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Columvi Prescribing Information
Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity
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,
, and
and ]
- Administer only as an intravenous infusion through a dedicated infusion line that includes a sterile 0.2-micron in-line filter.
- Administer COLUMVI diluted solution via intravenous bag infusion. The 2.5 mg dose may alternatively be administered via intravenous syringe infusion[see Dosage and Administration (2.5, 2.6, 2.7)].
- COLUMVI should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage severe CRS[see Dosage and Administration (2.4)].
- Ensure adequate hydration before administering COLUMVI.
- Premedicate before each dose[see Dosage and Administration (2.3)].
- Following pretreatment with obinutuzumab, administer COLUMVI according to the step-up dosing schedule in Table 1with appropriate premedication, including dexamethasone, to reduce the incidence and severity of CRS[see Dosage and Administration (2.3)].
- Due to the risk of CRS, patients should be hospitalized during and for 24 hours after completion of infusion of step-up dose 1 (2.5 mg on Cycle 1 Day 8)[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- For subsequent doses, patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after the completion of the next COLUMVI infusion.
Pretreatment with Obinutuzumab
Pretreat all patients with a single 1,000 mg dose of obinutuzumab administered as an intravenous infusion on Cycle 1 Day 1, 7 days prior to initiation of COLUMVI (see Table 1) to deplete the circulating and lymphoid tissue B cells.
Obinutuzumab should be administered as an intravenous infusion at 50 mg/hour. The rate of infusion can be escalated in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. Refer to the obinutuzumab prescribing information for complete dosing information.
COLUMVI Step-up Dose Schedule
COLUMVI dosing begins with a step-up dose schedule. Following completion of pretreatment with obinutuzumab on Cycle 1 Day 1, administer COLUMVI as an intravenous infusion according to the step-up dose schedule in Table 1. Administer premedications for each dose of COLUMVI as described in Table 3
[see Dosage and Administration (2.3)].
| Treatment cycle | Day | Dose of COLUMVI | Duration of infusion | |
|---|---|---|---|---|
Cycle 1 | Day 1 | ObinutuzumabRefer to " Pretreatment with obinutuzumab " described above. | ||
| Day 8 | Step-up dose 1 | 2.5 mg | 4 hoursFor patients who experience CRS with their previous dose of COLUMVI, the time of infusion may be extended up to 8 hours. | |
| Day 15 | Step-up dose 2 | 10 mg | ||
Cycle 2 | Day 1 | 30 mg | 4 hours | |
Cycle 3 to 12 | Day 1 | 30 mg | 2 hoursIf the patient experienced CRS with the previous dose, the duration of infusion should be maintained at 4 hours. | |
Continue COLUMVI for a maximum of 12 cycles (inclusive of Cycle 1 step-up dosing) or until disease progression or unacceptable toxicity, whichever occurs first.
Monitoring for Cytokine Release Syndrome
[see Warnings and Precautions (5.1)]
- Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.
- For the first COLUMVI step-up dose (2.5 mg on Cycle 1 Day 8), patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion.
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1.
- For subsequent infusions (30 mg on Day 1 of Cycle 2 or subsequent cycles), patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after completion of the next COLUMVI infusion.
- For monitoring after delayed or missed doses of COLUMVI, follow the recommendations in Table 2.
Delayed or Missed Doses
If a dose of COLUMVI is delayed, restart therapy based on the recommendations made in Table 2, then resume the treatment schedule accordingly.
For repeat of the 2.5 mg dose patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion. For the repeat of the 10 mg dose, patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion if any grade CRS occurred during the most recent 2.5 mg dose.
| Last Dose Administered | Time Since Last Dose Administered | Action for Next Dose(s)Administer premedication as per Table 3for all patients. |
|---|---|---|
| Obinutuzumab pretreatment (Cycle 1 Day 1) | ≤ 2 weeks |
|
| > 2 weeks |
| |
| COLUMVI 2.5 mg (Cycle 1 Day 8) | ≤ 2 weeks |
|
| > 2 to ≤ 4 weeks |
| |
| > 4 weeks |
| |
| COLUMVI 10 mg (Cycle 1 Day 15) | ≤ 2 weeks |
|
| > 2 to ≤ 6 weeks |
| |
| > 6 weeks |
| |
| COLUMVI 30 mg (Cycle 2 onwards) | ≤ 6 weeks |
|
| > 6 weeks |
|
Premedication
Administer the following premedications to reduce the risk of CRS and infusion-related reactions
[see Warnings and Precautions (5.1)]
.| Day of Treatment Cycle | Patients requiring premedication | Premedication | Administration |
|---|---|---|---|
Cycle 1, Day 8 and Day 15; Cycle 2; Cycle 3 | Dexamethasone 20 mg intravenouslyIf dexamethasone is not available, administer prednisone 100 mg, prednisolone 100 mg, or methylprednisolone 80 mg intravenously. | Completed at least 1 hour prior to COLUMVI infusion. | |
| All patients | Acetaminophen 500 mg to 1,000 mg orally | At least 30 minutes before COLUMVI infusion. | |
| Antihistamine (diphenhydramine 50 mg orally or intravenously or equivalent) | Completed at least 30 minutes before COLUMVI infusion. | ||
All subsequent infusions | All patients | Acetaminophen 500 mg to 1,000 mg orally | At least 30 minutes before COLUMVI infusion. |
| Antihistamine (diphenhydramine 50 mg orally or intravenously or equivalent) | Completed at least 30 minutes before COLUMVI infusion. | ||
| Patients who experienced any grade CRS with the previous dose | Dexamethasone 20 mg intravenously | Completed at least 1 hour prior to COLUMVI infusion. |
Tumor Lysis Syndrome Prophylaxis
Before starting COLUMVI, administer anti-hyperuricemics to patients at risk of tumor lysis syndrome, ensure adequate hydration status, and monitor as appropriate
[see Adverse Reactions (6.1)]
.Infection Prophylaxis
Before starting COLUMVI, consider initiation of antiviral prophylaxis to prevent herpes virus reactivation. Consider prophylaxis for cytomegalovirus infection, pneumocystis jirovecii pneumonia (PJP), and other opportunistic infections in patients at increased risk
[see Warnings and Precautions (5.3)]
.No dosage reduction for COLUMVI is recommended.
