REDEMPLO- plozasiran injection, solution

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REDEMPLO- plozasiran injection, solution
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Anum Ijaz M.B.B.S., M.D.[2]

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Overview

REDEMPLO- plozasiran injection, solution is an apolipoprotein C-III (apoC-III)-directed small interfering ribonucleic acid (siRNA) that is FDA approved for the treatment of for hypertriglyceridemia in adults with familial chylomicronemia syndrome (FCS), as an adjunct to diet.. Common adverse reactions include hyperglycemia, headache, nausea, and injection site reaction..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Familial Chylomicronemia Syndrome

  • REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

Dosing Information

  • The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months.
Important Administration Instructions
  • Prior to initiation, train patients and/or caregivers on proper preparation and administration of REDEMPLO.
  • Adhere to a low-fat diet (less than or equal to 20 grams fat per day) in conjunction with REDEMPLO.
  • Visually inspect the REDEMPLO pre-filled syringe prior to administration.
  • The solution should be clear and colorless to yellow.
  • Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration.
  • Inject REDEMPLO subcutaneously into the front of the thigh or abdomen.
  • The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection.
  • Do not inject REDEMPLO in an area where the skin is damaged (tender, bruised, red, hard, or cut).
  • Do not inject into areas with scars or stretch marks.
  • If a dose is missed, administer REDEMPLO as soon as possible.
  • Resume dosing every 3 months from the date of the most recently administered dose.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of REDEMPLO- plozasiran injection, solution in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of REDEMPLO- plozasiran injection, solution in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding REDEMPLO- plozasiran injection, solution FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of REDEMPLO- plozasiran injection, solution in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of REDEMPLO- plozasiran injection, solution in pediatric patients.

Contraindications

None.

Warnings

There is limited information regarding REDEMPLO- plozasiran injection, solution Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

Clinical Trials Experience

  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REDEMPLO cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The safety of REDEMPLO was evaluated in 75 patients with FCS enrolled in Trial 1 (NCT05089084).
  • In this trial, patients received at least one dose of REDEMPLO 25 mg (N=26) or 50 mg of plozasiran (N=24) and 25 patients received placebo.
  • Plozasiran 50 mg is not an approved dosage regimen for FCS.
  • Across treatment groups, the mean age was 46 years and 49% of patients were male.
  • Seventy-three percent (73%) of patients were White, 21% were Asian, and 5% were reported as other races; 3% identified as Hispanic or Latino ethnicity.
  • Fifty (50) patients were exposed to REDEMPLO for a median of 11.6 months; 26 patients were treated with REDEMPLO 25 mg every 3 months for a median of 11.8 months.
  • Adverse reactions led to discontinuation of treatment in 3 (6.0%) of REDEMPLO-treated patients and 0% of placebo-treated patients.
  • The reasons for REDEMPLO treatment discontinuation were hyperglycemia and urticaria.
  • Adverse reactions occurring in greater than or equal to 10% of REDEMPLO-treated patients and greater than 5% more frequently than in placebo-treated patients are listed below in Table 1.

Table 1

Adverse ReactionsPlacebo
(N=25)
(%)		REDEMPLO
(N=50)
(%)
Hyperglycemia12 (8%)10 (20%)
Headache2 (8%)8 (16%)
Nausea2 (8%)7 (14%)
Injection site reaction11 (4%)5 (10%)

1Grouped terms composed of several similar terms

Laboratory Tests

Increase in Glucose

  • Mean increases from baseline in HbA1c (up to 0.36%) and fasting glucose (up to 9 mg/dL) were observed over time in the 25 mg REDEMPLO group.
  • The incidence of hyperglycemia (defined as adverse events consistent with diabetes mellitus or hyperglycemia, new antidiabetic medication, or laboratory values) was higher in 25 mg REDEMPLO-treated patients without a medical history of diabetes at baseline (40%) compared to placebo-treated patients (20%).

Increase in Liver Enzymes

  • Increases from baseline liver enzymes within the normal range were observed with plozasiran treatment in the FCS population.
  • These increases occurred within the first 3 months of treatment and stabilized.

