TRUTAKNA Solution for injection Ref.[116723] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2026 

1. Indications and Usage

TRUTAKNA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

2. Dosage and Administration

2.1 Recommended Dosage

The recommended dosage of TRUTAKNA is 150 mg injected subcutaneously (SC) once weekly.

Missed Doses

If a dose is missed, administer the missed dose as soon as possible and then resume once weekly dosing thereafter, one week from administration of the missed dose.

2.2 Preparation and Administration Instructions

  • TRUTAKNA autoinjector is intended for SC administration by patients/caregivers at home. The TRUTAKNA "Instructions for Use" contains more detailed instructions on the preparation and administration of TRUTAKNA [see Instructions for Use].
  • Remove TRUTAKNA autoinjector from the refrigerator and allow it to sit for 15 to 30 minutes at room temperature between 15°C to 25°C (60°F to 77°F) prior to injecting.
  • Do not use an external heat source to heat TRUTAKNA, because heat may damage the product.
  • If needed, TRUTAKNA autoinjector may be stored at room temperature up to 25°C (77°F), for a single period of 3 days (72 hours). Once TRUTAKNA has been stored at room temperature, it should not be placed back into the refrigerator. Discard the autoinjector if not used within this 72‑hour period.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. TRUTAKNA should appear as a clear to slightly opalescent, brownish-yellow solution. Do not use if the liquid contains particles or is cloudy.
  • Administer each injection at a different location than the previous injection. Sites for injections include the abdomen and thigh.

16.2. Storage and Handling

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

If needed, TRUTAKNA autoinjector may be stored at room temperature up to 25°C (77°F), for a single period of 3 days (72 hours). Once TRUTAKNA has been stored at room temperature, it should not be placed back into the refrigerator. Discard the autoinjector if not used within this 72‑hour period. Do not freeze. Do not shake. Do not expose to heat.

< Previous: Overview
Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