Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Cardioxane 500 mg powder for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dexrazoxane hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Cardioxane contains a substance called dexrazoxane. This substance belongs to a group of medicines which protect the heart (cardioprotective medicines). Cardioxane is used to prevent heart damage when medicines called anthracyclines (such as doxorubicin or epirubicin) are used during breast cancer treatment in adults.
2.
What you need to know before you take it
Cardioxane
You must not be given Cardioxane − If you are under 18 years old and your planned dose of anthracycline is considered low – talk to your doctor about this. − If you are allergic (hypersensitive) to dexrazoxane. − If you are breast-feeding (see also "Pregnancy and breast-feeding"). − If you are given yellow-fever vaccine. If any of the above apply, you must not be given this medicine. Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Cardioxane: • If you have or have had liver or kidney problems. • If you have or have had a heart attack, heart failure, uncontrolled chest pain and heart valve problems. • If you are pregnant or plan to become pregnant (see also "Pregnancy and breast-feeding"). • If you are allergic to dexrazoxane.
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You should also be aware that: − Your doctor may carry out tests before and during the treatment with Cardioxane to see how well the treatment is working and to check the function of some of your organs, such as your heart, kidneys or liver. − Your doctor may carry out blood tests during the treatment with Cardioxane to monitor your bone marrow function. If you are receiving high-dose cancer treatment (e.g. chemotherapy or radiation) and are also being treated with high doses of Cardioxane, your bone marrow function may be reduced. This may affect the production of red blood cells, white blood cells, and platelets. − Cardioxane may increase the risk of developing leukaemia (cancer of the blood). − During treatment with Cardioxane, women of childbearing potential and men should use effective contraception. Women and men should continue using contraception for at least six months after Cardioxane treatment has been stopped (see also "Pregnancy and breast-feeding"). − The combination of Cardioxane with your cancer treatment may increase the risk of blood clots. − If Cardioxane powder or solution gets on your skin, tell your doctor straight away. You or your doctor should immediately rinse the affected area thoroughly with water. Children and adolescents The long-term benefits and risks of this medicine in children and adolescents are not yet clear. Your doctor will advise on benefits and risks of this medicine. Older people (over 65 years old) The doctor may adjust your treatment with Cardioxane according to your health condition (in case of heart, liver or kidney problems). Other medicines and Cardioxane Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is not advisable to take other medicines without telling your doctor as there may be interactions between Cardioxane and other medicines:
- Vaccines: you must not use Cardioxane if you will receive yellow fever vaccine and it is not recommended that you use Cardioxane if you will receive a vaccine containing live virus particles.
- Phenytoin, a treatment against seizures.
- Cyclosporin or tacrolimus (both treatments lower the body's immune system and are used to prevent organ rejection after an organ transplant).
- Myelosuppressive medicines (decrease production of red, white, or coagulating blood cells). Pregnancy and breast-feeding − You will not be given Cardioxane if you are pregnant or had planned to become pregnant, unless your doctor decides it is necessary. − Women of childbearing potential and men should use effective contraception during treatment with Cardioxane and for at least six months after Cardioxane treatment has been stopped. − Stop breast-feeding while you are receiving Cardioxane treatment. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. Driving and using machines Tiredness has been reported with Cardioxane treatment. Therefore if you feel sleepy, do not drive or use machines.
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3.
How Cardioxane is given
How to take it
to you This medicine is prepared and given to you by your doctor or other medical staff. The dose you will receive is decided by your doctor. − Cardioxane is given as a drip (infusion) into a vein over about 15 minutes. − This will start approximately 30 minutes before your cancer treatment (doxorubicin and/or epirubicin). If you think you have been given more Cardioxane than you should If you are given too much Cardioxane, tell your doctor or nurse straight away. You may experience some of the side effects listed in section 4, "Possible side effects".
