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UNDERSTANDING TEZSPIRE® (tezepelumab-ekko) with Dr Rohit Katial & Dr Nicole Chase

Автор: TEZSPIRE® (tezepelumab-ekko)

Загружено: 2023-11-30

Просмотров: 17317

Описание:

Dr Rohit Katial and Dr Nicole Chase discuss the clinical data for TEZSPIRE® (tezepelumab-ekko) and what this may mean for patients.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE 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-ekko 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.

INDICATION
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

Please see accompanying full Prescribing Information
(http://www.azpicentral.com/pi.html?pr...,
including Patient Information (https://www.azpicentral.com/pi.html?p...) and Instructions for Use
(https://www.azpicentral.com/pi.html?p....

You may report side effects related to AstraZeneca products by clicking here: https://us-aereporting.astrazeneca.co...

UNDERSTANDING TEZSPIRE® (tezepelumab-ekko) with Dr Rohit Katial & Dr Nicole Chase

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