Takhzyro® (lanadelumab-flyo) is now available in a prefilled syringe formulation for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
The prefilled syringe is provided as a 300mg/2mL (150mg/mL) ready-to-use solution for subcutaneous injection into the abdomen, thigh, or upper arm. Compared with the single-dose vials, the prefilled syringe does not require additional reconstitution or dilution for administration, which reduces the number of preparation steps.
Following training by a health care provider, Takhzyro may be self-administered or administered by a caregiver. The prefilled syringe should be taken out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature. Any unused portion of drug remaining in the prefilled syringe should be discarded.
In August 2018, the Food and Drug Administration (FDA) approved Takhzyro for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. The approval was based on data from clinical trials, including the phase 3 HELP (Hereditary Angioedema Long-Term Prophylaxis) study (ClinicalTrials.gov Identifier: NCT02586805) and the HELP open-label extension study (ClinicalTrials.gov Identifier: NCT02586805).
“By introducing Takhzyro prefilled syringe to the HAE community, our aim is to continue to enhance the patient experience. With this advancement, those taking Takhzyro can now live their life with a ready-to-use option that requires fewer steps and less waste than when using the single-dose vial to receive their injection,” said Cheryl Schwartz, senior vice president, Rare Disease Business Unit at Takeda Pharmaceutical Company Limited.
- Takeda’s Takhzyro® (lanadelumab-flyo) prefilled syringe now available for people with hereditary angioedema (HAE) ages 12 years and older in the United States. News release. Takeda Pharmaceutical Company Limited. Accessed April 18, 2022. https://www.businesswire.com/news/home/20220418005108/en/Takeda%E2%80%99s-TAKHZYRO%C2%AE-lanadelumab-flyo-Prefilled-Syringe-Now-Available-for-People-With-Hereditary-Angioedema-HAE-Ages-12-Years-and-Older-in-the-United-States
- Takhzyro. Package insert. Takeda Pharmaceutical Company Limited; 2022. Accessed April 18, 2022. https://www.shirecontent.com/PI/PDFs/TAKHZYRO_USA_ENG.pdf