Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Regeneron Ireland DAC., One Warrington Place, Dublin 2, D02 HH27, Ireland
LYNOZYFIC is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
LYNOZYFIC should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS), infusion-related reactions (IRR), or immune effector cell-associated neurotoxicity syndrome (ICANS) if they occur (see section 4.4).
Prior to initiating treatment, complete blood count should be performed. Any active infection should be ruled out (see section 4.4). Pregnancy in women of child-bearing potential should also be ruled out (see section 4.6).
Pretreatment medicinal products in Table 1 should be administered to reduce the risk of CRS and/or IRR (see sections 4.4 and 4.8). Pretreatment medicinal products should be administered until two full doses are tolerated without CRS and/or IRR.
Table 1. Pretreatment medicinal products:
| Dose | Pretreatment medicinal products | Administration relative to LYNOZYFIC infusion |
|---|---|---|
| Step up dosing (including the 1st 200 mg dose) | 40 mg dexamethasone IV | 1 to 3 hours prior to infusion |
| Antihistamine (e.g., diphenhydramine 25 mg oral or IV) | 30 to 60 minutes prior to infusion | |
| Paracetamol (e.g., 500 to 1000 mg oral) | 30 to 60 minutes prior to infusion | |
| 2nd 200 mg dose | Dexamethasone | 1 to 3 hours prior to infusion |
| 40 mg dexamethasone IV in patients who experienced CRS and/or IRR with prior infusion | ||
| 10 mg dexamethasone IV in patients who did not experience CRS and/or IRR with prior infusion | ||
| Antihistamine (e.g., diphenhydramine 25 mg oral or IV) | 30 to 60 minutes prior to infusion | |
| Paracetamol (e.g., 500 to 1000 mg oral) | 30 to 60 minutes prior to infusion | |
| Subsequent 200 mg doses | • If the patient experienced CRS and/or IRR with the prior infusion, repeat pretreatment medicinal products as described above for the 2nd 200 mg dose. • Once the 200 mg dose is tolerated without CRS and/or IRR: o If the patient received 40 mg dexamethasone IV with the prior infusion, step down to 10 mg dexamethasone IV and continue other pretreatment medicinal products as described above. o If the patient received 10 mg dexamethasone IV with the prior infusion, discontinue all pretreatment medicinal products. | |
Prophylactic treatment per local institutional guidelines for Pneumocystis jirovecii pneumonia (PJP) and herpes simplex and zoster viruses is recommended for all patients. Prophylactic antimicrobials and anti-virals, including prophylaxis against cytomegalovirus (CMV) infection, should be considered based on local institutional guidelines (see section 4.4).
The recommended step-up treatment doses, full treatment dose, and treatment frequency are presented in Table 2. Each dose should only be administered if the previous dose is tolerated. For doses that are not tolerated, refer to Table 3, Table 4, and Table 5.
All patients should be monitored for signs and symptoms of potential CRS, IRR, and ICANS during administration and for 24 hours after the end of the infusion of the first step‑up treatment dose. Patients should be instructed to remain with a caregiver within close proximity of the qualified treatment centre for 24 hours after the first step-up treatment dose (see section 4.4).
Patients who have experienced CRS, IRR, a neurologic adverse reaction, or any grade ≥ 2 adverse event, with the first step-up treatment dose administration should be monitored during administration and for 24 hours after the administration of the second step-up treatment dose and should be instructed to remain with a caregiver within close proximity of the qualified treatment centre for 24 hours (see section 4.4).
Table 2. Recommended posology:
| Dosing schedule | Daya | LYNOZYFIC dose | |
|---|---|---|---|
| Step-up dosing schedule | Week 1 Day 1 | Step-up treatment dose 1 | 5 mg |
| Week 2 Day 1 | Step-up treatment dose 2 | 25 mg | |
| Week 3 Day 1 | First full treatment dose | 200 mg | |
| Weekly dosing schedule | Week 4 to Week 13 for 10 treatment doses | Full treatment doses | 200 mg |
| Every 2 weeks dosing schedule | Week 14 and every 2 weeks thereafter | Full treatment doses | 200 mg |
| Patients who have received at least 17 doses of 200 mg and have confirmed response of very good partial response (VGPR) or better per international myeloma working group (IMWG) criteria at or after Week 24b | |||
| Every 4 weeks dosing schedule | At week 24 or after and every 4 weeks thereafter | Treatment doses | 200 mg |
a Weekly doses should be at least 5 days apart.
b Patients who have not achieved VGPR or better at Week 24 should continue receiving LYNOZYFIC every 2 weeks.
