Columvi Dosage
Generic name: GLOFITAMAB 10mg in 10mL
Dosage form: injection, concentrate
Drug class: Bispecific T-cell engagers (BiTE)
Medically reviewed by Drugs.com. Last updated on Jun 18, 2025.
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.
- COLUMVI should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage severe CRS.
- Ensure adequate hydration before administering COLUMVI.
- Premedicate before each dose.
- Following pretreatment with obinutuzumab, administer COLUMVI according to the step-up dosing schedule in Table 1 with appropriate premedication, including dexamethasone, to reduce the incidence and severity of CRS.
- 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).
- 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 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
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.
Treatment cycle | Day | Dose of COLUMVI | Duration of infusion | |
---|---|---|---|---|
|
||||
Cycle 1 | Day 1 | Obinutuzumab* | ||
Day 8 | Step-up dose 1 | 2.5 mg | 4 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 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
- 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)* |
---|---|---|
|
||
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 |
Recommended Premedication and Prophylactic Medications
Premedication
Administer the following premedications to reduce the risk of CRS and infusion-related reactions.
Day of Treatment Cycle | Patients requiring premedication | Premedication | Administration |
---|---|---|---|
|
|||
Cycle 1, Day 8 and Day 15; Cycle 2; Cycle 3 | Dexamethasone 20 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.
Dosage Modifications for Adverse Reactions
No dosage reduction for COLUMVI is recommended.
Cytokine Release Syndrome
Identify CRS based on clinical presentation. 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 4 and current practice guidelines. Administer supportive care for CRS, which may include intensive care for severe or life-threatening cases.
Grade* | Presenting Symptoms | Actions |
---|---|---|
|
||
Grade 1 | Temperature ≥ 100.4°F (38°C)† | |
Grade 2 | Temperature ≥ 100.4°F (38°C)† with: Hypotension not requiring vasopressors and/or Hypoxia requiring low-flow oxygen¶ 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 oxygen¶ by 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 | Severity*,† | Actions |
---|---|---|
|
||
Grade 1 |
|
|
Grade 2 | ||
Neurologic Toxicity* (including ICANS†) | Grade 3 |
|
Grade 4 |
|
Other Adverse Reactions
Adverse Reactions* | Severity* | Actions |
---|---|---|
|
||
Infections | Grades 1 – 4 |
|
Grade 1 |
|
|
Tumor flare | Grades 2 – 4 |
|
Neutropenia | Absolute neutrophil count less than 0.5 × 109/L |
|
Thrombocytopenia | Platelet count less than 50 × 109/L |
|
Other Adverse Reactions | Grade 3 or higher |
|
Preparation into an Intravenous Bag
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.
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 by withdrawing and discarding the 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.
Dose of COLUMVI | Size of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection infusion bag | Volume to be withdrawn and discarded from the infusion bag | Volume of COLUMVI to be added to the infusion bag | Total volume to be infused |
---|---|---|---|---|
2.5 mg | 50 mL | 27.5 mL | 2.5 mL | 25 mL |
10 mg | 50 mL | 10 mL | 10 mL | 50 mL |
100 mL | 10 mL | 10 mL | 100 mL | |
30 mg | 50 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.
Preparation of 2.5 mg Dose into an Intravenous Syringe
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.
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.
Dose of COLUMVI | Volume 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 mg | 22.5 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.
Storage and Administration
Storage of Diluted Product
Immediately 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 1 for 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.
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