Increase in LDL-cholesterol

  • Increases in low-density lipoprotein cholesterol (LDL-C) and total apolipoprotein B (apoB) were observed in the FCS population treated with REDEMPLO compared to those treated with placebo.
  • Despite increases in the LDL-C, the average LDL-C value at Month 12 was less than 50 mg/dL in the 25 mg REDEMPLO group.

Postmarketing Experience

There is limited information regarding REDEMPLO- plozasiran injection, solution Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding REDEMPLO- plozasiran injection, solution Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Risk Summary

  • There are insufficient data on REDEMPLO use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • Patients with FCS are at risk for pancreatitis during pregnancy because of defects in lipid metabolism and increased triglyceride levels.
  • In animal reproduction studies, no adverse drug-related developmental effects were observed in pregnant rats or rabbits with subcutaneous administration of plozasiran during organogenesis up to 23 and 140 times, respectively, the maximum recommended human dose (MRHD).
  • The background risk of major birth defects and miscarriage for the indicated population is unknown.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo-Fetal Risk

  • Triglyceride levels increase during the third trimester of pregnancy.
  • In patients with underlying defects in lipid metabolism, such as FCS, severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy.

Data

Animal Data

  • In an embryo-fetal development study, pregnant rats were administered plozasiran by subcutaneous injection at 0, 5, 15, or 60 mg/kg, or 60 mg/kg rat specific surrogate, once daily during the period of organogenesis (gestational days 6 to 17).
  • There was no evidence of drug-related embryo-fetal toxicity or fetal malformations up to 60 mg/kg plozasiran [23 times the MRHD based on body surface area (BSA)].
  • At maternally toxic doses there were embryo-fetal toxicities including increases in post-implantation loss and mean number of late resorptions at 60 mg/kg (23 times the MRHD based on BSA), early deliveries, reduced fetal body weight, and fetal skeletal developmental variations at ≥15 mg/kg (6 times the MRHD based on BSA).
  • No adverse embryo-fetal developmental effects were observed from a single subcutaneous administration of 50 mg/kg plozasiran (19 times the MRHD based on BSA) or the rat specific surrogate to pregnant rats on gestation day 10.
  • In an embryo-fetal development study in pregnant rabbits, plozasiran was administered by subcutaneous injection at 0, 30, 60, or 180 mg/kg/day once daily during the period of organogenesis (gestational days 7 to 19).
  • No evidence (of embryo-fetal toxicity or developmental abnormalities) was observed up to 180 mg/kg (140 times the MRHD based on BSA).
  • In a rat pre- and post-natal development study, plozasiran was administered at 0, 8, 24, or 80 mg/kg by subcutaneous injection once a week from gestation day 6 through lactation day 17.
  • Plozasiran increased the number of females with stillborn offspring and the increase in stillborn offspring per litter resulted in reductions in live birth index at 80 mg/kg (31 times the MRHD based on BSA).
  • There were decreases in offspring body weight and offspring survival at ≥24 mg/kg (9 times the MRHD based on BSA).
  • No adverse effects were noted on offspring development up to 80 mg/kg (31 times the MRHD based on BSA).


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of REDEMPLO- plozasiran injection, solution in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of REDEMPLO- plozasiran injection, solution during labor and delivery.

Nursing Mothers

Risk Summary

  • There is no information regarding the presence of plozasiran in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
  • Oligonucleotide-based products typically have poor oral bioavailability.
  • Therefore, it is considered that if plozasiran is present in breastmilk, it is unlikely to lead to clinically relevant levels in breastfed infants.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for REDEMPLO and any potential adverse effects on the breastfed infant from REDEMPLO or from the underlying maternal condition.

Pediatric Use

There is no FDA guidance on the use of REDEMPLO- plozasiran injection, solution in pediatric settings.

Geriatic Use

  • Of 75 patients randomized in Trial 1, 9 (12%) were 65 years or older, including 2 (3%) age 75 or older.
  • No overall differences in safety or effectiveness of REDEMPLO have been observed between patients 65 years of age and older and younger adult patients.

Gender

There is no FDA guidance on the use of REDEMPLO- plozasiran injection, solution with respect to specific gender populations.

Race

There is no FDA guidance on the use of REDEMPLO- plozasiran injection, solution with respect to specific racial populations.

