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Lynozyfic Dosage

Generic name: LINVOSELTAMAB 5mg in 2.5mL
Dosage form: injection, solution, concentrate
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Drugs.com. Last updated on Jul 2, 2025.

Important Administration Instructions

  • Administer LYNOZYFIC intravenously according to the step-up schedule to reduce the incidence and severity of cytokine release syndrome (CRS).
  • Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection.
  • Administer pretreatment medications.
  • LYNOZYFIC should be administered by a healthcare provider with immediate access to emergency equipment and appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS), infusion-related reactions (IRR), and neurologic toxicity, including ICANS.
  • Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 24 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose.

Recommended Dosage

The recommended dosage for LYNOZYFIC is presented in Table 1. In patients who experience CRS, ICANS, or neurologic adverse reactions, refer to Tables 3, 4, and 5, respectively, for recommendations regarding administration of the next LYNOZYFIC dose. Continue treatment until disease progression or unacceptable toxicity. The recommended dosing schedule for LYNOZYFIC is provided in Table 1. The recommended dosage of LYNOZYFIC is step-up doses of 5 mg, 25 mg, and 200 mg, followed by 200 mg weekly for 10 doses, followed by 200 mg biweekly (every 2 weeks). In patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg, decrease the dosing frequency to 200 mg every 4 weeks.

Table 1: LYNOZYFIC Dosing Schedule
Dosing Schedule Day* LYNOZYFIC Dose Duration of Infusion
*
Weekly doses should be at least 5 days apart. Biweekly doses should be at least 10 days apart. Every 4-week doses should be at least 24 days apart.
†
For patients who experienced CRS with the previous dose of LYNOZYFIC, the duration of infusion should be maintained at the duration of the previous infusion; reduce the duration of infusion sequentially in subsequent doses in patients who do not experience CRS (e.g., 4 hours, 1 hour, then 30 minutes).
Step-up Dosing Schedule Day 1 Step-up dose 1 5 mg 4 hours
Day 8 Step-up dose 2 25 mg
Day 15 First treatment dose 200 mg
Weekly Dosing Schedule One week after Day 15 treatment dose and once weekly from Week 4 to Week 13 for 10 treatment doses Second and subsequent treatment doses 200 mg 1 hour for the second treatment dose, and 30 minutes for subsequent doses†
Biweekly (Every 2 Weeks) Dosing Schedule Week 14 and every 2 weeks thereafter Subsequent treatment doses 200 mg 30 minutes
Patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg
Every 4 Weeks Dosing Schedule At Week 24 or after and every 4 weeks thereafter 200 mg 30 minutes

Recommended Pretreatment Medications

Administer the following pre-treatment medications before each dose of the LYNOZYFIC step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose, the second treatment dose, and if indicated, subsequent treatment doses (see Tables 1, 2, and 3), to reduce the risk of CRS and/or IRR:

  • acetaminophen (or equivalent) 650 mg to 1,000 mg orally 30 to 60 minutes prior to infusion
  • diphenhydramine (or equivalent) 25 mg orally or intravenously 30 to 60 minutes prior to infusion
  • dexamethasone (or equivalent) intravenously 1 to 3 hours prior to infusion
    • 40 mg dexamethasone (or equivalent) before step-up dose 1, step-up dose 2, and the first full treatment dose
    • Once a treatment dose of LYNOZYFIC is tolerated without CRS and/or IRR with 40 mg dexamethasone (or equivalent), administer 10 mg dexamethasone (or equivalent) prior to the subsequent LYNOZYFIC treatment dose

Pre-treatment medications may be discontinued once a treatment dose of LYNOZYFIC is tolerated without CRS and/or IRR following pre-treatment with 10 mg dexamethasone (or equivalent), acetaminophen (or equivalent), and diphenhydramine (or equivalent) as described.

Restarting LYNOZYFIC After Dosage Delay

Table 2 provides recommendations for restarting therapy after a dose delay. Refer to Table 3, Table 4, and Table 5 for recommendations about management of CRS, ICANS, or other adverse reactions.

Table 2: Recommendations for Restarting Therapy with LYNOZYFIC After a Dose Delay
Last Dose Administered Time since the last dose administered* Action for next dose.
(For CRS/IRR or ICANS, refer to the dose modifications in Table 3, Table 4, and Table 5.)
NOTE: Administer pre-treatment medications prior to step-up dose 1, step-up dose 2, the first treatment dose, the second treatment dose, and if indicated, subsequent treatment doses.
*
Consider benefit-risk of restarting LYNOZYFIC in patients who require a dose delay of more than 30 days.
5 mg 14 days or less Administer 25 mg
Greater than 14 days Restart step-up dosing from 5 mg
25 mg 14 days or less Administer 200 mg
Greater than 14 days and less than or equal to 28 days Restart step-up dosing from 25 mg
Greater than 28 days Restart step-up dosing from 5 mg
200 mg 49 days or less Administer 200 mg
Greater than 49 days Restart step-up dosing from 5 mg

Management of Adverse Reactions

Table 3 describes the management of CRS. Table 4 describes the management of ICANS. Table 5 describes the management of other adverse reactions.

