Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Fibrodysplasia ossificans progressiva (FOP)

Flare-up (acute) treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must be experiencing a FOP flare-up; or

Patient must be at high risk of a FOP flare-up; AND

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of FOP; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of FOP; AND

Patient must be a female aged 8 years or older; or

Patient must be a male aged 10 years or older.

Flare-up treatment should begin at the onset of the first symptom indicative of a FOP flare-up or substantial high-risk traumatic event likely to lead to a flare-up. Symptoms of a FOP flareup typically include but are not limited to localised pain, soft tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness. Examples of a high risk substantial traumatic event include surgery, intramuscular immunisation, mandibular blocks for dental work, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses.

At the time of the authority application, the medical practitioner must request the appropriate combination of packs to provide treatment at the recommended dose for flare-up treatment based on the age and weight of the patient, adequate for 12 weeks of treatment or in the presence of persistent flare-up symptoms to extend treatment in 4-week intervals according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested.

If the patient experiences another flare-up (i.e., new flare-up location or marked worsening of the original flare-up) at any time during flare-up treatment, the flare-up 12-week treatment should be restarted.