Lunsumio
Lunsumio (mosunetuzumab or mosunetuzumab-axgb) is an injection used to treat adults with follicular lymphoma that has come back or didn’t respond after at least two other treatments. As a bispecific antibody, it helps your immune system find and destroy cancer cells. The medication is given as an intravenous (IV) infusion by a healthcare professional in a clinic or hospital. Common side effects include rash, tiredness, headache, and a serious reaction called cytokine release syndrome (CRS).
What is Lunsumio (mosunetuzumab)?
What is Lunsumio (mosunetuzumab) used for?
- Relapsed or refractory follicular lymphoma in adults who've already tried at least two other therapies
How Lunsumio (mosunetuzumab) works
Lunsumio (mosunetuzumab) 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, Lunsumio (mosunetuzumab) brings T-cells close to the cancer cells, helping the immune system attack and destroy the cancer cells.
Drug facts
Side effects of Lunsumio (mosunetuzumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low white blood cells (100%)
- Blood electrolyte changes (up to 78%)
- Low red blood cells (68%)
- Low platelets (46%)
- Cytokine release syndrome (44%)
- Higher blood sugar (42%)
- Tiredness (42%)
- Liver enzyme changes (up to 39%)
- Rash (39%)
- Headache (32%)
- Fever (29%)
- Muscle pain (28%)
- Cough (22%)
- Itching (21%)
- Numbness (20%)
Less Common Side Effects
- Chills
- Cough
- Swelling
- Diarrhea
- Nausea
- Stomach pain
- Dry skin
- Dizziness
- Joint pain
- Shortness of breath
- Trouble sleeping
Lunsumio (mosunetuzumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome (CRS): fever, chills, low blood pressure, fast heartbeat, trouble breathing, headache
- Nervous system problems: headache, numbness, dizziness, confusion, sleepiness
- Serious infection: fever, body aches, chills, feeling very tired or weak, very fast heartbeat, cough, chest pain, shortness of breath, rash, sore throat
- __Hemophagocytic lymphohistiocytosis (HLH):__ fever, easy bruising, liver problems
- __Tumor flare:__ chest pain, trouble breathing, cough, swollen lymph nodes, pain or swelling at the tumor site
The following Lunsumio (mosunetuzumab) 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, headache, change in vision, confusion or trouble speaking, dizziness, loss of balance or coordination, trouble walking, tremors or shaking, 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):
- Back pain
- Cough
- Fatigue
- Headache
- Muscle pain
Pros and cons of Lunsumio (mosunetuzumab)
Pros
- Can lead to remission in follicular lymphoma when other treatments haven’t worked
- Works in a more specific, targeted way than traditional chemotherapy
- After “step-up” process is complete, doses are every 3 weeks
Cons
- Given as an injection, so requires a needle
- Raises your risk for infections
- Can cause serious side effects like cytokine release syndrome and nervous system problems
Pharmacist tips for Lunsumio (mosunetuzumab)
- To lower your risk of cytokine release syndrome (CRS) and infusion-related reactions, you’ll need to take premedications like dexamethasone, diphenhydramine, and acetaminophen 30 to 60 minutes before your Lunsumio (mosunetuzumab) doses in cycles 1 and 2. If you don’t experience CRS during these cycles, you might not need to continue premedications.
- Plan for extra time during the first few Lunsumio (mosunetuzumab) infusions. “Step-up” doses will take at least 4 hours, plus time for premedications. If you tolerate these well, your oncologist might reduce the infusion time to 2 hours after cycle 1.
- If you pause Lunsumio (mosunetuzumab) treatment for more than a week, you might need to repeat some or all of the “step-up” doses. Stopping the medication can raise your risk of CRS, similar to when you first started. Your oncologist will decide if you need “step-up” doses and how many.
- If your temperature reaches 100.4ºF or higher, it means you have a fever. Call your oncologist or get medical help right away. A fever while taking Lunsumio (mosunetuzumab) could be serious since it might mean you have an infection or it could be an early warning sign of CRS.
- If you experience CRS or nervous system problems like headache or dizziness after receiving Lunsumio (mosunetuzumab), avoid driving or using heavy or dangerous machinery until your symptoms go away.
- Lunsumio (mosunetuzumab) commonly causes low white blood cell counts. When your white blood cells are low, your body might not be able to fight infections as well. Be alert for symptoms like fever, chills, cough, or shortness of breath, and contact your oncologist if they occur.
- Avoid breastfeeding while taking Lunsumio (mosunetuzumab) and for 3 months after the last dose. It’s not known if this medication passes into breast milk, but it could potentially harm a nursing infant.
Common questions about Lunsumio (mosunetuzumab)
Yes. The FDA approved Lunsumio (mosunetuzumab) in 2022 under an accelerated process to treat relapsed and refractory follicular lymphoma after at least two other therapies. Additional studies are needed to confirm how well the medication works.
No. Lunsumio (mosunetuzumab) isn’t considered chemotherapy because it works differently. Chemotherapy attacks any cell that grows very quickly, while Lunsumio (mosunetuzumab) is an immunotherapy. It only binds to certain proteins on cancer and immune cells, helping your immune system specifically attack the cancer cells.
