Tezepelumab

Tezepelumab is a prescription medication used to treat the symptoms of severe asthma. 

• Tezepelumab is available under the following different brand names: Tezspire, tezepelumab-ekko.

Common side effects of Tezepelumab include:

• Sore throat, 
• Back pain, 
• Joint stiffness or pain, and  
• Injection site reactions (redness, swelling, pain, and hard lump)

Serious side effects of Tezepelumab include:

• Hives, 
• Difficulty breathing, 
• Swelling of your face, lips, tongue, or throat, 
• Severe dizziness, 
• Rash, and
• Red, irritated, or itchy eyes

Rare side effects of Tezepelumab include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 210 mg/1.91 mL single-dose vial or prefilled syringe

Severe Asthma

Adult dosage

• 210 mg subcutaneously every 4 weeks

Pediatric dosage

• Below 12 years: Safety and efficacy not established.
• Above 12 years: 210 mg subcutaneous every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tezepelumab has no noted severe interactions with any other drugs.
• Tezepelumab has no noted serious interactions with any other drugs.
• Tezepelumab has no noted moderate interactions with any other drugs.
• Tezepelumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to tezepelumab or its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tezepelumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tezepelumab?”

Cautions

• Hypersensitivity reactions (. g, rash, and allergic conjunctivitis) can occur after administration; typically occur within hours of administration, but some instances have a delayed onset (. e, days); in event of a hypersensitivity reaction, consider benefits and risks to determine whether to continue or discontinue treatment
• Do not use to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus; instruct patient to seek medical attention if asthma remains uncontrolled or worsens after treatment initiation.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating therapy; reduce corticosteroid dose gradually, if appropriate, under the direct supervision of a physician
• Treat preexisting helminth infection before initiating; if patients become infected while taking tezepelumab and do not respond to antihelminth treatment, discontinue tezepelumab until the infection resolves
• Concomitant use with live, attenuated vaccines has not been evaluated; avoid administering live vaccines while taking tezepelumab.

Pregnancy and Lactation

• Data are not available regarding use in pregnant females to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Placental transfer of monoclonal antibodies is greater during the third trimester; therefore, potential effects on the fetus are likely to be greater during that time.
• Clinical considerations
  • Females with poorly or moderately controlled asthma have an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age, in the neonate
  • Closely monitor asthma control in pregnant females and adjust treatment to maintain optimal control
• Lactation
  • Data are not available regarding the presence of tezepelumab in human milk, its effects on breastfed infants, or its effects on milk production.
  • IgG is present in human milk in small amounts; tezepelumab was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy.
  • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for tezepelumab and any potential adverse effects on the breastfed infant or from the underlying maternal condition.