Cytokine Release Syndrome
Identify CRS based on clinical presentation
[see Warnings and Precautions (5.1)]
. Evaluate for and treat other causes of fever, hypoxia, and hypotension.If CRS is suspected, withhold COLUMVI and manage according to the recommendations in Table 4and current practice guidelines. Administer supportive care for CRS, which may include intensive care for severe or life-threatening cases.
| GradeAmerican Society for Transplantation and Cellular Therapy (ASTCT) 2019 consensus grading criteria. | Presenting Symptoms | Actions |
|---|---|---|
| Grade 1 | Temperature ≥ 100.4°F (38°C)Premedication may mask fever. Therefore, if clinical presentation is consistent with CRS, follow these management guidelines. |
|
| Grade 2 | Temperature ≥ 100.4°F (38°C)with: Hypotension not requiring vasopressors and/or Hypoxia requiring low-flow oxygenLow-flow oxygen defined as oxygen delivered at < 6 L/minute, high-flow oxygen defined as oxygen delivered at ≥ 6 L/minute.by nasal cannula or blow-by |
|
| Grade 3 | Temperature ≥ 100.4°F (38°C)with: Hypotension requiring vasopressor (with or without vasopressin) and/or Hypoxia requiring high-flow oxygenby nasal cannula, face mask, non-rebreather mask, or Venturi mask |
|
| Grade 4 | Temperature ≥ 100.4°F (38°C)with: Hypotension requiring multiple vasopressors (excluding vasopressin) and/or Hypoxia requiring oxygen by positive pressure (e.g., CPAP, BiPAP, intubation, and mechanical ventilation) |
|
Neurologic Toxicity, Including ICANS
Management recommendations for neurologic toxicity, including ICANS, is summarized in Table 5. At the first sign of neurologic toxicity, including ICANS, consider neurology evaluation and withholding COLUMVI based on the type and severity of neurotoxicity. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care.
| Adverse Reaction | SeverityBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.,Based on ASTCT 2019 grading for ICANS. | Actions |
|---|---|---|
| Grade 1 |
| |
| Grade 2 |
| |
| Neurologic Toxicity(including ICANS) [see Warnings and Precautions (5.2)] | Grade 3 |
|
| Grade 4 |
|
Other Adverse Reactions
| Adverse ReactionsBased on NCI CTCAE, version 4.03. | Severity | Actions |
|---|---|---|
| Infections [see Warnings and Precautions (5.3)] | Grades 1 – 4 |
|
| Grade 1 |
| |
| Tumor flare [see Warnings and Precautions (5.4)] | Grades 2 – 4 |
|
| Neutropenia | Absolute neutrophil count less than 0.5 × 109/L |
|
| Thrombocytopenia | Platelet count less than 50 × 109/L |
|
| Other Adverse Reactions [see Adverse Reactions (6.1)] | Grade 3 or higher |
|
COLUMVI can cause serious and fatal cytokine release syndrome (CRS)
[see Adverse Reactions (6.1)]
.Among 145 patients who received COLUMVI, CRS occurred in 70%, with Grade 1 CRS developing in 52% of all patients, Grade 2 in 14%, Grade 3 in 2.8%, and Grade 4 in 1.4%. The most common manifestations of CRS included fever, tachycardia, hypotension, chills, and hypoxia.
CRS occurred in 56% of patients after the 2.5 mg dose of COLUMVI, 35% after the 10 mg dose, 29% after the initial 30 mg target dose, and 2.8% after subsequent doses. With the first step-up dose of COLUMVI, the median time to onset of CRS (from the start of infusion) was 14 hours (range: 5 to 74 hours). CRS after any dose resolved in 98% of cases, with a median duration of CRS of 2 days (range: 1 to 14 days). Recurrent CRS occurred in 34% of all patients. CRS can first occur with the 10 mg dose; of 135 patients treated with the 10 mg dose of COLUMVI, 15 patients (11%) experienced their first CRS event with the 10 mg dose, of which 13 events were Grade 1, 1 event was Grade 2, and 1 event was Grade 3.
Administer COLUMVI in a facility equipped to monitor and manage CRS. Initiate therapy according to the COLUMVI step-up dosing schedule to reduce the risk of CRS, administer pretreatment medications, and ensure adequate hydration
[ Dosage and Administration (2.3)]
. Patients should be hospitalized during and for 24 hours after completing infusion of the 2.5 mg step-up dose. Patients who experienced any grade CRS during the 2.5 mg step-up dose should be hospitalized during and for 24 hours after completion of the 10 mg step-up dose. For subsequent doses, patients who experienced Grade ≥ 2 CRS with the previous infusion should be hospitalized during and for 24 hours after the next COLUMVI infusion[see Dosage and Administration (2.1and 2.2)]
.At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care; withhold or permanently discontinue COLUMVI based on severity
[see Dosage and Administration (2.4)]
..
