Tezspire

About Tezepelumab-ekko

• Tezepelumab, marketed as Tezspire, stands as a breakthrough in asthma treatment. Functioning as a human monoclonal antibody, this medication is specifically designed for individuals, aged 12 and above, grappling with severe asthma inadequately controlled by their existing asthma medication. 
• Tezepelumab received approval for medical use in the United States in December 2021 and later gained approval in the European Union in September 2022. The US Food and Drug Administration (FDA) acknowledges it as a pioneering medication, it is hailed as a first-in-class treatment. 
• Tezepelumab is administered as an add-on, injectable therapy, Tezspire is intended for self-administration beneath the skin every four weeks. Unlike rescue medications, it is not geared towards relieving acute bronchospasm or status asthmaticus; instead, it focuses on averting severe asthma attacks and enhancing overall respiratory function.
• Tezepelumab operates as a thymic stromal lymphopoietin (TSLP) blocker, Tezspire is a human monoclonal antibody of the IgG2λ class. With its capacity to prevent severe asthma attacks and enhance breathing, Tezspire emerges as a valuable option for those dealing with uncontrolled severe asthma.

Strength: 

Tezspire injection is offered in a 210 mg/1.91 mL (110 mg/mL) solution, accessible in single-dose glass vials, pre-filled syringes, and pre-filled pens.

Recommended Dosage:

Tezspire vials and pre-filled syringes are for healthcare provider administration, while the pre-filled pen can be self-administered post-training. Each container holds a single dose of 210 mg Tezspire. Before use, allow it to reach room temperature for 60 minutes, avoiding heat and shaking. Do not use if the seal is broken, if the solution is cloudy or discolored, or if there’s damage or expiration. Administer subcutaneously into the thigh or abdomen, excluding a 2-inch radius around the navel. Rotate injection sites, avoiding tender or bruised areas.

Instructions for Administering Single-Dose Pre-filled Syringe: 

Keep the needle cover on until Step 2. Avoid touching the needle guard activation clips. Remove the pre-filled syringe from its tray by grasping the syringe body. Small air bubbles are normal; no need to expel them. When ready to inject, remove the needle cover by pulling straight off while holding the syringe body. A drop of liquid at the needle’s end is normal. Administer subcutaneously at a 45º angle in the recommended site. Inject the medication, activating the needle guard. After injection, maintain pressure on the plunger head, remove the needle, and release pressure to cover the needle with the guard. Do not recapture the syringe. Discard in a sharps container.

Instructions for Administering Single-Dose Pre-filled Pen:

Exclusively for healthcare providers, these instructions guide patients and caregivers to consult the ‘Instructions for Use’ accompanying the Tezspire pre-filled pen for detailed information on preparation and administration. The cap should not be removed until ready to inject, and the pre-filled pen, when taken from the tray, may contain small air bubbles, which are considered normal and do not require expulsion before administration. When ready to inject, the cap should be carefully removed without touching the needle or pushing the orange needle guard. Patients can gently pinch the skin or inject without pinching, administering Tezspire into the recommended site (upper arm, thigh, or abdomen). During injection, two audible clicks signify the start and completion of the process. The pen, positioned at a 90-degree angle with the orange needle guard against the skin, should be pressed firmly until the first click, and held for about 15 seconds until the second click. After completion, lifting the pre-filled pen locks the orange needle guard over the needle, and the used pen should be discarded in a sharps container.

• The recommended dosage is 210 mg to be administered once every 4 weeks. In the event of a missed dose, administer it at the earliest opportunity. 
• Subsequently, the patient can resume the regular dosing schedule on the usual administration day. 
• If the upcoming dose is already due, proceed with the planned administration as scheduled.

Important:

Inform your healthcare provider about your complete medication regimen, encompassing prescription and over-the-counter drugs, vitamins, and herbal supplements. Do not alter or discontinue your corticosteroid or other asthma medications unless directed by your healthcare provider. It is crucial to follow their guidance in managing your medication routine. If you don’t have an FDA-cleared sharps disposal container, you can use a household container made of heavy-duty plastic with a secure, puncture-resistant lid. Ensure the container is upright, stable, and leak-resistant during use. Properly label it to indicate the presence of hazardous waste.

Warnings & Precautions

• Tezepelumab-ekko or its excipients should not be administered to individuals with a known hypersensitivity to them. 
• Hypersensitivity reactions, including rash and allergic conjunctivitis, have been observed during Tezspire administration in clinical trials, with postmarketing cases reporting anaphylaxis. 
• In the event of a hypersensitivity reaction, appropriate treatment should be initiated as clinically indicated. 
• Abruptly discontinuing systemic or inhaled corticosteroids upon initiating Tezspire therapy is not recommended. 
• If corticosteroid reduction is necessary, it should be done gradually. Prior to Tezspire therapy, patients with pre-existing helminth infections should receive appropriate treatment. 
• If patients develop a parasitic infection during Tezspire treatment and do not respond to antihelminth therapy, discontinuation of Tezspire is advised until the parasitic infection resolves. Additionally, the use of live attenuated vaccines should be avoided.

Common Tezspire Side Effects:

• Body aches or pain
• Pharyngitis
• Athralgia
• Cough
• Difficulty in moving
• Dryness or soreness of the throat
• Muscle pain or stiffness
• Redness, pain, or itching at the injection site.
• Stuffy or runny nose
• Tender, swollen glands in the neck
• Trouble swallowing (Difficulty with swallowing food or liquids)
• Voice changes (Hoarseness or other vocal changes)

Use in Specific Population

• Limited data is available on the use of Tezspire in pregnant women, and there is insufficient information to assess the potential risks of major birth defects, miscarriage, or other adverse outcomes for both the mother and the fetus. 
• The presence of tezepelumab-ekko in human milk, its impact on breastfed infants, and its effects on milk production remain unknown. 
• The safety and efficacy of Tezspire have not been established in patients below 12 years of age. 
• However, no significant differences in safety or efficacy have been observed between patients aged 65 and older and their younger counterparts.

Storage and Handling

• Keep Tezspire refrigerated at temperatures between 36°F to 46°F (2°C to 8°C). If needed, the medication can be stored at room temperature ranging from 68°F to 77°F (20°C to 25°C) for a maximum of 30 days. 
• Once Tezspire reaches room temperature, it should not be returned to the refrigerator. 
• After removal from refrigeration, use Tezspire within 30 days or discard it. 
• Store the medication in its original carton to shield it from light until the time of use. 
• Avoid freezing, shaking, and exposure to heat.