Cytokine Release Syndrome

Identify CRS based on clinical presentation. Evaluate and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, withhold LYNOZYFIC until CRS resolves. CRS should be managed according to the recommendations in Table 3 and per current practice guidelines. Supportive therapy for CRS should be administered, which may include intensive care for severe or life-threatening CRS.

Table 3: Recommendations for Management of Cytokine Release Syndrome
Grade* Presenting Symptoms Recommendations
*
Based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria for grading CRS (2019).
†
Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as steroids, antipyretics, or anticytokine therapy.
‡
Administer pretreatment medications prior to next dose.
§
Follow the recommendations in Table 2 for restarting dosing.
Low-flow oxygen defined as oxygen delivered at less than 6 L/minute: high-flow oxygen defined as oxygen delivered at greater than or equal to 6 L/minute.
#
If the last dose administered was 5 mg, administer 2.5 mg. If the last dose administered was 25 mg, restart step-up dosing from 5 mg. If the last dose administered was 200 mg, refer to Table 2 for recommendations regarding restarting therapy based on time since the last dose.
Grade 1 Fever ≥100.4ºF (38ºC)†
  • Withhold LYNOZYFIC until CRS resolves.
  • Provide supportive care, which may include intensive care.
  • When CRS resolves, resume LYNOZYFIC.‡,§
Grade 2 Fever ≥100.4°F (38°C)† with:
Hypotension responsive to fluids and not requiring vasopressors
and/or
hypoxia requiring low-flow oxygen by nasal cannula or blow-by
  • Withhold LYNOZYFIC until CRS resolves.
  • Provide supportive care, which may include intensive care.
  • When CRS resolves, resume treatment with LYNOZYFIC.‡,§
    • Consider a decrease in infusion rate up to 50% (no more than 6 hours total) when resuming treatment. Increase rate on subsequent infusions if tolerated.
    • Monitor patients within proximity of a healthcare facility for 24 hours following this dose, and consider hospitalization.
Grade 3 Fever ≥100.4°F (38°C)† with:
Hypotension requiring a vasopressor (with or without vasopressin)
and/or
hypoxia requiring high-flow oxygen by nasal cannula, face mask, non-rebreather mask, or Venturi mask.
  • Withhold LYNOZYFIC until CRS resolves.
  • Provide supportive care, which may include intensive care.
  • When CRS resolves, resume treatment with LYNOZYFIC at reduced dose:‡, #
    • Decrease infusion rate up to 50% (no more than 6 hours total).
    • Hospitalize for 24 hours after the administration for this dose.
  • After resuming treatment, if the administered dose is tolerated:
    • Continue with the next dose of the recommended dosing regimen per Table 1.
    • If the full dose is tolerated, infusion rate can be increased to the rate prior to the adverse reaction.
  • Permanently discontinue LYNOZYFIC if Grade 3 CRS recurs with subsequent infusions.
Grade 4 Fever ≥100.4°F (38°C) † with:
Hypotension requiring multiple vasopressors (excluding vasopressin)
and/or
hypoxia requiring oxygen by positive pressure (e.g., continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation).
  • Discontinue LYNOZYFIC permanently.
  • CRS should be managed per Grade 3 recommendations.
Other AST/ALT greater than 5 times ULN associated with CRS Grade 3 or less
  • Withhold LYNOZYFIC until CRS resolves and AST/ALT are less than 3 times ULN if baseline was normal or 1.5 to 3 times baseline if baseline was abnormal.
  • Provide supportive care, which may include intensive care, and monitor.
  • No change in dose is needed in patients without CRS symptoms with transaminase levels that are trending towards baseline within 7 days.
  • If values do not trend towards baseline in 7 days, decrease the dose.#
  • See infusion rate information by CRS grade.

Neurologic Toxicity, including ICANS

Management recommendations for ICANS and neurologic toxicity are summarized in Table 4 and Table 5. At the first sign of suspected neurologic toxicity, including ICANS, withhold LYNOZYFIC and consider consultation with neurologist and other specialists for further evaluation and management. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care for severe or life-threatening ICANS. Manage per current practice guidelines.