Dosage and Administration (
Premedication Administer the following premedications to reduce the risk of CRS and infusion-related reactions [see Warnings and Precautions (5.1)] .
Tumor Lysis Syndrome Prophylaxis Before starting COLUMVI, administer anti-hyperuricemics to patients at risk of tumor lysis syndrome, ensure adequate hydration status, and monitor as appropriate [see Adverse Reactions (6.1)] .Infection Prophylaxis Before starting COLUMVI, consider initiation of antiviral prophylaxis to prevent herpes virus reactivation. Consider prophylaxis for cytomegalovirus infection, pneumocystis jirovecii pneumonia (PJP), and other opportunistic infections in patients at increased risk [see Warnings and Precautions (5.3)] .This section describes preparation of all doses of COLUMVI into an intravenous bag. For preparation instructions for the 2.5 mg dose into an intravenous syringe, see subsection 2.6 [see Dosage and Administration (2.6)] .Preparation
Dilution for Intravenous Bag Infusion
This section describes the alternative method of preparation of the 2.5 mg dose of COLUMVI into an intravenous syringe. For preparation instructions for all doses into an intravenous infusion bag, see subsection 2.5 [see Dosage and Administration (2.5)] .Preparation
Dilution for Intravenous Syringe Infusion (Alternative Method for 2.5 mg Dose Only)
Storage of Diluted Product Immediately use diluted COLUMVI solution. If not used immediately, the diluted solution can be stored:
Do not freeze the diluted infusion solution. Discard diluted infusion solution if storage time exceeds these limits. COLUMVI Administration
| 10/2025 |
COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and durability of response
[see
]
. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).The efficacy of COLUMVI was evaluated in Study NP30179 (NCT03075696), an open-label, multicenter, multicohort, single-arm clinical trial that included patients with relapsed or refractory LBCL after two or more lines of systemic therapy. The trial required an ECOG performance status of 0 or 1, absolute neutrophil count ≥ 1,500/µL, platelet count ≥ 75,000/µL independent of transfusion, serum creatinine ≤ 1.5 × ULN or CLcr ≥ 50 mL/min, and hepatic transaminases ≤ 3 × ULN. The trial excluded patients with active or previous CNS lymphoma or CNS disease, acute infection, recent infection requiring intravenous antibiotics, or prior allogeneic HSCT.
Following pretreatment with obinutuzumab on Cycle 1 Day 1, patients received COLUMVI by intravenous infusion, starting with a 2.5 mg step-up dose on Cycle 1 Day 8, followed by a 10 mg step-up dose on Cycle 1 Day 15, then 30 mg on Cycle 2 Day 1 and on Day 1 of each subsequent cycle. The cycle length was 21 days. COLUMVI was administered for up to 12 cycles unless patients experienced progressive disease or unacceptable toxicity.
The efficacy population consists of 132 patients with
de novo
DLBCL, NOS (80%) or LBCL arising from follicular lymphoma (20%) who received at least one dose of COLUMVI. The median age was 67 years (range: 21 to 90 years), 64% were male, 77% were White, 4.5% were Asian, 0.8% were Black or African American, 5% were Hispanic or Latino. The median number of prior lines of systemic therapy was 3 (range: 2 to 7). Most patients (83%) had refractory disease to the last therapy, 55% had primary refractory disease, 30% had received CAR-T cell therapy, and 19% had received autologous HSCT.Efficacy was based on objective response rate (ORR) and duration of response (DOR), as determined by an Independent Review Committee (IRC) using the 2014 Lugano criteria.
Efficacy results are summarized in Table 12. The median time to first response was 42 days (range: 31 to 178 days). Among responders, the estimated median follow-up for DOR was 11.6 months.
| Outcome per IRC | COLUMVI N=132 |
|---|---|
| CI = confidence interval; NE = not estimable | |
Overall Response Rate, n (%) | 74 (56) |
| (95% CI) | (47, 65) |
Complete Response, n (%) | 57 (43) |
| (95% CI) | (35, 52) |
Partial Response, n (%) | 17 (13) |
| (95% CI) | (8, 20) |
Duration of Response From date of first response (PR or CR) until disease progression or death due to any cause. | N = 74 |
| Median DOR, months (95% CI)Kaplan-Meier estimate. | 18.4 (11.4, NE) |
| 9-month estimate, % (95% CI) | 68.5 (56.7, 80.3) |
- Pretreat with a single 1,000 mg dose of obinutuzumab intravenously 7 days before initiation of COLUMVI (Cycle 1 Day 1). ()
2.2 Recommended DosagePretreatment with ObinutuzumabPretreat all patients with a single 1,000 mg dose of obinutuzumab administered as an intravenous infusion on Cycle 1 Day 1, 7 days prior to initiation of COLUMVI (see Table 1) to deplete the circulating and lymphoid tissue B cells.
Obinutuzumab should be administered as an intravenous infusion at 50 mg/hour. The rate of infusion can be escalated in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. Refer to the obinutuzumab prescribing information for complete dosing information.
COLUMVI Step-up Dose ScheduleCOLUMVI dosing begins with a step-up dose schedule. Following completion of pretreatment with obinutuzumab on Cycle 1 Day 1, administer COLUMVI as an intravenous infusion according to the step-up dose schedule in Table 1. Administer premedications for each dose of COLUMVI as described in Table 3
[see Dosage and Administration (2.3)].Table 1: COLUMVI Dosing Schedule (21-Day Treatment Cycles) Treatment cycle Day Dose of COLUMVI Duration of infusion Cycle 1Day 1 ObinutuzumabRefer to " Pretreatment with obinutuzumab" described above.Day 8 Step-up dose 1 2.5 mg 4 hoursFor patients who experience CRS with their previous dose of COLUMVI, the time of infusion may be extended up to 8 hours. Day 15 Step-up dose 2 10 mg Cycle 2Day 1 30 mg 4 hours Cycle 3 to 12Day 1 30 mg 2 hoursIf the patient experienced CRS with the previous dose, the duration of infusion should be maintained at 4 hours. Continue COLUMVI for a maximum of 12 cycles (inclusive of Cycle 1 step-up dosing) or until disease progression or unacceptable toxicity, whichever occurs first.
