Medicinal Products

EPIRUBICIN TEVA CLASSICS 2 mg / mL

Generic drug of Farmorubicin
Therapeutic class: Oncology and hematology
active ingredients: [Epirubicin hydrochloride, ]
laboratory: Teva Sante

Solution for injection or infusion
Box of 1 bottle (glass) of 10 ml
All forms

Indication

Epirubicin is used in the treatment of certain neoplasias, including:

· Carcinoma of the breast,

· Carcinoma of the stomach.

In intravesical administration, epirubicin has been shown to be beneficial in the treatment of:

· Transitional papillary carcinoma of the bladder,

· Carcinoma in situ,

· And for intravesical prophylaxis of the recurrence of superficial bladder carcinoma after transurethral resection.

Epirubicin hydrochloride 2 mg / ml may be used in multidrug regimens.

For intravesical use the positive benefit-risk ratio can be established only in patients for whom live BCG is contraindicated or inappropriate.

Dosage EPIRUBICINE TEVA CLASSICS 2 mg / mL Solution for injection or infusion Box of 1 vial (glass) 10 ml

Epirubicin is exclusively for intravenous or intravesical use.

Intravenous use

It is recommended to inject the red solution, which should be clear and transparent, into the tubing of an intravenous infusion of physiological saline or 5% glucose by slow injection over a maximum of 30 minutes (depending on the dose and the infusion volume). The needle should be properly placed in the vein. This method reduces the risk of thrombosis and extravasation that can lead to severe phlegmon and necrosis. In case of extravasation, stop the administration immediately. Injection into a small vein and repeated injection into the same vein may produce venous sclerosis.

Usual dose

In monotherapy, the recommended dose for adults is 60-90 mg / m² body surface area. Epirubicin should be injected intravenously in 3-5 minutes. The same dose is given 21 days later.

The hematological and medullary status of the patient should be taken into account in setting the timing of administration.

If signs of toxicity occur, including neutropenia / neutropenic fever and thrombocytopenia (may persist at day 21), it may be necessary to change the dose or delay the next dose.

High dose

In the treatment of breast carcinoma, epirubicin monotherapy at high dose should be administered according to the following scheme:

For high-dose treatment, epirubicin can be administered as an intravenous bolus in 3-5 minutes or as an infusion lasting up to 30 minutes.

Breast carcinoma

For adjuvant treatment of patients with early breast cancer and positive lymph nodes, intravenous doses of epirubicin 100 mg / m 2 (single dose on day 1) to 120 mg / m 2 (in two divided doses, Days 1 and 8) every 3-4 weeks are recommended in combination with intravenous cyclophosphamide and 5-fluorouracil and oral tamoxifen.

It is recommended to use a lower dose (60-75 mg / m² for usual treatment and 105 - 120 mg / m² for high dose) or to delay the next dose for patients with a reduction in bone marrow function due to previous chemotherapy or radiotherapy due to age or neoplastic infiltration of the bone marrow. The full dose per cycle can be administered in 2 - 3 consecutive days.

The following doses of epirubicin are commonly used as monotherapy and combination therapy for various tumors, as indicated:

Cancer

Epirubicin dose (mg / m²) *

monotherapy

Association treatment

Stomach cancer

60 - 90

50

Bladder cancer

50 mg / 50 ml or 80 mg / 50 ml

(carcinoma in situ )

Prophylaxis: 50 mg / 50 ml per week for 4 weeks then per month for 11 months

* Doses are usually given on day 1 or days 1, 2 and 3 at 21 days apart.

Association chemotherapy

When epirubicin hydrochloride 2 mg / ml is used in combination with other antitumor agents, the dose is reduced accordingly. The commonly used doses are shown in the table above.

Groups of individual patients

Elderly

In elderly patients, it is recommended to reduce the dose.

Child

The safety and effectiveness of epirubicin have not been established in children.

