXome
DaunoXome is not to be used:
if you are allergic (hypersensitive) to daunorubicin or any of the other ingredients of DaunoXome, or any other medicines belonging to the same group (these are called anthracyclines or anthracenediones). if you are pregnant or breastfeeding. If any of these applies to you, you must not be given DaunoXome. If in doubt, ask your doctor or pharmacist for advice.
DaunoXome can suppress bone marrow activity, which can cause fever; infections, including infection in the blood (sepsis); bleeding problems and reduced red blood cells (anaemia). Your doctor will carry out regular blood monitoring. The risk of bone marrow problems with DaunoXome is higher if you already have a weakened immune system. DaunoXome may also cause tissue damage such as redness, swelling or pain at the site of infusion if the product leaks from the vein. This damage usually resolves within 6 months. Tell your doctor if you notice a stinging pain, redness or leakage of fluid in the area of the infusion site. DaunoXome is not usually recommended for children or older people. Its safety and efficacy has not yet been studied in these two groups.
Pregnancy and breast-feeding
DaunoXome can cause serious birth defects if it is used during pregnancy. It may also pass into breast milk and cause problems if you are breastfeeding. Tell your doctor before receiving DaunoXome if you are planning to become pregnant, or if you are already pregnant or breast-feeding. You might not be treated with DaunoXome in this situation. Male and female patients should use contraception to avoid pregnancy during and after treatment with DaunoXome. Contraception should still be used for 24 weeks after the end of treatment.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
What DaunoXome is used for
DaunoXome is used for the treatment of a severe form of Kaposis sarcoma in patients with AIDS.
Take special care with DaunoXome
This medicine can cause heart problems (cardiac failure) because of its effects on heart muscle. Rarely, these heart problems can be fatal. Heart problems can develop suddenly and may occur weeks or months after the end of treatment. Damage to the heart may be irreversible. As a precaution, your doctor will carry out tests to monitor your hearts performance, before and during the treatment. Make sure your doctor knows about any heart problems you have had Tell your doctor if you have been treated before with any medicines in the same class as DaunoXome (anthracyclines or anthracenediones). The risk of heart problems is higher in some situations: if you have existing heart problems if you are over 65 years old if you have been given high doses of DaunoXome, or high total doses of other anthracycline medicines as well as DaunoXome if you have been treated with other medicines that may damage the heart if you have received radiation therapy to the chest.
Driving and using machines
Do not drive a car, or use any tools or machines immediately after treatment with DaunoXome, because the side effects of this medicine could stop you doing this safely. In particular, the medicine can cause dizziness, nausea or sickness (see also section 4, Possible side effects).
In this leaflet:
Other medicines and DaunoXome
Tell your doctor if you are taking any other medicines, or have recently taken any. This includes medicines and herbal products you bought without a prescription.
1. What DaunoXome is and what it is used for 2. Before you use DaunoXome 3. How DaunoXome is used 4. Possible side effects 5. How to store DaunoXome
83034406
Other medicines that affect the heart or bone marrow
Your doctor will be especially careful if DaunoXome is given at the same time as any medicine which reduces the function of the heart or of the bone marrow, and with medicines that suppress the immune system. This includes medicines in the same class as DaunoXome (anthracyclines or anthracenediones).
Anti-viral medicines for HIV
There is a possibility that DaunoXome may interact with two groups of anti-HIV medicines, protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NRTIs). Tell your doctor if you are taking or have recently taken any of these.
6. Further information
16/06/11
1
3. How DaunoXome is used
DaunoXome is always given to you by a doctor or nurse. It is given as an infusion into a vein (a drip). DaunoXome must not be given by any other method. Before use, DaunoXome will first be diluted with a solution of glucose (5%), and it will then be administered as an infusion into a vein (intravenously). Normally, DaunoXome should be used straight after it has been diluted. However, your doctor or pharmacist may decide to store the diluted DaunoXome for a maximum of 24 hours before use, depending on the solution. The infusion will usually take 30 to 60 minutes.
