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Farmorubicin CS 50 mg solution

Active ingredientAddictive drugPsychotropic
EpirubicinNoNo
Pharmacological groupCytotoxic antibiotics and related substances

All information

What is it and what is it used for?

WHAT FARMORUBICIN CS 50 MG SOLUTION IS AND WHAT IT IS USED FOR?
Farmorubicin CS 50 mg solution is a cytostatically effective antibiotic of the anthracycline group.
Farmorubicin CS 50 mg solution is used for


Farmorubicin CS 50 mg solution must not be used in
- Pronounced bone marrow depression (e.g. after pretreatment with chemotherapy and / or radiation therapy),
- pronounced inflammation of the mucous membranes in the mouth and / or gastrointestinal tract
Area,
- acute systemic infections,
- pronounced impairment of liver function,
- Cardiac muscle weakness (muscular heart failure) grade IV (rest failure),
- acute myocardial infarction and past myocardial infarction which has led to cardiac insufficiency (muscular heart failure) grade III and IV,
- heart muscle diseases (cardiomyopathy),
- acute inflammatory heart disease,
- unstable angina pectoris,
- Pronounced arrhythmias with serious effects on the cardiovascular system
Functions (hemodynamics), also in the past,
- previous treatment with epirubicin, other anthracyclines or anthracenediones up to the maximum cumulative dose,
- Hypersensitivity to epirubicin, other components of the drug, other anthracyclines or anthracenediones,
- and if you are breastfeeding.
Farmorubicin CS 50 mg solution must not be administered orally, subcutaneously, intramuscularly or intrathecally.

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What do you need to consider before use?

