Tezepelumab

Recommended dosage is 210 mg administered once every 4 weeks. ( 2.1 ) • Administer by subcutaneous injection. ( 2.1 ) • See full prescribing information for preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks. Missed Dose Information If a dose is missed, administer the dose as soon as possible. Thereafter, the patient can continue (resume) dosing on the usual day of administration. If the next dose is already due, then administer as planned. 2.2 Preparation and Administration Instructions TEZSPIRE vial and pre‑filled syringe are intended for administration by a healthcare provider. TEZSPIRE pre-filled pen can be administered by patients/caregivers or healthcare providers. Patients/caregivers may administer TEZSPIRE pre-filled pen after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate. Each vial, pre-filled syringe and pre‑filled pen contain a single dose of TEZSPIRE. • Prior to administration, remove TEZSPIRE from the refrigerator and allow it to reach room temperature. This generally takes 60 minutes. Do not expose to heat and do not shake. Do not use if the security seal on the carton has been broken. Do not put back in the refrigerator once TEZSPIRE has reached room temperature. • Visually inspect TEZSPIRE for particulate matter and discoloration prior to administration. TEZSPIRE is a clear to opalescent, colorless to light yellow solution. Do not use TEZSPIRE if liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. Do not use if the vial, pre-filled syringe or pre‑filled pen has been dropped or damaged or if the expiration date has passed. • Inject TEZSPIRE 210 mg (contents of one vial, one pre-filled syringe or one pre-filled pen as described below) subcutaneously into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. If a healthcare provider or caregiver administers the injection, the upper arm can also be used. A patient should not self-inject in the upper arm. TEZSPIRE should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. It is recommended to rotate the injection site with each injection. Administration Instructions for Single-Dose Pre-filled Syringe Refer to Figure 1 to identify the pre-filled syringe components for use in the administration steps. Do not remove the needle cover until Step 2 of these instructions when you are ready to inject TEZSPIRE. Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard. Figure 1 TEZSPIRE Pre-filled Syringe Components 1. Grasp the syringe body to remove the pre-filled syringe from its carton. Do not grab the pre-filled syringe by the plunger. The pre-filled syringe may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration. 2. Do not remove the needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover. You may see a drop of liquid at the end of the needle. This is normal. 3. Gently pinch the skin and administer subcutaneously at approximately 45° angle into the recommended injection site (i.e., upper arm, thigh, or abdomen). 4. Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard. 5. After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the pre-filled syringe. 6. Discard the used syringe into a sharps container. Administration Instructions for Single-Dose Pre-filled Pen These administration instructions are intended f