Pretty well. In a clinical study, 80% of people who received Lunsumio (mosunetuzumab) had their cancer shrink significantly or go away (overall response rate), and about 60% of them had a complete response, meaning no signs of cancer were found. Talk to your oncologist if you have questions about how well this medication might work for you.
How long you receive Lunsumio (mosunetuzumab) depends on how well it works for you and whether you have any side effects. If you tolerate the medication well and the cancer is completely gone (complete response), your oncologist might recommend stopping after 8 cycles. If the medication is helping but you don’t have a complete response by the 8th cycle, your oncologist might recommend continuing for up to 17 cycles total. But If you have any serious side effects, you might need to pause or stop treatment.
You can receive Lunsumio (mosunetuzumab) in a clinic, infusion center, or hospital. But you don’t need to be hospitalized when starting treatment unless your condition worsens or you have serious side effects like cytokine release syndrome (CRS). In some cases, hospitalization might be required to manage these specific side effects.
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Risks and warnings for Lunsumio (mosunetuzumab)
Lunsumio (mosunetuzumab) 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 (CRS)
Lunsumio (mosunetuzumab) can cause a serious condition called cytokine release syndrome (CRS). This happens when your body’s immune system overreacts to the medication. Symptoms of CRS include headache, chills, fever, low blood pressure, trouble breathing, fast heartbeat, and confusion. CRS is most likely to happen during the first cycle, usually starting within a few hours to a few days after the infusion.
To reduce your risk, you’ll take premedications and follow a “step-up” dosing process. Tell your care team right away if you notice any symptoms. If you develop mild CRS, you might be able to restart Lunsumio (mosunetuzumab) after symptoms go away. But if the symptoms are severe, you might have to stop the medication altogether. Avoid driving or using heavy machinery until the symptoms go away.
Serious nervous system problems
Some people receiving Lunsumio (mosunetuzumab) developed nervous system problems. These can be mild, like headache, dizziness, or numbness in the fingers and toes, or serious, such as a condition called immune effector-cell associated neurotoxicity syndrome (ICANS). In clinical studies, ICANS occurred anywhere from the day after the infusion to about a month and a half later. Tell your care team immediately if you have symptoms like confusion, trouble speaking, shakiness, sleepiness, trouble writing, or seizures. You might need to pause treatment while your oncologist looks into it. Depending on how serious the side effect is, you might be able to restart the medication or stop it completely.
Infections
- Risk factors: History of chronic infection | History of taking immunosuppressant medications
People taking Lunsumio (mosunetuzumab) have serious developed infections, including opportunistic infections. Opportunistic infections are infections that happen in people with immune systems that don’t work as well, like those with cancer or HIV. Infections can happen at any time after starting Lunsumio (mosunetuzumab). Don’t take this medication if you have an active infection. Contact your oncologist right away if you have any signs or symptoms of an infection, such as fever, chills, cough, or body aches.
Hemophagocytic Lymphohistiocytosis (HLH)
Lunsumio (mosunetuzumab) can cause a life-threatening condition called hemophagocytic lymphohistiocytosis (HLH), where your immune system becomes overactive. Your oncologist will monitor you for HLH, especially if CRS lasts longer than expected. Signs and symptoms include fever, easy bruising, liver problems, low blood cell counts, and enlarged spleen. If HLH is suspected, your oncologist might pause Lunsumio (mosunetuzumab) and begin treatment for HLH right away.
Low blood cells
Lunsumio (mosunetuzumab) commonly causes low blood cell counts, including white blood cells, red blood cells, and platelets. Low white blood cells make it harder to fight infections, low red blood cells can make you feel tired, and low platelets raise your risk of bleeding. If you have any unexplained bruising, blood in your urine, blood in your stool, or nosebleeds contact your care team right away.
Your oncologist will monitor your blood counts during treatment. If your blood cell levels drop too much, they might pause or stop Lunsumio (mosunetuzumab). You might also receive medications to help your body make more white blood cells.
Tumor flare
- Risk factors: Certain bulky tumors
Rarely, some people taking Lunsumio (mosunetuzumab) developed tumor flare, a condition that causes swelling and pain at the tumor site. For lymphoma, this might mean swelling and pain around lymph nodes. This is thought to happen because immune cells build up at the tumor site. It doesn’t mean your cancer is growing, but can cause temporary symptoms. If you notice new pain or swelling after starting Lunsumio (mosunetuzumab), contact your oncologist.
Harm to unborn baby
Based on the way Lunsumio (mosunetuzumab) 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 3 months after the last dose. Let your oncologist know if you’re pregnant or thinking about becoming pregnant while taking Lunsumio (mosunetuzumab).
Lunsumio (mosunetuzumab) dosage
Typical dosage for Lunsumio (mosunetuzumab)
The dosing follows a “step-up” schedule. Each dose is given as an intravenous (IV) infusion, starting with a low dose and increasing to the highest dose. Starting from Cycle 3, a maintenance dose of 30 mg is given. Each treatment cycle lasts 21 days.
- Cycle 1
- Day 1: 1 mg, Day 8: 2 mg, Day 15: 60 mg
- Cycle 2
- Day 1: 60 mg
- Cycle 3 and beyond
- Day 1: 30 mg
Lunsumio (mosunetuzumab) images