Special care is required when using Farmorubicin CS 50 mg solution
While treatment with high doses of epirubicin (e.g.? 90 mg / m2 every 3 to 4 weeks) generally leads to side effects similar to those of the standard doses (e.g. <90 mg / m2 every 3 to 4 weeks) leads, the manifestations of neutropenia and stomatitis / mucositis can be increased. Therapy with high doses of epirubicin therefore requires special control with regard to possible clinical complications of pronounced myelosuppression.
Cardiac function
Cardiotoxicity poses a risk of anthracycline treatment. This can manifest itself in early (e.g. acute) or late (e.g. delayed) events.
Early events (immediate type): Early cardiotoxic events of epirubicin are mainly sinus tachycardia and / or EKG changes such as non-specific ST segment changes. Tachyarrhythmias (including premature ventricular contractions, ventricular tachycardia, and bradycardia) as well as atrioventricular and bundle branch block have also been observed. These phenomena do not necessarily lead to the development of delayed cardiotoxicity, they are seldom clinically relevant, and usually not a reason to consider discontinuing epirubicin therapy.
Late events (delayed type): Delayed cardiotoxic events usually develop later during treatment with epirubicin or within 2 to 3 months of stopping therapy. However, later events (several months to years after the end of therapy) have also been reported. Delayed cardiomyopathy manifests itself in the form of a reduced left ventricular ejection fraction (LVEF) and / or as symptoms of decompensated heart failure such as dyspnoea, pulmonary edema, edema of the extremities, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion and gallop rhythm. Life-threatening decompensated heart failure is the most severe form of anthracycline-induced cardiomyopathy and represents the drug's dose-limiting, cumulative toxicity.
The risk of congestive heart failure increases rapidly with a total cumulative dose of epirubicin above 900 mg / m2. This total dose should only be exceeded with great caution.
Cardiac function must be monitored (ECG, radionuclide angiography or echocardiography (to determine the LVEF)) before starting therapy, during and after the end of therapy in order to reduce the risk of severe cardiac disorders. This is especially true for patients with risk factors for increased toxicity or with increased cumulative anthracycline doses. Regular monitoring of the LVEF and immediate discontinuation of therapy with epirubicin when the first signs of impaired organ function appear can reduce the risk of cardiac disorders.
In view of the risk of cardiomyopathy, a total cumulative epirubicin dose of 900 mg / m2 should only be exceeded with great caution.
Active or silent cardiovascular diseases, planned or currently ongoing radiation therapy in the area of ​​the mediastinum or pericardium, previous therapies with other anthracyclines or anthracenediones, as well as simultaneous treatment with drugs that can reduce cardiac contractibility or with cardiotoxic substances (e.g. B. trastuzumab) represent risk factors for cardiotoxicity. Depending on the presence of these risk factors, the cardiotoxicity of epirubicin can occur even at lower cumulative total doses.
The toxicity of epirubicin and other anthracyclines or anthracenediones is likely additive.
Haematological toxicity
Like other cytotoxic substances, epirubicin can lead to myelosuppression. Checks of the blood count (especially white blood cells, platelets, erythrocytes) are required before and during each treatment cycle. Dose-related, reversible leukopenia and / or granulocytopenia (neutropenia) is the predominant manifestation of the haematological toxicity of epirubicin and the most common acute dose-limiting toxicity of this drug. Leukopenia and neutropenia are usually more severe on high-dose regimens and reach the nadir in most cases between the 10th and 14th day after drug administration. This is usually temporary, with the white blood count / neutrophil count returning to normal by day 21 in most cases. Thrombopenia and anemia can also occur. Clinical consequences of severe myelosuppression include fever, infection, sepsis / septicemia, septic shock, hemorrhage, tissue hypoxia, or death.
Secondary leukemia
Secondary leukemia with or without a pre-leukemic phase has been reported in patients treated with anthracyclines including epirubicin. Secondary leukemia occurs more frequently when these substances are used together with DNA-damaging antineoplastic agents or with radiation, in patients who have been previously treated with high doses of cytostatics or when the dose of the anthracycline has been increased. These leukemias have a latency period of 1 to 3 years.
Gastrointestinal tract
Epirubicin causes vomiting. Mucositis / stomatitis occur soon after application and, if severe, can develop into mucosal ulcers within a few days. Most patients recover from this side effect by the third week of therapy.
Liver function
Epirubicin is largely eliminated through the hepatobiliary system. Total bilirubin and AST levels should be monitored prior to and during treatment with epirubicin. Clearance may be delayed in patients with elevated bilirubin or AST levels, resulting in increased overall toxicity. Lower doses are recommended in these patients. Epirubicin should not be given to patients with severely impaired liver function.
Kidney function
Serum creatinine should be checked before and during treatment with epirubicin. Dose adjustments must be made in patients with serum creatinine> 5 mg / dl.
Effects at the injection site
Phlebosclerosis (venous sclerosis) can occur from injection into a small vessel or from repeated injections into the same vein. By carefully following the recommended directions for use, the risk of phlebitis / thrombophlebitis at the injection site can be reduced.
Extravasation
Extravasation of epirubicin during intravenous administration can lead to local pain, severe tissue damage (vesication, severe cellulitis) and necrosis. If symptoms of extravasation occur during intravenous administration of epirubicin, the infusion must be stopped immediately. The patient's pain can be reduced by cooling the affected skin area for 24 hours. The patient should then be closely monitored, as necrosis can occur even after several weeks.
If extravasation occurs, a plastic surgeon should be consulted because of possible excision.
miscellaneous
Thrombophlebitis and thromboembolic phenomena including pulmonary embolism (in some cases fatal), as with other cytotoxic substances, have been reported with epirubicin therapy.
Tumor lysis syndrome
