Tezspire (tezepelumab-ekko)

No dosing information is available for this tab.

Tezepelumab-ekko is commercially available as a single-dose vial,single-dose prefilled syringe, or single-dose prefilled pen.

Store refrigerated at 2-8degreesC; do not freeze. Protect from light. If needed, the drug may be stored at room temperature between 20-25degreesC for no longer than 30 days. Do not refrigerate once the drug has been stored at room temperature.

Allow the product to reach room temperature before administration. This takes about 60 minutes once removed from refrigeration. Do not shake the drug or expose to heat.

Visually inspect the contents of the vial or prefilled syringe or pen for particulate matter and discoloration prior to administration. Tezepelumab is a clear to opalescent, colorless to light yellow solution; do not use if the liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter.

The manufacturer states that tezepelumab-ekko vials and prefilled syringes areintended for administration by a healthcare provider. Tezepelumab-ekko prefilled pens may be administered by a healthcare provider or by patients/caregivers after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate. Inject the entire contents of the vial, prefilled syringe,or pensubcutaneously into the thigh or abdomen, except for the 2 inches around the navel. The upper arm can also be used if a healthcare provider or caregiver administers the injection. Rotate injection sites. Do not inject into tender, bruised, erythematous, or hardened skin areas.

If a dose is missed, administer the dose as soon as possible. Resume regular dosing on the usual day of administration. If the next dose is already due, administer as planned.

No dosing information is available for this tab.

No formal drug interaction studies have been performed with tezepelumab.

Tezepelumab-ekko is not metabolized by hepatic enzymes.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

*Known history of hypersensitivity to the drug or any ingredient in the formulation.

• Acute asthma attack

• Parasitic infection

There are no moderate contraindications for this drug.

Adverse effects reported in >=3% of patients with severe asthma receiving tezepelumab in controlled clinical studies include pharyngitis, arthralgia, and back pain.

Adverse effects reported in >=3% of patients with CRSwNP receiving tezepelumab in controlled clinical studies include nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction, and arthralgia.

Rare or Very Rare

• Anaphylaxis
• Hypersensitivity drug reaction

More Frequent

• Arthralgia
• Back pain
• Epistaxis
• Influenza
• Injection site sequelae
• Pharyngitis
• Upper respiratory infection

Less Frequent

• Injection site erythema
• Injection site pain

Rare or Very Rare

• Allergic conjunctivitis
• Skin rash

No enhanced messaging available.

The safety and effectiveness of tezepelumab-ekko for the add-on maintenance treatment of severe asthma have been established in pediatric patients >=12 years of age. Use of tezepelumab for this indication is supported by evidence from a total of 82 pediatric patients 12-17 years of age enrolled in the NAVIGATOR study. Compared with placebo, improvements in annualized asthma exacerbation and FEV1 were observed in pediatric patients treated with tezepelumab-ekko. The safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population.

The safety and effectiveness of tezepelumab-ekko for the add-on maintenance treatment of inadequately controlled CRSwNP have been established in pediatric patients >=12 years of age. Use of tezepelumab for this indication is supported by evidence from a well-controlled study in adults, pharmacokinetic data in adults and pediatric patients >=12 years of age with severe asthma and adults with CRSwNP, and safety data in pediatric patients >=12 years of age with severe asthma.

The safety and effectiveness of tezepelumab-ekko in patients <12 years of age have not been established for either indication.

There are no available data on tezepelumab-ekko use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

In an enhanced pre- and post-natal development study conducted in cynomolgus monkeys, placental transport of tezepelumab was observed but there was no evidence of fetal harm following IV administration of tezepelumab 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 subcutaneously.

There is no information regarding the presence of tezepelumab in human milk, its effects on the breast-fed infant, or its effects on milk production. However, tezepelumab is a human monoclonal antibody immunoglobulin G2lambda (IgG2lambda), and immunoglobulin G (IgG) is present in human milk in small amounts. Tezepelumab was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy.

The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for tezepelumab and any potential adverse effects on the breast-fed infant from tezepelumab or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the 665 patients with asthma treated with tezepelumab-ekko in clinical trials (PATHWAY and NAVIGATOR) for severe asthma, 119 patients (18%) were >=65 years of age. No overall differences in safety or effectiveness of tezepelumab have been observed between these geriatric patients and younger patients.

Of the 203 patients with CRSwNP treated with tezepelumab-ekko in a clinical trial (WAYPOINT), 29 patients (14%) were >=65 years of age. No overall differences in safety or effectiveness of tezepelumab have been observed between these geriatric patients and younger patients.