This website is for Healthcare Professionals only.

ADJUSTING DOSAGE FOLLOWING CRS & ICANS REACTIONS IN YOUR PATIENTS

Management of CRS while using TEPKINLY¹

95% of CRS events occurred in the first cycle²

Grade^a	Recommended Therapy	TEPKINLY Dose Modification
Grade 1 Fever (temperature ≥38°C)	Provide supportive care such as antipyretics and intravenous hydration Dexamethasone^b may be initiated In cases of advanced age, high tumour burden, circulating tumour cells, fever refractory to antipyretics Anticytokine therapy, tocilizumab,^d should be considered For CRS with concurrent ICANS, refer to ICANS tab	Hold TEPKINLY until resolution of CRS event
Grade 2 Fever (temperature ≥38°C) and Hypotension not requiring vasopressors and/or Hypoxia requiring low-flow oxygen^e by nasal cannula or blow-by	Provide supportive care such as antipyretics and intravenous hydration Dexamethasone^b should be considered Anticytokine therapy, tocilizumab,^d is recommended If CRS is refractory to dexamethasone and tocilizumab: Alternative immunosuppressants^gand methylprednisolone 1000 mg/day intravenously should be administered until clinical improvement For CRS with concurrent ICANS, refer to ICANS tab	Hold TEPKINLY until resolution of CRS event
Grade 3 Fever (temperature ≥38°C) and Hypotension requiring a vasopressor with or without vasopressin and/or Hypoxia requiring high-flow oxygen^f by nasal cannula, facemask, non-breather mask, or venturi mask	Provide supportive care such as antipyretics and intravenous hydration Dexamethasone^c should be administered Anticytokine therapy, tocilizumab,^d is recommended If CRS is refractory to dexamethasone and tocilizumab: Alternative immunosuppressants^g and methylprednisolone 1000 mg/day intravenously should be administered until clinical improvement For CRS with concurrent ICANS, refer to ICANS tab	Hold TEPKINLY until resolution of CRS event In the event of grade 3 CRS lasting longer than 72 hours, TEPKINLY should be discontinued If more than 2 separate events of grade 3 CRS, even if each event resolved to grade 2 within 72 hours, TEPKINLY should be discontinued
Grade 4 Fever (temperature ≥38°C) and Hypotension requiring ≥2 vasopressors (excluding vasopressin) and/or Hypoxia requiring positive pressure ventilation (eg, CPAP, BiPAP, intubation, and mechanical ventilation)	Provide supportive care such as antipyretics and intravenous hydration Dexamethasone^c should be administered Anticytokine therapy, tocilizumab,^d is recommended If CRS is refractory to dexamethasone and tocilizumab: Alternative immunosuppressants^g and methylprednisolone 1000 mg/day intravenously should be administered until clinical improvement For CRS with concurrent ICANS, refer to ICANS tab	Permanently discontinue TEPKINLY

Grade^a

Recommended Therapy

TEPKINLY Dose Modification

Grade 1

Fever (temperature ≥38°C)

Provide supportive care such as antipyretics and intravenous hydration
Dexamethasone^b may be initiated
In cases of advanced age, high tumour burden, circulating tumour cells, fever refractory to antipyretics

Anticytokine therapy, tocilizumab,^d should be considered

For CRS with concurrent ICANS, refer to ICANS tab

Hold TEPKINLY until resolution of CRS event

Grade 2

Fever (temperature ≥38°C)
and
Hypotension not requiring vasopressors and/or
Hypoxia requiring low-flow oxygen^e by nasal cannula or blow-by

Provide supportive care such as antipyretics and intravenous hydration
Dexamethasone^b should be considered
Anticytokine therapy, tocilizumab,^d is recommended

If CRS is refractory to dexamethasone and tocilizumab:

Alternative immunosuppressants^gand methylprednisolone 1000 mg/day intravenously should be administered until clinical improvement

For CRS with concurrent ICANS, refer to ICANS tab

Hold TEPKINLY until resolution of CRS event

Grade 3

Fever (temperature ≥38°C)
and
Hypotension requiring a vasopressor with or without vasopressin
and/or
Hypoxia requiring high-flow oxygen^f by nasal cannula, facemask, non-breather mask, or venturi mask

Provide supportive care such as antipyretics and intravenous hydration
Dexamethasone^c should be administered

Anticytokine therapy, tocilizumab,^d is recommended

If CRS is refractory to dexamethasone and tocilizumab:

Alternative immunosuppressants^g and methylprednisolone 1000 mg/day intravenously should be administered until clinical improvement

For CRS with concurrent ICANS, refer to ICANS tab

Hold TEPKINLY until resolution of CRS event

In the event of grade 3 CRS lasting longer than 72 hours, TEPKINLY should be discontinued

If more than 2 separate events of grade 3 CRS, even if each event resolved to grade 2 within 72 hours, TEPKINLY should be discontinued

Grade 4

Fever (temperature ≥38°C) and
Hypotension requiring ≥2 vasopressors (excluding vasopressin)
and/or
Hypoxia requiring positive pressure ventilation (eg, CPAP, BiPAP, intubation, and mechanical ventilation)

Provide supportive care such as antipyretics and intravenous hydration
Dexamethasone^c should be administered

Anticytokine therapy, tocilizumab,^d is recommended

If CRS is refractory to dexamethasone and tocilizumab:

Alternative immunosuppressants^g and methylprednisolone 1000 mg/day intravenously should be administered until clinical improvement

For CRS with concurrent ICANS, refer to ICANS tab

Permanently discontinue TEPKINLY

^aCRS graded according to ASTCT consensus criteria.

