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 15, 2023.
Important Dosing Information
- Administer only as an intravenous infusion through a dedicated infusion line that includes a sterile 0.2-micron in-line filter.
- 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 1 with 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
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 | 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 [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)* |
---|---|---|
|
||
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 [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 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)].
Antiviral Prophylaxis
Before starting COLUMVI, consider initiation of antiviral prophylaxis to prevent herpes virus reactivation. Consider prophylaxis for cytomegalovirus infection in patients at increased risk [see Warnings and Precautions (5.3)].
Pneumocystis jirovecii Pneumonia (PJP)
Consider PJP prophylaxis prior to starting COLUMVI in patients at increased risk [see Warnings and Precautions (5.3)].
Dosage Modifications for Adverse Reactions
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 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†) [see Warnings and Precautions (5.2)] | Grade 3 |
|
Grade 4 |
|
Other Adverse Reactions
Adverse Reactions* | 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 |
|
Preparation and Administration
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.
- Determine the dose, total volume of COLUMVI solution, and the number of COLUMVI vials needed (see Table 7).
Dilution
- Withdraw the volume of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection from the infusion bag according to Table 7 and discard.
- Withdraw the required volume of COLUMVI from vial(s) using a sterile needle and syringe and dilute into the infusion bag of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection according to Table 7 to a final concentration of 0.1 mg/mL to 0.6 mg/mL. Discard any unused portion left in the vial.
Dose of COLUMVI | Size of infusion bag | Volume of 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection to be withdrawn and discarded | Volume of COLUMVI to be added in the infusion bag |
---|---|---|---|
2.5 mg | 50 mL | 27.5 mL | 2.5 mL |
10 mg | 50 mL | 10 mL | 10 mL |
100 mL | 10 mL | 10 mL | |
30 mg | 50 mL | 30 mL | 30 mL |
100 mL | 30 mL | 30 mL |
- Gently invert infusion bag to mix the solution, in order to avoid excessive foaming. Do not shake.
- 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 diluted with 0.9% Sodium Chloride Injection is compatible with intravenous infusion bags composed of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP) or non-PVC polyolefin. When diluted with 0.45% Sodium Chloride Injection, COLUMVI is compatible with intravenous infusion bags composed of PVC.
No incompatibilities have been observed with infusion sets with product-contacting surfaces of polyurethane (PUR), PVC, or PE, and in-line filter membranes composed of polyethersulfone (PES) or polysulfone.
COLUMVI Administration
- Administer COLUMVI as an intravenous infusion only through a dedicated infusion line that includes a sterile 0.2-micron in-line filter.
- 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).
- Do not mix COLUMVI with other drugs.
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