Version May 2024
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment based on renal function is unlikely to be necessary as tezepelumab is not renally eliminated.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adjustment based on hepatic impairment is unlikely to be necessary as tezepelumab is degraded by proteolytic enzymes and not metabolized by hepatic enzymes.
Refer to adult dosing.
(For additional information see "Tezepelumab: Pediatric drug information")
Asthma, severe; maintenance therapy: Children ≥12 years and Adolescents: SUBQ: 210 mg every 4 weeks.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied in severe impairment. Adjustment based on renal function is unlikely to be necessary as tezepelumab is not renally eliminated.
There are no dosage adjustments provided in the manufacturer's labeling; since degradation of tezepelumab occurs via enzymes found throughout the body, changes in hepatic function are not expected to influence tezepelumab clearance.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
1% to 10%:
Immunologic: Antibody development (2%; neutralizing: <1%)
Neuromuscular & skeletal: Arthralgia (4%), back pain (4%)
Respiratory: Pharyngitis (4%)
Frequency not defined:
Hypersensitivity: Hypersensitivity reaction
Local: Injection-site reaction (erythema at injection site, pain at injection site, swelling at injection site)
Postmarketing: Hypersensitivity: Anaphylaxis
Hypersensitivity to tezepelumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions (eg, rash, allergic conjunctivitis) may occur within hours of administration. Delayed hypersensitivity reactions, occurring days after administration, have also been reported. Consider benefits and risks for discontinuing use in patients who experience a hypersensitivity reaction.
Disease-related concerns:
• Asthma: Not indicated for the treatment of acute asthma symptoms (eg, acute bronchospasm) or acute exacerbations, including status asthmaticus. Seek medical advice if asthma remains uncontrolled or worsens after initiation of tezepelumab.
• Helminth infections: It is unknown if administration of tezepelumab will influence a patient's immune response against parasitic infections. Therefore, patients with preexisting helminth infections should undergo treatment of the infection prior to initiation of tezepelumab therapy. Patients who become infected during tezepelumab treatment and do not respond to antihelminth therapy should discontinue therapy until the infection resolves.
Concurrent drug therapy issues:
• Corticosteroids: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of tezepelumab. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Tezspire: Tezepelumab-ekko 210 mg/1.91 mL (1.91 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Tezspire: Tezepelumab-ekko 210 mg/1.91 mL (1.91 mL) [contains polysorbate 80]
No
Solution Auto-injector (Tezspire Subcutaneous)
210MG/1.91ML (per mL): $2,715.93
Solution Prefilled Syringe (Tezspire Subcutaneous)
210MG/1.91ML (per mL): $2,538.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Tezspire: Tezepelumab-ekko 210 mg/1.91 mL (1.91 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Tezspire: Tezepelumab-ekko 210 mg/1.91 mL (1 ea) [contains polysorbate 80]
SUBQ: Prior to administration, remove the vial, prefilled pen, or prefilled syringe from the refrigerator and allow to reach room temperature for ~60 minutes (do not shake or expose to heat). Once the product has reached room temperature, do not put back in refrigerator. Administer as a SUBQ injection into the thigh or lower abdomen (avoiding areas within 2 inches of navel); health care provider or caregiver may administer in upper arm. Rotate injection sites; do not inject into areas where the skin is tender, bruised, erythematous, or hardened. Vials and prefilled syringes are intended for administration by a health care provider; prefilled pens may be administered by a health care provider or patient/caregiver.
Parenteral: Intended for administration by a health care provider.
SUBQ: Administer subcutaneously into upper arm, thigh, or abdomen; avoid area within 2 inches of navel, and areas where skin is tender, bruised, erythematous, or hardened; rotate injection site with each injection.
Asthma: Add-on maintenance treatment of severe asthma in adult and pediatric patients ≥12 years of age.
Limitations of use: Not indicated for the relief of acute bronchospasm or status asthmaticus.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Vaccines (Live): Tezepelumab may enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Data related to the use of monoclonal antibodies for the treatment of asthma in pregnancy are limited. The long half-life of monoclonal antibodies should be considered when treating patients planning to become pregnant (Pfaller 2021). An agent other than tezepelumab may be preferred (ERS/TSANZ [Middleton 2020]).
Tezepelumab is a humanized monoclonal antibody (IgG2). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Pregnant patients were excluded in the original studies; outcome data following maternal use of tezepelumab during pregnancy are limited (Menzies-Gow 2020; Menzies-Gow 2021).
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).
Data related to the use of monoclonal antibodies for the treatment of severe asthma during pregnancy are limited (GINA 2023). Use of monoclonal antibodies may be considered when conventional therapies are insufficient (ERS/TSANZ [Middleton 2020]). In general, monoclonal antibodies should not be initiated during pregnancy. The option to continue treatment in patients who become pregnant during therapy should be considered as part of a shared decision-making process (Dorscheid 2022; Pfaller 2021; Shakuntulla 2022).
Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or http://mothertobaby.org). Patients may also enroll themselves.
It is not known if tezepelumab is present in breast milk.
Tezepelumab is a humanized monoclonal antibody (IgG2). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Use of monoclonal antibodies for the treatment of asthma in lactating patients may be considered when conventional therapies are insufficient; however, use of an agent other than tezepelumab may be preferred (ERS/TSANZ [Middleton 2019]).
Hypersensitivity reactions; FEV1, peak flow, and/or other pulmonary function tests; monitor for signs of infection. Monitor for increased use of short-acting beta-2 agonist inhalers; may be a marker of a deteriorating asthma condition.
Tezepelumab-ekko is a human monoclonal antibody IgG2λ that binds to human thymic stromal lymphopoietin (TSLP), an epithelial cytokine, and prevents human TSLP from interacting with the heterodimeric TSLP receptor. Blocking TSLP with tezepelumab-ekko reduces biomarkers and cytokines associated with inflammation including blood eosinophils, airway submucosal eosinophils, IgE, FeNO, IL-5, and IL-13; however, the mechanism of tezepelumab-ekko action in asthma has not been definitively established.
Onset: ~2 weeks.
Distribution: Vd : 3.9 L (central); 2.2 L (peripheral).
Metabolism: Undergoes proteolytic degradation via enzymes that are widely distributed in the body; not metabolized by hepatic enzymes.
Bioavailability: ~77%.
Half-life elimination: ~26 days.
Time to peak: ~3 to 10 days.
Excretion: Nonrenal; nonhepatic.
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