Renal Impairment

  • The recommended dosage of REDEMPLO in patients with mild or moderate renal impairment (eGFR ≥30 to <90 mL/min) is the same as those with normal renal function.
  • The impact of severe renal impairment or end stage renal disease is not known.

Hepatic Impairment

  • The recommended dosage of REDEMPLO in patients with mild hepatic impairment [total bilirubin ≤1 times the upper limit of normal (ULN) and AST >1 times ULN, or total bilirubin >1.0 to 1.5 times ULN and any AST] is the same as those with normal hepatic function.
  • The impact of moderate or severe hepatic impairment is not known.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of REDEMPLO- plozasiran injection, solution in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of REDEMPLO- plozasiran injection, solution in patients who are immunocompromised.

Administration and Monitoring

Administration

  • The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months.
  • Prior to initiation, train patients and/or caregivers on proper preparation and administration of REDEMPLO.
  • Adhere to a low-fat diet (less than or equal to 20 grams fat per day) in conjunction with REDEMPLO.
  • Visually inspect the REDEMPLO pre-filled syringe prior to administration.
  • The solution should be clear and colorless to yellow.
  • Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration.
  • Inject REDEMPLO subcutaneously into the front of the thigh or abdomen.
  • The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection.
  • Do not inject REDEMPLO in an area where the skin is damaged (tender, bruised, red, hard, or cut).
  • Do not inject into areas with scars or stretch marks.
  • If a dose is missed, administer REDEMPLO as soon as possible.
  • Resume dosing every 3 months from the date of the most recently administered dose.

Monitoring

There is limited information regarding REDEMPLO- plozasiran injection, solution Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of REDEMPLO- plozasiran injection, solution and IV administrations.

Overdosage

There is limited information regarding REDEMPLO- plozasiran injection, solution overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding REDEMPLO- plozasiran injection, solution Pharmacology in the drug label.

Mechanism of Action

  • Plozasiran is a siRNA conjugated with GalNAc that degrades the apoC-III mRNA through the RNA interference mechanism resulting in reduced levels of hepatic and serum apoC-III protein.
  • Reduction of apoC-III protein leads to increased clearance of serum triglycerides.

Structure

  • REDEMPLO contains plozasiran (present as plozasiran sodium), a small interfering RNA (siRNA) that degrades apolipoprotein C-III (apoC-III) mRNA by RNA interference.
  • Plozasiran contains a covalently linked ligand containing three N-acetylgalactosamine (GalNAc) residues to facilitate delivery to hepatocytes.
  • The 2´ positions of the ribose subunits in plozasiran are modified with either fluorine (2´F) or methoxy (2´O-Me) groups.

Add structure image

  • Each strand of plozasiran also includes multiple phosphorothioates.
  • The molecular formula of plozasiran sodium is C493H611F11N164Na43O311P43S7 and its molecular weight is 16,563.98 Da.
  • Plozasiran sodium is freely soluble in water.
  • REDEMPLO is a sterile, preservative-free, clear, colorless to yellow solution for subcutaneous use in a prefilled syringe.
  • Each syringe contains 0.5 mL of solution containing 25 mg plozasiran (present as 27 mg plozasiran sodium).
  • Inactive ingredients: sodium chloride to adjust tonicity, and water for injection.

Dosage Forms and Strengths

  • Injection: 25 mg/0.5 mL of plozasiran as a clear and colorless to yellow solution in a single-dose pre-filled syringe.

Pharmacodynamics

  • In Trial 1, following the recommended dose of 25 mg administered every 3 months in patients with FCS, REDEMPLO reduced median fasting serum apoC-III protein.
  • The placebo-corrected median percent change in fasting serum apoC-III protein from baseline was -90% at 1 month, -93% at 3 months, -82% at 6 months, -91% at 10 months, and -87% at 12 months.
  • At a dose 4 times the recommended dose of 25 mg administered every 3 months, clinically significant QTc interval prolongation was not observed.

Pharmacokinetics

  • REDEMPLO exhibited linear and time-invariant pharmacokinetics following subcutaneous injections within the dose range of 10 mg to 100 mg.
  • The following pharmacokinetic parameters were observed in healthy adults after receiving a 25 mg dose of REDEMPLO.

Absorption

  • Plozasiran peak plasma concentration (Cmax) is 68.5 ng/mL.
  • The median time to reach Cmax (Tmax) is 6 hours.