4. Possible side effects
Like all medicines, DaunoXome can cause side effects, although not everybody gets them. Tell your doctor at once if you notice any of these side effects, or any others not listed in this leaflet.
Uncommon side effects
(may affect up to 1 in every 100 people treated) an infection in the blood (sepsis) which can cause fever or chills, rapid heartbeat or rapid breathing; and/ or septic shock (a life-threatening form of sepsis) which also causes low blood pressure. disease of the heart muscle and heart failure. Your doctor may order some special heart function tests, both before and during your treatment.
5. How to store DaunoXome
Keep out of the reach and sight of children. Do not use DaunoXome after the expiry date which is stated on the label {Expiry Date}. The product must be used within 24 hours after dilution with 5% glucose. Store at 2C to 8C (in a refrigerator). Do not freeze. Keep the vial in the outer carton. Vials are for single use only. 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. Further information
What DaunoXome contains
The active substance is daunorubicin (as citrate salt) equivalent to 2 mg/ mL (total 50 mg) daunorubicin base, encapsulated in liposomes. The other ingredients in the liposome are distearoylphosphatidylcholine, cholesterol, citric acid (E330). The other ingredients in the buffer are sucrose, glycine (E640), calcium chloride (E509), water for injection.
Very common side effects
(may affect more than 1 in 10 people treated) damage to the bone marrow. Signs include frequent infections and bleeding, reduced levels of red blood cells (anaemia) infusion reactions. Signs include back pain, flushing, a tight feeling in the chest and shortness of breath. These reactions generally occur within the first 10 minutes of the infusion and subside when the infusion is slowed or stopped allergic reactions. These may include rash or wheezing headaches tiredness difficulty breathing chills, fever nausea, vomiting, diarrhoea, tummy ache hair loss inflammation of the mucous membranes (such as the lining of the mouth, throat, nose, rectum and vagina).
Rare side effects
(may affect up to 1 in every 1,000 people treated) anaphylactic reactions (lifethreatening type of allergic reaction). Signs include flushing, itching, wheezing, and swelling of the mouth, tongue or throat that can prevent breathing. heart attack; abnormal rhythm of the heart (atrial fibrillation) hand-foot syndrome, which is also known as Palmar-Plantar Erythrodysaesthesia (PPE). Signs are swelling, redness, pain, and tingling of the hands and feet, which may lead to peeling of the skin. Tell your doctor at once if you notice any of these side effects, or any others not listed in this leaflet.
What DaunoXome looks like and contents of the pack
DaunoXome is a red, clear or slightly cloudy solution in a 50 ml glass vial containing 25 ml of concentrate. Each vial contains daunorubicin hydrochloride, corresponding to 50 mg of daunorubicin.
Dosage for adults
The dose of DaunoXome is calculated on the basis of your body surface area (which is related to your height and weight). The starting dose is 40 milligrams per m2, given every two weeks. During your treatment, your doctor may also decide to raise or lower the amount you are given. Normally, he or she will treat you with DaunoXome for as long as it has a positive effect.
Marketing Authorisation Holder
Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK
Manufacturer
Gilead Sciences Ltd. IDA Business and Technology Park Carrigtohill Co. Cork Ireland DaunoXome is registered under the number PL 27827/0007 This leaflet was last approved in 10/2011.
If you are given too much DaunoXome
As your infusion is administered by a doctor or nurse, it is very unusual to be given too much of this medicine. Tell your doctor at once if you suspect that you have been given too much DaunoXome. In the event of an overdose, the side effects listed in section 4 may appear more pronounced. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Common side effects
(may affect up to 1 in 10 people treated) dehydration depression dizziness decreased ability of the left chamber of the heart to pump blood redness of the skin, pain and swelling around the infusion site, caused by leakage from a vein into surrounding tissue.
83034406
16/06/11
2
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
