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SOHONOS is a brand name for Palovarotene, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SOHONOS (palovarotene capsules) is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (FOP). 1.1 Pediatrics Pediatrics (<8 years (females)/<10 years (males)): Do not use…
Verbatim from this product's HC label. Tap a section to expand.
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).
1 Adverse Reaction Overview The most commonly reported adverse reactions (more than 10%) reported in subjects with FOP aged ≥8 years (females)/10 years (males) were: Cutaneous, including dry skin (80%), pruritus (56%), alopecia (42%), rash (41%), erythema (35%), skin exfoliation (32%), drug eruption (20%), eczema (16%), and skin irritation (12%); Gastrointestinal, including lip dry (59%), chapped lips (18%), dry mouth (14%), nausea (12%), and cheilitis (11%) ; Infections, including paronychia (14%); Investigations, including bone density decreased (10%); Musculoskeletal, including pain in extremity (17%), and arthralgia (17%); Ocular, including dry eye (27%); Injury, poisoning and procedural complications, including skin abrasion (22%); Respiratory, including epistaxis (12%) and Neurological, including headache (17%).
The majority of adverse reactions were mild or moderate in severity across all SOHONOS FOP trials. Serious adverse reactions occurred in 22 (16%) SOHONOS treated subjects in the 8/10 years or older population with the most common serious adverse reaction being PPC.
Serious adverse reactions of PPC reported in pediatric subjects with FOP aged ≥8 years (females)/10 years (males) to <14 years occurred in 13/42 subjects (31%) and <8 years (females) and 10 years (males) occurred in 14/25 subjects (56%).
Close monitoring of PPC is recommended (see Musculoskeletal). 9%). 7% of subjects. Adverse events (AEs) leading to permanent discontinuation occurred in 9% of SOHONOS treated subjects. 7% of subjects. No study drug discontinuations were reported in placebo/untreated subjects due to AEs.
Mucocutaneous AEs in subjects with FOP aged ≥ 8 years (females)/10 years (males) most commonly led to dose reductions during SOHONOS 20/10 mg flare-up treatment (37%) and during chronic treatment (3%). Overall, the most common AEs leading to dose reduction were mucocutaneous including pruritus (9%), dry skin (8%), drug eruption (7%), and skin exfoliation (4%).
, Reproductive Health: Female and Male Potential, Teratogenic Risk and Special Populations: Pregnant Women). SOHONOS® (palovarotene capsule) Page 5 of 46 • SOHONOS has been shown to cause premature physeal closure in growing children with FOP; periodic monitoring (every 3 months) is recommended (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal, Monitoring Recommendations).
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.
• Patients who are pregnant or breastfeeding. • Patients of childbearing potential unless all the conditions for pregnancy prevention are met, or they are not at risk of pregnancy due to physical limitations as assessed by the physician.
• Patients with a history of allergy or hypersensitivity to retinoids, or to any component of this product. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]
In FOP clinical trials, there was no treatment-related increase in suicide ideation, suicidal behaviour or psychiatric disorders overall relative to untreated subjects with FOP. There have been no reports of pregnancy or in utero exposure reported in clinical studies with SOHONOS.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in SOHONOS® (palovarotene capsule) Page 18 of 46 real-world use. 5years. 5 mg once daily for 4 weeks). The mean duration of exposure was 105 weeks for chronic dosing (N=131 subjects) and 41 weeks for flare-up dosing (N=110 subjects).
The mean age of these subjects was 19 years (range 8 to 61 years); 50% were male. Table 6. 0) […]
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. Dose Reduction of SOHONOS for use with Moderate CYP3A […]