Doxorubicin Hydrochloride Injection USP

Generic Name: Doxorubicin hydrochloride
Product Name: Doxorubicin Hydrochloride Injection USP

Indication

Doxorubicin Hydrochloride for Injection USP is used to produce regression in a number of neoplastic conditions such as:

Acute leukaemia.
Wilms tumour.
Neuroblastoma.
Soft tissue sarcomas.
Breast carcinoma.
Hodgkins and non-Hodgkins lymphoma.
Bronchogenic carcinoma.
Thyroid carcinoma.
Hepatoma.
Ovarian carcinoma.

Other cancers that have been found to have some response include:

Doxorubicin Hydrochloride for Injection USP can also be used in the management of non-metastatic carcinoma of the bladder, where it is administered intravesically.

Action

Doxorubicin is from the family of chemotherapy drugs known as anthracyclines. Anthracyclines act directly on DNA, blocking its production and inhibiting the enzyme responsible for DNA repair. Cells do not have to be actively dividing to be affected by Doxorubicin, as is the case with some chemotherapy drugs. Doxorubicin also suppresses the immune system.

Dose advice

Doxorubicin should be administered with care to reduce the chance of perivenous infiltration.

Recommended dosage regime

60-75mg/m² body surface area.
Dose should be administered as a single intravenous injection at 21 day intervals.

Alternative dosing regime

25-30mg/m² on three successive days.
Repeat every 3-4 weeks.

Recommended cumulative lifetime dose is 550mg/m².

Administration

Doxorubicin can be slowly administered into the tubing of a freely running sodium chloride infusion. Dose should be administered over not less than 3-5 minutes.
A burning or stinging sensation is indicative of extravasation and requires immediate cessation of injection.

Intravesical administration

Catheterise and empty bladder.
Add 80mg Doxorubicin to normal saline to achieve a final volume of 100ml.
Instil via catheter into bladder.
Patient should be instructed to lie on one side, then alternate sides every 15 minutes.
Bladder should be emptied after 1 hour.
Repeat procedure monthly.

Children

Adult dosage regimes may be appropriate for children.
Children should be periodically monitored for evidence of cardiac toxicity after cessation of treatment.

Hepatic impairment

Dosage adjustment should be made depending on serum bilirubin levels and bromsulfophthalein (BSP) retention.
If bilirubin is 20-50micromol/L and BSP is 9-15%: give half the normal dose.
If bilirubin is over 50micromol/L and BSP is over 15%: give one quarter of the normal dose.

Schedule

Common side effects

Cardiotoxicity, manifesting as cardiomyopathy or cardiac failure may occur during or up to years after therapy. Extravasation (escape of Doxorubicin from vein into surrounding tissue) may result in skin death, severe inflammation and ulcers. Other side effects that may occur include:

Hair loss.
Nausea and vomiting.
Mucositis (inflammation of mouth and oesophagus).
Diarrhoea.
Dehydration.
Reduction in white blood cell numbers, which can increase infection risk.
Red discolouration of urine.

Cardiotoxicity – The anthracycline antibiotics have a cumulative cardiotoxicity. The damage to the heart is reduced when doxorubicin is given as an infusion over 24 hours. Haematological – Doxorubicin will suppress the production of all blood cells. Nausea / Vomiting – Doxorubicin can cause quite severe nausea but the patients responds well to antiemetic treatment. Alopecia – Hair loss is common whilst on doxorubicin. Hair does return following completion of treatment .