Ok-432 (Picibanil)

What it is and how it works

OK-432 (picibanil) is a lyophilised preparation of a low-virulence strain of Streptococcus pyogenes (group A) inactivated with benzylpenicillin. Injected locally, it induces an intense inflammatory response with release of cytokines and recruitment of immune cells, leading to fibrosis and obliteration of cystic spaces and anti-tumour immune effects.

Indications

Intralesional sclerotherapy of lymphatic malformations (cystic lymphangioma); in some countries, intracavitary treatment of malignant pleural effusion or ascites and adjunct immunotherapy of certain cancers.

Dosage and administration (summary)

Dosing is individualised: administered by intralesional or intracavitary injection by a specialist according to lesion size and protocol.

Contraindications

Hypersensitivity to penicillin or to streptococcal preparations.

Warnings and precautions

Fever, local pain and swelling are expected after injection; swelling of lesions near the airway may cause airway compromise, so monitoring is required. Anaphylaxis may occur, particularly in penicillin-allergic patients. Use only in specialist centres.

Pregnancy

Safety in pregnancy has not been established.

Storage and supply

Store at 2–8 °C in a refrigerator.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.