Référentiel des médicaments
Palovarotene
Palovarotene is a medicine in the class miscellaneous. It is used for heterotopic ossification.
- Classe médicamenteuse: Miscellaneous
- Indications: heterotopic ossification
Dernière mise à jour Sources: US FDA label
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L'essentiel
- Classe médicamenteuse
- Miscellaneous
- Formes courantes
- gélule
- Interactions connues
- 47 (Contre-indiquée: 2 · Majeure: 34 · Modérée: 7 · Mineure: 4)
- Noms commerciaux
- 1
- Pays et marchés
- 1
Indications
Mécanisme d'action
Retinoic acid receptor agonist with selectivity for the gamma subtype (RARγ). Binding to RARγ decreases BMP/ALK2 downstream signaling by inhibiting SMAD1/5/8 phosphorylation, which reduces endochondral bone formation.
Posologie adulte habituelle (résumé de la notice)
FOP, adults and patients 14 years and older, daily dose: 5 mg orally once daily with food. Stop daily dosing when flare-up dosing begins.
Grossesse et allaitement
- Grossesse
- Unsafe Contraindicated in pregnancy; can cause fetal harm. Retinoid-type malformations were seen in rats. No human data are available.
- Allaitement
- Unsafe No data on presence in milk. Breastfeeding is not recommended during treatment and for at least 1 month after the final dose.
Effets indésirables signalés
- Dry skin
- Dry lips
- Arthralgia
- Pruritus
- Pain in extremity
- Rash
Mises en garde encadrées
- Embryo-fetal toxicity: contraindicated in pregnancy and may cause fetal harm. Give only if conditions for pregnancy prevention are met.
Contre-indications
- Pregnancy.
- History of allergy or hypersensitivity to retinoids or any component of SOHONOS.
Précautions particulières
- Embryo-fetal toxicity: verify non-pregnancy before, during and 1 month after treatment; use effective contraception; do not donate blood during therapy and for 1 week after.
- Irreversible premature epiphyseal closure in growing children; assess baseline skeletal maturity and monitor every 6 to 12 months.
- Mucocutaneous reactions occurred in 98% of patients and may increase the risk of skin and soft tissue infections; photosensitivity may occur.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
Principales interactions (47)
- Acitretin + Palovarotene Contraindicated
- Isotretinoin + Palovarotene Contraindicated
- Amiodarone + Palovarotene Major
- Amobarbital + Palovarotene Major
- Apalutamide + Palovarotene Major
- Aprepitant + Palovarotene Major
- Carbamazepine + Palovarotene Major
- Chloramphenicol + Palovarotene Major
- Clarithromycin + Palovarotene Major
- Crizotinib + Palovarotene Major
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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Questions fréquentes
What is Palovarotene used for?
Palovarotene is a medicine in the class miscellaneous. It is used for Heterotopic ossification.
What side effects have been reported with Palovarotene?
Dry skin, Dry lips, Arthralgia, Pruritus, Pain in extremity, Rash. Serious warning: Embryo-fetal toxicity: contraindicated in pregnancy and may cause fetal harm.
Can Palovarotene be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Contraindicated in pregnancy; can cause fetal harm. Retinoid-type malformations were seen in rats. No human data are available. Breastfeeding: Unsafe. No data on presence in milk. Breastfeeding is not recommended during treatment and for at least 1 month after the final dose.
What does Palovarotene interact with?
MediHelp lists 47 known interactions for Palovarotene. Contraindicated: 2 · Major: 34 · Moderate: 7 · Minor: 4. The most serious include Acitretin, Isotretinoin, Amiodarone.
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