Pegvaliase-pqpz

Warning

Anaphylaxis

• Risk of anaphylaxis; may occur at any time during therapy. (See Anaphylaxis under Cautions.)

• Administer initial dose under supervision of a healthcare provider capable of managing anaphylaxis and closely monitor patient for ≥60 minutes following injection.

• Prior to self-administration, confirm patient competency, including ability to recognize signs and symptoms of anaphylaxis and administer an epinephrine autoinjector. Consider having an adult observer present during and for ≥60 minutes after administration for patients who may require assistance recognizing and managing anaphylaxis; the adult observer should be able to administer an epinephrine autoinjector and call for emergency medical support upon its use.

• Prescribe an epinephrine autoinjector for patients to have available at all times during pegvaliase therapy; instruct patients and/or caregivers on how to recognize signs and symptoms of anaphylaxis, and how to administer the epinephrine autoinjector.

• If anaphylaxis occurs, assess risks and benefits of continuing therapy. If decision is made to continue therapy, administer first dose under supervision of a healthcare provider prepared to manage anaphylaxis; closely monitor patient for ≥60 minutes after administration.

• Because of risk of anaphylaxis, pegvaliase-pqpz is available only through a restricted distribution program (REMS). (See REMS and also see Restricted Distribution Program under Dosage and Administration.)

Risk Evaluation and Mitigation Strategy (REMS):

FDA approved a REMS for pegvaliase-pqpz to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of pegvaliase-pqpz and consists of the following: elements to assure safe use and implementation system. See https://www.accessdata.fda.gov/scripts/cder/rems/.