Table 4: Recommendations for Management of ICANS
Grade* Presenting Symptoms† Recommendations
*
Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.
†
Management is determined by the most severe event, not attributable to any other cause.
‡
If 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, e.g., point to clock, pen, button=3 points); Following Commands (e.g., "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.
§
Not attributable to any other cause.
Follow the recommendations in Table 2 for restarting dosing.
#
All references to dexamethasone administration are dexamethasone or equivalent.
Þ
If the last dose administered was 5 mg, administer 2.5 mg. If the last dose administered was 25 mg, restart step-up dosing from 5 mg. If the last dose administered was 200 mg, refer to Table 2 for recommendations regarding restarting therapy based on time since the last dose.
Grade 1 ICE‡ score 7-9,
or depressed level of consciousness§: awakens spontaneously.
  • Withhold until neurologic symptoms resolve or return to baseline.
  • Provide supportive therapy. Manage per current practice guidelines.
  • Consider non-sedating, anti-seizure medications for seizure prophylaxis.
Grade 2 ICE‡ score 3-6,
or depressed level of consciousness§: awakens to voice.
  • Withhold until neurologic symptoms resolve or return to baseline.
  • Provide supportive therapy. Manage per current practice guidelines.
  • Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
  • Consider non-sedating, anti-seizure medications for seizure prophylaxis.
  • Monitor patients within proximity of a healthcare facility for 24 hours following the next dose of LYNOZYFIC and consider hospitalization.
Grade 3 ICE‡ score 0-2,
or depressed level of consciousness§: awakens only to tactile stimulus,
or seizures, either:
  • any clinical seizure, focal or generalized, that resolves rapidly, or
  • non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention,
or raised intracranial pressure: focal/local edema on neuroimaging.
  • Withhold until neurologic symptoms resolve or return to baseline.
  • Provide supportive therapy, which may include intensive care. Manage per current practice guidelines.
  • Consider neurology evaluation.
  • Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
  • Consider non-sedating, anti-seizure medications for seizure prophylaxis.
  • Permanently discontinue LYNOZYFIC for recurrent Grade 3 ICANS.
  • Resume treatment with LYNOZYFIC at a reduced doseÞ and hospitalize for 24 hours after the administration of the dose. After resuming treatment, if the administered dose is tolerated, continue with the next dose of the recommended dosing regimen per Table 1.
Grade 4 ICE‡ score 0,
or depressed level of consciousness§: either:
  • patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or
  • stupor or coma,
or seizures, either:
  • life-threatening prolonged seizure (>5 minutes), or
  • repetitive clinical or electrical seizures without return to baseline in between,
or motor findings:
  • deep focal motor weakness such as hemiparesis or paraparesis,
or raised intracranial pressure/cerebral edema, with signs/ symptoms such as:
  • diffuse cerebral edema on neuroimaging, or
  • decerebrate or decorticate posturing, or
  • cranial nerve VI palsy, or
  • papilledema, or
  • Cushing's triad.
  • Permanently discontinue LYNOZYFIC.
  • Provide supportive therapy, which may include intensive care. Manage per current practice guidelines.
  • Consider neurology evaluation.
  • Administer dexamethasone# 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper.
  • Consider non-sedating, anti-seizure medications for seizure prophylaxis.

Other Adverse Reactions

Management recommendations for other adverse reactions are summarized in Table 5.

