NATULAN

What it is

Natulan contains procarbazine (as the hydrochloride). Each capsule contains 50 mg procarbazine (as the hydrochloride). It is supplied as hard capsules (opaque ivory coloured with a white to yellowish fine granular powder). Natulan is a derivative of methylhydrazine with cytostatic properties.

Approved indications

— Treatment of Hodgkin's disease (multiple lymphadenoma). — Treatment of other malignant lymphomas including lymphosarcoma, reticulosarcoma, Brill-Symmers disease.

Dosing overview

Natulan is given by mouth, initially starting at 50 mg on the first day, increasing by 50 mg daily up to 250 to 300 mg daily after 5 or 6 days. Dosage is maintained at this level until the greatest possible remission has occurred. Maintenance dosage is 50 to 150 mg daily until a total dose of 6 g has been given.

Key safety warnings

Bone marrow depression may occur, and full blood count, liver and renal function tests should be performed prior to each cycle of administration of procarbazine. If during treatment leucopoenia of about 3,000/mm³ or thrombocytopaenia of about 80,000/mm³ occurs, treatment should be suspended until leucocyte and platelet levels recover and then recommenced. The immunosuppressant effect of procarbazine may increase the risk of infections caused by pathogenic or opportunistic micro-organism, may reduce the response to vaccines, and there is a possibility of generalised infection with live vaccines. Use of live vaccines should generally be avoided. Secondary non-lymphoid malignancies such as acute myeloid leukaemia and lung cancer have occurred in patients with Hodgkin's disease receiving procarbazine in combination with other chemotherapy and/or radiation therapy. Intolerance to alcohol may develop and abstinence may be advisable during therapy.

Contraindications

Natulan is contraindicated in patients with known hypersensitivity to the active substance or any of the listed excipients. It is contraindicated in patients with pre-existing leucopoenia or thrombocytopenia, or severe hepatic or renal damage. Natulan is contraindicated in pregnancy and breastfeeding.

PBS listing

No information about PBS listing is provided in the source documents.

Regulatory history

NATULAN procarbazine 50 mg (as hydrochloride) capsule was first listed on the ARTG on 23 August 1991. The product was first approved in October 1995. A blister pack variant was first listed on the ARTG on 10 February 2015.