Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
TALVEY 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 an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Treatment with TALVEY should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
TALVEY should be administered by a healthcare professional with adequately-trained medical personnel and appropriate medical equipment to manage severe reactions, including cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
Pre-treatment medicinal products should be administered prior to each dose of TALVEY during the step-up phase (see below).
TALVEY should be administered subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule according to Table 1. Patients who receive talquetamab according to the 0.4 mg/kg weekly dosing schedule and have attained an adequate clinical response that is confirmed in at least two consecutive disease assessments can be considered for switch to the 0.8 mg/kg biweekly dosing schedule.
Table 1. Recommended TALVEY dose:
| Dosing schedule | Phase | Day | TALVEY dosea |
|---|---|---|---|
| Weekly dosing schedule | Step-up phase | Day 1 | 0.01 mg/kg |
| Day 3b | 0.06 mg/kg | ||
| Day 5b | 0.4 mg/kg | ||
| Treatment phase | Once a week thereafterc | 0.4 mg/kg | |
| Biweekly (every 2 weeks) dosing schedule | Step-up phase | Day 1 | 0.01 mg/kg |
| Day 3b | 0.06 mg/kg | ||
| Day 5b | 0.4 mg/kg | ||
| Day 7b | 0.8 mg/kg | ||
| Treatment phase | Once every 2 weeks thereafterc | 0.8 mg/kg |
a Based on actual body weight and administered subcutaneously.
b Dose may be administered between 2 to 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions.
c Maintain a minimum of 6 days between weekly doses and a minimum of 12 days between biweekly (every 2 weeks) doses.
Patients should be instructed to remain within proximity of a healthcare facility and monitored for 48 hours after administration of all doses within the TALVEY step-up phase for signs and symptoms of CRS and ICANS (see section 4.4).
Patients should be treated with TALVEY until disease progression or unacceptable toxicity.
The following pre-treatment medicinal products must be administered 1 to 3 hours before each dose of TALVEY during the step-up phase to reduce the risk of CRS (see section 4.4).
Pre-treatment medicinal products should be administered prior to subsequent doses for patients who repeat doses within the TALVEY step-up phase due to dose delays (see Table 2) or for patients who experienced CRS (see Table 3).
Prior to starting treatment with TALVEY, prophylaxis should be considered for the prevention of infections, per local institutional guidelines.
If a dose of TALVEY is delayed, therapy should be restarted based on recommendations in Table 2, and weekly or biweekly dosing should be resumed accordingly (see Posology above). Pre-treatment medicinal products should be administered prior to restarting TALVEY, and patients should be monitored accordingly (see section 4.2).
Table 2. Recommendations for restarting TALVEY after dose delay:
| Dosing schedule | Last dose administered | Time from last dose administered | TALVEY recommendation* |
|---|---|---|---|
| Weekly dosing schedule | 0.01 mg/kg | More than 7 days | Restart at 0.01 mg/kg |
| 0.06 mg/kg | 8 to 28 days | Repeat 0.06 mg/kg | |
| More than 28 days | Restart at 0.01 mg/kg | ||
| 0.4 mg/kg | 8 to 35 days | Repeat 0.4 mg/kg | |
| 36 to 56 days | Restart at 0.06 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| Biweekly (every 2 weeks) dosing schedule | 0.01 mg/kg | More than 7 days | Restart at 0.01 mg/kg |
| 0.06 mg/kg | 8 to 28 days | Repeat 0.06 mg/kg | |
| More than 28 days | Restart at 0.01 mg/kg | ||
| 0.4 mg/kg | 8 to 35 days | Repeat 0.4 mg/kg | |
| 36 to 56 days | Restart at 0.06 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| 0.8 mg/kg | 14 to 35 days | Repeat 0.8 mg/kg | |
| 36 to 56 days | Restart at 0.4 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg |
* Administer pretreatment medicinal products prior to restarting TALVEY. After restarting TALVEY, resume weekly or biweekly (every 2 weeks) dosing accordingly (see section 4.2).
Dose delays may be required to manage toxicities related to TALVEY (see section 4.4). See Table 2 for recommendations on restarting TALVEY after a dose delay.
See Tables 3 and 4 for recommended actions for the management of CRS and ICANS. See Table 6 for recommended dose modifications for other adverse reactions.