Monitoring for Cytokine Release Syndrome[see Warnings and Precautions (5.1)]- Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.
- For the first COLUMVI step-up dose (2.5 mg on Cycle 1 Day 8), patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion.
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1.
- For subsequent infusions (30 mg on Day 1 of Cycle 2 or subsequent cycles), patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after completion of the next COLUMVI infusion.
- For monitoring after delayed or missed doses of COLUMVI, follow the recommendations in Table 2.
Delayed or Missed DosesIf a dose of COLUMVI is delayed, restart therapy based on the recommendations made in Table 2, then resume the treatment schedule accordingly.
For repeat of the 2.5 mg dose patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion. For the repeat of the 10 mg dose, patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion if any grade CRS occurred during the most recent 2.5 mg dose.
Table 2: Recommendations for Restarting COLUMVI After Dose Delay Last Dose Administered Time Since Last Dose Administered Action for Next Dose(s)Administer premedication as per Table 3for all patients. Obinutuzumab pretreatment (Cycle 1 Day 1) ≤ 2 weeks - Administer COLUMVI 2.5 mg (Cycle 1 Day 8)Patients should be hospitalized during and for 24 hours after completing infusion of the 2.5 mg dose., then resume the planned treatment schedule.
> 2 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1).
- Then administer COLUMVI 2.5 mg (Cycle 1 Day 8)and resume the planned treatment schedule.
COLUMVI 2.5 mg
(Cycle 1 Day 8)≤ 2 weeks - Administer COLUMVI 10 mg (Cycle 1 Day 15)Patients should be hospitalized during and for 24 hours after completing infusion of the 10 mg dose if CRS occurred during the most recent 2.5 mg dose., then resume the planned treatment schedule.
> 2 to ≤ 4 weeks - Repeat COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
> 4 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1) and COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
COLUMVI 10 mg
(Cycle 1 Day 15)≤ 2 weeks - Administer COLUMVI 30 mg (Cycle 2 Day 1), then resume the planned treatment schedule.
> 2 to ≤ 6 weeks - Repeat COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
> 6 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1), COLUMVI 2.5 mg (Cycle 1 Day 8), and COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
COLUMVI 30 mg
(Cycle 2 onwards)≤ 6 weeks - Administer COLUMVI 30 mg, then resume the planned treatment schedule.
> 6 weeks - Repeat the Cycle 1 regimen described in Table 1: obinutuzumab 1,000 mg pretreatment (Day 1), COLUMVI 2.5 mg (Day 8), and COLUMVI 10 mg (Day 15).
- Then administer COLUMVI 30 mg (Day 1 of next cycle) and resume the planned treatment schedule.
- Administer premedications as recommended. ()
2.3 Recommended Premedication and Prophylactic MedicationsPremedicationAdminister the following premedications to reduce the risk of CRS and infusion-related reactions
[see Warnings and Precautions (5.1)].Table 3: Premedications to be Administered for COLUMVI Infusion Day of Treatment Cycle Patients requiring premedication Premedication Administration Cycle 1, Day 8 and Day 15; Cycle 2; Cycle 3Dexamethasone 20 mg intravenouslyIf dexamethasone is not available, administer prednisone 100 mg, prednisolone 100 mg, or methylprednisolone 80 mg intravenously. Completed at least 1 hour prior to COLUMVI infusion. All patients Acetaminophen 500 mg to 1,000 mg orally At least 30 minutes before COLUMVI infusion. Antihistamine (diphenhydramine 50 mg orally or intravenously or equivalent) Completed at least 30 minutes before COLUMVI infusion. All subsequent infusionsAll patients Acetaminophen 500 mg to 1,000 mg orally At least 30 minutes before COLUMVI infusion. Antihistamine (diphenhydramine 50 mg orally or intravenously or equivalent) Completed at least 30 minutes before COLUMVI infusion. Patients who experienced any grade CRS with the previous dose Dexamethasone 20 mg intravenously Completed at least 1 hour prior to COLUMVI infusion. Tumor Lysis Syndrome ProphylaxisBefore starting COLUMVI, administer anti-hyperuricemics to patients at risk of tumor lysis syndrome, ensure adequate hydration status, and monitor as appropriate
[see Adverse Reactions (6.1)].Infection ProphylaxisBefore starting COLUMVI, consider initiation of antiviral prophylaxis to prevent herpes virus reactivation. Consider prophylaxis for cytomegalovirus infection, pneumocystis jirovecii pneumonia (PJP), and other opportunistic infections in patients at increased risk[see Warnings and Precautions (5.3)]. - Administer only as an intravenous infusion. ()
2.1 Important Dosing Information- Administer only as an intravenous infusion through a dedicated infusion line that includes a sterile 0.2-micron in-line filter.
- Administer COLUMVI diluted solution via intravenous bag infusion. The 2.5 mg dose may alternatively be administered via intravenous syringe infusion[see Dosage and Administration (2.5, 2.6, 2.7)].
- COLUMVI should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage severe CRS[see Dosage and Administration (2.4)].
