Columvi
Columvi (glofitamab) is an injectable medication used to treat certain types of large B-cell lymphoma (LBCL) in adults who have had at least two other treatments that didn’t work or stopped working. It's given as an intravenous (IV) infusion over a fixed treatment period, typically completed in about 8.5 months. Columvi (glofitamab) is a bispecific monoclonal antibody that helps your immune system find and destroy cancer cells. Common side effects include low blood cell counts, muscle pain, tiredness, and a serious reaction called cytokine release syndrome (CRS).
What is Columvi (glofitamab)?
What is Columvi (glofitamab) used for?
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) in adults who've already tried at least two other therapies
How Columvi (glofitamab) works
Columvi (glofitamab) is a bispecific T-cell engager (BiTE), which is a type of monoclonal antibody that’s designed to bind to two different targets. One side of the antibody attaches to CD20, a protein on cancer cells, while the other side binds to CD3, a protein on T-cells in your immune system. By connecting these two cells, Columvi (glofitamab) brings T-cells close to the cancer cells, helping the immune system attack and destroy the cancer cells.
Drug Facts
What are the side effects of Columvi (glofitamab)?
Common Side Effects
- Low white blood cells (up to 90%)
- Low fibrinogen in blood (84%)
- Low red blood cells (72%)
- Cytokine release syndrome (70%)
- Changes in blood electrolytes (up to 69%)
- Low platelets (56%)
- Blood electrolyte changes (up to 49%)
- Muscle pain (21%)
- Tiredness (20%)
- Rash (20%)
Other Side Effects
- Swelling
- Fever
- Constipation
- Diarrhea
- Tumor flare
- Headache
- Nausea
- Stomach pain
- Vomiting
- Tremor
Serious Side Effects
- Cytokine release syndrome (CRS): fever, chills or shaking, fast or irregular heartbeat, dizziness or light-headedness, trouble breathing, shortness of breath
- Nervous system problems: headache, confusion, difficulty paying attention or understanding things, trouble speaking, sleepiness, memory problems, dizziness, numbness or tingling of the hands or feet, shaking
- Serious infection: fever, chills, weakness, cough, shortness of breath, sore throat
- Tumor flare: tender or swollen lymph nodes, pain or swelling at the site of the tumor, chest pain, cough, trouble breathing
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Swelling and pain of the tumor site or lymph nodes
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone pain
- Constipation
- Diarrhea
- Fatigue
- Muscle pain
- Skin rash
Pros and cons of Columvi (glofitamab)
Pros
Works in a more specific, targeted way than traditional chemotherapy
Fixed treatment duration so not lifelong
Given every 3 weeks after initial doses
Cons
Requires a step-up dose process that might require at least one hospital visit
Commonly causes muscle pain, rash, and tiredness
Risk of serious infections
Pharmacist tips for Columvi (glofitamab)
Columvi (glofitamab) can cause a serious immune reaction called cytokine release syndrome (CRS). Let your oncologist know right away if you get fever, chills, fast or irregular heartbeat, trouble breathing, or dizziness.
To help prevent CRS, you will take premedications like dexamethasone, diphenhydramine, and acetaminophen 30 minutes to 1 hour before your Columvi (glofitamab) doses.
Columvi (glofitamab) can raise your risk of serious infections. Your oncologist might recommend you take an antiviral medication like acyclovir or an antibiotic like sulfamethoxazole and trimethoprim (Bactrim) to help prevent certain infections.
You will need to stay in the hospital for your first Columvi (glofitamab) step-up dose and 24 hours after. This is the time when CRS usually happens, so it’s important to be monitored closely.
If you didn’t have any problems with your first Columvi (glofitamab) doses, you might not need to stay in the hospital next time. But if you had more than mild CRS, your next dose will need to be given in the hospital again.
Each Columvi (glofitamab) dose in the first two cycles will take at least 4 hours. If you tolerate those doses well, you might be able to receive it faster over 2 hours. But if you experience CRS, your infusion could take up to 8 hours.
If you stop receiving Columvi (glofitamab) for more than a few weeks, you might need to repeat “step-up” doses. Your oncologist will decide if this is needed to help avoid CRS when restarting the medication.
A fever of 100.4°F or higher during Columvi (glofitamab) treatment could be a sign of CRS or infection. Call your oncologist or get help right away if this happens.
