No black box warning on record for Tezepelumab

As of the latest FDA labeling reviewed, Tezepelumab (tezepelumab) does not carry a black box warning. Standard warnings and precautions still apply — see the full Tezepelumab medicine page for the complete safety profile.

Other warnings & precautions

HYPERSENSITIVITY REACTIONS: Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tezepelumab. These reactions may occur hours to days after administration. Discontinue tezepelumab immediately and initiate appropriate therapy if a serious allergic reaction occurs. Do not readminister to patients who have experienced a severe hypersensitivity reaction.
DO NOT USE FOR ACUTE ASTHMA ATTACKS: Tezepelumab is not a rescue medication and is not indicated for the relief of acute bronchospasm or status asthmaticus. Patients must have a short-acting bronchodilator (rescue inhaler) available at all times.
HELMINTH INFECTIONS: TSLP is involved in immune defense against parasitic worm infections. Tezepelumab may increase susceptibility to helminth infections. Treat pre-existing helminth infections before starting therapy. Monitor patients in endemic areas and treat any infections that occur during therapy.
DO NOT ABRUPTLY REDUCE CORTICOSTEROIDS: If systemic corticosteroids are being tapered as a result of improved asthma control on tezepelumab, the taper should be gradual and physician-supervised. Rapid discontinuation may unmask adrenal insufficiency or result in sudden asthma deterioration.
LIVE VACCINES: Administration of live attenuated vaccines during treatment with tezepelumab is not recommended. Complete vaccination with live vaccines prior to initiating treatment where possible.
PREGNANCY AND LACTATION: Data on tezepelumab use in human pregnancy are limited. IgG monoclonal antibodies cross the placenta. The potential risks and benefits should be carefully discussed with the patient. It is unknown whether tezepelumab is excreted in human milk.

Other warnings & precautions

HYPERSENSITIVITY REACTIONS: Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tezepelumab. These reactions may occur hours to days after administration. Discontinue tezepelumab immediately and initiate appropriate therapy if a serious allergic reaction occurs. Do not readminister to patients who have experienced a severe hypersensitivity reaction.

DO NOT USE FOR ACUTE ASTHMA ATTACKS: Tezepelumab is not a rescue medication and is not indicated for the relief of acute bronchospasm or status asthmaticus. Patients must have a short-acting bronchodilator (rescue inhaler) available at all times.

HELMINTH INFECTIONS: TSLP is involved in immune defense against parasitic worm infections. Tezepelumab may increase susceptibility to helminth infections. Treat pre-existing helminth infections before starting therapy. Monitor patients in endemic areas and treat any infections that occur during therapy.

DO NOT ABRUPTLY REDUCE CORTICOSTEROIDS: If systemic corticosteroids are being tapered as a result of improved asthma control on tezepelumab, the taper should be gradual and physician-supervised. Rapid discontinuation may unmask adrenal insufficiency or result in sudden asthma deterioration.

LIVE VACCINES: Administration of live attenuated vaccines during treatment with tezepelumab is not recommended. Complete vaccination with live vaccines prior to initiating treatment where possible.

PREGNANCY AND LACTATION: Data on tezepelumab use in human pregnancy are limited. IgG monoclonal antibodies cross the placenta. The potential risks and benefits should be carefully discussed with the patient. It is unknown whether tezepelumab is excreted in human milk.

Tezepelumab Black Box Warning

No black box warning on record for Tezepelumab

Other warnings & precautions

Tezepelumab Black Box Warning

No black box warning on record for Tezepelumab

Other warnings & precautions