- Ensure adequate hydration before administering COLUMVI.
- Premedicate before each dose[see Dosage and Administration (2.3)].
- Following pretreatment with obinutuzumab, administer COLUMVI according to the step-up dosing schedule in Table 1with appropriate premedication, including dexamethasone, to reduce the incidence and severity of CRS[see Dosage and Administration (2.3)].
- Due to the risk of CRS, patients should be hospitalized during and for 24 hours after completion of infusion of step-up dose 1 (2.5 mg on Cycle 1 Day 8)[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- For subsequent doses, patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after the completion of the next COLUMVI infusion.
- Recommended dosage ():
2.2 Recommended DosagePretreatment with ObinutuzumabPretreat all patients with a single 1,000 mg dose of obinutuzumab administered as an intravenous infusion on Cycle 1 Day 1, 7 days prior to initiation of COLUMVI (see Table 1) to deplete the circulating and lymphoid tissue B cells.
Obinutuzumab should be administered as an intravenous infusion at 50 mg/hour. The rate of infusion can be escalated in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. Refer to the obinutuzumab prescribing information for complete dosing information.
COLUMVI Step-up Dose ScheduleCOLUMVI dosing begins with a step-up dose schedule. Following completion of pretreatment with obinutuzumab on Cycle 1 Day 1, administer COLUMVI as an intravenous infusion according to the step-up dose schedule in Table 1. Administer premedications for each dose of COLUMVI as described in Table 3
[see Dosage and Administration (2.3)].Table 1: COLUMVI Dosing Schedule (21-Day Treatment Cycles) Treatment cycle Day Dose of COLUMVI Duration of infusion Cycle 1Day 1 ObinutuzumabRefer to " Pretreatment with obinutuzumab" described above.Day 8 Step-up dose 1 2.5 mg 4 hoursFor patients who experience CRS with their previous dose of COLUMVI, the time of infusion may be extended up to 8 hours. Day 15 Step-up dose 2 10 mg Cycle 2Day 1 30 mg 4 hours Cycle 3 to 12Day 1 30 mg 2 hoursIf the patient experienced CRS with the previous dose, the duration of infusion should be maintained at 4 hours. Continue COLUMVI for a maximum of 12 cycles (inclusive of Cycle 1 step-up dosing) or until disease progression or unacceptable toxicity, whichever occurs first.
Monitoring for Cytokine Release Syndrome[see Warnings and Precautions (5.1)]- Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.
- For the first COLUMVI step-up dose (2.5 mg on Cycle 1 Day 8), patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion.
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1.
- For subsequent infusions (30 mg on Day 1 of Cycle 2 or subsequent cycles), patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after completion of the next COLUMVI infusion.
- For monitoring after delayed or missed doses of COLUMVI, follow the recommendations in Table 2.
Delayed or Missed DosesIf a dose of COLUMVI is delayed, restart therapy based on the recommendations made in Table 2, then resume the treatment schedule accordingly.
For repeat of the 2.5 mg dose patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion. For the repeat of the 10 mg dose, patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion if any grade CRS occurred during the most recent 2.5 mg dose.
Table 2: Recommendations for Restarting COLUMVI After Dose Delay Last Dose Administered Time Since Last Dose Administered Action for Next Dose(s)Administer premedication as per Table 3for all patients. Obinutuzumab pretreatment (Cycle 1 Day 1) ≤ 2 weeks - Administer COLUMVI 2.5 mg (Cycle 1 Day 8)Patients should be hospitalized during and for 24 hours after completing infusion of the 2.5 mg dose., then resume the planned treatment schedule.
> 2 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1).
- Then administer COLUMVI 2.5 mg (Cycle 1 Day 8)and resume the planned treatment schedule.
COLUMVI 2.5 mg
(Cycle 1 Day 8)≤ 2 weeks - Administer COLUMVI 10 mg (Cycle 1 Day 15)Patients should be hospitalized during and for 24 hours after completing infusion of the 10 mg dose if CRS occurred during the most recent 2.5 mg dose., then resume the planned treatment schedule.
> 2 to ≤ 4 weeks - Repeat COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
> 4 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1) and COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
COLUMVI 10 mg
(Cycle 1 Day 15)≤ 2 weeks - Administer COLUMVI 30 mg (Cycle 2 Day 1), then resume the planned treatment schedule.
> 2 to ≤ 6 weeks - Repeat COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
> 6 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1), COLUMVI 2.5 mg (Cycle 1 Day 8), and COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
COLUMVI 30 mg
(Cycle 2 onwards)≤ 6 weeks - Administer COLUMVI 30 mg, then resume the planned treatment schedule.
> 6 weeks - Repeat the Cycle 1 regimen described in Table 1: obinutuzumab 1,000 mg pretreatment (Day 1), COLUMVI 2.5 mg (Day 8), and COLUMVI 10 mg (Day 15).
- Then administer COLUMVI 30 mg (Day 1 of next cycle) and resume the planned treatment schedule.
Treatment CycleCycle = 21 days Day Dose of COLUMVI Day 1 Obinutuzumab 1,000 mg Cycle 1 Day 8 Step-up dose 1 2.5 mg Day 15 Step-up dose 2 10 mg Cycle 2 to 12 Day 1 30 mg - Administer in a facility equipped to monitor and manage CRS. (,
2.1 Important Dosing Information- Administer only as an intravenous infusion through a dedicated infusion line that includes a sterile 0.2-micron in-line filter.