Hepatic insufficiency

Epirubicin is excreted mainly by the liver. In patients with impaired liver function, the dose should be reduced as follows to avoid an increase in systemic toxicity:

Serum bilirubin

AST (aspartate aminotransferase)

Dose reduction

1.4 - 3 mg / 100 ml

2 - 4 times the upper normal limit

50% dose reduction

> 3 mg / 100 ml

> 4 times the normal limit

75% dose reduction

Renal failure

Moderate renal impairment does not require dose reduction, given the small amount of epirubicin excreted renally. However, a dose reduction is recommended for patients with severe renal impairment (serum creatinine> 450 μmol / l).

Intravesical use

See also the Instructions for Use, Handling and Disposal Instructions for Product Dilution Instructions.

Epirubicin can be administered intravesically for the treatment of superficial bladder carcinoma, carcinoma in situ and prophylaxis to prevent recurrence after transurethral resection. It should not be administered intravesically for the treatment of invasive tumors that have entered the vesicular wall, as systemic treatment or surgery is more appropriate for these cases.

Various administration schemes are used. Guidelines that can be used:

Superficial bladder carcinoma: Weekly bladder lavage with 50 mg / 50 ml (dilution with physiological saline or sterile water) for 8 weeks. A dose reduction of 30 mg per 50 ml is recommended in case of local toxicity (chemical cystitis).

Carcinoma in situ: up to 80 mg / 50 ml (depending on the patient's tolerance).

Prophylaxis of recurrence after transurethral resection: 4 weekly administrations of 50 mg / 50 ml followed by 11 monthly instillations of the same dose.

DILUTION TABLE FOR SOLUTIONS FOR VESIC INSTILLATION

Required epirubicin dose

Volume of epirubicin injection at 2 mg / ml

Thinner volume, sterile water for injection or sterile 0.9% saline solution

Total volume for bladder instillation

30 mg

15 ml

35 ml

50 ml

50 mg

25 ml

25 ml

50 ml

80 mg

40 ml

10 ml

50 ml

The solution should be kept in the bladder for 1 - 2 hours. To avoid excessive dilution in urine, the patient should be advised not to drink anything within 12 hours of instillation. During instillation, the patient should turn around occasionally; it should also be told to urinate at the end of the instillation period.

Against indications

· Hypersensitivity to epirubicin, other anthracyclines and / or anthracenediones or to any of the excipients.

· Breastfeeding

Intravenous way

· Persistent medullary depression.

· Severe liver failure.

· Severe myocardial insufficiency (including: Grade 4 heart failure, acute heart attack and history of heart attack resulting in grade 3 and 4 heart failure, acute inflammatory heart disease).

· Recent myocardial infarction.

· Severe arrhythmias.

· Earlier treatments with maximum cumulative doses of epirubicin and / or other anthracyclines and anthracenediones (see Warnings and Precautions ) section.

· Patients with acute systemic infections.

· Angina pectoris unstable.

· Cardiomyopathy.

Intravesical pathway

· Urinary tract infections.

· Inflammation of the bladder.

· Hematuria.

· Invasive tumors entering the bladder.

· Catheterization problems.

· Large residual urine volume.

· Contractions of the bladder.

Adverse effects Epirubicin Teva Classics

The following side effects have been observed and reported during treatment with epirubicin at the following frequencies. Very common (≥ 1/10) frequent (≥ 1/100 and <1/10); uncommon (≥ 1/1000 and ≤ 1/100); rare (≥ 1/10 000 and </ 1 000); very rare (</ 10 000), unknown frequency (can not be determined based on available data)

More than 10% of treated patients should expect to develop side effects. The most common side effects are bone marrow depression, side effects on the gastrointestinal system, anorexia, alopecia and infection.

Classes of organ systems

Frequency

Side effects

Infections and infestations

· Frequent

· Infection.

· Frequency unknown

· Septic shock (may occur due to bone marrow depression), sepsis, pneumonia.