Treatment should be continued until disease progression or unacceptable toxicity.
Table 3 describes the management of CRS. Table 4 describes the management of ICANS. Table 5 describes the management of other adverse events.
Identify CRS based on clinical presentation (see section 4.4). 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:
| Gradea | Presenting symptoms | Recommendations |
|---|---|---|
| Grade 1 | Fever ≥ 38ºCb | • Withhold treatment until CRS resolves. • Provide supportive care, which may include intensive care. • Consider anticytokine therapyc and/or corticosteroidsd. • When restarting treatment, refer to Table 6. |
| Grade 2 | Fever ≥ 38ºCb with: Hypotension responsive to fluids and not requiring vasopressors and/or hypoxia requiring low-flow oxygene by nasal cannula or blow-by | • Withhold treatment until CRS resolves. • Provide supportive care, which may include intensive care. • If symptoms do not improve within 4 hours, administer anticytokine therapyc. • In patients with organ toxicities, administer corticosteroidsd. • When restarting treatment, refer to Table 6. |
| Grade 3 | Fever ≥ 38ºCb with: Hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high-flow oxygene by nasal cannula, face mask, non-rebreather mask, or Venturi mask. | • Withhold treatment until CRS resolves. • Provide supportive care, which may include intensive care, including anticytokine therapyc and corticosteroidsd. • When restarting treatment, refer to Table 6. • Permanently discontinue treatment if Grade 3 CRS recurs with subsequent infusions. |
| Grade 4 | Fever ≥ 38°Cb 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 treatment permanently. • CRS should be managed per Grade 3 recommendations. |
| Other | AST/ALT > 5× ULN associated with CRS Grade 3 or less | • Withhold treatment until CRS resolves and AST/ALT are < 3× ULN if baseline was normal or 1.5 to 3× baseline if baseline was abnormal. • Provide supportive care, which may include intensive care, and monitor. • When restarting treatment, refer to Table 6. |
a Based on Lee criteria for grading CRS (Lee et al., 2019).
b 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.
c 8 mg/kg tocilizumab infused over 1 hour, not to exceed 800 mg, may be considered.
d E.g., 20 mg dexamethasone per day in divided doses or equivalent.
e Low-flow oxygen defined as oxygen delivered at < 6 L/minute: high-flow oxygen defined as oxygen delivered at ≥ 6 L/minute.
Management recommendations for ICANS are summarized in Table 4. At the first sign of suspected 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.
Table 4. Recommendations for management of ICANS:
| Gradea | Presenting symptomsb | Recommendations |
|---|---|---|
| All grades | See information per grade. | • Provide supportive therapy, which may include intensive care. Manage per current practice guidelines. • Consider non-sedating, anti-seizure medicinal products for seizure prophylaxis. |
| Grade 1 | ICEc score 7-9, or depressed level of consciousnessd: awakens spontaneously. | • Withhold treatment until neurologic symptoms resolve or return to baseline. • When restarting treatment, refer to Table 6. |
| Grade 2 | ICEc score 3-6, or depressed level of consciousnessd: awakens to voice. | • Withhold treatment until neurologic symptoms resolve or return to baseline. • Administer dexamethasonee 10 mg IV every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. • When restarting treatment, refer to Table 6. |
| Grade 3 | ICEc score 0-2, or depressed level of consciousnessd: 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 oedema on neuroimaging. | • Withhold treatment until neurologic symptoms resolve or return to baseline. • Consider neurology evaluation. • Administer dexamethasonee 10 mg IV every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. • When restarting treatment, refer to Table 6. • Permanently discontinue treatment for recurrent Grade 3 ICANS. |
| Grade 4 | ICEc score 0, or depressed level of consciousnessd: 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 oedema, with signs/ symptoms such as: • diffuse cerebral oedema on neuroimaging, or • decerebrate or decorticate posturing, or • cranial nerve VI palsy, or • papilledema, or • Cushing’s triad. | • Permanently discontinue treatment. • Consider neurology evaluation. • Administer dexamethasonee 10 mg IV every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. |
a Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.
b Management is determined by the most severe event, not attributable to any other cause.
c 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.
d Not attributable to any other cause.
e All references to dexamethasone administration are dexamethasone or equivalent.
Management recommendations for other adverse reactions are summarized in Table 5.