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and need immediate medical attention: Very common (may affect more than 1 in 10 patients): − Frequent infections, fever, sore throat, unexpected bruising and bleeding (signs of blood disorders such as low red blood cell counts, low white blood cell counts, low level of platelets and low level of granulocytes. Your blood counts may however return to normal after each treatment cycle.) Common (may affect up to 1 in 10 patients): − Swelling and reddening of a vein Uncommon (may affect up to 1 in 100 patients): − Leukaemia (cancer of the blood) − Sudden loss of consciousness − Swelling and pain in one part of the body that can be caused by blood clotting within vein − Tissue swelling in limbs The following side effects have been reported in very few patients during treatment with Cardioxane: − Allergic reactions including itching, rash, facial/throat swelling, wheezing, breathlessness or difficult breathing, changes in levels of consciousness, hypotension − Sudden onset of shortness of breath, coughing up blood and chest pain (signs of blood clot in the lung) If you get any of the above, tell your doctor straight away or go to the nearest emergency unit. Other side effects include: Very common (may affect more than 1 in 10 patients): − Hair loss. − Vomiting, mouth sores, nausea − Weakness Common (may affect up to 1 in 10 patients): − Diarrhoea, stomach pain, constipation, fullness in stomach and loss of appetite − Decreased heart muscle function, fast heart beat − Pain, redness and swelling of the moist lining of the internal passageways such as the airways or food pipe − Nail disorders such as blackening − Skin reaction such as swelling, redness, pain, burning sensation, itching at the site of injection − Tingling or numbness of the hands or feet, dizziness, headache − Tiredness, generally feeling unwell − Slight fever, chest pain, elevated/increased heart rate, shortness of breath or rapid breathing − Abnormal liver function test results Uncommon (may affect up to 1 in 100 patients): − Increase in blood cell counts 4
− − − −
Vertigo, ear infection Bleeding, tender or enlarged gums, oral thrush Thirst Redness, hotness and tenderness caused by inflammation under the skin
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Cardioxane
− − − −
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package in order to protect from light. Do not use this medicine after the expiry date which is stated on the pack. 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 to protect the environment.
6.
Contents of the pack and other information
What Cardioxane contains − The active substance is dexrazoxane (as dexrazoxane hydrochloride). − Each vial contains 500 mg of dexrazoxane. Cardioxane contains no other ingredients. What Cardioxane looks like and contents of the pack Cardioxane is a white to off-white powder for solution for infusion available in packs of one vial and packs of four vials. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder CNX Therapeutics Limited 3 Bunhill Row London EC1Y 8YZ United Kingdom Manufacturer Cenexi Laboratoires Thissen S.A. Rue de la Papyrée 2-4-6 1420 Braine-l'Alleud Belgium
This leaflet was last revised in 01/2024.
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————————————————————————————————————————THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY CARDIOXANE 500 mg powder for solution for infusion Dexrazoxane
POSOLOGY AND METHOD OF ADMINISTRATION Cardioxane is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10 times the doxorubicin-equivalent dose level and 10 times the epirubicin-equivalent dose. Thus it is recommended that Cardioxane is given at a dose of 500 mg/m2 when the commonly used dosage schedule for doxorubicin of 50 mg/m2 is employed or 600 mg/m2 when the commonly used dosage schedule for epirubicin of 60 mg/m2 is employed. Paediatric population The safety and efficacy of Cardioxane in children aged 0 to 18 years have not been established. Cardioxane is contraindicated in children aged 0 to 18 years who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline. Renal impairment In patients with moderate to severe renal dysfunction (creatinine clearance < 40 ml/min) the dexrazoxane dose should be reduced by 50%. Hepatic impairment The dose ratio should be kept, i.e. if the anthracycline dose is reduced the dexrazoxane dose should be reduced accordingly. Older people (over 65 years old) The dose may be adjusted during treatment with Cardioxane according to health condition (in case of heart, liver or kidney problems). In case of overdose, symptomatic treatment should be provided. INSTRUCTIONS FOR USE Recommendations for safe handling Prescribers should refer to national or recognised guidelines on handling cytotoxic agents when using Cardioxane. Reconstitution should only be carried out by trained staff in a cytotoxic designated area. The preparation should not be handled by pregnant staff. Use of gloves and other protective clothing to prevent skin contact is recommended. Skin reactions have been reported following contact with Cardioxane. If Cardioxane powder or solution comes into contact with the skin or mucosal surfaces, the affected area should immediately be rinsed thoroughly with water.