^bDexamethasone should be administered at 10-20 mg per day (or equivalent).

^cDexamethasone should be administered at 10-20 mg intravenously every 6 hours.

^dTocilizumab 8 mg/kg intravenously over 1 hour (not to exceed 800 mg per dose). Repeat tocilizumab after at least 8 hours as needed. Maximum of 2 doses in a 24-hour period.

^eLow-flow oxygen is defined as oxygen delivered at <6 L/minute.

^fHigh-flow oxygen is defined as oxygen delivered at ≥6 L/minute.

^gRiegler L, et al (2019).

Management of ICANS while using TEPKINLY¹

Recommended dose modifications for other adverse reactions¹

Grade^a	Recommended Therapy	TEPKINLY Dose Modification
Grade 1^b ICE score^c 7-9^bor, depressed level of consciousness^b: awakens spontaneously	Treatment with dexamethasone^d Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS No concurrent CRS: Anticytokine therapy not recommended For ICANS with concurrent CRS; Treatment with dexamethasone^d Choose immunosuppressant alternatives^e to tocilizumab, if possible	Hold TEPKINLY until resolution of event
Grade 2^b ICE score^c 3-6^bor, depressed level of consciousness^b: awakens to voice	Treatment with dexamethasone^f Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS No concurrent CRS: Anticytokine therapy not recommended For ICANS with concurrent CRS: Treatment with dexamethasone^d Choose immunosuppressant alternatives^e to tocilizumab, if possible	Hold TEPKINLY until resolution of event
Grade 3^b ICE score^c 0-2or, depressed level of consciousness^b: awakens only to tactile stimulus, or seizures,^b either: any clinical seizure, focal or generalised that resolves rapidly, or non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention or raised intracranial pressure: focal/local oedema^b on neuroimaging^c	Treatment with dexamethasone^g If no response, initiate methylprednisolone 1000 mg/day Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS No concurrent CRS: Anticytokine therapy not recommended For ICANS with concurrent CRS: Treatment with dexamethasone If no response, initiate methylprednisolone 1000 mg/day Choose immunosuppressant alternatives^e to tocilizumab, if possible	Permanently discontinue TEPKINLY
Grade 4^b ICE score^b,c 0or, depressed level of consciousness^b either: patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or stupor or coma, or seizures,^b either: life-threatening prolonged seizure (>5 minutes), or repetitive clinical or electrical seizures without return to baseline in between, or motor findings^b: deep focal motor weakness such as hemiparesis or paraparesis, or raised intracranial pressure/cerebral oedema,^b with signs/symptoms such as: diffuse cerebral oedema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilloedema, or Cushing’s triad	Treatment with dexamethasone^g If no response, initiate methylprednisolone 1000 mg/day Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS No concurrent CRS: Anticytokine therapy not recommended For ICANS with concurrent CRS: Treatment with dexamethasone If no response, initiate methylprednisolone 1000 mg/day Choose immunosuppressant alternatives^e to tocilizumab, if possible	Permanently discontinue TEPKINLY

Grade^a

Recommended Therapy

TEPKINLY Dose Modification

Grade 1^b

ICE score^c 7-9^bor, depressed level
of consciousness^b:
awakens spontaneously

Treatment with dexamethasone^d
Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS

No concurrent CRS:

Anticytokine therapy not recommended

For ICANS with concurrent CRS;

Treatment with dexamethasone^d
Choose immunosuppressant alternatives^e to tocilizumab, if possible

Hold TEPKINLY until resolution of event

Grade 2^b

ICE score^c 3-6^bor, depressed level
of consciousness^b:
awakens to voice

Treatment with dexamethasone^f
Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS
No concurrent CRS:

Anticytokine therapy not recommended

For ICANS with concurrent CRS:

Treatment with dexamethasone^d
Choose immunosuppressant alternatives^e to tocilizumab, if possible

Hold TEPKINLY until resolution of event

Grade 3^b

ICE score^c 0-2or, depressed level
of consciousness^b:
awakens only to tactile stimulus, or
seizures,^b either:

any clinical seizure, focal or generalised that resolves rapidly,
or
non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention or
raised intracranial pressure: focal/local

oedema^b on neuroimaging^c

Treatment with dexamethasone^g

If no response, initiate methylprednisolone 1000 mg/day
Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS
No concurrent CRS:
Anticytokine therapy not recommended

For ICANS with concurrent CRS:

Treatment with dexamethasone
- If no response, initiate methylprednisolone 1000 mg/day