- Administer COLUMVI diluted solution via intravenous bag infusion. The 2.5 mg dose may alternatively be administered via intravenous syringe infusion[see Dosage and Administration (2.5, 2.6, 2.7)].
- COLUMVI should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage severe CRS[see Dosage and Administration (2.4)].
- Ensure adequate hydration before administering COLUMVI.
- Premedicate before each dose[see Dosage and Administration (2.3)].
- Following pretreatment with obinutuzumab, administer COLUMVI according to the step-up dosing schedule in Table 1with appropriate premedication, including dexamethasone, to reduce the incidence and severity of CRS[see Dosage and Administration (2.3)].
- Due to the risk of CRS, patients should be hospitalized during and for 24 hours after completion of infusion of step-up dose 1 (2.5 mg on Cycle 1 Day 8)[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- For subsequent doses, patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after the completion of the next COLUMVI infusion.
)2.2 Recommended DosagePretreatment with ObinutuzumabPretreat all patients with a single 1,000 mg dose of obinutuzumab administered as an intravenous infusion on Cycle 1 Day 1, 7 days prior to initiation of COLUMVI (see Table 1) to deplete the circulating and lymphoid tissue B cells.
Obinutuzumab should be administered as an intravenous infusion at 50 mg/hour. The rate of infusion can be escalated in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. Refer to the obinutuzumab prescribing information for complete dosing information.
COLUMVI Step-up Dose ScheduleCOLUMVI dosing begins with a step-up dose schedule. Following completion of pretreatment with obinutuzumab on Cycle 1 Day 1, administer COLUMVI as an intravenous infusion according to the step-up dose schedule in Table 1. Administer premedications for each dose of COLUMVI as described in Table 3
[see Dosage and Administration (2.3)].Table 1: COLUMVI Dosing Schedule (21-Day Treatment Cycles) Treatment cycle Day Dose of COLUMVI Duration of infusion Cycle 1Day 1 ObinutuzumabRefer to " Pretreatment with obinutuzumab" described above.Day 8 Step-up dose 1 2.5 mg 4 hoursFor patients who experience CRS with their previous dose of COLUMVI, the time of infusion may be extended up to 8 hours. Day 15 Step-up dose 2 10 mg Cycle 2Day 1 30 mg 4 hours Cycle 3 to 12Day 1 30 mg 2 hoursIf the patient experienced CRS with the previous dose, the duration of infusion should be maintained at 4 hours. Continue COLUMVI for a maximum of 12 cycles (inclusive of Cycle 1 step-up dosing) or until disease progression or unacceptable toxicity, whichever occurs first.
Monitoring for Cytokine Release Syndrome[see Warnings and Precautions (5.1)]- Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.
- For the first COLUMVI step-up dose (2.5 mg on Cycle 1 Day 8), patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion.
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1.
- For subsequent infusions (30 mg on Day 1 of Cycle 2 or subsequent cycles), patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after completion of the next COLUMVI infusion.
- For monitoring after delayed or missed doses of COLUMVI, follow the recommendations in Table 2.
Delayed or Missed DosesIf a dose of COLUMVI is delayed, restart therapy based on the recommendations made in Table 2, then resume the treatment schedule accordingly.
For repeat of the 2.5 mg dose patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion. For the repeat of the 10 mg dose, patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion if any grade CRS occurred during the most recent 2.5 mg dose.
Table 2: Recommendations for Restarting COLUMVI After Dose Delay Last Dose Administered Time Since Last Dose Administered Action for Next Dose(s)Administer premedication as per Table 3for all patients. Obinutuzumab pretreatment (Cycle 1 Day 1) ≤ 2 weeks - Administer COLUMVI 2.5 mg (Cycle 1 Day 8)Patients should be hospitalized during and for 24 hours after completing infusion of the 2.5 mg dose., then resume the planned treatment schedule.
> 2 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1).
- Then administer COLUMVI 2.5 mg (Cycle 1 Day 8)and resume the planned treatment schedule.
COLUMVI 2.5 mg
(Cycle 1 Day 8)≤ 2 weeks - Administer COLUMVI 10 mg (Cycle 1 Day 15)Patients should be hospitalized during and for 24 hours after completing infusion of the 10 mg dose if CRS occurred during the most recent 2.5 mg dose., then resume the planned treatment schedule.
> 2 to ≤ 4 weeks - Repeat COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
> 4 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1) and COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
COLUMVI 10 mg
(Cycle 1 Day 15)≤ 2 weeks - Administer COLUMVI 30 mg (Cycle 2 Day 1), then resume the planned treatment schedule.
> 2 to ≤ 6 weeks - Repeat COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
> 6 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1), COLUMVI 2.5 mg (Cycle 1 Day 8), and COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
COLUMVI 30 mg
(Cycle 2 onwards)≤ 6 weeks - Administer COLUMVI 30 mg, then resume the planned treatment schedule.
> 6 weeks - Repeat the Cycle 1 regimen described in Table 1: obinutuzumab 1,000 mg pretreatment (Day 1), COLUMVI 2.5 mg (Day 8), and COLUMVI 10 mg (Day 15).
- Then administer COLUMVI 30 mg (Day 1 of next cycle) and resume the planned treatment schedule.
- Patients should be hospitalized for the 2.5 mg step-up dose and for subsequent infusions as recommended. (,
2.1 Important Dosing Information- Administer only as an intravenous infusion through a dedicated infusion line that includes a sterile 0.2-micron in-line filter.
- Administer COLUMVI diluted solution via intravenous bag infusion. The 2.5 mg dose may alternatively be administered via intravenous syringe infusion[see Dosage and Administration (2.5, 2.6, 2.7)].
