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PHARMORUBICIN is a brand name for Epirubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pharmorubicin has produced responses in a wide range of neoplastic conditions, including breast, ovarian, gastric, lung and colorectal carcinomas, malignant lymphomas, leukaemias and multiple myeloma. Intravesical administration of Pharmorubicin has been found to be beneficial in the treatment of superficial bladder…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Pharmorubicin is not active when given orally and should not be injected intramuscularly or intrathecally. It is advisable to give the drug via the tubing of a freely-running IV saline infusion after checking that the needle is well placed in the vein.
This method minimises the risk of drug extravasation and makes sure that the vein is flushed with saline after the administration of the drug. Extravasation of Pharmorubicin from the vein during injection may give rise to severe tissue lesions, even necrosis.
Venous sclerosis may result from injection into small vessels or repeated injections into the same vein. V. over 3-5 minutes and, depending on the patient's haematomedullary status, the dose should be repeated at 21-day intervals.
High doses:
Pharmorubicin as a single agent for the treatment of lung cancer at high doses should be administered according to the following regimens: Lung cancer - Small cell lung cancer (previously untreated): 120 mg/m2 day 1, every 3 weeks.
- Non small cell lung cancer (squamous, large cell, and adenocarcinoma previously untreated): 135 mg/m2 day 1 or 45 mg/m2 days 1, 2, 3, every 3 weeks. Breast cancer In the adjuvant treatment of early breast cancer patients with positive lymph nodes, intravenous doses of epirubicin ranging from 100 mg/m2 (as a single dose on day 1) to 120 mg/m2 (in two divided doses on days 1 and 8) every 3-4 weeks, in combination with intravenous cyclophosphamide and 5-fluorouracil and oral tamoxifen, are recommended.
V. bolus over 3-5 minutes or as an infusion up to 30 minutes. Lower doses (60-75 mg/ m2 for conventional treatment and 105-120 mg/ m2 for high dose schedules) are recommended for patients whose bone marrow function has already been impaired by previous chemotherapy or radiotherapy, by age, or neoplastic bone-marrow infiltration.
The total dose per cycle may be divided over 2-3 successive days. When the drug is used in combination with other antitumour agents, the doses need to be adequately reduced. Since the major route of elimination of Pharmorubicin is the hepatobiliary system, the dosage should be reduced in patients with impaired liver function, in order to avoid an increase of overall toxicity.
4 - 3 mg/100 ml) requires a 50% reduction of dose, while severe impairment (bilirubin > 3mg/100 ml) necessitates a dose reduction of 75%. Moderate renal impairment does not appear to require a dose reduction in view of the limited amount of Pharmorubicin excreted by this route.
The following undesirable effects have been observed and reported during treatment with epirubicin with the following frequencies: System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very Rare < 1/10,000 Freq know (can estim from avai Infections and infestations Infection, Conjunctivitis Sepsis,* Pneumonia* Neoplasms benign, malignant and unspecified (including cysts and polyps) Acute myeloid leukaemia, Acute lymphocytic leukaemia Blood and lymphatic system Anaemia, Leukopenia, Neutropenia, System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very Rare < 1/10,000 Freq know (can estim from avai disorders Thrombocytopenia Febrile neutropenia Immune system disorders Anaphylactic reaction* Metabolism and nutrition disorders Decreased appetite Dehydration* Hyperuricaemia* Eye disorders Keratitis Cardiac disorders Ventricular tachycardia, Atrioventricular block, Bundle branch block, Bradycardia, Cardiac failure congestive Vascular disorders Hot flush, Phlebitis* Haemorrhage,* Flushing* Embolism, Embolism arterial,* Thrombophlebitis* Shoc Respiratory, thoracic and mediastinal disorders Pulmonary embolism* Gastrointestinal disorders Nausea, Vomiting, Stomatitis, Mucosal inflammation, Diarrhoea Gastrointestinal pain,* Gastrointestinal erosion,* Gastrointestinal ulcer* Gastrointestinal haemorrhage* Abdo disco Pigm bucc Skin and subcutaneous tissue disorders Alopecia, Skin toxicity Rash/Pruritus, Nail pigmentation,* Skin disorder, Skin hyperpigmentation* Urticaria* Erythema* Phot react Renal and urinary disorders Chromaturia*† Reproductive system and breast disorders Amenorrhoea General disorders and administration site conditions Malaise, Pyrexia* Chills* Asthenia Investigations Transaminases abnormal Ejection fraction decreased System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very Rare < 1/10,000 Freq know (can estim from avai Injury, poisoning and procedural complications Chemical cystitis*§ Reca phen * ADR identified post-marketing.
General - Epirubicin should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment before beginning treatment with epirubicin.
