Redemplo (plozasiran sodium)
Antihyperlipidemic - apolipoprotein Synthesis Inhibitors Subcutaneous Syringe (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Plozasiran sodium is an apolipoprotein C-III (apoC-III)-directed small interfering ribonucleic acid (siRNA).
Plozasiran sodium is an apolipoprotein C-III (apoC-III)-directed small interfering ribonucleic acid (siRNA); the drug moiety is conjugated to a ligand containing 3 N-acetylgalactosamine (GalNAc) residues to facilitate delivery to hepatocytes. In familial chylomicronemia syndrome (FCS), impaired clearance of triglyceride-rich lipoproteins leads to severe hypertriglyceridemia and an increased risk of pancreatitis. Plozasiran degrades apoC-III messenger RNA (mRNA) through RNA interference, resulting in reduced hepatic and serum apoC-III protein levels and increased clearance of serum triglycerides.
In clinical trials, administration of plozasiran 25 mg subcutaneously once every 3 months reduced median fasting serum apoC-III protein by 90% at 1 month, 93% at 3 months, 82% at 6 months, 91% at 10 months, and 87% at 12 months.
Plozasiran exhibits linear pharmacokinetics over a 10-100 mg dosage range. After a 25 mg subcutaneous dose, peak plasma concentrations are reached at a median of 6 hours. Plozasiran is 78% protein bound.
Plozasiran is primarily metabolized by nucleases to shorter oligonucleotides, has a terminal plasma half-life of approximately 3-4 hours, with approximately 16-19% of the dose excreted in urine.
USES: This medication is used along with a proper diet to help lower fats (triglycerides) in the blood. It is used by people who have a certain inherited condition (familial chylomicronemia syndrome) that causes high levels of triglycerides in the blood. Plozasiran works by improving how well your body gets rid of triglycerides.
Generic name: plozasiran sodium
Drug class: Antihyperlipidemic - apolipoprotein Synthesis Inhibitors
Therapeutic class: Cardiovascular Therapy Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Redemplo
Indications
The following indications are listed for Redemplo:
- Familial Chylomicronemia Syndrome
Dosing
Dosage of plozasiran sodium is expressed in terms of plozasiran.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Redemplo 25 Mg/0.5 Ml Syringe | Maintenance | Inject 25 mg by subcutaneous route every 3 months. |
No dosing information is available for this tab.
Drug interactions
In vitro, plozasiran was not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) enzymes at clinically relevant concentrations.
Plozasiran is not a substrate or inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter 1 (OAT1), organic anion transporter 3 (OAT3), organic cation transporter 1 (OCT1), organic cation transporter 2 (OCT2), organic anion transporting polypeptide 1B1 (OATP1B1), organic anion transporting polypeptide 1B3 (OATP1B3), multidrug and toxin extrusion protein 1 (MATE1), or multidrug and toxin extrusion protein 2-K (MATE2-K).
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
Most common adverse reactions (>=10% of patients treated with plozasiran and >5% than placebo) are hyperglycemia, headache, nausea, and injection site reaction.
There are no severe adverse reactions for this drug.
More Frequent
- Headache disorder
- Hyperglycemia
- Injection site sequelae
- Nausea
Less Frequent
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of plozasiran have not been established in pediatric patients.
Data on plozasiran use in pregnancy are insufficient to determine drug-associated risk of major defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS remain at increased risk of severe hypertriglyceridemia and acute pancreatitis during pregnancy as triglyceride levels increase during the third trimester of pregnancy, possibly resulting in severe gestational hypertriglyceridemia and pancreatitis.
There are no data on plozasiran in human or animal milk, its effects on the breastfed infant, or its effects on milk production; however, clinically relevant infant exposure through breast milk is expected to be low because oligonucleotide products have poor oral bioavailability. The benefits of breastfeeding should be weighed against the need for plozasiran and any potential risks to the infant.
The manufacturer makes no specific dosage adjustment for geriatric patients.
No overall differences in safety or effectiveness of plozasiran were observed between older adults and younger adults, although limited numbers of patients >=65 years of age were studied.
ICD codes
| Code | Type | Description |
|---|---|---|
| Familial chylomicronemia syndrome | ||
| E78.3 | ICD10CM | Hyperchylomicronemia |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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