- COLUMVI should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage severe CRS[see Dosage and Administration (2.4)].
- Ensure adequate hydration before administering COLUMVI.
- Premedicate before each dose[see Dosage and Administration (2.3)].
- Following pretreatment with obinutuzumab, administer COLUMVI according to the step-up dosing schedule in Table 1with appropriate premedication, including dexamethasone, to reduce the incidence and severity of CRS[see Dosage and Administration (2.3)].
- Due to the risk of CRS, patients should be hospitalized during and for 24 hours after completion of infusion of step-up dose 1 (2.5 mg on Cycle 1 Day 8)[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1[see Dosage and Administration (2.2)and Warnings and Precautions (5.1)].
- For subsequent doses, patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after the completion of the next COLUMVI infusion.
)2.2 Recommended DosagePretreatment with ObinutuzumabPretreat all patients with a single 1,000 mg dose of obinutuzumab administered as an intravenous infusion on Cycle 1 Day 1, 7 days prior to initiation of COLUMVI (see Table 1) to deplete the circulating and lymphoid tissue B cells.
Obinutuzumab should be administered as an intravenous infusion at 50 mg/hour. The rate of infusion can be escalated in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. Refer to the obinutuzumab prescribing information for complete dosing information.
COLUMVI Step-up Dose ScheduleCOLUMVI dosing begins with a step-up dose schedule. Following completion of pretreatment with obinutuzumab on Cycle 1 Day 1, administer COLUMVI as an intravenous infusion according to the step-up dose schedule in Table 1. Administer premedications for each dose of COLUMVI as described in Table 3
[see Dosage and Administration (2.3)].Table 1: COLUMVI Dosing Schedule (21-Day Treatment Cycles) Treatment cycle Day Dose of COLUMVI Duration of infusion Cycle 1Day 1 ObinutuzumabRefer to " Pretreatment with obinutuzumab" described above.Day 8 Step-up dose 1 2.5 mg 4 hoursFor patients who experience CRS with their previous dose of COLUMVI, the time of infusion may be extended up to 8 hours. Day 15 Step-up dose 2 10 mg Cycle 2Day 1 30 mg 4 hours Cycle 3 to 12Day 1 30 mg 2 hoursIf the patient experienced CRS with the previous dose, the duration of infusion should be maintained at 4 hours. Continue COLUMVI for a maximum of 12 cycles (inclusive of Cycle 1 step-up dosing) or until disease progression or unacceptable toxicity, whichever occurs first.
Monitoring for Cytokine Release Syndrome[see Warnings and Precautions (5.1)]- Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.
- For the first COLUMVI step-up dose (2.5 mg on Cycle 1 Day 8), patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion.
- Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1.
- For subsequent infusions (30 mg on Day 1 of Cycle 2 or subsequent cycles), patients who experienced Grade ≥ 2 CRS with their previous infusion should be hospitalized during and for 24 hours after completion of the next COLUMVI infusion.
- For monitoring after delayed or missed doses of COLUMVI, follow the recommendations in Table 2.
Delayed or Missed DosesIf a dose of COLUMVI is delayed, restart therapy based on the recommendations made in Table 2, then resume the treatment schedule accordingly.
For repeat of the 2.5 mg dose patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion. For the repeat of the 10 mg dose, patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion if any grade CRS occurred during the most recent 2.5 mg dose.
Table 2: Recommendations for Restarting COLUMVI After Dose Delay Last Dose Administered Time Since Last Dose Administered Action for Next Dose(s)Administer premedication as per Table 3for all patients. Obinutuzumab pretreatment (Cycle 1 Day 1) ≤ 2 weeks - Administer COLUMVI 2.5 mg (Cycle 1 Day 8)Patients should be hospitalized during and for 24 hours after completing infusion of the 2.5 mg dose., then resume the planned treatment schedule.
> 2 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1).
- Then administer COLUMVI 2.5 mg (Cycle 1 Day 8)and resume the planned treatment schedule.
COLUMVI 2.5 mg
(Cycle 1 Day 8)≤ 2 weeks - Administer COLUMVI 10 mg (Cycle 1 Day 15)Patients should be hospitalized during and for 24 hours after completing infusion of the 10 mg dose if CRS occurred during the most recent 2.5 mg dose., then resume the planned treatment schedule.
> 2 to ≤ 4 weeks - Repeat COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
> 4 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1) and COLUMVI 2.5 mg (Cycle 1 Day 8).
- Then administer COLUMVI 10 mg (Cycle 1 Day 15)and resume the planned treatment schedule.
COLUMVI 10 mg
(Cycle 1 Day 15)≤ 2 weeks - Administer COLUMVI 30 mg (Cycle 2 Day 1), then resume the planned treatment schedule.
> 2 to ≤ 6 weeks - Repeat COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
> 6 weeks - Repeat obinutuzumab 1,000 mg pretreatment (Cycle 1 Day 1), COLUMVI 2.5 mg (Cycle 1 Day 8), and COLUMVI 10 mg (Cycle 1 Day 15).
- Then administer COLUMVI 30 mg (Cycle 2 Day 1) and resume the planned treatment schedule.
COLUMVI 30 mg
(Cycle 2 onwards)≤ 6 weeks - Administer COLUMVI 30 mg, then resume the planned treatment schedule.
> 6 weeks - Repeat the Cycle 1 regimen described in Table 1: obinutuzumab 1,000 mg pretreatment (Day 1), COLUMVI 2.5 mg (Day 8), and COLUMVI 10 mg (Day 15).
- Then administer COLUMVI 30 mg (Day 1 of next cycle) and resume the planned treatment schedule.
