Glofitamab
Brand names: Columvi
Drug class:
Antineoplastic Agents
Usage of Glofitamab
Glofitamab-gxbm has the following uses:
Glofitamab-gxbm 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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How to use Glofitamab
General
Glofitamab-gxbm is available in the following dosage form(s) and strength(s):
Dosage
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Adults
Dosage and AdministrationCycle = 21 days
For patients who experience CRS with their previous dose of glofitamab-gxbm, the time of infusion may be extended up to 8 hours
If the patient experienced CRS with the previous dose, the duration of infusion should be maintained at 4 hours
Table 1: Recommended Dosage of Glofitamab-gxbmTreatment Cycle
Treatment
Cycle 1 Day 1
Pretreat with obinutuzumab 1,000 mg
Cycle 1 Day 8
Glofitamab-gxbm 2.5 mg IV infusion over 4 hours (step-up dose 1)
Cycle 1 Day 15
Glofitamab-gxbm 10 mg IV infusion over 4 hours (step-up dose 2)
Cycle 2 Day 1
Glofitamab-gxbm 30 mg IV infusion over 4 hours
Cycles 3 to 12 Day 1
Glofitamab-gxbm 30 mg IV infusion over 2 hours
Warnings
Contraindications
Warnings/Precautions
Cytokine Release Syndrome
Glofitamab can cause serious and fatal cytokine release syndrome (CRS).
Among 145 patients who received glofitamab-gxbm, 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 glofitamab-gxbm, 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 glofitamab-gxbm, 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. CRS can first occur with the 10 mg dose; of 135 patients treated with the 10 mg dose of glofitamab-gxbm, 15 patients (11%) experienced their first CRS event with the 10 mg dose, of which 13 events were Grade 1, 1 event was Grade 2, and 1 event was Grade 3.
Administer glofitamab-gxbm in a facility equipped to monitor and manage CRS. Initiate therapy according to the step-up dosing schedule to reduce the risk of CRS, administer pretreatment medications, and ensure adequate hydration. Patients should be hospitalized during and for 24 hours after completing infusion of the 2.5 mg step-up dose. Patients who experienced any grade CRS during the 2.5 mg step-up dose should be hospitalized during and for 24 hours after completion of the 10 mg step-up dose. For subsequent doses, patients who experienced Grade ≥ 2 CRS with the previous infusion should be hospitalized during and for 24 hours after the next glofitamab infusion.
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care; withhold or permanently discontinue glofitamab based on severity.
Neurologic Toxicity
Glofitamab can cause serious and fatal neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS).
Among 145 patients who received glofitamab-gxbm, the most frequent neurologic toxicities of any grade were headache (10%), peripheral neuropathy (8%), dizziness or vertigo (7%), and mental status changes (4.8%, including confusional state, cognitive disorder, disorientation, somnolence, and delirium). Grade 3 or higher neurologic adverse reactions occurred in 2.1% of patients and included somnolence, delirium, and myelitis. Cases of ICANS of any grade occurred in 4.8% of patients.
Coadministration of glofitamab with other products that cause dizziness or mental status changes may increase the risk of neurologic toxicity. Optimize concomitant medications and hydration to avoid dizziness or mental status changes. Institute fall precautions as appropriate.
Monitor patients for signs and symptoms of neurologic toxicity, evaluate, and provide supportive therapy; withhold or permanently discontinue glofitamab based on severity.
Evaluate patients who experience neurologic toxicity such as tremors, dizziness, or adverse reactions that may impair cognition or consciousness promptly, including potential neurology evaluation. Advise affected patients to refrain from driving and/or engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurologic toxicity fully resolves.
Serious Infections
Glofitamab can cause serious or fatal infections.
Serious infections were reported in 16% of patients, including Grade 3 or 4 infections in 10%, and fatal infections in 4.8% of patients. Grade 3 or higher infections reported in ≥2% of patients were COVID-19 infection (6%), including COVID-19 pneumonia, and sepsis (4.1%). Febrile neutropenia occurred in 3.4% of patients.
Glofitamab should not be administered to patients with an active infection. Administer antimicrobial prophylaxis according to guidelines. Monitor patients before and during glofitamab-gxbm treatment for infection and treat appropriately. Withhold or consider permanent discontinuation of glofitamab-gxbm based on severity.
Tumor Flare
Glofitamab can cause serious tumor flare. Manifestations include localized pain and swelling at the sites of the lymphoma lesions and/or dyspnea from new pleural effusions.
Tumor flare was reported in 12% of patients who received glofitamab-gxbm, including Grade 2 tumor flare in 4.8% of patients and Grade 3 tumor flare in 2.8%. Recurrent tumor flare occurred in two (12%) of the affected patients. Most tumor flare events occurred during Cycle 1, with a median time to first onset of 2 days (range: 1 to 16 days) after the first dose of the drug. The median duration was 3.5 days (range: 1 to 35 days).
Patients with bulky tumors or disease located in close proximity to airways or a vital organ should be monitored closely during initial therapy. Monitor for signs and symptoms of compression or obstruction due to mass effect secondary to tumor flare, and institute appropriate treatment. Withhold glofitamab until tumor flare resolves.
Embryo-fetal Toxicity
Based on its mechanism of action, glofitamab may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with glofitamab and for 1 month after the last dose.
Specific Populations
PregnancyBased on its mechanism of action glofitamab may cause fetal harm when administered to a pregnant woman. There are no available data on the use of glofitamab-gxbm in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm.
Glofitamab 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 can cause B-cell lymphocytopenia in infants exposed to the drug in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, glofitamab 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.
LactationThere are no data on the presence of glofitamab-gxbm in human milk or the effects on the breastfed child or milk production. Because human IgG is present in human milk, and there is potential for drug absorption leading to B-cell depletion, advise women not to breastfeed during treatment with glofitamab and for 1 month after the last dose of the drug.
Females and Males of Reproductive PotentialGlofitamab may cause fetal harm when administered to a pregnant woman
Verify pregnancy status in females of reproductive potential prior to initiating the drug.
Advise female patients of reproductive potential to use effective contraception during treatment with glofitamab and for 1 month after the last dose of the drug.
Pediatric UseThe safety and efficacy of glofitamab-gxbm in pediatric patients have not been established.
Geriatric UseOf the 145 patients with relapsed or refractory large B-cell lymphoma (LBCL) who received glofitamab-gxbm in study NP30179, 55% were 65 years of age or older, and 23% were 75 years of age or older. There was a higher rate of fatal adverse reactions, primarily from COVID-19, in patients 65 years of age or older compared to younger patients. No overall differences in efficacy were observed between patients 65 years of age or older and younger patients.
Common Adverse Effects
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 decreased lymphocyte count, decreased phosphate, decreased neutrophil count, decreased uric acid, and decreased fibrinogen.
What other drugs will affect Glofitamab
Specific Drugs
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
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 glofitamab.
Glofitamab causes the release of cytokines 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 glofitamab 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 cytokine release syndrome (CRS).
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