Description

Indications
Adrim has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.

Dosage and Administration: Intravenous route: When Adrim is used as a single antitumor agent the recommended dose in adults is 60-75 mg/m2 of body surface area by intravenous injection every three weeks, dependent on bone- marrow reserves. The lower dose (60 mg/m2) is recommended for patients with inadequate marrow reserves as a result of old age, previous therapy or neoplastic marrow infiltration.

The above dose can be given as a single injection or subdivided over 2-3 consecutive days An alternative dosage of 30 mg/m2/day I.V. for three consecutive days has been suggested specifically for pediatric use the course should be repeated every 4 weeks.

The cumulative dose of Adrim by the intravenous route irrespective of the dosage schedule should not exceed 550 mg/m2 of body surface area.

Adrim is presently also used extensively in combination chemotherapy at usual doses of 25-50 mg/m2 every 3-4 weeks if combined with other myelo-suppressive drugs and at doses of 60-75 mg/m2 if used in combination with drugs that are not myelo-suppressive.

The dosage of Adrim should be reduced in patients with impaired hepatic function to prevent an increase of overall toxicity

Generally when serum bilirubin levels are approximately 1.2-3 mg% and BSP retention is 9-15% it is recommended that half the normal dose of Adrim be used. If serum bilirubin levels and BSP retention are even higher it is recommended that a quarter of the usual doses be given.

In view of the low renal excretion of Adrim moderate impairment of renal function does not usually require a reduction in the recommended dose.

Intravesical route
The recommended dosage for topical intravesical treatment is 30-50 mg per instillation to be administered at intervals varying from 1 week to one month depending on whether the treatment is prophylactic or therapeutic. The frequency of administration and duration of treatment are dependent on the physician.

Adrim Rapid Dissolution is not active orally, and must not be administered intramuscularly or intrathecally. Adrim Rapid Dissolution should be administered solely by intravenous injection or – In the case of local – regional treatment of tumours – by slow intra-arterial infusion or by topical intravesical administration by means of a catheter. It is recommended that Adrim Rapid Dissolution, when given intravenously, be administered through the tubing of a freely running infusion of physiological solution, after confirmation that the needle is correctly inserted into the vein This technique reduces the risk of perivenous extravasation of the drug and ensures the washing of the vein after administration Adrim Rapid Dissolution should not be mixed with heparin as a precipitate may form. Adrim Rapid Dissolution may be used in combination with other chemotherapeutic antitumour agents but drugs must not be mixed in the same syringe. In the case of intravesical therapy Adrim Rapid Dissolution should be dissolved in Water for Injection at room temperature. The recommended concentration is 1 mg/ml.

Contraindications
Therapy with Adrim is contra-indicated in patients with active myelosuppression induced by previous treatment with other antitumor agents or by radiotherapy and in patients already treated with the recommended cumulative doses of Adrim. Adrim is not recommended in patients with cardiopathy, or with a record of cardiopathy, although conclusive data are not yet available on the importance of this risk -factor concerning Adrim induced cardiac toxicity. Topical intravesical therapy with Adrim is also contra-indicated in patients with bladder tumours complicated by narrowing of the urethra which prevents the use of urethral catheters or by urinary tract infections resistant to usual therapy.

Hypersensitivity to hydroxibenzoates is a contra-indication.

Presentation: Each vial contains 10 mg of Doxorubicin Hydrochloride as a freeze-dried powder, to be dissolved in 5ml of WFI.

Storage
Store at a temperature not exceeding 25°C. Protect from light.