Choose immunosuppressant alternatives^e to tocilizumab, if possible

Permanently discontinue TEPKINLY

Grade 4^b

ICE score^b,c 0or, depressed level
of consciousness^b either:

patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse,
or
stupor or coma, or seizures,^b either:
life-threatening prolonged seizure (>5 minutes),
or
repetitive clinical or electrical seizures without return to baseline in between,
or
motor findings^b:
deep focal motor weakness such as hemiparesis or paraparesis,
or
raised intracranial pressure/cerebral oedema,^b with signs/symptoms such as:
diffuse cerebral oedema on neuroimaging,
or
decerebrate or decorticate posturing,
or
cranial nerve VI palsy, or
papilloedema, or
Cushing’s triad

Treatment with dexamethasone^g

If no response, initiate methylprednisolone 1000 mg/day

Consider nonsedating antiseizure medicinal products (eg, levetiracetam) until resolution of ICANS
No concurrent CRS:

Anticytokine therapy not recommended

For ICANS with concurrent CRS:

Treatment with dexamethasone
- If no response, initiate methylprednisolone 1000 mg/day
Choose immunosuppressant alternatives^e to tocilizumab, if possible

Permanently discontinue TEPKINLY

^aICANS graded according to ASTCT ICANS Consensus Grading.

^bICANS grade is determined by the most severe event (ICE score, level of consciousness, seizures, motor findings, raised ICP/cerebral oedema) not attributable to any other cause.

^cIf patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital=4 points); Naming (name 3 objects, eg, point to clock, pen, button=3 points); Following Commands (eg, “show me 2 fingers” or “close your eyes and stick out your tongue”=1 point); Writing (ability to write a standard sentence=1 point); and Attention (count backwards from 100 by ten=1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS)=0 points.

^dDexamethasone should be administered at 10 mg intravenously every 12 hours.

^eRiegler L, et al (2019).

^fDexamethasone 10-20 mg intravenously every 12 hours.

^gDexamethasone 10-20 mg intravenously every 6 hours.

Recommended dose modifications for other adverse reactions¹

Adverse Reaction¹	Severity^a	Action
Infections	Grades 1-4	Withhold TEPKINLY in patients with active infection, until the infection resolves For grade 4, consider permanent discontinuation of TEPKINLY
Neutropenia or febrile neutropenia	Absolute neutrophil count less than 0.5 x 10⁹/L	Withhold TEPKINLY until absolute neutrophil count is 0.5 x 10⁹/L or higher
Thrombocytopenia	Platelet count less than 50 x 10⁹/L	Withhold TEPKINLY until platelet count is 50 x 10⁹/L or higher
Other adverse reactions	Grade 3 or higher	Withhold TEPKINLY until the toxicity resolves to grade 1 or baseline
^aBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

See guidance on restarting TEPKINLY once events have resolved.

RESTARTING TEPKINLY

[INCLUDE SAFETY INFORMATION PER LOCAL REGULATIONS]

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CONTACT ABBVIE

Explore the subcutaneous dosing schedule for TEPKINLY and important administration tips.

VIEW DOSING & ADMINISTRATION INFORMATION

ASTCT=American Society for Transplantation and Cellular Therapy; BiPAP=bilevel positive airway pressure; CPAP=continuous positive airway pressure; CRS=cytokine release syndrome; EEG=electroencephalogram; ICANS=immune effector cell-associated neurotoxicity syndrome; ICE=immune effector cell-associated encephalopathy; ICP=intracranial pressure.

TEPKINLY as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.¹

References: 1. TEPKINLY Summary of Product Characteristics. AbbVie Inc. 2. Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell–engaging antibody, in relapsed or refractory large B-cell lymphoma: dose expansion in a phase I/II trial. J Clin Oncol. (suppl). Published online December 22, 2022. doi:10.1200/jco.22.01725

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Oncology

Neuroscience

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Eye Care

Trainings

ADJUSTING DOSAGE FOLLOWING CRS & ICANS REACTIONS IN YOUR PATIENTS

Management of CRS while using TEPKINLY¹

95% of CRS events occurred in the first cycle²

Management of ICANS while using TEPKINLY¹

Recommended dose modifications for other adverse reactions¹

Recommended dose modifications for other adverse reactions¹

See guidance on restarting TEPKINLY once events have resolved.

Our therapy areas

Our therapy areas

Additional info

Additional info

This website is intended for Healthcare Professionals

This website is intended for Italy Healthcare Professionals

Africa

Asia Pacific

Europe

Middle East

North America

Latin America / Caribbean

South America

test

ADJUSTING DOSAGE FOLLOWING CRS & ICANS REACTIONS IN YOUR PATIENTS

Management of CRS while using TEPKINLY1

95% of CRS events occurred in the first cycle2

Management of ICANS while using TEPKINLY1

Recommended dose modifications for other adverse reactions1

Recommended dose modifications for other adverse reactions1

See guidance on restarting TEPKINLY once events have resolved.

Our therapy areas

Our therapy areas

Additional info

Additional info

This website is intended for Healthcare Professionals

This website is intended for Italy Healthcare Professionals

Management of CRS while using TEPKINLY¹

95% of CRS events occurred in the first cycle²

Management of ICANS while using TEPKINLY¹

Recommended dose modifications for other adverse reactions¹

Recommended dose modifications for other adverse reactions¹