Because of the extensive purine catabolism with rapid, drug-induced lysis of neoplastic cells (tumor lysis syndrome), epirubicin can lead to hyperuricemia. After starting treatment, uric acid, potassium, calcium phosphate, and creatinine levels should be checked. Hydration, alkalinization of the urine, and prophylactic administration of allopurinol to avoid hyperuricemia can reduce the risk of potential complications of tumor lysis syndrome.
Immunosuppressive effects / increased susceptibility to infections
Giving live vaccine or live attenuated vaccine to patients who are immunocompromised by chemotherapy drugs, including epirubicin, can result in serious or fatal infections.
Genital organs
Epirubicin can be genotoxic. Men and women should use effective contraception during treatment with eprubicin. After the end of therapy, genetic counseling should be given in patients who wish to have children, if necessary and if available.
Chemical incompatibilities (incompatibilities)
Because of chemical incompatibility, Farmorubicin CS 50 mg solution should not be mixed with heparin. If Farmorubicin CS 50 mg solution is administered in combination with other cytostatics, no direct mixture should occur.
Farmorubicin CS 50 mg solution should also not be brought into contact with an alkaline solution (hydrolysis).
When using Farmorubicin CS 50 mg solution with other medicinal products
Since epirubicin is mostly used as part of a combination therapy with other cytostatics, the overall toxicity, especially with regard to bone marrow damage and damage to the gastrointestinal tract, can increase.
The simultaneous use of epirubicin and other cardiotoxic substances (e.g. 5-fluorouracil, cyclophosphamide, cisplatin, taxanes) or radiation therapy of the mediastinum increases the cardiotoxicity of epirubicin. Therefore, here, as well as with the simultaneous use of other cardioactive substances (e.g. calcium channel blockers), particularly careful monitoring of the cardiac function is required during the entire therapy.
Even patients who only receive anthracyclines after completing therapy with other cardiotoxic substances, especially those with a long half-life (e.g. trastuzumab), may be at an increased risk of cardiotoxic symptoms. The half-life of trastuzumab is around 28.5 days and the substance can remain in the body for up to 24 weeks. Therefore, if possible, anthracycline therapy should be avoided for up to 24 weeks after stopping trastuzumab. If anthracyclines are used before this time, close monitoring of cardiac function is recommended.
In the case of (pre-) treatment with drugs that affect the bone marrow function (e.g. cytostatics, sulfonamides, chloramphenicol; diphenylhydantoin, amidopyrine derivatives, antiretroviral drugs), the possibility of pronounced hematopoiesis disorders must be taken into account. The dosage of epirubicin should be modified if necessary. When combined with other cytostatics (e.g. cytarabine, cisplatin, cyclophosphamide), the toxic effects of epirubicin therapy can be intensified.
Epirubicin is mainly metabolized in the liver; any concomitant medication that affects liver function may also affect the metabolism or pharmacokinetics of epirubicin and, consequently, its efficacy and / or toxicity.
The combination of epirubicin with potentially hepatotoxic drugs can lead to an increase in the toxicity of the substance if the hepatic metabolism and / or biliary excretion of epirubicin is impaired. This can increase the side effects.
The simultaneous use of other cytotoxic drugs increases the risk of gastrointestinal side effects.
Medicines that delay the excretion of uric acid (e.g. sulphonamides, certain diuretics) can lead to increased hyperuricaemia if epirubicin is used at the same time.
Epirubicin binds to heparin; precipitation and loss of effectiveness of both active ingredients can occur.
Concomitant use of verapamil reduces the systemic availability of epirubicin by increasing its clearance. This leads to an increased systemic availability of the epirubicin metabolites. Dexverapamil can alter the pharmacokinetics of epirubicin and possibly increase its bone marrow-suppressing effect.
Cimetidine increases the AUC ("area under the curve") of epirubicin by 50%. For this reason, treatment with cimetidine should be interrupted during treatment with epirubicin hydrochloride.
If paclitaxel is administered prior to administration of epirubicin, it can cause increased plasma concentrations of unchanged epirubicin and its metabolites. However, the metabolites are neither toxic nor pharmacologically active. Concomitant administration of paclitaxel or docetaxel did not affect the pharmacokinetics of epirubicin when the taxane was administered after the anthracycline.
This combination can be used if the two active ingredients are administered staggered (at least 24 hours).
Patients receiving eprubicin should not be vaccinated with a live vaccine. Vaccines that have been killed or inactivated can be administered - but the success of the vaccination may be reduced.
One study showed that docetaxel can increase plasma concentrations of the metabolites of epirubicin when administered immediately after epirubicin.
Quinine can accelerate the initial distribution of epirubicin from the blood into the body tissue and influence the distribution of epirubicin to the red blood cells.
Simultaneous administration of interferon-alpha-2b can reduce both the terminal half-life and the overall clearance of epirubicin.
Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
pregnancy and breast feeding period
Ask your doctor or pharmacist for advice before taking / using any medicine.
Farmorubicin CS 50 mg solution can cause birth defects in the child if it is used during pregnancy. It is very important to tell your doctor if you are pregnant or become pregnant during treatment. You must not use Farmorubicin CS 50 mg, solution during pregnancy unless your doctor has instructed you to do so.
If you or your partner are treated with Farmorubicin CS 50 mg solution, effective contraception must be used during treatment and for 6 months after it has ended. Genetic counseling is recommended if pregnancy occurs during treatment.
Treatment with Farmorubicin CS 50 mg solution can cause infertility. Male patients should therefore consider preserving semen prior to treatment with Farmorubicin CS 50 mg solution.
Farmorubicin CS 50 mg solution can harm a breastfed child, therefore breastfeeding must be stopped before starting treatment with Farmorubicin CS 50 mg solution.
In pre-menopausal women, epirubicin can cause amenorrhea and premature menopause.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.