Table 5. Recommendations for management of other adverse reactions:
| Adverse reaction | Grade | Recommendations |
|---|---|---|
| Infusion- related reactions (IRR) | 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. • When restarting treatment, refer to Table 6. |
| Grade 3 | • Stop infusion and treat symptoms. • May resume when symptoms are Grade 1 or baseline. • When restarting treatment, refer to Table 6. • Permanently discontinue treatment if Grade 3 IRR recurs with subsequent infusions. | |
| Grade 4 | • Permanently discontinue treatment and treat symptoms. | |
| Neurologic adverse event (excluding ICANS) | Grade 2 | • Withhold treatment until symptoms resolve to Grade 1 or baseline. • When restarting treatment, refer to Table 6. |
| Grade 3 | • Withhold treatment until Grade 1 or baseline. • When restarting treatment, refer to Table 6. | |
| Grade 4 | • Consider permanent discontinuation of treatment. • If treatment is not permanently discontinued, withhold subsequent treatment doses until Grade 1 or baseline and refer to Table 6 for restarting treatment. | |
| Infections | Grade 3 | • Withhold treatment in patients with active infection until the infection improves to Grade 1 or less. • When restarting treatment, refer to Table 6. |
| Grade 4 | • Consider permanent discontinuation of treatment. If treatment is not permanently discontinued, withhold subsequent treatment doses until Grade 1 or baseline and follow the recommendations in Table 6 for restarting dosing. | |
| Other non- haematologic adverse reactions | Grade 3 | • Withhold treatment until Grade 1 or baseline. • When restarting treatment, refer to Table 6. |
| Grade 4 | • Consider permanent discontinuation of treatment. • If treatment is not permanently discontinued, withhold subsequent treatment doses until Grade 1 or baseline and follow the recommendations in Table 6 for restarting dosing. | |
| Haematologic adverse reactions | Platelet count less than 50 000/mcL with bleeding OR less than 25 000/mcL | • Withhold treatment until 25 000/mcL or higher and no evidence of bleeding. • When restarting treatment, refer to Table 6. |
| Absolute neutrophil count less than 1.0 × 109/L with Grade 2 or higher infection OR less than 0.5 × 109/L | • Withhold treatment until 0.5 × 109/L or higher and the infection improves to Grade 1 or less. • When restarting treatment, refer to Table 6. | |
| Febrile neutropenia | • Withhold treatment until neutrophil count is greater than 1.0 × 109/L and fever resolves. • When restarting treatment, refer to Table 6. |
Dose delays may be required to manage toxicities related to LYNOZYFIC (see section 4.4). See Tables 3, 4, and 5 for the management of adverse reactions. The recommendations for restarting therapy with LYNOZYFIC after an adverse reaction are listed in Table 6.
When restarting therapy, doses should be administered at least 5 days from the previously administered dose. Step-up treatment doses may be repeated based on clinical judgement. Doses should not exceed those recommended in Table 2. Administer pretreatment medicinal products as per Table 1. After resuming treatment, if the administered dose is tolerated, continue with the next dose of the recommended dosing regimen per Table 2.
Table 6. Recommendations for restarting therapy with LYNOZYFIC after an adverse reaction:
| Last dose administered | Adverse reaction and grade | Dose for restarting therapy at the next scheduled dosea | Additional recommendations for restarting therapyb |
|---|---|---|---|
| 5 mg | Grade 1: CRS and ICANS | If ≤ 14 days since last dose, administer 25 mg | • Administer at the same infusion rate from prior dose. |
| If > 14 days since last dose, restart step-up dosing from 5 mg | |||
| Grade 2: CRS, IRR, or ICANS | If ≤ 14 days since last dose, administer 25 mg | • If prior CRS or IRR, consider a decrease in infusion rate up to 50% (no more than 6 hours total) when resuming treatment. • If prior CRS or ICANS, monitor for 24 hours | |
| If > 14 days since last dose, restart step-up dosing from 5 mg | |||
| Grade 3: CRS, IRR, or ICANS | Administer 2.5 mg | • If prior CRS or IRR, decrease infusion rate up to 50% (no more than 6 hours total) when resuming treatment. Increase rate on subsequent infusions if tolerated. • If prior CRS or ICANS, hospitalise for 24 hours. | |
| Recurrent Grade 3: CRS, IRR, or ICANS | Permanently discontinue treatment | N/A | |
| Grade 4: CRS, IRR, or ICANS | |||