Table 5: Recommendations for Management of Other Adverse Reactions
Adverse Reaction Severity* Recommendations
*
Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0
†
If the last dose administered was 5 mg, administer 2.5 mg. If the last dose administered was 25 mg, restart step-up dosing from 5 mg. If the last dose administered was 200 mg, refer to Table 2 for recommendations regarding restarting therapy based on time since the last dose.
‡
Follow the recommendations in Table 2 for restarting dosing.
Infusion-Related Reactions Grade 2
  • Stop infusion and treat symptoms.
  • May resume treatment with the remaining infusion (total infusion time must not exceed 6 hours total) when symptoms are Grade 1 or baseline.
  • Consider decreasing infusion rate by up to 50% when resuming treatment. If tolerated, infusion rate can be increased with subsequent doses.
Grade 3
  • Stop infusion and treat symptoms.
  • May resume when symptoms are Grade 1 or baseline.
  • After resolution of the adverse event, follow the recommendations:
    • Decrease the infusion rate up to 50% (no more than 6 hours total).
    • Resume at reduced dose.†
    • If the administered dose is tolerated, continue with the next dose of the recommended dosing regimen at the decreased infusion rate.
    • Infusion rate can be increased if tolerated.
  • Permanently discontinue LYNOZYFIC if Grade 3 IRR recurs with subsequent infusions.
Grade 4
  • Permanently discontinue LYNOZYFIC and treat symptoms.
Neurologic Adverse Reactions (excluding ICANS) Grade 2
  • Withhold LYNOZYFIC until symptoms resolve to Grade 1 or baseline.‡
Grade 3 (First occurrence)
  • Withhold LYNOZYFIC until Grade 1 or baseline.‡
Grade 3 (Recurrent)
Grade 4
  • Permanently discontinue LYNOZYFIC.
Infections Grades 2 or 3
  • Withhold LYNOZYFIC in patients with active infection until the infection improves to Grade 1 or less.‡
Grade 4
  • Consider permanent discontinuation of LYNOZYFIC. If treatment is not permanently discontinued, withhold subsequent treatment doses until Grade 1 or baseline.‡
Other Non-hematologic Adverse Reactions Grade 3
  • Withhold LYNOZYFIC until Grade 1 or baseline.‡
Grade 4
  • Consider permanent discontinuation of LYNOZYFIC.
  • If LYNOZYFIC is not permanently discontinued, withhold subsequent treatment doses until Grade 1 or baseline.‡
Hematologic Adverse Reactions Platelet count less than 50,000/mcL with bleeding
OR
less than 25,000/mcL
  • Withhold LYNOZYFIC until 25,000/mcL or higher and no evidence of bleeding.‡
Absolute neutrophil count less than 1 × 109/L with Grade 2 or higher infection
OR
less than 0.5 × 109/L
  • Withhold LYNOZYFIC until 0.5 × 109/L or higher.‡
Febrile neutropenia
  • Withhold LYNOZYFIC until neutrophil count is greater than 1 × 109/L and fever resolves.‡
Hemoglobin less than 8 g/dL
  • Withhold LYNOZYFIC until hemoglobin is 8 g/dL or higher.‡

Preparation and Administration

Preparation

  • Use aseptic technique to prepare LYNOZYFIC. Each vial is intended for one time use only. Do not shake.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. LYNOZYFIC is a clear to slightly opalescent, colorless to pale yellow solution. Discard the vial if the solution is cloudy, discolored, or contains particulate matter.
  • Determine the dose, total volume of LYNOZYFIC solution, and the number of LYNOZYFIC vials needed (see Table 6).

Dilution

  • Withdraw the desired dose from the vial of LYNOZYFIC and transfer into an intravenous infusion bag [polyvinyl chloride (PVC) or polyolefin (PO)] of 0.9% Sodium Chloride Injection, according to Table 6. Discard any unused portion left in the vial.
  • Mix diluted solution by gentle inversion. Do not shake the solution.
Table 6: Dilution of LYNOZYFIC
LYNOZYFIC
dose		 LYNOZYFIC
vial strength		 Volume of LYNOZYFIC to be added to the infusion bag Size of 0.9% Sodium Chloride Injection Infusion Bag (PVC or PO)
*
Modified dose due to adverse reaction. For instructions on when to use the modified dose refer to Table 3, Table 4, and Table 5.
2.5 mg* 5 mg/2.5 mL 1.25 mL 50 mL
5 mg 5 mg/2.5 mL 2.5 mL 50 mL or 100 mL
25 mg 5 mg/2.5 mL 12.5 mL 50 mL or 100 mL
200 mg 200 mg/10 mL 10 mL 50 mL or 100 mL

Diluted LYNOZYFIC Storage

Use diluted LYNOZYFIC immediately. If not used immediately, store the solution:

  • at room temperature up to 25°C (77°F) for no more than 8 hours from preparation to the start of the infusion.
    Or
  • under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 48 hours from preparation to the start of the infusion.

Do not freeze.

Do not shake.

Administration

  • Administer as an intravenous infusion only.
  • Refer to Dosage and Administration (2.2) for infusion rates.
  • Connect the prepared intravenous infusion bag containing the final LYNOZYFIC solution to intravenous tubing constructed of PVC, polyethylene (PE)-lined PVC, or polyurethane (PU).
  • Use of a 0.2-micron to 5-micron polyethersulfone (PES) filter is required.
  • Prime with LYNOZYFIC to the end of the intravenous tubing.
  • Do not mix LYNOZYFIC with other drugs or concurrently administer other drugs through the same intravenous line.
  • Upon completion of LYNOZYFIC infusion, flush the infusion line with an adequate volume of sterile 0.9% Sodium Chloride Injection to ensure that the entire contents of the infusion bag are administered.
  • Total infusion time should include flushing of the infusion line.

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