CRS should be identified based on clinical presentation (see section 4.4). Other causes of fever, hypoxia, and hypotension should be evaluated and treated. If CRS is suspected, TALVEY should be withheld until CRS resolves and should be managed according to the recommendations in Table 3. Supportive therapy for CRS should be administered, which may include intensive care for severe or life-threatening CRS. Laboratory testing should be considered to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.
Table 3. Recommendations for management of CRS:
| CRS Gradea | TALVEY actions | Tocilizumabb | Corticosteroidsc |
|---|---|---|---|
| Grade 1 Temperature ≥38°Cd | Withhold TALVEY until CRS resolves. Administer pre-treatment medicinal product prior to next dose of TALVEY. | May be considered. | Not applicable |
| Grade 2 Temperature ≥38°Cd with either: Hypotension responsive to fluids and not requiring vasopressors, or Oxygen requirement of low-flow nasal cannulae or blow-by. | Withhold TALVEY until CRS resolves. Administer pre-treatment medicinal products prior to next dose of TALVEY. Monitor patient for 48 hours following the next dose of TALVEY. Instruct patients to remain within proximity of a healthcare facility during monitoring. | Administer tocilizumabc 8 mg/kg intravenously over 1 hour (not to exceed 800 mg). Repeat tocilizumab every 8 hours as needed, if not responsive to intravenous fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. | If no improvement within 24 hours of starting tocilizumab, administer methylprednisolone 1 mg/kg intravenously twice daily, or dexamethasone 10 mg intravenously every 6 hours. Continue corticosteroid use until the event is Grade 1 or less, then taper over 3 days. |
| Grade 3 Temperature ≥38°Cd with either: Hypotension requiring one vasopressor, with or without vasopressin, or Oxygen requirement of high-flow nasal cannulae, facemask, non-rebreather mask, or Venturi mask | Duration <48 hours: Per Grade 2. Recurrent or Duration ≥48 hours Permanently discontinue TALVEY. | Administer tocilizumab 8 mg/kg intravenously over 1 hour (not to exceed 800 mg). Repeat tocilizumab every 8 hours as needed, if not responsive to intravenous fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. | If no improvement, administer methylprednisolone 1 mg/kg intravenously twice daily or dexamethasone (e.g., 10 mg intravenously every 6 hours). Continue corticosteroid use until the event is Grade 1 or less, then taper over 3 days. |
| Grade 4 Temperature ≥38°Cd with either: Hypotension requiring multiple vasopressors (excluding vasopressin), or oxygen requirement of positive pressure (e.g., continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation, and mechanical ventilation) | Permanently discontinue TALVEY. | Administer tocilizumab 8 mg/kg intravenously over 1 hour (not to exceed 800 mg). Repeat tocilizumab every 8 hours as needed, if not responsive to intravenous fluids or increasing supplemental oxygen. Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses. | As above or administer methylprednisolone 1 000 mg intravenously per day for 3 days, per physician discretion. If no improvement or if condition worsens, consider alternate immunosuppressants.c |
a Based on ASTCT grading for CRS (Lee et al 2019).
b Refer to tocilizumab prescribing information for details.
c Treat unresponsive CRS per institutional guidelines.
d Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as antipyretics or anticytokine therapy (e.g., tocilizumab or corticosteroids).
e Low-flow nasal cannula is ≤ 6 L/min, and high-flow nasal cannula is >6 L/min.
At the first sign of neurologic toxicity, including ICANS, TALVEY should be withheld and neurology evaluation should be considered. Other causes of neurologic symptoms should be ruled out.
Supportive therapy should be provided, which may include intensive care, for severe or life-threatening ICANS (see section 4.4). Management recommendations for ICANS are summarised in Table 4.
