Genetically confirmed familial chylomicronemia syndrome (FCS)

Active Ingredient: Olezarsen

Indication for Olezarsen

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Olezarsen is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).

For this indication, competent medicine agencies globally authorize below treatments:

80 mg once monthly

For:

Dosage regimens

Subcutaneous, 80 milligrams olezarsen, once monthly.

Detailed description

The recommended dose of olezarsen is 80 mg administered by subcutaneous injection once monthly.

Missed dose

If a dose is missed, olezarsen should be administered as soon as possible. Dosing at monthly intervals should be resumed from the date of the most recently administered dose.

Dosage considerations

Olezarsen is intended for subcutaneous use only. It should not be administered intramuscularly.

This medicinal product should be administered into the abdomen or front of the thigh. The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection. It should not be injected into skin that is bruised, tender, red, or hard, into scars or damaged skin; the area around the navel should be avoided.

Some patients might not be responsive to the treatment after 6 months, in such a case the discontinuation of olezarsen should be considered on an individual basis by the prescribing physician.

Active ingredient

Olezarsen

Olezarsen is an antisense oligonucleotide-triantennary N-acetylgalactosamine (GalNAc 3) conjugate that causes degradation of apolipoprotein C3 (apoC-III) messenger ribonucleic acid (mRNA) through selective binding to its mRNA, which leads to ribonuclease H1 (RNase H1)-mediated cleavage of apoC-III mRNA. Olezarsen is perfectly complementary to the site on chromosome 11 positions 116, 833, 046 through 116, 833, 065, corresponding to the gene apoC-III according to Ensembl version 109 (GRCh38 build) of the homo sapiens genome. This results in specific reductions of serum apoC-III protein leading to plasma triglyceride reductions.

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