Cardioxane 500 mg powder for solution for infusion
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Cardioxane 500 mg powder for solution for infusion
Dexrazoxane
Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Package leaflet contents:
- What Cardioxane is and what it is used for
- What you need to know before using Cardioxane
- How Cardioxane is administered
- Possible adverse effects
- Storage of Cardioxane
- Contents of the pack and other information
1. What Cardioxane is and what it is used for
Cardioxane contains the active substance called dexrazoxane, which belongs to a group of medicines that protect the heart (cardioprotective medicines).
This medicine is used to prevent heart damage when medications known as anthracyclines (such as doxorubicin or epirubicin) are used during the treatment of breast cancer in adults.
2. What you need to know before using Cardioxane
Do not administer Cardioxane
- if you are under 18 years of age and the intended dose of anthracycline for you is considered low. Please consult your doctor about this.
- if you are allergic (hypersensitive) to dexrazoxane
- if you are breastfeeding (see also “Pregnancy and breastfeeding”)
- if you are receiving the yellow fever vaccine
If any of these apply to you, you must not be given this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving 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, or heart valve problems.
- if you are pregnant or planning to become pregnant (see also “Pregnancy and breastfeeding”).
- if you are allergic to dexrazoxane.
You should also be aware that:
- Your doctor may perform tests before and during treatment with this medicine to monitor your response to treatment and to check the function of certain organs, such as the heart, kidneys, or liver.
- Your doctor may carry out blood tests during treatment with Cardioxane to monitor the function of your bone marrow. If you are receiving cancer treatment (e.g. chemotherapy or radiation) at high doses and are also being treated with high doses of Cardioxane, 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 leukemia (blood cancer).
- During treatment with Cardioxane, women of childbearing potential and men must use effective contraceptive methods. Women and men should continue using them for at least six months after completing treatment with Cardioxane (see also “Pregnancy and breastfeeding”).
- The combination of Cardioxane with your cancer treatment may increase the risk of blood clots.
- If Cardioxane powder or solution comes into contact with the skin, inform your doctor immediately. You or your doctor should immediately wash the affected area thoroughly with plenty of water.
Children and adolescents
The long-term benefit-risk balance of the medicine in children and adolescents has not yet been established. Your doctor will inform you about the benefit-risk profile of this medicine.
Elderly patients (over 65 years of age)
Your doctor may adjust your treatment with this medicine according to your health status (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 informing your doctor, as interactions may occur between Cardioxane and other medicines:
- Vaccines: you should not use this medicine if you are due to receive the yellow fever vaccine, and it is not recommended to use Cardioxane if you are due to receive a vaccine containing live virus particles.
- Phenytoin, a treatment for seizures.
- Cyclosporine or tacrolimus (both are immunosuppressive treatments used to prevent organ rejection after organ transplantation).
- Myelosuppressive medicines (medicines that reduce the production of red blood cells, white blood cells, or platelets).
Pregnancy and breastfeeding
- Cardioxane will not be administered to you if you are pregnant or planning to become pregnant, unless your doctor considers it necessary.
- Women of childbearing potential and men must use effective contraceptive methods during treatment with Cardioxane and for at least six months after completing treatment with Cardioxane.
- Breastfeeding must be interrupted while receiving treatment with this medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this medicine.
Driving and using machines
Fatigue has been reported during treatment with Cardioxane. Therefore, if you experience drowsiness, do not drive or operate machinery.
3. How Cardioxane is administered
How Cardioxane will be administered to you
This medicine is prepared and administered by a doctor or other healthcare professional. Your doctor will decide the dose you should receive.
- Cardioxane is given as an intravenous infusion (drip) over approximately 15 minutes.
- Administration will begin approximately 30 minutes before your cancer treatment (doxorubicin and/or epirubicin) is given.
If you think you have been given more Cardioxane than you should
If you are given too much Cardioxane, inform your doctor or nurse immediately. You may experience some of the adverse effects listed in section 4, "Possible side effects".
4. Possible adverse effects
Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.
Some adverse effects may be serious and require 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 count, low white blood cell count, low platelet count, and low granulocyte count. However, blood cell levels may return to normal after completing each treatment cycle)
Common (may affect up to 1 in 10 patients):
- Swelling and redness in a vein
Uncommon (may affect up to 1 in 100 patients):
- Leukemia (blood cancer)
- Sudden loss of consciousness
- Swelling and pain in part of the body which may be caused by blood clots in the vein
- Swelling of leg tissue
The following adverse reactions have been reported in very few patients during treatment with Cardioxane:
- Allergic reactions including itching, rash, swelling of the face/throat, wheezing, difficulty breathing, changes in level of consciousness, low blood pressure
- Sudden onset of shortness of breath, coughing up blood, and chest pain (signs of blood clots in the lungs)
If you experience any of the adverse effects described above, inform your doctor immediately or go to the nearest emergency room.
Other adverse 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):
− | Diarrhea, stomach pain, constipation, feeling of fullness in the stomach, and loss of appetite |
− | Reduced heart muscle function, rapid heartbeat |
− | Inflammation, redness, and swelling of mucous membranes in internal passages such as the respiratory or digestive tracts |
− | Nail abnormalities such as black discoloration |
− | Skin reactions at injection site such as swelling, redness, pain, burning sensation, itching |
− | Tingling or numbness in hands or feet, dizziness, headache |
− | Feeling of tiredness, general malaise |
− | Mild fever (febrile state), chest pain, increased heart rate, shortness of |
rapid breathing
- Abnormal liver function tests
Uncommon (may affect up to 1 in 100 patients)
− | Increase in blood cell count |
− | Dizziness, ear infection |
− | Bleeding, tender or swollen gums, oral candidiasis |
− | Thirst |
− | Redness, warmth, and pain due to inflammation beneath the skin |
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet.
