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Brand Name :
Forzinity
Synonyms :
Elamipretide
Class :
Mitochondrial Cardiolipin Binder
Brand Name :
Forzinity
Synonyms :
Elamipretide
Class :
Mitochondrial Cardiolipin Binder
ADULT DOSING
Dosage Forms & Strengths
Solution
280mg/3.5ml
Administer dose of 40 mg through subcutaneous route daily
Refer adult dosing
Elamipretide is a small molecule peptide that has mitochondrial-targeting properties.
It modulates mitochondrial function and has potential therapeutic applications in various mitochondrial diseases and disorders.
It can help preserve mitochondrial integrity and promote efficient energy production by stabilizing the membrane potential.
Mitochondrial dysfunction can lead to increased production of reactive oxygen species (ROS) that causes oxidative stress and cellular damage.
It promotes mitochondrial fusion and inhibits excessive mitochondrial fission, which can help maintain mitochondrial structure and function.
Frequency defined
>10%
Injection site bruising
Injection site urticaria
Injection site erythema
Injection site induration
Injection site pruritus
Injection site pain
None
Contraindications:
Hypersensitivity
Caution:
Risk of benzyl alcohol toxicity in neonates
Serious allergic reactions occur within minutes to months after start of treatment.
Patients who have had a severe hypersensitivity reaction should not be re-challenged.
Pregnancy consideration: N/A
Lactation: N/A
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
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
Pharmacology:
Elamipretide acts on the mitochondria, the cellular organelles responsible for energy production.
To stabilize the structure of the mitochondrial cristae, lower oxidative stress, and increase the synthesis of adenosine triphosphate (ATP), this mitochondrial cardiolipin binder, which binds to the inner mitochondrial membrane, enhances the shape and function of the mitochondria.
Pharmacodynamics:
The peptide elamipretide has alternating cationic and aromatic residues and is cell permeable.
Because of its positive charge and aromaticity, it localizes specifically to the inner mitochondrial membrane (IMM).
It has a strong affinity for cardiolipin, a special phospholipid present in the IMM that is essential for preserving the shape of the mitochondrial cristae and arranging the respiratory chain complexes.
Pharmacokinetics:
Absorption:
It shows bioavailability up to 92%.
It has peak plasma time of 0.5 to 1 hour.
Distribution:
It has volume of distribution of 0.5 L/kg
It shows protein binding up to 39%.
Metabolism:
It metabolized through sequential C-terminal degradation to M1 tripeptide and M2 dipeptide metabolites pathways.
Excretion and elimination:
It is excreted through urine as parent drug.
It is administered subcutaneously.
Give the dosage at the same time every day.
SC should be administered in the outer thigh or abdomen, minimum 2 inches from the navel.
The injection site should be rotated on daily basis.
Avoid injecting in areas of skin that are hard, red, bruised, or painful.
Keep your injections away from stretch marks and scars.
Take the following dosage at the regularly scheduled time and skip the missing dose.
Patient information leaflet
Generic Name: elamipretide
Why do we use elamipretide?
It is indicated for children and adults with Barth syndrome who weigh at least 30 kg to increase their muscle strength.
Clinical studies showed that forzinity injection significantly increased the strength of the knee extensor muscles.
Stretching muscles improves the cellular energy generation of muscle cells.
By restoring mitochondrial activity, this focused strategy treats the underlying cause of muscular weakness in individuals with Barth syndrome.
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