| AST/ALT > 5× ULN associated with CRS Grade 2 or less | Transaminase levels that are trending towards baseline within 7 days from elevation onset, administer 25 mg | • For Grade 2 CRS, consider decreasing the infusion rate up to 50% (no more than 6 hours total) when resuming treatment. | |
| Transaminase levels that do not trend towards baseline in 7 days from elevation onset, administer 2.5 mg | |||
| All other adverse reactions in Table 5 | If ≤ 14 days since last dose, administer 25 mg | • Administer at the same infusion rate from prior dose | |
| If > 14 days since last dose, restart step-up dosing from 5 mg | |||
| 25 mg | Grade 1: CRS and ICANS | If ≤ 14 days since last dose, administer 200 mg | • Administer at the same infusion rate from prior dose |
| If > 14 and ≤ 28 days since last dose, restart step-up dosing from 25 mg | |||
| If > 28 days since last dose, restart step-up dosing from 5 mg | |||
| Grade 2: CRS, IRR, or ICANS | If ≤ 14 days since last dose, administer 200 mg | • If prior CRS or IRR, consider a decrease in infusion rate up to 50% (no more than 6 hours total) when resuming treatment. | |
| If > 14 and ≤ 28 days since last dose, restart step-up dosing from 25 mg | |||
| If > 28 days since last dose, restart step-up dosing from 5 mg | • If prior CRS or ICANS, monitor for 24 hours | ||
| Grade 3: CRS, IRR, or ICANS | Administer 5 mg | • If prior CRS or IRR, decrease infusion rate up to 50% (no more than 6 hours total) when resuming treatment. • If prior CRS or ICANS, hospitalise for 24 hours | |
| Recurrent Grade 3: CRS, IRR, or ICANS | Permanently discontinue treatment | N/A | |
| Grade 4: CRS, IRR, or ICANS | |||
| AST/ALT > 5× ULN associated with CRS Grade 2 or less | Transaminase levels that are trending towards baseline within 7 days from elevation onset, administer 200 mg | • For Grade 2 CRS, consider decreasing the infusion rate up to 50% (no more than 6 hours total) when resuming treatment. | |
| Transaminase levels that do not trend towards baseline within 7 days from elevation onset, restart step-up dosing from 5 mg | |||
| All other adverse reactions in Table 5 | If ≤ 14 days since last dose, administer 200 mg | • Administer at the same infusion rate from prior dose | |
| If > 14 and ≤ 28 days since last dose, restart step-up dosing from 25 mg | |||
| If > 28 days since last dose, restart step-up dosing from 5 mg | |||
| 200 mg | Grade 1: CRS and ICANS | If ≤ 49 days since last dose, administer 200 mg | • Administer at the same infusion rate from prior dose |
| If > 49 days since last dose, restart step-up dosing from 5 mg | |||
| Grade 2: CRS, IRR, or ICANS | If ≤ 49 days since last dose, administer 200 mg | • If prior CRS or IRR, consider a decrease in infusion rate up to 50% (no more than 6 hours total) when resuming treatment. • If prior CRS or ICANS, monitor for 24 hours | |
| If > 49 days since last dose, restart step-up dosing from 5 mg | |||
| Grade 3: CRS, IRR, or ICANS | If ≤ 49 days since last dose, administer 25 mg | • If prior CRS or IRR, decrease infusion rate up to 50% (no more than 6 hours total) when resuming treatment. • If prior CRS or ICANS, hospitalise for 24 hours | |
| If > 49 days since last dose, restart step-up dosing from 5 mg | |||
| Recurrent Grade 3: CRS, IRR, or ICANS | Permanently discontinue treatment | N/A | |
| Grade 4: CRS, IRR, or ICANS\ | |||
| AST/ALT > 5× ULN associated with CRS Grade 2 or less | Transaminase levels that are trending towards baseline within 7 days, administer 200 mg | • For Grade 2 CRS, consider decreasing the infusion rate up to 50% (no more than 6 hours total) when resuming treatment. | |
| Transaminase levels that do not trend towards baseline in 7 days and it has been ≤ 49 days since last dose, administer 25 mg | |||
| Transaminase levels that do not trend towards baseline in 7 days and it has been > 49 days since the last dose, restart step-up dosing from 5 mg | |||
| All other adverse reactions in Table 5 | If ≤ 49 days since last dose, administer 200 mg | • Administer at the same infusion rate from prior dose | |
| If > 49 days since last dose, restart step-up dosing from 5 mg |
a When restarting therapy, doses should be administered at least 5 days from the previously administered dose.
b If infusion rate was decreased and the treatment dose is tolerated, infusion rate can be increased gradually based on clinical judgment on subsequent infusions (minimum duration of 30 minutes).
If a dose is missed for a reason not included in Tables 3, 4 and 5, the dose should be administered as soon as possible based on Table 7.
