1 Dosing Considerations Pregnancy testing and contraceptive measures must be followed prior to dosing SOHONOS in patients of childbearing potential. Patients who are pregnant, or who intend to become pregnant, should avoid contact with SOHONOS.
If pregnancy does occur during treatment with SOHONOS or for one month after its discontinuation, SOHONOS treatment must be immediately stopped if not already discontinued and patient should discuss with their physician. g. a resealable bag).
2 Recommended Dose and Dosage Adjustment Chronic Regimen Recommended dosing: 5 mg once daily (chronic treatment) Chronic treatment should stop at the time of initiation of flare-up treatment, and re-initiated after completion of the flare-up treatment.
Weight-adjusted dosage is required in children who are under 14 years of age (see Table 1). Flare-up Regimen Recommended Dosing: 20 mg once daily for 4 weeks, followed by 10 mg once daily for 8 weeks for a total of 12 weeks (20/10 mg flare-up treatment) even if symptoms resolve earlier.
In the presence of persistent flare-up symptoms, treatment may be extended in 4-week intervals with 10 mg SOHONOS and continued until the flare-up symptoms resolve. Should the patient experience another flare-up (new flare-up location or marked worsening of the original flare-up) at any time during flare-up treatment, the aforementioned flare-up 12- week treatment protocol should be restarted.
g. surgery, intramuscular immunization, mandibular blocks for dental work, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses), likely to lead to a flare-up, under the guidance of a health care professional.
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. Weight-adjusted dosage is required in children who are under 14 years of age (see Table 1).
SOHONOS® (palovarotene capsule) Page 6 of 46 Dose Adjustment in Children Under 14 Years of Age SOHONOS dosage is weight-adjusted in patients under 14 years of age (see Table 1). The health care professional should prescribe the most appropriate dosage based on weight for children aged from 8 years (females) and 10 years (males) to less than 14 years (see Musculoskeletal and 14 CLINICAL TRIALS).
Table 1. 5 mg 10 mg 5 mg *All children ≥14 years of age and adults should receive the dose in the ≥60 kg weight category Dose Modification for Adverse Reactions If, during chronic or flare-up (Weeks 1-12) SOHONOS treatment, a patient experiences an adverse reaction that is not tolerable and does not require immediate drug discontinuation, the daily dose should be reduced in a stepwise way at the discretion of the physician (see Table 2 for the chronic dosing and Table 3 and Table 4 for the flare-up dosing).
If the chronic dose reduction is not tolerated, consider discontinuation of the chronic dosing and only treating flare- ups. Additional dose reduction should occur if adverse reactions continue to be intolerable. If the patient is already receiving the lowest dose, then consideration should be given to discontinue therapy, temporarily or permanently, or switch to flare-up treatment only (see Flare- up only regimen).
Subsequent flare-up treatment should be initiated at the same reduced treatment dose that was tolerated previously. Table 2. 5 mg 10 to <20 kg 1 mg *All children ≥14 years of age and adults should receive the dose in the ≥60 kg weight category SOHONOS® (palovarotene capsule) Page 7 of 46 Table 3.
5 mg 3 mg *All children ≥14 years of age and adults should receive the dose in the ≥60 kg weight category Table 4. 5 mg *All children ≥14 years of age and adults should receive the dose in the ≥60 kg weight category Flare-up only regimen: If the patient experiences intolerable adverse reactions while taking chronic daily treatment and dose reduction does not alleviate the adverse reactions, then the patient may take SOHONOS only at the time of flare-up (or substantial high-risk traumatic event).
Dose Modification for Drug Interactions Moderate CYP3A Inhibitors:
Avoid concomitant use of a moderate CYP3A inhibitor, if possible. 2 Drug Interactions Overview). Table 5. 5 mg 10 mg 5 mg *All pediatric patients ≥ 14 years of age and adults should receive the dose in the ≥ 60 kg weight category. 4 Administration SOHONOS should be taken with food, preferably at the same time […]