, ≥ 90 mg/m2 every 3 to 4 weeks) causes adverse events generally similar to those seen at standard doses (< 90 mg/m2 every 3 to 4 weeks), the severity of the neutropenia and stomatitis/mucosal inflammation may be increased. Treatment with high doses of epirubicin does require special attention for possible clinical complications due to profound myelosuppression.
, delayed) events. , Acute) Events. Early cardiotoxicity of epirubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities such as non-specific ST-T wave changes. Tachyarrhythmias, including premature ventricular contractions, ventricular tachycardia, and bradycardia, as well as atrioventricular and bundle- branch block have also been reported.
These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not a consideration for the discontinuation of epirubicin treatment. , Delayed) Events. Delayed cardiotoxicity usually develops late in the course of therapy with epirubicin or within 2 to 3 months after treatment termination, but later events (several months to years after completion of treatment) have also been reported.
Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF) such as dyspnoea, pulmonary oedema, dependent oedema, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion, and gallop rhythm.
Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug. 1). Cardiac function should be assessed before patients undergo treatment with epirubicin and must be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment.
1, other anthracyclines or anthracenediones. 4) • patients with acute systemic infections • unstable angina pectoris • myocardiopathy Intravesical use: • urinary tract infections • inflammation of the bladder • haematuria • invasive tumours penetrating the bladder • catheterisation problems
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Intravesical administration:
Pharmorubicin can be given by intravesical administration for the treatment of superficial bladder cancer and carcinoma-in-situ. It should not be used in this way for the treatment of invasive tumours which have penetrated the bladder wall where systemic therapy or surgery is more appropriate.
Epirubicin has also been successfully used intravesically as a prophylactic agent after transurethral resection of superficial tumours in order to prevent recurrences. While many regimens have been used, the following may be helpful as a guide: for therapy, 8 x weekly instillations of 50 mg/50 ml (diluted with saline or distilled sterile water).
In the case of local toxicity (chemical cystitis), a dose reduction to 30 mg/50ml is advised. For carcinoma-in-situ, depending on the individual tolerability of the patient, the dose may be increased up to 80 mg/50 ml. For prophylaxis, 4 x weekly administrations of 50 mg/50 ml, followed by 11 x monthly instillations at the same dosage, is the schedule most commonly used.
The solution should be retained intravesically for 1 hour. To avoid undue dilution with urine, the patient should be instructed not to drink any fluid in the 12 hours prior to instillation. During the instillation, the patient should be rotated occasionally and should be instructed to void at the end of the instillation time.
† Red coloration of urine for 1 to 2 days after administration. § Following intravesical administration. Δ Hypersensitivity to irradiated skin (radiation-recall reaction). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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The risk may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of epirubicin at the first sign of impaired function. The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO).
A baseline cardiac evaluation with an ECG and either a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiotoxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
The technique used for assessment should be consistent throughout follow-up. Given the risk of cardiomyopathy, a cumulative dose of 900 mg/m2 epirubicin should be exceeded only with extreme caution. 5) with an increased risk in the elderly.
Heart failure (New York Heart Association [NYHA] class II-IV) has been observed in patients receiving trastuzumab therapy alone or in combination with anthracyclines such as epirubicin. This may be moderate to severe and has been associated with death.
Trastuzumab and anthracyclines such as epirubicin should not be used currently in combination except in a well-controlled clinical trial setting with cardiac monitoring. Patients who have previously received anthracyclines are also at risk of cardiotoxicity with trastuzumab treatment, although the risk is lower than with concurrent use of traztuzumab and anthracyclines.
The reported half-life of trastuzumab is variable. The substance may persist in circulation for up to 7 months. Therefore, physicians should avoid anthracycline- based therapy for up to 7 months after stopping trastuzumab when possible.
If this is not possible, the patient’s cardiac function should be monitored carefully. If symptomatic cardiac failure develops during trastuzumab therapy after epirubicin therapy, it should be treated with the standard medications for this purpose.
Cardiac function monitoring must be particularly strict in patients receiving high cumulative doses and in those with risk factors. However, cardiotoxicity with epirubicin may occur at lower cumulative doses whether or not cardiac risk factors are present.
6). It is probable that the toxicity of epirubicin and other anthracyclines or anthracenediones is additive. Haematologic Toxicity - As with other cytotoxic agents, epirubicin may produce myelosuppression. Haematologic profiles should be assessed before and during each cycle of therapy with epirubicin, including differential white blood cell (WBC) counts.
A dose-dependent, reversible leucopoenia and/or granulocytopenia (neutropenia) is the predominant manifestation of epirubicin haematologic toxicity and is the most common acute dose-limiting toxicity of this drug. Leucopoenia and neutropenia are generally more severe with high-dose schedules, […]