Redemplo

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months.
• ( 2.1 ) 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.
• ( 2.2 )
• 2.1 Recommended Dosage The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months.
• 2.2 Important Administration Instructions Prior to initiation, train patients and/or caregivers on proper preparation and administration of REDEMPLO [see Instructions for Use ] .
• 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.

Quoted from the official label, section “Dosage & Administration”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

The safety and effectiveness of REDEMPLO in pediatric patients with FCS have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the 75 patients with FCS randomized in Trial 1, 9 (12%) were 65 years of age or older, including 2 (3%) patients who were 75 years of age 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Arrowhead Pharmaceuticals Inc. at 1-844-REDEMPLO (1-844-733-3675), or https://arrowheadpharma.com/safetyreporting, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 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) [see Clinical Studies ( 14 )] .
• 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 [see Dosage and Administration ( 2.1 )] .
• 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 Reactions Occurring in Greater than or Equal to 10% of REDEMPLO-treated Patients and Greater than 5% More Frequently than with Placebo in Trial 1 1 Grouped terms composed of several similar terms Adverse Reactions Placebo (N=25) (%) REDEMPLO (N=50) (%) Hyperglycemia 1 2 (8%) 10 (20%) Headache 2 (8%) 8 (16%) Nausea 2 (8%) 7 (14%) Injection site reaction 1 1 (4%) 5 (10%) 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 [see Clinical Studies ( 14 )] .
• 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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) [see Dosage and Administration ( 2.2 )] .
• 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 [see Dosage and Administration ( 2.2 )] .
• Distributed by: Arrowhead Pharmaceuticals, Inc.
• Pasadena, CA 91105 © 2025, Arrowhead Pharmaceuticals, Inc.
• All rights reserved.
• REDEMPLO is a registered trademark of Arrowhead Pharmaceuticals, Inc.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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. Injection:
• 25 mg/0.5 mL solution in a single-dose pre-filled syringe. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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.

Quoted from the official label, section “How Supplied”.

What is in it

• 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.
• Each strand of plozasiran also includes multiple phosphorothioates.
• The molecular formula of plozasiran sodium is C 493 H 611 F 11 N 164 Na 43 O 311 P 43 S 7 and its molecular weight is 16,563.98 Da.
• Plozasiran sodium is freely soluble in water.
• Plozasiran has the following structural formula: Abbreviations: A = 2’-O-methyladenosine;
• A = 2’-fluoro(2’-deoxy-2’-fluoro)adenosine;
• C = 2’-O-methylcytidine;
• C = 2’-fluorocytidine;
• G = 2’-O-methylguanosine;
• G = 2’-fluoroguanosine;
• I = 2’-O-methylinosine;
• U = 2’-O-methyluridine;
• U = 2’-fluorouridine; - (single line) = phosphodiester linkage; = (double line) = phosphorothioate linkage; · (middle dot) depicts base pairing between the two strands 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), sodium chloride to adjust tonicity, and water for injection.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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