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Preparation for intravenous administration Reconstitution of Cardioxane For reconstitution the contents of each vial should be dissolved in 25 ml of water for injections. The vial contents will dissolve within a few minutes with gentle shaking. The resultant solution has a pH of approximately 1.6. This solution should be further diluted before administration to the patient. Dilution of Cardioxane To avoid the risk of thrombophlebitis at the injection site, Cardioxane must be diluted prior to infusion with one of the solutions mentioned in Table1. The final volume is proportional to the number of Cardioxane vials used and the amount of infusion fluid for dilution, which can be between 25 ml and 100 ml per vial. Table 1. below summarises the final volume and the approximate pH of reconstituted and diluted product for one vial and four vials of Cardioxane. The minimum and maximum volumes of infusion fluids to be used per vial are shown in Table 1. Table 1. Reconstitution and dilution of Cardioxane vials Infusion fluid used for Volume of fluid used to Final Final pH dilution dilute 1 vial of volume volume (approximate) reconstituted from 1 vial from 4 vials Cardioxane Ringer lactate 25 ml 50 ml 200 ml 2.2 100 ml 125 ml 500 ml 3.3 0.16 M sodium lactate* 25 ml 50 ml 200 ml 2.9 100 ml 125 ml 500 ml 4.2 * Sodium lactate 11.2% should be diluted by a factor of 6 to reach a concentration of 0.16 M The use of larger dilution volumes (with a maximum of 100 ml of additional infusion fluid per 25 ml reconstituted Cardioxane) is usually recommended to increase the pH of the solution. Smaller dilution volumes (with a minimum of 25 ml of additional infusion fluid per 25 ml reconstituted Cardioxane) can be used if needed, based on the haemodynamic status of the patient. Reconstituted, diluted Cardioxane is for single use only. The diluted solution should be used immediately or stored for not longer than 4 hours between +2°C and +8°C and protected from light. Parenteral medicinal products should be inspected visually for particulate matter whenever the solution and container permit. Cardioxane is normally a colourless to yellow solution immediately on reconstitution, but some variability in colour may be observed over time, which does not indicate loss of activity if the product has been stored as recommended. It is however recommended to dispose of the product if the colour immediately on reconstitution is not colourless to yellow. Incompatibilities Cardioxane must not be mixed with any products other than the solutions for dilution mentioned above. Storage Do not use Cardioxane after the expiry date which is stated on the pack. Before opening Do not store above 25°C. Store Cardioxane vials in the original package in order to protect from light. After reconstitution and dilution The diluted solution of Cardioxane is physically and chemically stable for 4 hours at 25°C. From a microbiological point of view, the readily prepared infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. These must not exceed 4 hours at 2°C to 8°C (in a refrigerator), protected from light.
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Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Adequate care and precaution should be taken in the disposal of items used to reconstitute and dilute Cardioxane.
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Frequently asked questions about Cardioxane 500 mg powder for solution for infusion
How do I take Cardioxane 500 mg powder for solution for infusion?
Cardioxane 500 mg powder for solution for infusion comes as infusion containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Cardioxane 500 mg powder for solution for infusion?
The active substance in Cardioxane 500 mg powder for solution for infusion is dexrazoxane hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cardioxane 500 mg powder for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Cardioxane 500 mg powder for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dexrazoxane hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Cardioxane is indicated in adults for the prevention of chronic cumulative cardiotoxicity caused by anthracycline use in advanced and/or metastatic breast cancer patients who have received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required.
4.2. Posology and method of administration
Posology
Cardioxane is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10 times the doxorubicin-equivalent dose and 10 times the epirubicin-equivalent dose.
Thus it is recommended that Cardioxane is given at a dose of 500 mg/m2 when the commonly used dosage schedule for doxorubicin of 50 mg/m2 is employed or 600 mg/m2 when the commonly used dosage schedule for epirubicin of 60 mg/m2 is employed.
Paediatric population
The safety and efficacy of Cardioxane in children aged 0 to 18 years have not been established. Currently available data are described in section 4.3, 4.4, 4.8, 5.1 and 5.2.
Renal impairment
In patients with moderate to severe renal impairment (creatinine clearance < 40 ml/min) the dexrazoxane dose should be reduced by 50% (see section 4.4).
Hepatic impairment
The dosage ratio should be kept, i.e. if the anthracycline dose is reduced the dexrazoxane dose should be reduced accordingly.
Method of administration
Intravenous use
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Cardioxane is contraindicated in children aged 0 to 18 years who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline (see sections 4.4 and 4.8).