- See Full Prescribing Information for instructions on preparation and administration. (,
2.5 Preparation into an Intravenous BagThis section describes preparation of all doses of COLUMVI into an intravenous bag. For preparation instructions for the 2.5 mg dose into an intravenous syringe, see subsection 2.6[see Dosage and Administration (2.6)].Preparation- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLUMVI is a colorless clear solution. Discard the vial if the solution is cloudy, discolored, or contains visible particles.
- Use aseptic technique when preparing the COLUMVI diluted solution for intravenous infusion.
Dilution for Intravenous Bag Infusion- Determine the dose, total volume of COLUMVI solution, and the number of COLUMVI vials needed (see Table 7).
- Select an appropriate size infusion bag of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection (see Table 7).
- COLUMVI diluted with 0.9% Sodium Chloride Injection is compatible with intravenous infusion bags composed of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP) or polyolefin.
- COLUMVI diluted with 0.45% Sodium Chloride Injection is compatible with intravenous infusion bags composed of PVC.
- Prepare the infusion bag bywithdrawinganddiscardingthe volume from the infusion bag according to Table 7.
- Withdraw the required volume of COLUMVI from the vial(s) using a sterile needle and syringe and dilute into the infusion bag to a final concentration of 0.1 mg/mL to 0.6 mg/mL according to Table 7.
Table 7: Dilution of COLUMVI into an intravenous infusion bag Dose of COLUMVISize of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection infusion bag Volume to be withdrawnanddiscardedfrom the infusion bagVolume of COLUMVI to be added to the infusion bag Total volume to be infused 2.5 mg50 mL 27.5 mL 2.5 mL 25 mL 10 mg50 mL 10 mL 10 mL 50 mL 100 mL 10 mL 10 mL 100 mL 30 mg50 mL 30 mL 30 mL 50 mL 100 mL 30 mL 30 mL 100 mL - Discard any unused COLUMVI left in the vial.
- Gently invert the infusion bag to mix the solution, in order to avoid excess foaming. Do not shake.
,2.6 Preparation of 2.5 mg Dose into an Intravenous SyringeThis section describes the alternative method of preparation of the 2.5 mg dose of COLUMVI into an intravenous syringe. For preparation instructions for all doses into an intravenous infusion bag, see subsection 2.5[see Dosage and Administration (2.5)].Preparation- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLUMVI is a colorless clear solution. Discard the vial if the solution is cloudy, discolored, or contains visible particles.
- Use aseptic technique when preparing the COLUMVI diluted solution for intravenous syringe infusion.
Dilution for Intravenous Syringe Infusion (Alternative Method for 2.5 mg Dose Only)- Draw 22.5 mL of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection into a 30 mL syringe composed of PP (see Table 8).
- Withdraw 2.5 mL of COLUMVI from the vial using a sterile needle into a second syringe (see Table 8). Discard any unused COLUMVI left in the vial.
- Attach a connector to the two syringes and transfer COLUMVI into the 30 mL syringe. The final concentration of COLUMVI should be 0.1 mg/mL.
Table 8: Dilution of COLUMVI into an intravenous syringe Dose of COLUMVIVolume of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection to be added to the syringe Volume of COLUMVI to be added to the syringe Total volume to be infused 2.5 mg22.5 mL 2.5 mL 25 mL - Disconnect the syringes. Draw air into the syringe containing the COLUMVI diluted solution and close.
- Gently invert the syringe to mix the solution, in order to avoid excessive foaming. Do not shake.
- Remove air bubbles from the syringe before administration.
)2.7 Storage and AdministrationStorage of Diluted ProductImmediately use diluted COLUMVI solution. If not used immediately, the diluted solution can be stored:- Refrigerated at 2°C to 8°C (36°F to 46°F) for up to 64 hours, or
- At room temperature up to 25°C (77°F) for up to 4 hours.
Do not freeze the diluted infusion solution.Discard diluted infusion solution if storage time exceeds these limits.COLUMVI Administration- Administer COLUMVI as an intravenous infusion only through a dedicated infusion line that includes a sterile 0.2-micron in-line filter using an intravenous infusion pump or syringe pump. Prime the infusion line with the diluted infusion solution.
- No incompatibilities have been observed with infusion sets with product-contacting surfaces of polyurethane (PUR), PVC, PE, polybutadiene (PBD), polyetherurethane (PEU), polycarbonate (PC), silicone, polytetrafluoroethylene (PTFE), or acrylonitrile butadiene styrene (ABS), and in-line filter membranes composed of polyethersulfone (PES) or polysulfone.
- See Table 1for duration of infusion. The maximum time for the administration of the diluted infusion solution may be extended up to 8 hours (see Table 4).
- To ensure the entire dose of COLUMVI is administered, replace the empty infusion bag or syringe with an infusion bag or syringe containing 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection connected to the same infusion line. Continue the infusion at the same rate until the recommended infusion duration is reached according to Table 1.
- Do not mix COLUMVI with other drugs.
Injection:
- 2.5 mg/2.5 mL (1 mg/mL) clear, colorless solution in a single-dose vial.
- 10 mg/10 mL (1 mg/mL) clear, colorless solution in a single-dose vial.
Lactation
: Advise not to breastfeed. (Risk Summary
There are no data on the presence of glofitamab-gxbm in human milk or the effects on the breastfed child or milk production. Because human IgG is present in human milk, and there is potential for glofitamab-gxbm absorption leading to B-cell depletion, advise women not to breastfeed during treatment with COLUMVI and for 1 month after the last dose of COLUMVI.
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