How is it used?

HOW TO USE Farmorubicin CS 50 mg, solution?
Treatment should only be carried out by doctors who are experienced in tumor treatment, in a clinic or in collaboration with a clinic.In particular, the dose-intensified treatment requires close monitoring of the patient because of possible complications due to the severe bone marrow depression. The application is to be carried out strictly according to the regulations.
The following recommendations apply:
1. Conventional dosage
Interval therapy with epirubicin hydrochloride 75 to 90 mg / m body surface area as a single dose every third week.
2. Polychemotherapy
If Farmorubicin CS 50 mg solution is used in combination with other cytostatics, the dose should be adjusted to the toxicity of the other cytostatics.
A dose reduction (60 to 75 mg / m or 105 to 120 mg / m for dose-intensified regimens) or longer intervals between treatment cycles may be necessary in the treatment of very old patients, in patients with neoplastic bone marrow infiltration and in patients whose bone marrow function is impaired previous chemotherapy or radiation therapy has already been damaged.
In addition, in the case of a palliative treatment concept to reduce side effects or in patients for whom epirubicin hydrochloride cannot be administered in the above-mentioned dosage for medical reasons, the following dosage can be used:
- weekly administration of 20 to 30 mg / m body surface.
type of application
Before use, the injection solution must be checked to ensure that it is free from particles. Injection solutions that contain particles must not be used and must be disposed of in accordance with the disposal regulations for cytostatics.
Instructions for use and handling
Farmorubicin CS 50 mg solution is a ready-to-use solution and has a pH of 3.0. Farmorubicin CS 50 mg solution should be brought to room temperature before administration.
Farmorubicin CS 50 mg solution does not contain any preservatives and is therefore not intended for multiple use.
Protective clothing must be worn when handling Farmorubicin CS 50 mg solution. If Farmorubicin CS 50 mg solution comes into contact with the skin or mucous membrane, careful washing with soap and water is recommended.
However, a hand brush should not be used to avoid additional mechanical damage to the skin.
In case of contact with skin or eyes, rinse thoroughly with water or with soap and water or with sodium bicarbonate solution and consult a doctor.
The recommendations? Safe handling of cytostatics in leaflet M 620 of the professional association for health and welfare services should be observed.
Intravenous application
Farmorubicin CS 50 mg solution is administered intravenously.
Accidental intra-arterial or paravenous application of Farmorubicin CS 50 mg solution must be ruled out with systemic administration.
Farmorubicin CS 50 mg solution must not be administered orally, subcutaneously, intramuscularly or intrathecally!
Since extravascular injections of epirubicin can cause serious tissue damage and also necrosis, it is recommended that the drug be preferably put into the tube of an ongoing i.v. v. infusion with 0.9% sodium chloride solution. To check the correct position of the infusion needle, a few ml of an infusion solution (e.g. 0.9% NaCl solution) are administered beforehand. The total amount of Farmorubicin CS 50 mg solution is i. v. administered. Venous sclerosis can be caused by injections into veins that are too small or repeated injections into the same vein. After the administration, the vein is flushed with the rest of the infusion solution.
Duration of application
The duration of the application depends on the treatment protocol. There is no time limit for the application.
The duration of the treatment is limited by reaching the cumulative maximum dose (900 mg / m2 BSA).
Please talk to your doctor or pharmacist if you have the impression that the effect of Farmorubicin CS 50 mg solution is too strong or too weak.
If more Farmorubicin CS 50 mg solution is used than intended
Signs of overdose
Very high single doses of Farmorubicin CS 50 mg solution can cause heart muscle weakness (acute myocardial degeneration) within 24 hours and severe bone marrow depression within 10 to 14 days.
Acute overdose can lead to toxic gastrointestinal symptoms (especially mucositis) and acute complications of the cardiovascular system.
In the event of overdose, subsequent heart failure has been observed up to 6 months after treatment with anthracyclines.
Treatment of overdose
If symptoms of poisoning occur, the application of epirubicin should be stopped immediately and symptomatic therapy initiated.
In the event of cardiac involvement, a cardiologist should be consulted.
If the myelosuppression is pronounced, substituting the missing blood components and moving the patient to a sterile room should be considered.
Epirubicin is not effectively dialyzable in vivo.
A specific antidote is not known.
Extravasation
A paravenous incorrect injection leads to local necrosis and thrombophlebitis. If a burning sensation develops in the area of ​​the infusion needle, this indicates a paravenous application.
Therapy of extravasation
If extravasation has occurred, the infusion or injection must be stopped immediately; the cannula should be left in place for the time being so that it can be removed after a brief aspiration. It is recommended to apply dimethyl sulfoxide (DMSO) 99% locally over an area twice the size of the affected area (4 drops on 10 cm of skin surface) and to repeat this three times a day over a period of at least 14 days. If necessary, debridement should be considered. Because of the opposite mechanism, cooling of the area, e.g. B. to reduce pain, take place sequentially with the DMSO application (vasoconstriction vs. vasodilation). Other measures are controversial in the literature and of ambiguous value.
If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, Farmorubicin CS 50 mg solution can cause side effects, although not everybody gets them.
The frequency of side effects is based on the following categories:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data
Investigations
Rare: changes in transaminase levels
Unknown: asymptomatic decrease in left ventricular ejection fraction
Heart disease
Rare: decompensated heart failure (dyspnoea, edema, enlarged liver, ascites, pulmonary edema, pleural effusions, gallop rhythm), cardiotoxicity (e.g. EKG changes, arrhythmias, cardiomyopathy), ventricular tachycardia, bradycardia, AV block, bundle branch blocks
Blood and lymphatic system disorders
Very common: myelosuppression (leukopenia, granulocytopenia and neutropenia, anemia, febrile neutropenia
Uncommon: thrombocytopenia
Unknown: haemorrhages and tissue hypoxia as a result of myelosuppression
Nervous system disorders
Rare: dizziness
Eye diseases
Unknown: conjunctivitis, keratitis
Gastrointestinal disorders
Common: mucositis, esophagitis and stomatitis, which can be manifested by pain, burning sensation, erosion, ulceration and bleeding; Abdominal pain, vomiting, diarrhea, nausea
Unknown: hyperpigmentation of the oral mucosa
Kidney and urinary tract disorders
Very common: urine turns red for 1 to 2 days after administration
Skin and subcutaneous tissue disorders
Very common: alopecia
Rare: urticaria
Unknown: Local reactions, redness, itching, skin changes, erythema, flush, hyperpigmentation of the skin and nails, light sensitivity, hypersensitivity to radiation (recall phenomenon)
Metabolism and nutrition disorders
Common: loss of appetite, dehydration
Rare: hyperuricemia (due to rapid lysis of neoplastic cells (tumor lysis syndrome))
Infections and parasitic diseases
Very common: infections
Unknown: pneumonia, sepsis, septic shock
Neoplasms benign, malignant, and unspecified (including cysts and polyps)
Rare: acute lymphoblastic leukemia, acute myeloid leukemia
Vascular diseases
Common: hot flashes
Uncommon: phlebitis, thrombophlebitis
Unknown: shock, thromboembolic events (including pulmonary embolism (in individual cases fatal))
General disorders and administration site conditions
Common: redness along the infusion vein
Rare: malaise, weakness, fever, chills
Unknown: phlebosclerosis, headache, local pain, severe cellulitis and tissue necrosis after accidental paravenous injection
Immune system disorders
Rare: anaphylactic / anaphylactoid reactions (including rash, itching, fever, chills)
Unknown: anaphylactic shock
Reproductive system and breast disorders
Rare: amenorrhea, azoospermia
Unknown: premature menopause in premenopausal women
Please inform your doctor or pharmacist if you become seriously affected by any of the side effects listed, or if you notice any side effects not listed in this leaflet.