Carry a Patient Wallet Card while taking Columvi (glofitamab). This card lists the CRS symptoms and tells you when to get emergency medical help.
Columvi (glofitamab) can affect your brain and nerves. If you get symptoms like headache, dizziness, confusion, or tingling, tell your oncology care team right away. Don’t drive or use heavy machines until your symptoms go away.
Columvi (glofitamab) can harm an unborn baby. If you can become pregnant, use birth control while taking this medication and for 1 month after your last dose. Let your oncologist know right away if you become pregnant during treatment.
Avoid breastfeeding while taking Columvi (glofitamab) and for 1 month after the last dose. It’s not known if this medication passes into breast milk, but it could potentially harm a nursing infant.
Frequently asked questions about Columvi (glofitamab)
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What are the risks and warnings for Columvi (glofitamab)?
Columvi (glofitamab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
Columvi (glofitamab) can cause a reaction called cytokine release syndrome (CRS), which can be serious or even life-threatening. CRS happens when your immune system overreacts to the medication. Symptoms can include headache, chills, fever, low blood pressure, trouble breathing, fast heartbeat, and confusion. CRS usually happens during the “step up” doses, often starting a few hours after your infusion and lasting a few days.
To help reduce your risk, you’ll take premedications before your Columvi (glofitamab) doses and follow a “step-up” dosing process. You’ll need to stay in the hospital during and for 24 hours after your first “step-up” dose and again after the second “step-up” dose if you had any CRS symptoms. If you had a moderate or serious reaction before, you’ll also need to stay in the hospital for future doses. If you start to feel sick after at any point, get medical help right away — your treatment might need to be paused or stopped depending on how serious the reaction is.
Serious nervous system problems
Risk factors: Taking other medications that cause drowsiness and confusion
Columvi (glofitamab) can cause serious nervous system problems, including a condition called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your care team immediately if you have symptoms like headache, tingling or numbness, dizziness, confusion, sleepiness, or trouble focusing. If you have any changes in how you think or stay alert, don’t drive or use heavy equipment until you feel back to normal.
Infections
Columvi (glofitamab) can cause serious or even deadly infections, including COVID-19 pneumonia and sepsis. Your oncologist might prescribe antibiotics or antivirals to help prevent infections while you’re getting treatment. Contact your care team right away if you have any signs or symptoms of infection such as fever, body aches, chills, or cough.
Tumor flare
Risk factors: Bulky tumors near your lungs or other organs
Columvi (glofitamab) can cause a reaction called tumor flare, which can be serious. Tumor flare can lead to pain or swelling where your cancer is located, and sometimes trouble breathing if fluid builds up near your lungs. This usually happens during the first cycle of treatment, often starting around 2 days after the first “step-up” dose and lasting a few days.
Harm to unborn baby
Based on the way Columvi (glofitamab) works, it might cause harm to an unborn baby. If you’re able to get pregnant, use birth control while taking this medication and for 1 month after the last dose. Let your oncologist know if you’re pregnant or thinking about becoming pregnant while taking Columvi (glofitamab).
Columvi (glofitamab) dosage forms
Typical dosing for Columvi (glofitamab)
Before starting Columvi (glofitamab), you’ll take a one-time dose of another medication called Gazyva (obinutuzumab).
After that, you’ll begin Columvi (glofitamab) on a step-up dosing schedule, which means the dose will start low and gradually increase to the full dose. Each dose is given as an injection through the vein (intravenous, IV), and each treatment cycle lasts 21 days.
Cycle 1
Day 1: Gazyva (obinutuzumab) 1000 mg
Day 8: Columvi (glofitamab) 2.5 mg
Day 15: Columvi (glofitamab) 10 mg
Cycles 2 to 12
Day 1: Columvi (glofitamab) 30 mg
What are alternatives to Columvi (glofitamab)?
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) in adults who've already tried at least two other therapies
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma in adults who've already tried at least two other therapies
Relapsed or refractory follicular lymphoma in adults who've already tried at least two other therapies
Multiple myeloma after at least one previous therapy, given together with Velcade (bortezomib) and dexamethasone
Multiple myeloma after at least four previous therapies, given together with dexamethasone
Advanced diffuse large B-cell lymphoma after at least two previous therapies
Columvi (glofitamab) images
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