How Far Is Too Far? The Ethics of Mini Brain Research
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Brand Name :
Sohonos
Synonyms :
palovarotene
Class :
Retinoic Acid Receptor Gamma Agonists
Brand Name :
Sohonos
Synonyms :
palovarotene
Class :
Retinoic Acid Receptor Gamma Agonists
Dosage Forms & Strengths
capsule
1mg
1.5mg
2.5mg
5mg
10mg
Fibrodysplasia Ossificans Progressiva
Take a dose of 5 mg orally daily
Dosing Considerations
Get a negative pregnancy test as soon as possible before starting therapy and then every few weeks after that
Dosage Forms & Strengths
capsule
1mg
1.5mg
2.5mg
5mg
10mg
Fibrodysplasia Ossificans Progressiva
For 8 to 13 years old:
For 10 to 19.9 kg body weight, take a dose of 2.5 mg orally every day
For ≥60 kg body weight, take a dose of 5 mg orally every day
For ≥14 years old:
Take a dose of 5 mg orally every day
Dosing Considerations
Get a negative pregnancy test as soon as possible before starting therapy and then every few weeks after that
Refer to adult dosing
Actions and Spectrum
The retinoic acid receptor gamma (RAR) is selectively activated by palovarotene to produce its effects. Nuclear receptor RAR is play a key role in the control of bone and skeletal development.
None
Black Box Warning:
None
Contraindication/Caution:
None
Pregnancy warnings:
Pregnancy category: Contraindicated during pregnancy.
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
<b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
acology
For the prevention of heterotopic ossification linked to fibrodysplasia ossificans progressiva, a selective retinoic-acid receptor gamma (RAR) agonist is used.
Pharmacodynamics
Limited information available
Pharmacokinetics
Absorption
Its absorption occurs in the gastrointestinal tract.
Distribution
palovarotene is distributed throughout the body.
Metabolism
palovarotene undergoes metabolism in the liver by various cytochrome P450 enzymes,
Elimination and excretion
The elimination of palovarotene and its metabolites occurs through the feces.
Administration
palovarotene is administered orally in the form of tablets or capsules.
Patient information leaflet
Generic Name: palovarotene
Why do we use palovarotene?
palovarotene is recommended to treat adults and children ((≥8 years old for females and ≥10 years old for males) with Fibrodysplasia Ossificans Progressiva (FOP) to lessen the development of heterotopic ossification.
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