How should it be stored?

Store drug out of reach of children.
According to the? Use by? On the outer carton and on the label, the medicinal product may be used. specified expiry date can no longer be used. The expiry date refers to the last day of the month.
Storage conditions
Storage must take place at +2 ° C to +8 ° C. The solution can take on a gel-like consistency. After 2 to a maximum of 4 hours at room temperature (15 ° C to 25 ° C), the solution regains its original viscosity.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

additional Information

What Farmorubicin CS 50 mg solution contains
The active substance is epirubicin hydrochloride. 1 vial of Farmorubicin CS 50 mg solution with 25 ml solution for injection contains 50 mg epirubicin hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid 1.8%, water for injections.
What Farmorubicin CS 50 mg solution looks like and contents of the pack
Farmorubicin CS 50 mg solution is a red solution for injection in polypropylene vials. It is available in packs with 1 (N1) and 6 (N1) vial (s) of 25 ml with 50 mg epirubicin hydrochloride and as a clinical pack with 10 (10 x 1) vials of 25 ml with 50 mg epirubicin hydrochloride.
Pharmaceutic entrepreneur
PHARMACIA GmbH
Linkstrasse 10
10785 Berlin
Tel .: 030 550055-51000
Fax: 030 550054-10000
Manufacturer
Pfizer Service Company bvba
Hoge Wei 10
1930 Zaventem
Belgium
Co-Distributor
PFIZER PHARMA GmbH
Linkstrasse 10
10785 Berlin
Tel .: 030 550055-51000
Fax: 030 550054-10000
This leaflet was last revised in August 2011.
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