Tezepelumab

Tezepelumab is a prescription medication indicated:

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

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

Common side effects of Tezepelumab include:

• pharyngitis
• nasopharyngitis
• upper respiratory tract infections
• epistaxis
• influenza
• back pain
• arthralgia
• injection site reactions (redness, swelling, pain, and hard lump)

Serious side effects of Tezepelumab include:

• hypersensitivity reactions

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

Chronic Rhinosinusitis with Nasal Polyps

Adult dosage

• 210 mg subcutaneously every 4 weeks

Pediatric dosage

• Children younger than 12 years: Safety and efficacy not established
• Children aged 12 years and older: 210 mg subcutaneous every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

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
  • Hypersensitivity reactions (e.g., rash, and allergic conjunctivitis) can occur after administration; typically occur within hours of administration, but in some instances have a delayed onset (e, days)
  • In the event of a hypersensitivity reaction, consider the benefits and risks to determine whether to continue or discontinue treatment
• Acute asthma symptoms or deteriorating disease
  • Do not use it to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus
  • Instruct patients to seek medical attention if asthma remains uncontrolled or worsens after treatment initiation
• Abrupt reduction of corticosteroid dosage
  • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating therapy
  • Reduce corticosteroid dose gradually, if appropriate, under the direct supervision of a physician
• Parasitic (helminth) infection
  • Treat pre-existing helminth infection before initiating
  • If patients become infected while taking tezepelumab and do not respond to antihelminth treatment, discontinue until the infection resolves
• Live attenuated vaccine
  • 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.