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Glofitamab-Gxbm: uses, dosing, side effects & brands

Glofitamab-Gxbm is a medicine sold in the U.S. under one brand, for diffuse large b-cell lymphoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Diffuse Large B-Cell Lymphoma
Available as
Solution
Sold as
Columvi
Prescription?
Prescription only
Generic available?
Not in our catalog
Boxed warning
Boxed warning

How glofitamab-gxbm is dosed

From the FDA label for Columvi (application BLA761309). Other glofitamab-gxbm products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

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…

Glofitamab-Gxbm side effects

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…

Who shouldn’t take glofitamab-gxbm

None. None. ( 4 )

Glofitamab-Gxbm drug interactions

For certain CYP substrates where minimal concentration changes may lead to serious adverse reactions, monitor for toxicities or drug concentrations of such CYP substrates when coadministered with COLUMVI. Glofitamab-gxbm causes the release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress the activity of CYP enzymes, resulting in increased exposure of CYP substrates. Increased exposure of CYP substrates is more likely to occur after the first dose of COLUMVI on Cycle 1 Day 8 and up to 14 days after the first 30 mg dose on Cycle 2 Day 1 and during and after CRS [see Warnings and Precautions (5.1) ] .

Every glofitamab-gxbm product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Columvi.

What people report to the FDA about glofitamab-gxbm

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7 reports naming glofitamab-gxbm, and the FDA flagged 86% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • cytokine release syndrome2 reports
  • acute hepatic failure1 reports
  • cytomegalovirus infection1 reports
  • facial paresis1 reports
  • fatigue1 reports
  • haemorrhagic stroke1 reports
  • hemiparesis1 reports
  • lower gastrointestinal haemorrhage1 reports

Read these as a signal, not a rate. A report does not mean glofitamab-gxbm caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is glofitamab-gxbm?

Columvi (Glofitamab-Gxbm) is a medication used to treat Diffuse Large B-Cell Lymphoma.

Can you take glofitamab-gxbm with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run glofitamab-gxbm against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does glofitamab-gxbm come in?

Across the brands we track, glofitamab-gxbm is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic glofitamab-gxbm?

We do not currently list a generic-labelled glofitamab-gxbm product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Glofitamab-Gxbm: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/glofitamab-gxbm
MLA
“Glofitamab-Gxbm: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/glofitamab-gxbm.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for glofitamab-gxbm on DailyMed (NIH) ↗ — including its boxed warning in full.