Distribution

  • Plozasiran is 78% protein bound in vitro at the clinically relevant plasma concentrations.
  • Following subcutaneous multiple administration of 25 mg plozasiran, the apparent volume of distribution is approximately 146 L.
  • Plozasiran is distributed in plasma and extracellular body water before its uptake by hepatocytes to decrease apoC-III mRNA expression and reduce serum triglycerides.

Elimination

  • The terminal elimination half-life of plozasiran in plasma is approximately 3 to 4 hours.
  • The mean apparent systemic clearance is 33.8 L/hour.

Metabolism

  • Plozasiran is primarily metabolized by nucleases to shorter oligonucleotides of varying lengths.

Excretion

  • Approximately 16 to 19% of REDEMPLO dose is excreted in urine.

Specific Populations

  • No clinically significant differences in plozasiran pharmacokinetics based on age, sex, race, mild and moderate renal impairment (eGFR ≥30 to <90 mL/min), or mild hepatic impairment (total bilirubin ≤1 times ULN and AST >1 times ULN, or total bilirubin >1.0 to 1.5 times ULN and any AST) were found in the population pharmacokinetic analysis.
  • The impact of severe renal impairment, end-stage renal impairment, or moderate to severe hepatic impairment is not known.

Drug Interaction Studies

In Vitro Assessment of Drug Interactions

CYP450 Enzymes
  • Plozasiran is not a substrate, inhibitor, or inducer of CYP450 enzymes at clinically relevant concentrations.
Transporter Systems
  • Plozasiran is not a substrate or an inhibitor of P-gp, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2-K.

Immunogenicity

  • The observed incidence of anti-drug antibodies (ADAs) is highly dependent on the sensitivity and specificity of the assay.
  • Differences in assay methods preclude meaningful comparisons of the incidence of ADAs in the trial described below with the incidence of anti-drug antibodies in other studies, including those of plozasiran.
  • In Trial 1, none of the 50 FCS-patients treated with REDEMPLO over a period of 12 months developed treatment-induced or treatment-boosted ADAs.
  • Because ADAs were not observed in the limited number of REDEMPLO-treated patients, the effect of ADAs on the pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of REDEMPLO products is unknown.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

  • In a 26-week study in RasH2Tg mice, plozasiran was administered subcutaneously once every 8 weeks at dose levels of 30, 60, and 120 mg/kg.
  • Plozasiran was not carcinogenic up to the highest tested dose of 120 mg/kg (23-times MRHD based on BSA).

Mutagenesis

  • Plozasiran was not mutagenic or clastogenic in a standard battery of genetic toxicity assays, including a bacterial mutation (Ames) assay, and in vitro and in vivo mouse micronucleus assays.

Impairment of Fertility

  • In a fertility and early embryonic-development study, male and female rats were administered subcutaneously with vehicle or plozasiran at the doses of 12.5, 25 or 50 mg/kg or rat specific surrogate at 25 mg/kg.
  • Males were treated once weekly before and throughout cohabitation, while females received treatment either once every 3 days or once weekly before and through mating until gestation day 6.
  • There were no adverse effects on mating and fertility in males or females up to 50 mg/kg corresponding to 19-times the MRHD, based on BSA.