Table 4. Recommendations for management of ICANS:
| ICANS Gradea,b | Concurrent CRS | No concurrent CRS |
|---|---|---|
| Grade 1 ICEc score 7-9 or depressed level of consciousnessd: awakens spontaneously. | Management of CRS per Table 3. Monitor neurologic symptoms and consider neurology consultation and evaluation, per physician discretion. | Monitor neurologic symptoms and consider neurology consultation and evaluation, per physician discretion. |
| Withhold TALVEY until ICANS resolves. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. | ||
| Grade 2 ICEc score 3-6 or depressed level of consciousnessd: awakens to voice. | Administer tocilizumab per Table 3 for management of CRS. If no improvement after starting tocilizumab, administer dexamethasonee 10 mg intravenously every 6 hours if not already taking other corticosteroids. Continue dexamethasone use until resolution to Grade 1 or less, then taper. | Administer dexamethasonee 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. |
| Withhold TALVEY until ICANS resolves. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Consider neurology consultation and other specialists for further evaluation, as needed. Monitor patient for 48 hours following the next dose of TALVEY. Instruct patients to remain within proximity of a healthcare facility during monitoring. | ||
| Grade 3 ICEc score 0-2 (If ICE score is 0, but the patient is arousable (e.g., awake with global aphasia) and able to perform assessment) or depressed level of consciousnessd: awakens only to tactile stimulus, or seizuresd, 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 on neuroimagingd. | Administer tocilizumab per Table 3 for management of CRS. Administer dexamethasonee 10 mg intravenously with the first dose of tocilizumab and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. | Administer dexamethasonee 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. |
| Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Consider neurology consultation and other specialists for further evaluation, as needed. First Occurrence: Withhold TALVEY until ICANS resolves. Monitor patient for 48 hours following the next dose of TALVEY. Instruct patients to remain within proximity of a healthcare facility during monitoring. Recurrent: Permanently discontinue TALVEY. | ||
| Grade 4 ICEc score 0 (Patient is unarousable and unable to perform ICE assessment) or depressed level of consciousnessd either: • patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or • stupor or coma, or seizuresd, either: • life-threatening prolonged seizure (>5 minutes), or • repetitive clinical or electrical seizures without return to baseline in between, or motor findingsd: • deep focal motor weakness such as hemiparesis or paraparesis, or raised intracranial pressure/cerebral oedemad, 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. | Administer tocilizumab per Table 3 for management of CRS. Administer dexamethasonee 10 mg intravenously and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Alternatively, consider administration of methylprednisolone 1 000 mg per day intravenously with first dose of tocilizumab, and continue methylprednisolone 1 000 mg per day intravenously for 2 or more days. | Administer dexamethasonee 10 mg intravenously and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Alternatively, consider administration of methylprednisolone 1 000 mg per day intravenously for 3 days; if improves, then manage as above. |
| Permanently discontinue TALVEY. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Consider neurology consultation and other specialists for further evaluation, as needed. In case of raised intracranial pressure/cerebral oedema, refer to local institutional guidelines for management. | ||
a Management is determined by the most severe event, not attributable to any other cause.
b ASTCT 2019 grading for ICANS.
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 Attributable to no other cause.
e All references to dexamethasone administration are dexamethasone or equivalent
Table 5. Recommendations for management of neurologic toxicity (excluding ICANS):
| Adverse Reaction | Severitya | Actions |
|---|---|---|
| Neurologic Toxicitya (excluding ICANS) | Grade 1 | • Withhold TALVEY until neurologic toxicity symptoms resolve or stabilise.b |
| Grade 2 Grade 3 (First occurrence) | • Withhold TALVEY until neurologic toxicity symptoms improve to Grade 1 or less.b • Provide supportive therapy. | |
| Grade 3 (Recurrent) Grade 4 | • Permanently discontinue TALVEY. • Provide supportive therapy, which may include intensive care. |
a Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
b See Table 2 for recommendations on restarting TALVEY after dose delays.
The recommended dose modifications for other adverse reactions are provided in Table 6.