Cardioxane is also contraindicated in the following circumstances:
- Hypersensitivity to dexrazoxane
- Breast-feeding (see section 4.6)
- Concomitant vaccination with yellow fever vaccine (see section 4.5)
4.4. Special warnings and precautions for use
Myelosuppression
Myelosuppressive effects that may be additive to those of chemotherapy were reported with Cardioxane (see section 4.8). Cell counts at nadir may be lower in patients treated with dexrazoxane. Haematological monitoring is thus necessary. Leucopenia and thrombocytopenia generally reverse quickly upon cessation of treatment with Cardioxane.
At higher doses of chemotherapy, where the Cardioxane dose exceeds 1000 mg/m2, myelosuppression may increase significantly.
Second primary malignancies
Since dexrazoxane is a cytotoxic agent, with topoisomerase II inhibition activity, combination of dexrazoxane with chemotherapy may lead to an increased risk of second primary malignancy.
Oncology patients have an increased risk of second primary malignancies, regardless of treatment. Patients who have received cancer therapy also have an increased risk of second primary malignancy.
Acute Myeloid Leukaemia (AML) has been reported uncommonly in adult breast cancer patients post-marketing (see section 4.8).
In paediatric patients, second primary malignancies, including acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), have been reported in clinical trials in both dexrazoxane and control groups. Although second primary malignancies were numerically higher in the dexrazoxane arm, there was no statistical difference between groups. Overall, the rates of second primary malignancies in the available paediatric studies in the dexrazoxane group are similar to rates determined for relevant populations in other studies (historical data). However, the long term effect of dexrazoxane on second primary malignancies is not known and cannot be estimated from the available data. In clinical trials, second primary malignancies, in particular AML and myelodysplastic syndrome (MDS), have been reported in paediatric patients with Hodgkin's disease and acute lymphoblastic leukaemia receiving chemotherapy regimens including several cytotoxics (e.g. etoposide, doxorubicin, cyclophosphamide) (see section 4.8).
Interference with chemotherapy
Since both dexrazoxane and anthracyclines are topoisomerase inhibitors, it has been suggested that dexrazoxane may interfere with the anti-tumour efficacy of anthracyclines based on mechanism of action. However, in most adult studies no significant difference has been identified in response rate and overall survival between dexrazoxane and control groups. A significant decrease in tumour response rate was reported in one study of advanced breast cancer patients treated with doxorubicin and dexrazoxane compared to patients treated with doxorubicin and placebo. In this study placebo response rate was considered to be high (60.5%), which may be a contributing factor to the observed difference in response rate. Despite the difference in response rates, there was no significant difference in time to progression or overall survival between patients that had received either dexrazoxane or placebo in this study.
No paediatric study has reported a difference in oncological outcome (event free survival) between groups treated with dexrazoxane and those treated with anthracycline alone.
Patients with renal impairment
Clearance of dexrazoxane and its active metabolites may be reduced in patients with decreased creatinine clearance (see Section 4.2).
Liver disorders
Since liver dysfunction was occasionally observed in patients treated with Cardioxane (see section 4.8), it is recommended that routine liver function tests be performed before and during administration of dexrazoxane in patients with known liver function disorders.
Patients with cardiac disorders
Standard cardiac monitoring associated with doxorubicin or epirubicin treatment should be continued.
There are no data that support the use of dexrazoxane in patients with myocardial infarction within the past 12 months, pre-existing heart failure (including clinical heart failure secondary to anthracycline treatment), uncontrolled angina or symptomatic valvular heart disease.
Thromboembolism
Combination of dexrazoxane with chemotherapy may lead to an increased risk of thromboembolism (see section 4.8).
Women of child-bearing potential / Contraception in males and females
Since dexrazoxane is a cytotoxic agent, sexually active men and women should use effective contraception during treatment. Women and men should continue using effective methods of contraception for at least 6 months after cessation of treatment with dexrazoxane (see section 4.6).
Geriatric patients (age 65 years or above)
There are no clinical trials comparing the efficacy or safety of dexrazoxane in geriatric patients to that in younger patients. However, in general, caution is required when treating elderly patients due to their greater use of other medicinal products, higher rates of concomitant diseases and possible reduced hepatic, renal or cardiac function.
Anaphylactic reaction
Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with Cardioxane and anthracyclines (see section 4.8). Previous history of allergy to dexrazoxane should be carefully considered prior to administration (see section 4.3).
