Tezspire (Tezepelumab-Ekko)

Indications and Usage (

TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated:

• •for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (
  1.1 Asthma

  TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

  Limitations of Use:

  TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
  )
•  
  Limitations of Use:
•  Not for relief of acute bronchospasm or status asthmaticus. (
  1.1 Asthma

  TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

  Limitations of Use:

  TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
  )
• •for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (
  1.2 Chronic Rhinosinusitis with Nasal Polyps

  TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
  )

Recommended dosage is 210 mg administered once every 4 weeks. (

• •Administer by subcutaneous injection. (
  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.
  )
• •See full prescribing information for preparation and administration instructions. (
  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

  1.000000000000000e+002.000000000000000e+003.000000000000000e+004.000000000000000e+005.000000000000000e+006.000000000000000e+00

  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.
  	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.
  	Gently pinch the skin and administer subcutaneously at approximately 45° angle into the recommended injection site (i.e., upper arm, thigh, or abdomen).
  	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.
  	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.
  Discard the used syringe into a sharps container.

  Administration Instructions for Single-Dose Pre-filled Pen

  These administration instructions are intended for healthcare providers use only. Patients and caregivers should refer to the TEZSPIRE pre-filled pen ‘Instructions for Use’ for more detailed instructions on the preparation and administration of TEZSPIRE pre-filled pen

  [See Instructions for Use]

  .

  Patients/caregivers may inject after proper training in subcutaneous injection technique according to the ‘Instructions for Use’, and after the healthcare provider determines it is appropriate.

  Refer to Figure 2 to identify the pre-filled pen components for use in the administration steps.

  Do not remove the cap until you are ready to inject TEZSPIRE.

  Figure 2 TEZSPIRE Pre-filled Pen Components

  1.000000000000000e+002.000000000000000e+003.000000000000000e+004.000000000000000e+005.000000000000000e+006.000000000000000e+007.000000000000000e+008.000000000000000e+00

  Grab the middle of the pre-filled pen body to remove the pre-filled pen from its carton. The pre-filled pen may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration.
  	Do not remove the cap until ready to inject. Hold the pre-filled pen body with 1 hand and carefully pull the cap straight off with your other hand. Do not touch the needle or push the orange needle guard with your finger. Do not put the cap back on the pre-filled pen. You could cause the injection to happen too soon or damage the needle.
  Gently pinch the skin at the injection site or give the injection without pinching the skin. Inject TEZSPIRE by following the steps into the recommended injection site (i.e., upper arm, thigh, or abdomen). When injecting, you will hear the first click that tells you the injection has started. Press and hold the pre-filled pen for 15 seconds until you hear the second click. Do not change the position of the pre-filled pen after the injection has started.
  		Position the pre-filled pen. Place the orange needle guard flat against the skin (90‑degree angle). Make sure you can see the viewing window.
  		Press down firmly until you cannot see the orange needle guard. You will hear the first ‘click’, this tells you the injection has started. The orange plunger will move down in the viewing window during the injection.
  		Hold down firmly for about 15 seconds. You will hear a second ‘click’, this tells you the injection has finished. The orange plunger will fill the viewing window.
  		After you have completed the injection, lift the pre-filled pen straight up. The orange needle guard will slide down and lock into place over the needle.
  Discard the used pre-filled pen into a sharps container.

  

  

  

  

  

  

  

  

  

  

  

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Injection: a clear to opalescent, colorless to light yellow solution available as:

• •210 mg/1.91 mL (110 mg/mL) solution in a single-dose glass vial.
• •210 mg/1.91 mL (110 mg/mL) solution in a single-dose pre-filled syringe.
• •210 mg/1.91 mL (110 mg/mL) solution in a single‑dose pre‑filled pen.

There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal development (ePPND) study conducted in cynomolgus monkeys, placental transport of tezepelumab-ekko was observed but there was no evidence of fetal harm following intravenous administration of tezepelumab-ekko throughout pregnancy at doses that produced maternal exposures up to 168 times the exposure at the maximum recommended human dose (MRHD) of 210 mg administered subcutaneously

The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

In the ePPND study, pregnant cynomolgus monkeys received tezepelumab-ekko from GD20 to GD22 (dependent on pregnancy determination), at the beginning of organogenesis, and once every 7 days until the end of gestation at doses that produced exposures up to 168 times that achieved with the MRHD (on an AUC basis with maternal intravenous doses up to 300 mg/kg/week). There were no tezepelumab-ekko related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development up to 6.5 months of age. Tezepelumab-ekko crossed the placenta in cynomolgus monkeys and tezepelumab-ekko serum concentrations were 0.5- to 6.7-fold higher in infants relative to maternal animals.