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Intravenous Administration: Under conditions of normal recovery from drug-induced toxicity (particularly bone marrow depression and stomatitis), the recommended dosage schedule in adults, as described as follows, is as a single intravenous injection administered at 21 day intervals.
Standard doses are 75 to 90 mg/m2. Pharmorubicin produces predominantly haematological dose limiting toxicities which are predicted from the known dose-response profile of the drug. Based on the patient's haematological status the physician should determine the choice of dose.
Higher doses, up to 135 mg/m2 as a single agent and 120 mg/m2 in combination, every 3-4 weeks have been effective in the treatment of breast cancer. In the adjuvant treatment of early breast cancer patients with positive lymph nodes, doses ranging from 100 mg/m2 to 120 mg/m2 every 3-4 weeks are recommended. Careful monitoring in regards to increased myelosuppression, nausea, vomiting and mucositis are recommended in this high dose setting.
Consideration should be given to the administration of lower starting doses (not exceeding 75-90 mg/m2) for heavily pre-treated patients, patients with pre-existing bone marrow depression or in the presence of neoplastic bone marrow infiltration. If Pharmorubicin is used in combination with other cytotoxic drugs with potentially overlapping toxicities, the recommended dose per cycle should be reduced accordingly.
Intravesical Administration: For the treatment of papillary transitional cell carcinoma of the bladder, a therapy of 8 weekly instillations of 50 mg is recommended.
In the case of local toxicity (chemical cystitis) a dose reduction up to 30 mg is advised. For carcinoma in-situ, depending on the individual tolerability of the patient, the dose may be increased up to 80 mg.
For prophylaxis of recurrences after transurethral resection of superficial tumours, 4 weekly administrations of 50 mg followed by 11 monthly instillations at the same dosage are recommended.
To avoid undue dilution with the urine, the patient should be instructed not to drink any fluid in the twelve hours prior to instillation.
Intravesical administration is not suitable for the treatment of invasive tumours which have penetrated the muscular layer of the bladder wall.
Preparation of Solution (see Precautions): Pharmorubicin can be used in combination with other anti-tumour agents, but it is not recommended that it be mixed with these drugs in the same container (also see Incompatibilities under Cautions for Usage).
Storage of the Pharmorubicin ready-to-use solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after two to a maximum of four hours equilibration at room temperature (15°C-25°C).
Pharmorubicin contains no antimicrobial preservative. Pharmorubicin are single use only vials and any unused portion must be discarded after use. From a microbiological point of view, the products should be used immediately after first penetration of the rubber stopper.
Compatibility: Pharmorubicin is compatible with the following infusion media: 0.9% Sodium chloride, 5% Glucose, 0.9% Sodium chloride with 5% glucose.
Pharmaceutical Precautions: The following protective recommendations are given due to the toxic nature of this substance: Personnel should be trained in good technique for reconstitution and handling.
Pregnant staff should be excluded from working with this drug.
Personnel handling Pharmorubicin should wear protective clothing: goggles, gowns and disposable gloves and masks.
A designated area should be defined for reconstitution (preferably under a laminar flow containment system). The work surface should be protected by disposable, plastic-backed absorbent paper.
All items used for reconstitution, administration or cleaning, including gloves, should be placed in high-risk, waste-disposal bags for high temperature incineration.
Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water.
All cleaning materials should be disposed of as indicated previously.
Accidental contact with the eyes or skin should be treated immediately. Copious lavage with water is appropriate treatment for contact with the eyes, whereas water or soap and water, or sodium bicarbonate solution may be used on the skin; medical attention should be sought.
Pharmorubicin Injection should be stored at 2°C to 8°C (Refrigerate, do not freeze). The product contains no antimicrobial preservative.
Use in one patient on one occasion only. Discard any residue.
Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug.
Method of Administration: Pharmorubicin is intended for intravenous or intravesical administration only. It must not be administered by the intramuscular, subcutaneous or oral routes.
Intravenous Administration: Care in the intravenous administration of Pharmorubicin will reduce the chance of perivenous infiltration (see Extravasation under Precautions). It may also decrease the chance of local reactions, such as urticaria and erythematous streaking.
It is recommended that Pharmorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection USP or 5% Glucose Injection USP. The tubing should be attached to a Butterfly needle inserted preferably into a large vein. The rate of administration is dependent on the size of the vein and the dosage. To minimise the risk of thrombosis or perivenous extravasation, the usual infusion times range between 3 and 20 minutes. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid administration. A burning or stinging sensation may be indicative of perivenous infiltration and the infusion should be immediately terminated and restarted in another vein (see Extravasation under Precautions).
Intravesical Administration: Pharmorubicin, to be instilled using a catheter, should be retained intravesically for 1 hour. The patient should be instructed to void at the end of this time. During instillation, the pelvis of the patient should be rotated to ensure extensive contact of the solution with the vesical mucosa.
Dose Adjustment: Renal Impairment: While no specific dose recommendation can be made based on the limited available data in patients with renal impairment, lower starting doses should be considered in patients with severe renal impairment (serum creatinine >5 mg/dL).
Hepatic Impairment: As clinical toxicity may be increased by the presence of impaired liver function, Pharmorubicin dosage must be reduced if hepatic function is impaired, according to the following table: (See table.)
Click on icon to see table/diagram/imageOther Special Populations: Haematological toxicity may require dose reduction, delay or suspension of Pharmorubicin therapy. Lower doses may be necessary if Pharmorubicin is used concurrently with other anti-neoplastic agents.