4.5. Interaction with other medicinal products and other forms of interaction
Cardioxane is excreted unchanged via the kidney, as well as metabolized by dihydropyrimidine amidohydrolase (DHPase) in the liver and kidney to ring-opened metabolites. Co-administration of doxorubicin (50 to 60 mg/m2) or epirubicin (60 to 100 mg/m2) did not affect Cardioxane pharmacokinetics significantly.
In studies, Cardioxane did not affect the pharmacokinetics of doxorubicin. There is limited evidence from studies that suggests that epirubicin clearance may be increased when dexrazoxane is pre-administered, this occurred at high doses of epirubicin (120-135 mg/m2).
Cardioxane may increase haematological toxicity induced by chemotherapy or radiation, requiring careful monitoring of haematological parameters during the first two treatment cycles (see section 4.4).
Cardioxane should not be mixed with any other medicinal products during infusion.
Concomitant use contraindicated:
Yellow fever vaccine: Risk of fatal generalised vaccine disease (see section 4.3).
Concomitant use not recommended:
Other live attenuated vaccines: risk of systemic, possible fatal disease. This risk is increased in subjects who are already immunosuppressed by their underlying disease. Use an inactivated vaccine where this exists (poliomyelitis).
Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions. Dexrazoxane is not recommended in combination with phenytoin.
Concomitant use to assess carefully:
Ciclosporin, tacrolimus: Excessive immunosuppression with risk of lymphoproliferative disease.
Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and femalesBoth sexually active men and women should use effective methods of contraception during treatment. For women and men the contraception should be continued for at least 6 months after cessation of treatment with Cardioxane (see section 4.4).
Pregnancy
There are no adequate data from the use of dexrazoxane in pregnant women. Animal studies showed embryotoxic and teratogenic effects (see section 5.3). The potential risk for humans is unknown. Cardioxane is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties. Cardioxane should not be used during pregnancy unless clearly necessary.
Breast-feeding
There are no animal studies on the transfer of the active substance and/or its metabolites into milk. It is unknown whether dexrazoxane and/or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in infants exposed to Cardioxane, breast-feeding is contraindicated during Cardioxane treatment (see section 4.3).
Fertility
The effect of Cardioxane on the fertility of humans has not been studied.
There are limited fertility data from animal studies available, but testicular changes were observed in rats and dogs following repeat dosing (see Section 5.3).
4.7. Effects on ability to drive and use machines
Cardioxane has moderate influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with Cardioxane.
4.8. Undesirable effects
Summary of the safety profile
Cardioxane is administered together with anthracycline chemotherapy and, consequently, the relative contributions of anthracycline and Cardioxane to the adverse reaction profile may be unclear. The most common adverse reactions are haematological and gastroenterological reactions, primarily anaemia, leukopenia, nausea, vomiting and stomatitis, as well as asthenia and alopecia. Myelosuppressive effects of Cardioxane may be additive to those of chemotherapy (see section 4.4).
Tabulated list of adverse reactions
The following table includes reactions from clinical trials and from post-marketing use. Due to the spontaneous nature of post-marketing reporting, such events are listed with frequency “not known” if they were not already identified as reactions from clinical trials.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); not known (cannot be estimated from the available data).
Table 1
Infections and infestations
Uncommon
Infection, sepsis
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Uncommon
Acute myeloid leukaemia
Blood and lymphatic system disorders
Very common
Anaemia, leukopenia
Common
Neutropenia, thrombocytopenia, febrile neutropenia, granulocytopenia, febrile bone marrow aplasia, white blood cell count decreased
Uncommon
Eosinophil count increased, neutrophil count increased, platelet count increased, white blood cell count increased, lymphocyte count decreased, monocyte count decreased
Immune system disorders
Not known
Anaphylactic reaction, hypersensitivity
Metabolism and nutrition disorders
Common
Anorexia
Nervous system disorders
Common
Paraesthesia, dizziness, headache, peripheral neuropathy
Uncommon
Syncope
Ear and labyrinth disorders
Uncommon
Vertigo, ear infection
Cardiac disorders
Common
Ejection fraction decreased, tachycardia
Vascular disorders
Common
Phlebitis
Uncommon
Venous thrombosis, lymphoedema
Not known
Embolism
Respiratory, thoracic and mediastinal disorders
Common
Dyspnoea, cough, pharyngitis, respiratory tract infections
Not known
Pulmonary embolism
Gastrointestinal disorders
Very common
Nausea, vomiting, stomatitis
Common
Diarrhoea, constipation, abdominal pain, dyspepsia
Uncommon
Gingivitis, oral candidiasis
Hepatobiliary disorders
Common
Transaminases increased
Skin and subcutaneous tissue disorders
Very common
Alopecia
Common
Nail disorder, erythema
Uncommon
Cellulitis
General disorders and administration site conditions
Very common
Asthenia
Common
Mucosal inflammation, pyrexia, fatigue, malaise, injection site reaction (including pain, swelling, burning sensation, erythema, pruritus, thrombosis), oedema
Uncommon
Thirst
Clinical trial data
The above table shows adverse reactions reported in clinical studies and having a reasonable possibility of a causal relationship with Cardioxane. These data are derived from clinical trials in cancer patients where Cardioxane was used in combination with anthracycline-based chemotherapy, and where in some cases a control group of patients receiving chemotherapy alone can be referred to.