Clinical Studies

  • The efficacy of REDEMPLO was demonstrated in a randomized, placebo-controlled, double-blind trial in adult patients with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet (≤20 grams fat per day) (Trial 1; NCT05089084).
  • Patients were randomized to receive four total doses of REDEMPLO 25 mg (n=26) or matching placebo (n=25), injected subcutaneously once every 3 months over a 12-month treatment period
  • The diagnosis of FCS was based on adults with a screening fasting TG ≥880 mg/dL refractory to lipid-lowering therapy, with a history of elevated triglycerides (in excess of 1,000 mg/dL at least three times), and evidence of FCS by known genotypes, evidence of low lipoprotein lipase activity, or a clinical diagnosis.
  • In this trial, for patients with clinically diagnosed FCS, the inclusion criteria specified at least one of the following: recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis; recurrent hospitalizations for severe abdominal pain without other explainable cause; childhood pancreatitis; or family history of hypertriglyceridemia-induced pancreatitis.
  • Patient demographics were generally similar across the treatment groups.
  • At enrollment, the percentage of patients with genetic confirmation of FCS was 46% in the REDEMPLO 25 mg group compared with 56% in the placebo group; diabetes was 15% in the REDEMPLO 25 mg group compared with 32% in the placebo group; and a history of documented acute pancreatitis in the prior 5 years was 54% in the REDEMPLO 25 mg group compared with 68% in the placebo group.
  • Patients in the REDEMPLO 25 mg and placebo groups were treated with statins (43%), omega-3 fatty acids (29%), fibrates (69%), or no background TG lowering therapies (25%) at study entry.
  • Mean (SD) and median fasting TG levels at baseline were 2,311 (1,258) mg/dL and 2,030 mg/dL, respectively (range of 747 to 5,596 mg/dL).
  • The primary efficacy endpoint was percent change in fasting triglycerides from baseline at Month 10 (average of 2 assessments, 2 to 7 days apart).
  • The median difference between REDEMPLO 25 mg and the placebo group in percent change in fasting triglyceride levels from baseline to Month 10 was -58.7% (95% CI: -89.6, -27.9; p< 0.0001).
  • For additional results see Table 2.

Baseline and Percent Changes from Baseline in Lipid/Lipoprotein Parameters in Patients with FCS at Month 10 in Trial 1

Parameter (mg/dL)REDEMPLO 25 mg
N=26		Placebo (pooled)
N=25		REDEMPLO 25 mg vs. Placebo
Treatment Difference
% change (95% CI) at Month 10
BL% change at Month 10BL% change at Month 10
Triglyceridesb2008-802053-17-59a (-90, -28)
Non-HDL-Cc279-392684-42 (-67, -18)
LDL-Cc24112282092 (4, 180)
Total ApoBc7227791215 (-16, 46)
ApoB-48c10-611145-106 (-180, -33)

a Reached statistical significance (p value < 0.0001).

b Median; Hodges-Lehmann method was used to estimate the median difference (location shift) and its corresponding 95% confidence interval for percent changes. Missing data were imputed using washout imputation.

c Mean; Analysis of covariance (ANCOVA) model was used to estimate the mean difference and its corresponding 95% confidence interval for percent changes. Missing data were imputed using washout imputation.

  • Median percent change in TG from baseline (Figure 1) and median absolute TG values (Figure 2) over time demonstrated a consistent lowering effect during the 12-month treatment period.
  • Over the 12-month treatment period, the numerical incidence of acute pancreatitis in patients treated with REDEMPLO 25 mg was lower compared with placebo [2 (8%) patients in the REDEMPLO 25 mg group compared with 5 (20%) patients in the placebo group].

How Supplied

  • Injection: 25 mg/0.5 mL of plozasiran as a clear and colorless to yellow solution in a single-dose pre-filled syringe.
  • REDEMPLO injection is a clear and colorless to yellow solution supplied in a single-dose prefilled syringe.
  • Each prefilled syringe of REDEMPLO is filled to deliver 0.5 mL of solution containing 25 mg of plozasiran.
  • REDEMPLO is available in cartons containing one 25 mg single-dose prefilled syringe each (NDC 84141-025-01).

Storage

  • Store REDEMPLO refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton, until ready for use.
  • REDEMPLO prefilled syringe can also be kept at room temperature at 20°C to 25°C (68°F to 77°F) in the original carton for up to 30 days.
  • If not used within the 30 days stored at room temperature, discard REDEMPLO.

Images

Drug Images

Package and Label Display Panel

PD panel 1.

Patient Counseling Information

General Instruction

  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Adherence to Diet

  • Advise patients with FCS that use of lipid-regulating agents does not reduce the importance of adhering to a low-fat diet (less than or equal to 20 grams fat per day).

Missed Dose

  • Instruct patients to take REDEMPLO as prescribed.
  • If a dose is missed, instruct patients to take as soon as they remember.
  • Resume dosing every 3 months from the date of the most recently administered dose.

Precautions with Alcohol

Alcohol-REDEMPLO- plozasiran injection, solution interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Redemplo

Look-Alike Drug Names

There is limited information regarding REDEMPLO- plozasiran injection, solution Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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