Inhibits binding of human thymic stromal lymphopoietin to receptors on mast cells and eosinophils, preventing the release of mediators of airway inflammation.
Therapeutic effects:
Decreased incidence of asthma exacerbations.
Pharmacokinetics⬆⬇
Absorption: 77% absorbed following SUBQ administration.
Distribution: Not widely distributed to tissues.
Metabolism/Excretion: Degraded by proteolytic enzymes; eliminated by intracellular catabolism.
Half-Life: 26 days.
Time/Action Profile⬆⬇
(plasma concentrations)
ROUTE
ONSET
PEAK
DURATION
SUBQ
unknown
3–10 days
4 wk
Contraind./Precautions⬆⬇
Contraindicated in:
Hypersensitivity;
Acute bronchospasm or status asthmaticus;
Pre-existing helminth infection.
Use Cautiously in:
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <12 yr (safety and effectiveness not established).
SC (Adults and Children ≥12 yr): 210 mg every 4 wk.
Availability⬆⬇
Solution for injection (vials, prefilled syringes, and prefilled pens): 110 mg/mL
Assessment⬆⬇
Monitor signs and symptoms of asthma at baseline. Patients should be evaluated for uncontrolled or worsening asthma and symptomatic response to therapy. Tezepelumab should not be used for treatment of acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Monitor for signs and symptoms of hypersensitivity reactions (rash, urticaria, pruritus, flushing, dizziness, vomiting, abdominal pain) and angioedema (swelling of throat, lips, tongue, or face; dyspnea; wheezing; hoarseness). Discontinue tezepelumab immediately and provide supportive care.
Assess for signs and symptoms of helminth infection (fever, malaise, weight loss, diarrhea, abdominal pain, bloating, rectal prolapse, dry cough, eosinophilia) prior to treatment and during therapy. If patients become infected during treatment and infection is unresponsive to antihelminth treatment, discontinue tezepelumab. Patients with pre-existing helminth infections should be treated prior to initiating therapy.
Implementation⬆⬇
Systemic or inhaled corticosteroids should not be abruptly discontinued with initiation of therapy. ↓ in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Remove the vial, prefilled syringe, or prefilled pen from the refrigerator and allow it to reach room temperature (approximately 60 min). Do not place back into refrigerator once the product has reached room temperature. Protect from light. Do not freeze, shake, or expose to heat. Use within 30 days after removal from the refrigerator. Discard unused portion.
SC: Inject into the thigh or abdomen every 4 wk. If a health care provider or caregiver administers the injection, the upper arm can also be used. Rotating injection sites is recommended. Do not inject into areas where skin is tender, bruised, erythematous, or hardened, and avoid the area within 2 inches of the navel.
Patient/Family Teaching⬆⬇
Explain purpose and side effects of tezepelumab. Instruct patient or caregiver in correct technique for injection, storage, and discarding of syringes and needles. If a dose is missed, administer as soon as possible and resume dosing on the usual day of administration. If the next dose is already due, administer as planned. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patient to seek immediate treatment for signs and symptoms of hypersensitivity reactions or allergic reaction (rash; hives; itching; dizziness; vomiting; abdominal pain; swelling of throat, lips, tongue, or face; trouble breathing; wheezing; or hoarseness.
Warn patient that drug is not for acute asthma symptoms or acute exacerbations and to report uncontrolled or worsening asthma symptoms.
Advise patient to not discontinue systemic or inhaled corticosteroids abruptly while taking tezepelumab. ↓ in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician.
Advise patient against sudden discontinuation of drug due to potential withdrawal symptoms.
Tell patient to avoid live attenuated vaccines while taking the drug.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Closely monitor asthma control in pregnant women, as ↑ risk of pre-eclampsia has occurred in poorly or moderately controlled disease.
