LABELS · 05b6e27f-40ba-4939-a0c3-8e8ae1feae98

ZENBEXUS

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-08-13
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment [ Contraindications (4) , see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] . Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS [see Warnings and Precautions (5.2) ] . Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY • ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment. (4 , 5.1 , 8.1 , 8.3) • Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS. (4 , 5.1 , 8.1 , 8.3) • Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS). (5.2) Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM • Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS. Anti-thrombotic prophylaxis is recommended. Monitor patients for signs and symptoms of thromboembolic event during treatment with ZENBEXUS. Interrupt ZENBEXUS and initiate anticoagulant therapy as appropriate. (2.3 , 5.3)

Indications and usage: exact source text

1 INDICATIONS AND USAGE ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Full extracted label fields

application numbers

NDA221075

boxed warning exact

WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment [ Contraindications (4) , see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] . Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS [see Warnings and Precautions (5.2) ] . Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY • ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment. (4 , 5.1 , 8.1 , 8.3) • Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS. (4 , 5.1 , 8.1 , 8.3) • Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS). (5.2) Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM • Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS. Anti-thrombotic prophylaxis is recommended. Monitor patients for signs and symptoms of thromboembolic event during treatment with ZENBEXUS. Interrupt ZENBEXUS and initiate anticoagulant therapy as appropriate. (2.3 , 5.3)

brand names

ZENBEXUS

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https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
status category
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status event date
2026-08-13
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exact text: ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2205b6e27f-40ba-4939-a0c3-8e8ae1feae98%22

spl effective date

2026-08-13

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · approval contingency

application numbers

NDA221075

brand names

ZENBEXUS

classification reasons

approval_contingency_words

clinical review status

pending

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approval_contingency

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exact text: ase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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05b6e27f-40ba-4939-a0c3-8e8ae1feae98

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Source null

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exact text: (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time.
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source text sha256: 7a19ab342663a731922f28ebba663b0d8fd3d0e976fc9405818204ff77462585
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2205b6e27f-40ba-4939-a0c3-8e8ae1feae98%22

spl effective date

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 6 · approval contingency

application numbers

NDA221075

brand names

ZENBEXUS

classification reasons

approval_contingency_words

clinical review status

pending

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approval_contingency

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end: 1190
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exact text: g a proteasome inhibitor and an immunomodulatory agent. (1) This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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05b6e27f-40ba-4939-a0c3-8e8ae1feae98

positive predicate support span

Source null

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schema version

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end: 1190
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exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
label id: 05b6e27f-40ba-4939-a0c3-8e8ae1feae98
offset unit: unicode_code_points
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source text sha256: 7a19ab342663a731922f28ebba663b0d8fd3d0e976fc9405818204ff77462585
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2205b6e27f-40ba-4939-a0c3-8e8ae1feae98%22

spl effective date

2026-08-13

spl set id

3663d9cb-3f66-48ae-bf0a-6958bc0888de

spl version

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not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice