Active Ingredient: Palovarotene
Palovarotene is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient is female and patient age in years is ≥ 8 and patient age in years is ≤ 13 and patient weight is ≥ 10 kg and patient weight is ≤ 19.9 kg, oral, 2.5 milligrams palovarotene, once daily to meals.
Regimen B: In case that patient is female and patient age in years is ≥ 8 and patient age in years is ≤ 13 and patient weight is ≥ 20 kg and patient weight is ≤ 39.9 kg, oral, 3 milligrams palovarotene, once daily to meals.
Regimen C: In case that patient is female and patient age in years is ≥ 8 and patient age in years is ≤ 13 and patient weight is ≥ 40 kg and patient weight is ≤ 59.9 kg, oral, 4 milligrams palovarotene, once daily to meals.
Regimen D: In case that patient is female and patient age in years is ≥ 8 and patient age in years is ≤ 13 and patient weight is ≥ 60 kg, oral, 5 milligrams palovarotene, once daily to meals.
Regimen E: In case that patient is male and patient age in years is ≥ 10 and patient age in years is ≤ 13 and patient weight is ≥ 10 kg and patient weight is ≤ 19.9 kg, oral, 2.5 milligrams palovarotene, once daily to meals.
Regimen F: In case that patient is male and patient age in years is ≥ 10 and patient age in years is ≤ 13 and patient weight is ≥ 20 kg and patient weight is ≤ 39.9 kg, oral, 3 milligrams palovarotene, once daily to meals.
Regimen G: In case that patient is male and patient age in years is ≥ 10 and patient age in years is ≤ 13 and patient weight is ≥ 40 kg and patient weight is ≤ 59.9 kg, oral, 4 milligrams palovarotene, once daily to meals.
Regimen H: In case that patient is male and patient age in years is ≥ 10 and patient age in years is ≤ 13 and patient weight is ≥ 60 kg, oral, 5 milligrams palovarotene, once daily to meals.
Regimen I: In case that patient age in years is ≥ 14, oral, 5 milligrams palovarotene, once daily.
The recommended dosing for palovarotene includes a chronic daily dosage (daily dose) which can then be modified/increased in the event of FOP flare-up symptoms (flare-up dose).
Initiate flare-up treatment 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 (e.g., surgery, intramuscular immunization, mandibular blocks for dental procedures, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses). Symptoms of a FOP flare-up typically include but are not limited to localized pain, soft tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness.
Table 1. Recommended palovarotene weight-based dosage for pediatric patients aged 8 to 13 years for females and 10 to 13 years for males*:
| Weight | Daily dosage | Week 1 to 4 flare-up dosage | Week 5 to 12 flare-up dosage |
|---|---|---|---|
| 10 kg to 19.9 kg | 2.5 mg | 10 mg | 5 mg |
| 20 kg to 39.9 kg | 3 mg | 12.5 mg | 6 mg |
| 40 kg to 59.9 kg | 4 mg | 15 mg | 7.5 mg |
| ≥60 kg | 5 mg | 20 mg | 10 mg |
* once daily
If a dose of palovarotene is missed, take the missed dose as soon as possible. If the dose has been missed by more than 6 hours, skip the missed dose, and continue with the next scheduled dose. Do not take two doses at the same time or in the same day.
If patients experience adverse reactions that require dosage reduction during either the palovarotene daily dosing or flare-up dosing, reduce the daily dosage to the next lower dose as shown in Table 2 at the discretion of the healthcare provider; reduce the dosage further if adverse reactions do not improve. If the patient is already receiving the lowest possible tolerated dose, then consider discontinuing palovarotene temporarily or permanently. Initiate subsequent flare-up dosing at the same reduced dose that was tolerated previously.
Table 2. Dose reduction of palovarotene for flare-up and chronic treatment:
| Dose Prescribed | Reduced Dose |
|---|---|
| 20 mg | 15 mg |
| 15 mg | 12.5 mg |
| 12.5 mg | 10 mg |
| 10 mg | 7.5 mg |
| 7.5 mg | 5 mg |
| 6 mg | 4 mg |
| 5 mg | 2.5 mg |
| 4 mg | 2 mg |
| 3 mg | 1.5 mg |
| 2.5 mg | 1 mg |
Take palovarotene with food preferably at the same time each day.
Do not administer with grapefruit, pomelo, or juices containing these fruits.
For:
Oral, 5 milligrams palovarotene, once daily.
The recommended dosing for palovarotene includes a chronic daily dosage (daily dose) which can then be modified/increased in the event of FOP flare-up symptoms (flare-up dose).
Initiate flare-up treatment 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 (e.g., surgery, intramuscular immunization, mandibular blocks for dental procedures, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses). Symptoms of a FOP flare-up typically include but are not limited to localized pain, soft tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness.
If a dose of palovarotene is missed, take the missed dose as soon as possible. If the dose has been missed by more than 6 hours, skip the missed dose, and continue with the next scheduled dose. Do not take two doses at the same time or in the same day.
If patients experience adverse reactions that require dosage reduction during either the palovarotene daily dosing or flare-up dosing, reduce the daily dosage to the next lower dose as shown in the table below at the discretion of the healthcare provider; reduce the dosage further if adverse reactions do not improve. If the patient is already receiving the lowest possible tolerated dose, then consider discontinuing palovarotene temporarily or permanently. Initiate subsequent flare-up dosing at the same reduced dose that was tolerated previously.
Dose reduction of palovarotene for flare-up and chronic treatment:
| Dose Prescribed | Reduced Dose |
|---|---|
| 20 mg | 15 mg |
| 15 mg | 12.5 mg |
| 12.5 mg | 10 mg |
| 10 mg | 7.5 mg |
| 7.5 mg | 5 mg |
| 6 mg | 4 mg |
| 5 mg | 2.5 mg |
| 4 mg | 2 mg |
| 3 mg | 1.5 mg |
| 2.5 mg | 1 mg |
Take palovarotene with food preferably at the same time each day.
Do not administer with grapefruit, pomelo, or juices containing these fruits.
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