AdultPediatricDosage Forms & Strengths injectable solution 210mg/1.91mL single-dose vial or prefilled syringe Severe Asthma Indicated for add-on maintenance treatment of severe asthma 210 mg SC q4Weeks Dosage Modifications Renal impairment No formal studies conducted Mild-to-moderate (CrCl ≥30 mL/min): No dose adjustment required; clearance similar with normal renal function Severe (CrCl <30 mL/min): Not studied Hepatic impairment No formal studies conducted Since tezepelumab is degraded by proteolytic enzymes and widely distributed in the body and is not metabolized by hepatic-specific enzymes, change in hepatic function is not expected to influence clearance Dosing Considerations Limitations of use: Not indicated for the relief of acute bronchospasm or status asthmaticusDosage Forms & Strengths injectable solution 210mg/1.91mL single-dose vial or prefilled syringe Severe Asthma Indicated for add-on maintenance treatment of severe asthma in adults and adolescents aged ≥12 years <12 years: Safety and efficacy not established ≥12 years: 210 mg SC q4Weeks Dosage Modifications Renal impairment No formal studies conducted Mild-to-moderate (CrCl ≥30 mL/min): No dose adjustment required; clearance similar with normal renal function Severe (CrCl <30 mL/min): Not studied Hepatic impairment No formal studies conducted Since tezepelumab is degraded by proteolytic enzymes and widely distributed in the body and is not metabolized by hepatic-specific enzymes, change in hepatic function is not expected to influence clearance Dosing Considerations Limitations of use: Not indicated for the relief of acute bronchospasm or status asthmaticus 1-10% Pharyngitis (4%) Arthralgia (4%) Back pain (4%) Injection-site reactions (3.3%) Contraindications Hypersensitivity to tezepelumab or its excipients Cautions Hypersensitivity reactions (eg, rash and allergic conjunctivitis) can occur after administration; typically occur within hours of administration, but some instances have a delayed onset (ie, 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 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 infection resolves Concomitant use with live, attenuated vaccines has not been evaluated; avoid administering live vaccines while taking tezepelumab Pregnancy 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 third trimester; therefore, potential effects on fetus are likely to be greater during that time Animal studies In an enhanced prenatal and postnatal development study conducted in cynomolgus monkeys, placental transport of tezepelumab observed There was no evidence of fetal harm following IV administration 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 SC Clinical considerations Females with poorly or moderately controlled asthma have 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, effects on breastfed infants, or 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 conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Human monoclonal antibody immunoglobulin G2 (IgG2)-lambda that inhibits thymic stromal lymphopoietin (TSLP) TSLP is a key epithelial cytokine involved in multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic, and other types of airway inflammation associated with severe asthma TSLP released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses, and other airborne particles; increased expression of TSLP in the airways of patients with asthma has been correlated with disease severity Blocking TSLP may prevent release of proinflammatory cytokines by immune cells, resulting in prevention of asthma exacerbations and improved asthma control Absorption Peak plasma concentration: 3-10 days Bioavailability: ~77% Distribution Vd: 3.9 L (central); 2.2 L (peripheral) Metabolism Degraded by proteolytic enzymes and widely distributed in the body and not metabolized by hepatic enzymes Elimination Half-life: ~26 days Clearance: 0.17 L/day SC Preparation Before administration, remove from refrigerator and allow vial/syringe to reach room temperature (~60 minutes) Do not expose to heat and do not shake Do not use if security seal on carton has been broken Do not put back in the refrigerator once drug has reached room temperature; after removal from the refrigerator, must be used within 30 days or discarded Prefilled syringe may contain small air bubbles (this is normal); do not expel the air bubbles before administering Visually inspect for particulate matter and discoloration; solution should appear clear to opalescent, colorless to light yellow; discard if liquid is cloudy, discolored, or contains large particles or foreign particulate matter SC Administration Inject SC into upper arm, thigh, or abdomen, except for the 2 inches (5 cm) around navel Avoid injecting into areas where skin is tender, bruised, erythematous, or hardened Rotate injection site with each administration See prescribing information for diagrams on SC prefilled syringe Missed dose Administer dose as soon as possible Thereafter, resume dosing on the usual day of administration If the next dose is already due, then administer as planned Storage Refrigerate at 36-46ºF (2-8ºC) If necessary, may be kept at room temperature, between 68-77ºF (20-25ºC), for up to 30 days Do not put back in the refrigerator once drug has reached room temperature; discard after 30 days Store in original carton to protect from light Do not freeze, do not shake, do not expose to heat No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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