Patients receiving chemotherapy and Cardioxane (n=375):
• Of these 76% were treated for breast cancer and 24% for a variety of advanced cancers.
• Cardioxane treatment: a mean dose of 1010 mg/m² (median: 1000 mg/m²) in combination with doxorubicin, and a mean dose of 941 mg/m² (median: 997 mg/m²) in combination with epirubicin.
• Chemotherapy treatment received by patients treated for breast cancer: 45% combination therapy with doxorubicin 50 mg/m² (mainly with 5-fluorouracil and cyclophosphamide): 17% with epirubicin alone; 14% combination therapy with epirubicin 60 or 90 mg/m² (mainly with 5-fluorouracil and cyclophosphamide).
Patients receiving chemotherapy alone (n=157)
• All were treated for breast cancer
• Chemotherapy treatment received: 43% single agent epirubicin 120 mg/m²; 33% combination therapy with 50 mg/m² doxorubicin (mainly with 5-fluorouracil and cyclophosphamide); 24% combination therapy with epirubicin at 60 or 90 mg/m² (mainly with 5-fluorouracil and cyclophosphamide).
Description of selected adverse drug reactions
Second primary malignancies
AML has been reported uncommonly in adult breast cancer patients post-marketing.
Safety profile at maximum tolerated dose
Dexrazoxane's maximum tolerated dose (MTD) when given as monotherapy by short infusion every three weeks for cardioprotection has not been specifically studied. In studies of dexrazoxane as a cytotoxic, its MTD is shown to be dependent on posology and dosing schedule, and varies from 3750 mg/m2 when short infusions are given in divided doses over 3 days to 7420 mg/m2 when given weekly for 4 weeks, with myelosuppression and abnormal liver function tests becoming dose-limiting. The MTD is lower in patients who have been heavily pre-treated with chemotherapy, and those with pre-existing immunosuppression (e.g. AIDS).
The following are adverse reactions reported when Cardioxane was given at doses around the MTD: neutropenia, thrombocytopenia, nausea, vomiting, and increase in hepatic parameters. Other toxic effects were malaise, low grade fever, increased urinary clearance of iron and zinc, anaemia, abnormal blood clotting, transient elevation of serum triglyceride and amylase levels, and a transient decrease in serum calcium level.
Paediatric population
The safety experience in children is based primarily on literature reports of clinical trials in acute lymphoblastic leukaemia, non-Hodgkin's lymphoma, Hodgkin's disease and osteosarcoma, and post-marketing data.
In paediatric patients, second primary malignancies, including acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), have been reported in clinical trials in both dexrazoxane and control groups. Although second primary malignancies were numerically higher in the dexrazoxane arms, there was with no statistical difference between groups. In addition, the long term effect of dexrazoxane on secondary primary malignancies is not known (cannot be estimated from the available data) (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The signs and symptoms of overdose are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia. There is no specific antidote and symptomatic treatment should be provided.
Management should include prophylaxis and treatment of infections, fluid regulation, and maintenance of nutrition.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- CYRDANAX 20 mg/ml prescriptionDEXRAZOXANUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- CardioxaneDexrazoxanum · injection / infusion
- SaveneDexrazoxanum · injection / infusion
- CyrdanaxDexrazoxanum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Cardioxane 500 mg powder for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.