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palovarotene (Sohonos)
Indications:
- reduction in volume of heterotopic ossification
- males with fibrodysplasia ossificans progressiva
Contraindications:
- pregnancy
Dosage:
- 5 mg PO QD
- increase to 20 mg PO QD with flare for 4 weeks
- taper to 10 mg PO QD for 8 weeks.
Capsules: 1 mg, 1,5 mg, 2.5 mg, 5 mg, 10 mg
Adverse effects:
- headache, back pain
- premature epiphyseal closure
- decreased vertebral bone mineral conted
- dry skin, dry lips, pruritus, rash, alopecia, skin exfoliation, dry eye
- depression, anxiety
- night blindness
Drug interactions:
- CYP3A4 inhibitors may increase palovarotene exposure
- CYP3A4 inducers may decrease palovarotene exposure
- avoid concurrent use of tetracyclnes
- vitamin A may have additive effects
Mechanism of action:
- retinoic acid receptor agonist, with particular selectivity for RAR-gamma
- through binding of RAR-gamma, palovarotene decreases BMP/ALK2 downstream signaling by inhibiting phosphorylation of SMAD1/5/8
- this reduces ALK2/SMAD-dependent chondrogenesis & osteocyte differentiation resulting in reduced endochondral bone formation
General
metabolic agent (metabolic modifier)
Database Correlations
PUBCHEM cid=10295295
References
- Highlights of prescribing information
SOHONOS (palovarotene) capsules, for oral use
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215559s000lbl.pdf