Benign, malignant and unspecified neoplasia (including cysts and polyps)

· Rare

· Acute lymphocytic leukemia, acute myeloid leukemia with or without a pre-leukemic phase, in patients treated with epirubicin combined with antineoplastic agents that damage DNA. These leukemias have a short latency (1-3 years).

Blood and lymphatic system disorders

· Very common

· Medullary depression (leukopenia, granulocytopenia and neutropenia, anemia and febrile neutropenia).

· Rare

· Thrombocytopenia.

· Frequency unknown

· Haemorrhage and tissue hypoxia resulting from bone marrow depression.

Immune system disorders

· Rare

· Anaphylaxis (anaphylactic / anaphylactoid reactions with or without shock, including rash, pruritus, fever and chills).

Metabolism and nutrition disorders

· Frequent

· Anorexia, dehydration.

· Rare

· Hyperuricemia (See Warnings and Precautions for Use section ).

Nervous system disorders

· Rare

· Dizziness.

· Frequency unknown

· Peripheral neuropathy (high dose), headache.

Eye disorders

· Frequency unknown

· Conjunctivitis, keratitis.

Heart conditions

· Rare

· Congestive heart failure (see Warnings and precautions for use ), (dyspnea, edema, hepatomegaly, ascites, pulmonary edema, pleural effusions, galloping noise), cardiotoxicity (ECG abnormalities, arrhythmias, cardiomyopathy), ventricular tachycardia, bradycardia, AV block, branch block.

Vascular disorders

· Frequent

· Hot flashes, phlebosclerosis.

· Rare

· Phlebitis, thrombophlebitis.

· Frequency unknown

· Shock, thromboembolism, including pulmonary embolism (with fatal outcome in isolated cases)

Gastrointestinal disorders

· Frequent

· Inflammation of the mucosa (may occur 5 to 10 days after initiation of treatment), esophagitis, inflammation of the stomach, vomiting, diarrhea that may lead to dehydration, nausea (nausea and vomiting often occur during the first 24 hours [in almost all the patients]).

· Frequency unknown

· Erosion of the oral mucosa, mouth ulcers, oral pain, burning of the mucous membrane, oral bleeding and discolouration of the oral cavity (oral pigmentation)

Skin and subcutaneous tissue disorders

· Very common

· Alopecia (in 60 to 90% of treated cases implicates a weak growth of the beard in the men.Alopecie is dose-dependent and reversible in most cases).

· Rare

· Urticaria, pruritus, local erythematous reactions along the vein used for injection.

· Frequency unknown

· Local toxicity, skin rash, itching, skin changes, erythema, flushing, skin and nail changes (hyperpigmentation), photosensitivity, hypersensitivity to irradiated skin (radiodermite).

Renal and urinary disorders

· Very frequent

· Staining of urine in red for 1 to 2 days after administration.

· Frequency unknown

· Proteinuria in patients treated at a high dose.

Reproductive system disorders and breast disorders

· Rare

· Amenorrhea, azoospermia.

General disorders and affecting the administration site

· Frequent

· Erythema at the infusion point.

· Rare

· Malaise, asthenia, fever, chills, hyperpyrexia.

· Frequency unknown

· Local pain, severe cellulitis, tissue necrosis, phlebosclerosis after accidental paravenous injection.

exams

· Rare

· Increases in transaminase levels.

· Frequency unknown

· Asymptomatic reductions in left ventricular ejection fraction.

Injuries, poisoning and procedural complications

· Frequent

· Chemical cystitis, sometimes haemorrhagic, observed after intravesical administration (see Warnings and Precautions ).

Intravesical administration:

Since only a small amount of the active ingredient is reabsorbed after intravesical instillation, undesirable, systemic and serious drug effects and allergic reactions are rare. Local reactions such as burning sensation and frequent urination (pollakiuria) are commonly reported. Occasional bacterial or chemical cystitis has been reported (see Warnings and Precautions ). These EMIs are mostly reversible.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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