pharmacopeia
GET
/api/v1/drug/glofitamab

Boxed warning

CYTOKINE RELEASE SYNDROME 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 [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning 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. ( 2.1 , 2.2 , 2.3 , 2.4 , 5.1 )

Mechanism of action

Sourced from openFDA

Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B cells, and to CD3 receptor expressed on the surface of T cells. Glofitamab-gxbm causes T-cell activation and proliferation, secretion of cytokines, and the lysis of CD20-expressing B cells.

CD3 ReceptorCytochrome P450

Indications

Sourced from openFDA
  • 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 Clinical Studies (14.1) ] .ICD-10: C85.90

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

Pretreat with a single 1,000 mg dose of obinutuzumab intravenously 7 days before initiation of COLUMVI (Cycle 1 Day 1). ( 2.2 ) Administer premedications as recommended. ( 2.3 ) Administer only as an intravenous infusion. ( 2.1 ) Recommended dosage ( 2.2 ): Treatment Cycle Cycle = 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 , 2.2 ) Patients should be hospitalized for the 2.5 mg step-up dose and for subsequent infusions as recommended. ( 2.1 , 2.2 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.5 , 2.6 , 2.7 ) 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) ] .

Warnings & precautions

Sourced from openFDA

Neurologic Toxicity : Can cause serious neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Monitor for neurologic toxicity; withhold or permanently discontinue based on severity. ( 5.2 ) Serious Infections : Can cause serious or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. ( 5.3 ) Tumor Flare : Can cause serious tumor flare reactions. Monitor patients at risk for complications of tumor flare. ( 5.4 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome 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.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity [see Warnings and Precautions (5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Tumor Flare [see Warnings and Precautions (5.4) ] The most common (≥ 20%) adverse reactions, excluding laboratory abnormalities, are cytokine release syndrome, musculoskeletal pain, rash, and fatigue. The most common (≥ 20%) Grade 3 to 4 laboratory abnormalities are lymphocyte count decreased, phosphate decreased, neutrophil count decreased, uric acid increased, and fibrinogen decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory DLBCL, NOS or LBCL Arising from Follicular Lymphoma Study NP30179 The safety of COLUMVI was evaluated in Study NP30179, a multi-cohort, multicenter, single-arm clinical trial that included 154 adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy [see Clinical Studies (14.1) ] .

Use in specific populations

Sourced from openFDA

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action COLUMVI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of COLUMVI in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm. Glofitamab-gxbm causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B cells and the finding of B-cell depletion in non-pregnant animals, glofitamab-gxbm can cause B-cell lymphocytopenia in infants exposed to glofitamab-gxbm in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, COLUMVI has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of glofitamab-gxbm was determined following pretreatment with a single dose of obinutuzumab of 1,000 mg and the pharmacokinetic parameters are presented as geometric mean (CV%) unless otherwise specified. Glofitamab-gxbm exposure increased dose-proportionally over the dose range from 0.005 to 30 mg (0.000167 to 1 time the recommended treatment dosage).

Approval history

Sourced from openFDA
  • Jun 15, 2023BLABLA761309Genentech Inc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,047 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Cytokine Release Syndrome65132%
  2. 2Disease Progression35517%
  3. 3Death26013%
  4. 4Off Label Use25613%
  5. 5Pyrexia1778.6%
  6. 6Neutropenia1718.4%
  7. 7Covid-191035.0%
  8. 8Immune Effector Cell-associated Neurotoxicity Syndrome1014.9%
  9. 9Febrile Neutropenia984.8%
  10. 10Infection914.4%
  11. 11Anaemia854.2%
  12. 12Drug Ineffective834.1%
  13. 13Pneumonia793.9%
  14. 14Thrombocytopenia613.0%
  15. 15Alanine Aminotransferase Increased562.7%

Clinical trials

View JSON

The 10 most recently updated of 88 ClinicalTrials.gov registrations naming Glofitamab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Glofitamab work?
Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B cells, and to CD3 receptor expressed on the surface of T cells. Glofitamab-gxbm causes T-cell activation and proliferation, secretion of cytokines, and the lysis of CD20-expressing B cells.
What is Glofitamab used for?
According to FDA labeling, Glofitamab carries indications including: 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 Clinical Studies (14.1) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Glofitamab?
Glofitamab is classified as Other monoclonal antibodies and antibody drug conjugates, Bispecific CD20-directed CD3 T Cell Engager, CD20-directed Antibody Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists, Cytochrome P450 Inhibitors, Increased B Lymphocyte Destruction, Increased Cytokine Activity, Increased T Lymphocyte Activation, Increased T Lymphocyte Production.
What are the brand names for Glofitamab?
Glofitamab is marketed under brand names including Columvi.
What are the contraindications for Glofitamab?
Glofitamab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for glofitamab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients