COLUMVI
Clinical safety rating
cautionComprehensive clinical and safety monograph for COLUMVI (COLUMVI).
Comprehensive clinical and safety monograph for COLUMVI (COLUMVI).
Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapyRelapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
CD20-directed cytolytic antibody; binds to CD20 antigen on B-lymphocytes, inducing antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
| Metabolism | Metabolized via non-specific proteolysis into small peptides and amino acids; not metabolized by CYP450 enzymes. |
| Excretion | Primarily eliminated via biliary/fecal route; renal excretion is minimal (less than 1% of dose). |
| Half-life | Terminal half-life approximately 20 days (range 14-28 days), consistent with IgG1 monoclonal antibody clearance via intracellular catabolism. |
| Protein binding | No specific protein binding data; as a monoclonal antibody, it is not bound to plasma proteins in a significant manner. |
| Volume of Distribution | Approximately 4.5 L (0.06 L/kg assuming 70 kg), indicating limited extravascular distribution, primarily confined to plasma and interstitial space. |
| Bioavailability | Intravenous administration yields 100% bioavailability. |
| Onset of Action | Clinical response (tumor reduction) observed within 4-8 weeks of initiating therapy. |
| Duration of Action | Duration of action persists for months post-last dose due to prolonged half-life; median duration of response approximately 18 months in clinical trials. |
| Molecular Weight | 146000 |
12 mg/kg intravenously on Day 1 of each 21-day cycle for 12 cycles in combination with bendamustine. For patients with relapsed or refractory follicular lymphoma after two or more prior therapies, the recommended dose is 12 mg/kg intravenously on Day 1 of each 28-day cycle until disease progression or unacceptable toxicity.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment recommended for mild to moderate renal impairment (CrCl ≥30 mL/min). Not studied in severe renal impairment (CrCl <30 mL/min) or on dialysis. |
| Liver impairment | No dose adjustment recommended for mild hepatic impairment (Child-Pugh A). Not studied in moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment recommended for elderly patients (≥65 years). Clinical studies included patients up to 88 years; no overall differences in safety or efficacy observed. |
| 1st trimester | Avoid use during first trimester due to potential fetal harm; no adequate human data, but animal studies show embryotoxicity. |
| 2nd trimester | Avoid use during second trimester; potential risk of fetal harm based on mechanism of action. |
| 3rd trimester | Avoid use during third trimester; may cause fetal harm due to pharmacological effects. |
Clinical note
Comprehensive clinical and safety monograph for COLUMVI (COLUMVI).
| Placental transfer | Human IgG is known to cross the placental barrier; columvi is a monoclonal antibody (IgG1), so placental transfer is expected, especially during the third trimester. |
| Breastfeeding | It is unknown if columvi is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is not recommended during therapy and for at least 6 months after the last dose. |
| Lactation Rating | L5 - Contraindicated |
| Teratogenic Risk | COLUMVI (glofitamab) is a CD3/CD20 bispecific antibody. Based on its mechanism of action and animal studies, there is a potential for fetal harm. IgG molecules cross the placenta; fetal exposure increases as pregnancy progresses, with the largest amount transferred during the third trimester. Glofitamab may cause fetal B-cell depletion and immune dysfunction. There are no adequate human data. Contraindicated during pregnancy; advise effective contraception during treatment and for 3 months after the last dose. |
| Fetal Monitoring | Monitor for infusion-related reactions, cytokine release syndrome (CRS), and neurologic toxicity during and after infusion. Perform pregnancy testing prior to initiation. If used during pregnancy, monitor for fetal B-cell depletion and immune function at birth. Monitor thyroid function and electrolytes due to potential tumor lysis syndrome. No specific fetal monitoring patterns established. |
| Fertility Effects | No dedicated fertility studies conducted. Glofitamab targets CD20 on B cells and may affect reproductive tissues expressing CD20. Preclinical studies have not reported direct effects on male or female fertility, but B-cell depletion could theoretically impact ovarian function. Based on mechanism, potential for impairment of fertility due to immunomodulation. Advise patients of possible fertility concerns. |
■ FDA Black Box Warning
WARNING: CYTOKINE RELEASE SYNDROME (CRS). Serious or life-threatening CRS can occur, including infusion-related reactions. Premedicate and monitor during infusion. Withhold or permanently discontinue as recommended.
| Serious Effects |
Hypersensitivity to columvi or any excipientsActive severe infection
| Precautions | Cytokine release syndrome (CRS), including serious or life-threatening reactions, Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), Infections, including serious and opportunistic infections, Tumor flare reaction, Embryo-fetal toxicity |
| Food/Dietary | Avoid grapefruit and grapefruit juice. No other specific food interactions reported. Maintain adequate hydration to prevent tumor lysis syndrome. |
| Clinical Pearls | COLUMVI (glofitamab) is a CD3xCD20 bispecific antibody for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Administer with prior rituximab and premedication to mitigate cytokine release syndrome (CRS). Monitor for CRS closely during step-up dosing; consider tocilizumab for management. Ensure adequate IV hydration and uric acid monitoring for tumor lysis syndrome. Do not coadminister with other systemic immunosuppressants unless necessary. Assess for hepatitis B reactivation prior to initiation. |
| Patient Advice | COLUMVI is an infusion that helps your immune system attack lymphoma cells. · You will receive a low first dose and gradually higher doses to reduce side effects like fever and chills. · Common side effects include infusion reactions, tiredness, and low blood counts. Report fever, chills, or trouble breathing immediately. · Avoid grapefruit or grapefruit juice during treatment as they may affect how the medication works. · Stay well hydrated and contact your doctor if you have signs of infection or bleeding. · Do not receive live vaccines during treatment and for at least 6 months after the last dose. |
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