You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Cardioxane
Keep this medicine out of the sight and reach of children.
- Do not store above 25°C. Store in the original packaging to protect from light.
- Do not use this medicine after the expiry date stated on the container after EXP.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cardioxane
- The active substance is dexrazoxane (as dexrazoxane hydrochloride).
- Each vial contains 500 mg of dexrazoxane. Cardioxane contains no other ingredients.
Appearance of Cardioxane and contents of the pack
Cardioxane is a white to off-white powder for infusion solution, available in packs of one vial and packs of four vials. Only certain pack sizes may be marketed.
Marketing Authorization Holder
CNX Therapeutics Ireland Limited
5th Floor Rear
Connaught House
1 Burlington Road
Dublin 4
Dublin, Ireland
Manufacturer
Cenexi Laboratoires Thissen S.A.
Rue de la Papyrée 2-4-6
1420 Braine-l’Alleud
Belgium
Date of the most recent review of this summary: 22/08/2017.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es
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THIS INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Cardioxane 500 mg powder for solution for infusion
Dexrazoxane
DOSAGE AND METHOD OF ADMINISTRATION
Cardioxane is administered by short intravenous infusion (15 minutes), approximately 30 minutes before the administration of the anthracycline, at a dose equal to 10 times the doxorubicin equivalent and 10 times the epirubicin equivalent dose.
Therefore, it is recommended to administer Cardioxane at a dose of 500 mg/m² when using the standard doxorubicin dosing regimen of 50 mg/m², or at a dose of 600 mg/m² when using the standard epirubicin dosing regimen of 60 mg/m².
Paediatric population
The safety and efficacy of this medicinal product have not been established in children aged 0 to 18 years.
Cardioxane is contraindicated in children aged 0 to 18 years who are expected 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 impairment (creatinine clearance < 40 ml/min), the dose of dexrazoxane should be reduced by 50%.
Hepatic impairment
The dose ratio should be maintained; that is, if the anthracycline dose is reduced, the dexrazoxane dose should be reduced accordingly.
Elderly patients (over 65 years)
The dose may be adjusted during treatment with Cardioxane according to the patient's health status (in case of heart, liver or kidney problems).
In case of overdose, symptomatic treatment should be administered.
INSTRUCTIONS FOR USE
Recommendations for safe handling
Prescribers should consult national or recognized guidelines on the handling of cytotoxic agents when using Cardioxane. Reconstitution must only be performed by trained personnel in a designated area for cytotoxic drugs. Pregnant individuals must not handle the preparation.
It is recommended to wear gloves and other protective clothing to avoid skin contact. Skin reactions have been reported following contact with Cardioxane. If Cardioxane comes into direct contact with the skin or mucous membranes, the affected area should be washed immediately with plenty of water.
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 dissolve within a few minutes with gentle agitation. The resulting solution has a pH of approximately 1.6. This solution must 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 before infusion with one of the solutions listed in Table 1. The final volume should be proportional to the number of Cardioxane vials used and the volume of infusion solution for dilution, which may range from 25 ml to 100 ml per vial.
The following table (Table 1) summarizes the final volume and approximate pH of the reconstituted and diluted product from one vial and four vials of Cardioxane. The minimum and maximum volumes of infusion solution to be used per vial are indicated in Table 1.
Table 1. Reconstitution and dilution of Cardioxane vials
Infusion solution used for dilution | Volume of liquid used to dilute one reconstituted vial of Cardioxane | Final volume from one vial | Final volume from four vials | pH (approximate) |
Lactated Ringer's | 25 ml 100 ml | 50 ml 125 ml | 200 ml 500 ml | 2.2 3.3 |
Sodium lactate 0.16M* | 25 ml 100 ml | 50 ml 125 ml | 200 ml 500 ml | 2.9 4.2 |
- Sodium lactate 11.2% must be diluted by a factor of 6 to achieve a concentration of 0.16 M.
To increase the pH of the solution, it is generally recommended to use larger dilution volumes (with a maximum of 100 ml of additional infusion fluid for each 25 ml of reconstituted Cardioxane). Smaller volumes may be used if necessary (with a minimum of 25 ml of additional infusion fluid for each 25 ml of reconstituted Cardioxane), depending on the patient's hemodynamic status.
The reconstituted and diluted Cardioxane solution is for single use only. Once the product has been diluted, it must be used immediately or within four hours thereafter, provided it is stored at a temperature between 2°C and 8°C and protected from light.
Where possible and permitted by the solution and its container, parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Cardioxane usually appears as a colorless to yellow solution immediately after reconstitution; however, some variation in color may occur over time, which does not indicate loss of activity as long as the product has been stored according to the recommended storage conditions. Nevertheless, the product should be discarded if it is not colorless or yellow immediately after reconstitution.
Incompatibilities
Cardioxane must not be mixed with other medicinal products except for the dilution solutions mentioned above.
Storage
Do not use Cardioxane after the expiry date stated on the container.
Before opening
Do not store above 25°C. Keep in the original packaging to protect from light.
After reconstitution and dilution
The diluted Cardioxane solution is physically and chemically stable for 4 hours at 25°C.
From a microbiological standpoint, the freshly prepared infusion solution should be used immediately. Otherwise, responsibility for the storage duration and conditions prior to administration lies with the user, and under no circumstances should storage exceed 4 hours at a temperature between 2°C and 8°C (in the refrigerator), with protection from light.
Disposal
Disposal of the used medicine and materials that have been in contact with it must be carried out in accordance with local regulations. Care and caution must be exercised when discarding items used to reconstitute and dilute Cardioxane.