Table 6. Recommended dose modifications for other adverse reactions:
| Adverse reaction | Severity | Dose modification |
|---|---|---|
| Serious infections (see section 4.4) | All Grades | • Do not administer TALVEY step-up dosing schedule in patients with active infection. • Withhold TALVEY in the step-up phase until infection resolves. |
| Grade 3-4 | • Withhold TALVEY during the treatment phase until infection improves to Grade 2 or better. | |
| Cytopenias (see section 4.4) | Absolute neutrophil count less than 0.5 × 109/L | • Withhold TALVEY until absolute neutrophil count is 0.5 × 109/L or higher. |
| Febrile neutropenia | • Withhold TALVEY until absolute neutrophil count is 1.0 × 109/L or higher and fever resolves. | |
| Haemoglobin less than 8 g/dL | • Withhold TALVEY until haemoglobin is 8 g/dL or higher. | |
| Platelet count less than 25 000/µL Platelet count between 25 000/µL and 50 000/µL with bleeding | • Withhold TALVEY until platelet count is 25 000/µL or higher and no evidence of bleeding. | |
| Oral toxicity, including weight loss (see section 4.4) | Toxicity not responding to supportive care | Interrupt TALVEY until stabilisation or improvement, and consider restarting on modified schedule as follows: • If current dose is 0.4 mg/kg every week, change to 0.4 mg/kg every two weeks • If current dose is 0.8 mg/kg every two weeks, change to 0.8 mg/kg every four weeks |
| Skin reactions, including nail disorders (see section 4.4) | Grade 3-4 | • Withhold TALVEY until adverse reaction improves to Grade 1 or baseline. |
| Other non-haematologic adverse reactionsa (see section 4.8) | Grade 3-4 | • Withhold TALVEY until adverse reaction improves to Grade 1 or baseline. |
a Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03.
There is no relevant use of TALVEY in the paediatric population in the treatment of multiple myeloma.
No dose adjustment is required (see section 5.2).
No dose adjustment is recommended for patients with mild or moderate renal impairment (see section 5.2).
No dose adjustment is recommended for patients with mild hepatic impairment (see section 5.2). Limited or no data are available in patients with moderate and severe hepatic impairment.
TALVEY is for subcutaneous use.
The required volume of TALVEY should be injected into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TALVEY may be injected into the subcutaneous tissue at other sites (e.g., thigh). If multiple injections are required, TALVEY injections should be at least 2 cm apart.
TALVEY must not be injected into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.
For instructions on handling of the medicinal product before administration, see section 6.6.
The maximum tolerated dose of talquetamab has not been determined. In clinical studies, doses of up to 1.2 mg/kg once every 2 weeks and 1.6 mg/kg every month have been administered.
In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.
Unopened vial:
15 months.
Prepared syringe:
Chemical and physical in-use stability has been demonstrated up to 24 hours at 2 to 8°C followed by up to 24 hours at temperature of 15°C to 30°C.
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 preparation has taken place in controlled and validated aseptic conditions. Discard if stored for more than 24 hours refrigerated or more than 24 hours of being at ambient temperature.
The prepared syringe should be stored protected from light.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after opening of the medicinal product, see section 6.3.
TALVEY 2 mg/mL solution for injection: 1.5 mL solution for injection in a Type 1 glass vial with an elastomeric stopper and an aluminium seal with a light green flip-off cap containing 3 mg of talquetamab.
Pack size of 1 vial.
TALVEY 40 mg/mL solution for injection: 1 mL solution for injection in a Type 1 glass vial with an elastomeric stopper and an aluminium seal with a violet flip-off cap containing 40 mg of talquetamab.
Pack size of 1 vial.
The TALVEY vials are supplied as ready-to-use solution for injection that do not need dilution prior to administration.
TALVEY vials of different concentrations should not be combined to achieve treatment dose.
Aseptic technique should be used to prepare and administer TALVEY.
Refer to the following reference tables for the preparation of TALVEY
Use Table 13 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.01 mg/kg dose using TALVEY 2 mg/mL vial.
Table 13. 0.01 mg/kg dose: injection volumes using TALVEY 2 mg/mL vial:
| 0.01 mg/kg dose | Body weight (kg) | Total dosea (mg) | Volume of injection (mL) | Number of vials (1 vial = 1.5 mL) |
| 35 to 39 | 0.38 | 0.19 | 1 | |
| 40 to 45 | 0.42 | 0.21 | 1 | |
| 46 to 55 | 0.5 | 0.25 | 1 | |
| 56 to 65 | 0.6 | 0.3 | 1 | |
| 66 to 75 | 0.7 | 0.35 | 1 | |
| 76 to 85 | 0.8 | 0.4 | 1 | |
| 86 to 95 | 0.9 | 0.45 | 1 | |
| 96 to 105 | 1.0 | 0.5 | 1 | |
| 106 to 115 | 1.1 | 0.55 | 1 | |
| 116 to 125 | 1.2 | 0.6 | 1 | |
| 126 to 135 | 1.3 | 0.65 | 1 | |
| 136 to 145 | 1.4 | 0.7 | 1 | |
| 146 to 155 | 1.5 | 0.75 | 1 | |
| 156 to 160 | 1.6 | 0.8 | 1 |
a The Total dose (mg) is calculated based on the rounded Volume of injection (mL)
Use Table 14 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.06 mg/kg dose using TALVEY 2 mg/mL vial.