Table 7. Recommendations for restarting therapy with LYNOZYFIC after a missed dose:
| Last dose administered | Time since the last dose administereda | Action for next dose. |
|---|---|---|
| 5 mg | ≤ 14 days | Administer 25 mg |
| > 14 days | Restart step-up dosing from 5 mg | |
| 25 mg | ≤ 14 days | Administer 200 mg |
| > 14 days and ≤ 28 days | Restart step-up dosing from 25 mg | |
| > 28 days | Restart step-up dosing from 5 mg | |
| 200 mg | ≤ 49 days | Administer 200 mg |
| > 49 days | Restart step-up dosing from 5 mg |
NOTE: Administer pretreatment medicinal products as per Table 1.
a Consider benefit-risk of restarting LYNOZYFIC in patients who require a dose delay of more than 30 days.
No dose adjustment is recommended for elderly patients (see section 5.2).
No dose adjustment is recommended for patients with mild (CrCL ≥ 60 to < 90 mL/min), moderate (CrCL ≥ 30 to < 60 mL/min), or severe renal impairment (CrCL ≥ 15 to < 30 mL/min) (see section 5.2).
No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin > ULN to 1.5 × ULN or AST > ULN). LYNOZYFIC has not been studied in patients with moderate (total bilirubin > 1.5 to 3 × ULN, any AST) or severe (total bilirubin > 3 to 10 × ULN, any AST) hepatic impairment. No dose recommendations can be made for patients with moderate or severe hepatic impairment (see section 5.2).
There is no relevant use of LYNOZYFIC in the paediatric population for the treatment of multiple myeloma.
LYNOZYFIC is for intravenous use only.
LYNOZYFIC should be administered as an intravenous infusion through a dedicated infusion line. It is recommended to use a 0.2-micron to 5-micron polyethersulfone (PES) filter (see section 6.6).
For instructions on dilution of the medicinal product before administration, see section 6.6.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Unopened vial:
18 months.
Infusion solution:
Once prepared, administer diluted solution immediately. Chemical and physical in-use stability has been demonstrated for the diluted infusion solution as follows:
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Protect the infusion solution from light during storage.
Store in a refrigerator at 2°C to 8°C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
5 mg concentrate for solution for infusion:
2.5 mL of concentrate in a 5 mL Type 1 clear glass vial with a grey chlorobutyl stopper with coating and a 20 mm aluminium seal cap with a white flip-off button.
Pack of one vial.
200 mg concentrate for solution for infusion:
10 mL of concentrate in a 20 mL Type 1 clear glass vial with a grey chlorobutyl stopper with coating and a 20 mm aluminium seal cap with a blue flip-off button.
Pack of one vial.
Use aseptic technique to prepare LYNOZYFIC. Each vial is intended for single-dose only. Discard any unused portion left in the vial.
Do not shake the vial.
Visually inspect for particulate matter and discoloration prior to administration. LYNOZYFIC is a clear to slightly opalescent, colourless to pale yellow liquid that is essentially free from visible particulates. Discard the vial if the solution is cloudy, discoloured, or contains particulate matter.
Withdraw the desired dose from the vial of LYNOZYFIC based on Table 12 and transfer into an intravenous infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection. LYNOZYFIC is compatible with polyvinyl chloride (PVC) non-di-ethylhexylphthalate (non-DEHP), polyolefin (PO), or ethyl vinyl acetate (EVA) infusion bags. Mix diluted solution by gentle inversion. Do not shake the solution.
Table 12. LYNOZYFIC volumes for addition to infusion bag:
| LYNOZYFIC dose (mg) | Amount of LYNOZYFIC per vial (mg) | Concentration of vial (mg/mL) | Number of vials required | Total volume of LYNOZYFIC to prepare dose (mL) | Sodium Chloride 9 mg/mL (0.9%) Injection, USP Infusion Bag (PVC or PO) Volume (mL) |
|---|---|---|---|---|---|
| 5 | 5 | 2 | 1 | 2.5 | 50 or 100 |
| 25 | 5 | 2 | 5 | 12.5 | 50 or 100 |
| 200 | 200 | 20 | 1 | 10 | 50 or 100 |
| Modified dose due to adverse eventa | |||||
| 2.5 | 5 | 2 | 1 | 1.25 | 50 |
a For instructions on when to use the modified dose refer to Tables 3, 4, and 5.
For storage conditions of the infusion solution, see section 6.3.
After LYNOZYFIC has been diluted as instructed, administer as follows:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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