Guidelines:

Kyoto Prefectural University of Medicine

PROTOCOL FOR OK-432 THERAPY

1. Case selection:

a. Patients with cystic hygromas (cystic lymphangioma) are recommendable.

b. Patients with a known allergy to Penicillin G are excluded.

2. Before OK-432 therapy:

a. Pretherapeutic photos of the patients are necessary.

b. Dimensions of the lesions should be measured by ultrasonography. Of these, measurement of the depth of the lesion is most important. In addition, cystography with conor MR are recommended.

3. OK-432 Therapy:

a. OK-432 is available in 0.1 mg vials or 0.5 mg vials. The OK-432 solution is prepared by dissolving 0.1 mg of OK-432 in 10 ml of physiological saline (0.01 mg of OK-432 / 1 ml of physiologic saline).

b. Intracystic fluid is aspirated using a 25 or 23-gauge needle. Following aspiration, OK-432 solution at a concentration of 0.01mg/ml is injected into cyst lumen, replacing aspirated material with OK-432 solution to a maximum dose of 0.2 mg (20 ml) at one injection.

c. When aspiration of intracystic fluid is difficult, OK-432 solution is injected into the lesion at a few sites until the lesion is slightly expanded; no more than 0.2 mg of OK-432 is injected at one time.

4. Response:

a. A typical response includes a low-grade fever of 38 to 39 degrees centigrade approximately six hours after injection. An inflammatory response may develop two to five days after the initial injection. Fever is transient and responds to antipyretics.

b. If this response is not seen, the injection of OK-432 solution is repeated seven days after the initial injection.

5. Subsequent therapy:

a. The next injection (second or third) is given six weeks later.

b. Post-therapeutic photos and ultrasonogram are taken to document the extent of residual disease. CT and/ or MR are recommended.

Courtesy of and with thanks to S.Ogita, MD

Note: Please store OK-432 in the REFRIGERATOR not in the Freezer !

Any comments? mail me at i.kenney@bspr.org.uk

Comments so far;

We have used this on several occassions over the past 2 years with mixed results.
The OK-432 needs to be refrigerated as you said and this means that the delivery time from Japan i think has to be no more than 1 week, ? max 10 days. We recently had a problem with 2 deliveries held up at Heathrow airport and could not use it !
Deliveries are generally good and our pharmacy speaks directly to the prof in japan who seems very obliging.
We have some more literature on OK-432 if anybody needs

Philip John, Birmingham

Hi ian..our surgeons like it - I am not sure OK-432 is licenced in the UK so should we be offering guidelines (from japan)?. Just a thought
Keiran McHugh, Great Ormond Street