Table 14. 0.06 mg/kg dose: injection volumes using TALVEY 2 mg/mL vial:
| 0.06 mg/kg dose | Body weight (kg) | Total dosea (mg) | Volume of injection (mL) | Number of vials (1 vial = 1.5 mL) |
| 35 to 39 | 2.2 | 1.1 | 1 | |
| 40 to 45 | 2.6 | 1.3 | 1 | |
| 46 to 55 | 3 1. | 5 | 1 | |
| 56 to 65 | 3.6 | 1.8 | 2 | |
| 66 to 75 | 4.2 | 2.1 | 2 | |
| 76 to 85 | 4.8 | 2.4 | 2 | |
| 86 to 95 | 5.4 | 2.7 | 2 | |
| 96 to 105 | 6 | 3 | 2 | |
| 106 to 115 | 6.6 | 3.3 | 3 | |
| 116 to 125 | 7.2 | 3.6 | 3 | |
| 126 to 135 | 7.8 | 3.9 | 3 | |
| 136 to 145 | 8.4 | 4.2 | 3 | |
| 146 to 155 | 9 | 4.5 | 3 | |
| 156 to 160 | 9.6 | 4.8 | 4 |
a The Total dose (mg) is calculated based on the rounded Volume of injection (mL)
Use Table 15 to determine total dose, injection volume and number of vials required based on patient’s actual body weight for the 0.4 mg/kg dose using TALVEY 40 mg/mL vial.
Table 15. 0.4 mg/kg dose: injection volumes using TALVEY 40 mg/mL vial:
| 0.4 mg/kg dose | Body weight (kg) | Total dosea (mg) | Volume of injection (mL) | Number of vials (1 vial = 1.0 mL) |
| 35 to 39 | 14.8 | 0.37 | 1 | |
| 40 to 45 | 16 | 0.4 | 1 | |
| 46 to 55 | 20 | 0.5 | 1 | |
| 56 to 65 | 24 | 0.6 | 1 | |
| 66 to 75 | 28 | 0.7 | 1 | |
| 76 to 85 | 32 | 0.8 | 1 | |
| 86 to 95 | 36 | 0.9 | 1 | |
| 96 to 105 | 40 | 1 | 1 | |
| 106 to 115 | 44 | 1.1 | 2 | |
| 116 to 125 | 48 | 1.2 | 2 | |
| 126 to 135 | 52 | 1.3 | 2 | |
| 136 to 145 | 56 | 1.4 | 2 | |
| 146 to 155 | 60 | 1.5 | 2 | |
| 156 to 160 | 64 | 1.6 | 2 |
a The Total dose (mg) is calculated based on the rounded Volume of injection (mL)
Use Table 16 to determine total dose, injection volume, and number of vials required based on patient’s actual body weight for the 0.8 mg/kg dose using TALVEY 40 mg/mL vial.
Table 16. 0.8 mg/kg dose: injection volumes using TALVEY 40 mg/mL vial:
| 0.8 mg/kg dose | Body weight (kg) | Total dosea (mg) | Volume of injection (mL) | Number of vials (1 vial = 1.0 mL) |
| 35 to 39 | 29.6 | 0.74 | 1 | |
| 40 to 45 | 34 | 0.85 | 1 | |
| 46 to 55 | 40 | 1 | 1 | |
| 56 to 65 | 48 | 1.2 | 2 | |
| 66 to 75 | 56 | 1.4 | 2 | |
| 76 to 85 | 64 | 1.6 | 2 | |
| 86 to 95 | 72 | 1.8 | 2 | |
| 96 to 105 | 80 | 2 | 2 | |
| 106 to 115 | 88 | 2.2 | 3 | |
| 116 to 125 | 96 | 2.4 | 3 | |
| 126 to 135 | 104 | 2.6 | 3 | |
| 136 to 145 | 112 | 2.8 | 3 | |
| 146 to 155 | 120 | 3 | 3 | |
| 156 to 160 | 128 | 3.2 | 4 |
a The Total dose (mg) is calculated based on the rounded Volume of injection (mL)
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