In Treatment of:
Epirubicin is used in combination with other medications to treat breast cancer in patients who have had surgery to remove the tumor. Epirubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body.
Epirubicin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
3. sores in the mouth and throat
4. Stomach pain
6. loss of appetite or weight
7. unusual tiredness or weakness
8. Hair loss
9. hot flashes
10. red discoloration of urine (for 1 to 2 days after dose)
11. sore or red eyes
12. eye pain
13. darkening of the skin or nails
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
1. pale skin
7. difficulty breathing or swallowing
Epirubicin is contraindicated in:
1. Patients who have demonstrated hypersensitivity to epirubicin or to any of the excipients, and/or other anthracyclines or anthracenediones
For Intravenous use, epirubicin is contraindicated in:
1. Patients with persistent myelosuppression or myelosuppression induced by previous treatment with either other anti-neoplastic agents or radiotherapy
2. Patients with severe hepatic impairment
3. Patients previously treated with maximum cumulative doses of epirubicin and/or other anthracyclines (doxorubicin or daunorubicin) and anthracenediones (see section 4.4)
4. Patients with current or previous history of cardiac impairment such as those who exhibit severe arrhythmias, severe myocardial insufficiency, recent myocardial infarction, myocardiopathy and patients with unstable angina pectoris
5. Patients with acute systemic infections
6. For Intravesical use, epirubicin is contraindicated in:
7. Patients with urinary tract infections
8. Patients with inflammation of the bladder
9. Patients who have invasive tumours penetrating the bladder
10. Patients with catheterisation problems
Before receiving epirubicin injection,
1. tell your doctor and pharmacist if you are allergic to epirubicin, daunorubicin (Cerubidine, DaunoXome), doxorubicin (Doxil), idarubicin (Idamycin), any other medications, or any of the ingredients in epirubicin injection. Ask your pharmacist for a list of the ingredients.
2. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan); certain chemotherapy medications such as docetaxel (Taxotere) or paclitaxel (Abraxane, Onxol); or cimetidine (Tagamet). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Other medications may also interact with epirubicin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
3. tell your doctor if you previously received radiation therapy or have or have ever had liver or kidney disease.
4. you should know that epirubicin may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin receiving this drug. You should not become pregnant or breast-feed while you are receiving epirubicin injection. If you become pregnant while receiving epirubicin, call your doctor. Talk to your doctor about birth control methods to use during your treatment. Epirubicin may harm the fetus.
5. do not have any vaccinations without talking to your doctor.
It is not recommended that Epirubicin Hydrochloride 2 mg/ml Injection be mixed with other medicinal products.
Epirubicin can be used in combination with other anti-cancer agents but patients should be monitored for additive toxicity. Additive toxicity may occur especially with regard to bone marrow/haematologic and gastro-intestinal effects (see section 4.4). The use of epirubicin in combination chemotherapy with other potentially cardiotoxic drugs, as well as the concomitant use of other cardioactive compounds (e.g., calcium channel blockers), requires monitoring of cardiac function throughout treatment.
Epirubicin is extensively metabolised by the liver. Changes in hepatic function induced by concomitant therapies may affect epirubicin metabolism, pharmacokinetics, therapeutic efficacy and/or toxicity (see section 4.4).
Anthracyclines including epirubicin should not be administered in combination with other cardiotoxic agents unless the patient's cardiac function is closely monitored. Patients receiving anthracyclines after discontinuing treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at high risk of developing cardiotoxicity. The half-life of trastuzumab is approximately 28.5 days and may persist in the circulation for up to 24 weeks. Therefore, physicians should avoid anthracycline-based therapy for up to 24 weeks after discontinuing trastuzumab. If anthracyclines are used before this length of time, careful monitoring of cardiac function is recommended.
Vaccination with a live vaccine should be avoided in patients receiving epirubicin. Killed or inactivated vaccines may be administered, however, the response to such vaccines may be diminished.
Drug interactions with epirubicin have been observed with cimetidine, dexverapamil, dexrazoxane, docetaxel, interferon alfa-2b, paclitaxel and quinine.
Cimetidine 400 mg b.i.d given prior to epirubicin 100 mg/m2 every 3 weeks led to a 50% increase in epirubicin AUC and a 41% increase in epirubicinol AUC (latter p<0.05). The AUC of the 7-deoxy-doxorubicinol aglycone and liver blood flow were not reduced, so results are not explained by reduced cytochrome P-450 activity. Cimetidine should be discontinued during treatment with epirubicin.
When given prior to epirubicin, paclitaxel can cause increased plasma concentrations of unchanged epirubicin and its metabolites, the latter being, however, neither toxic nor active.
Co-administration of paclitaxel or docetaxel did not affect the pharmacokinetics of epirubicin when epirubicin was administered prior to the taxane. In one study, haematological toxicity was greater when paclitaxel was administered before epirubicin compared with after epirubicin.
This combination may be used if using staggered administration between the two agents. Infusion of epirubicin and paclitaxel should be performed with at least a 24 hour interval between the 2 agents.
Dexverapamil may alter the pharmacokinetics of epirubicin and possibly increase its bone marrow depressant effects.
One study found that docetaxel may increase the plasma concentrations of epirubicin metabolites when administered immediately following epirubicin.
Quinine may accelerate the initial distribution of epirubicin from blood into the tissues and may have an influence on the red blood cells partitioning of epirubicin.
The co-administration of interferon alfa-2b may cause a reduction in both the terminal elimination half-life and the total clearance of epirubicin.
The possibility of a marked disturbance of haematopoiesis needs to be kept in mind with a (pre) treatment with medications which influences the bone marrow (i.e. cytostatic agents, sulphonamide, chloramphenicol, diphenylhydantoin, amidopyrine-derivate and antiretroviral agents).
Epirubicin comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a medical facility along with other chemotherapy medications. It may be injected once every 21 days for 6 cycles of therapy or it may be injected twice (on days 1 and 8) every 28 days for six cycles of therapy.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.