Satralizumab

Safety Monitoring During Treatment Liver Transaminases Monitor ALT and AST levels every 4 weeks for the first 3 months of treatment with ENSPRYNG, followed by every 3 months for one year, and thereafter as clinically necessary [see Warnings and Precautions ]. If an ALT or AST elevation of greater than 5 times the ULN occurs, discontinue ENSPRYNG as follows: If associated with any bilirubin elevation, discontinue ENSPRYNG, and reinitiation is not recommended .

If not associated with any bilirubin elevation above the ULN, when the ALT or AST level has returned to the normal range and following a benefit-risk assessment of the patient, treatment with ENSPRYNG can be restarted per the schedule in Table 2 . [See table below.] If treatment is restarted, the liver parameters must be closely monitored, and if any subsequent increase in ALT/AST and/or bilirubin above the ULN is observed, ENSPRYNG should be discontinued, and another reinitiation is not recommended.

Neutrophil Counts Monitor neutrophils 4 to 8 weeks after initiation of therapy and thereafter at regular clinically determined intervals. If the neutrophil count is below 1.0 × 10 9 /L and confirmed by repeat testing, ENSPRYNG should be interrupted until the neutrophil count is > 1.0 × 10 9 /L [see Warnings and Precautions ].

Important Administration Instructions ENSPRYNG is intended for patient self-administration by subcutaneous injection under the guidance of a health care professional (HCP). After proper training in subcutaneous injection technique, a patient may self-inject ENSPRYNG or the patient's caregiver may administer ENSPRYNG, if the HCP determines that it is appropriate.

Refer patients and/or caregivers to the ENSPRYNG "Instructions for Use" (IFU) for the prefilled syringe or the IFU for the autoinjector, as appropriate, for more detailed instructions on the preparation and administration of ENSPRYNG. Patients or caregivers should seek immediate medical attention if the patient develops symptoms of a serious allergic reaction and should not administer further doses until evaluated by an HCP [see Contraindications and Warning and Precautions ] .

Prior to use, remove ENSPRYNG from the refrigerator and allow it to sit at room temperature outside of the carton for 30 minutes. Do not warm ENSPRYNG in any other way. Inspect visually for particulate matter and discoloration prior to administration. ENSPRYNG solution should be clear and colorless to slightly yellow. Do not use ENSPRYNG if the solution is cloudy, discolored, contains particles, or if the prefilled syringe or the autoinjector appears to be damaged or has been dropped.

Instruct patients who are prescribed the prefilled syringe to inject the full amount (1 mL), which provides 120 mg of ENSPRYNG, according to the directions provided in the IFU. Administer ENSPRYNG by subcutaneous injection in the abdomen or thigh. Do not inject into the 2-inch (5 cm) area around the navel. Rotate injection sites with each administration.

Each injection must be at least 1 inch (2.5 cm) away from the most recent injection site. Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.