Linvoseltamab-gcpt (Lynozyfic™)

How to Take Linvoseltamab-gcpt (Lynozyfic™)

Linvoseltamab-gcpt is given through an intravenous (IV, into a vein) infusion. This medication is given in different doses on certain days of treatment. With this “step-up dosing,” you will receive a smaller dose on days 1 and 8 of treatment. If you tolerate those doses, you will then receive the normal dose for the remainder of your treatment course. You will receive the first 2 doses (days 1 and 8) in the hospital or in an outpatient office. You will need to be monitored in the hospital for 24 hours after these first two infusions finish.

You will be given “pre-medications” to prevent an infusion or allergic reaction before the first step-up dose on day 1, the second step-up dose on day 8, the first full dose on day 15, and the second full dose one week after day 15. These medications include acetaminophen (Tylenol®), diphenhydramine (Benadryl®), and a steroid, such as dexamethasone. Some patients will need these pre-medications before every dose depending on how they tolerate linvoseltamab-gcpt.

Linvoseltamab-gcpt is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LYNOZYFIC REMS. This ensures that the facility where you are receiving this medication is qualified to administer the medication and has the required supportive medications available to treat side effects if you should need them.

Possible Side Effects of Linvoseltamab-gcpt

There are a number of things you can do to manage the side effects of linvoseltamab-gcpt. Talk to your provider about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Cytokine Release Syndrome (CRS)

After you have this medication, large numbers of white blood cells are activated and release inflammatory cytokines, which can lead to cytokine release syndrome (CRS). Severe cases are referred to as cytokine storms. Signs include high fever, lower than normal blood pressure, difficulty breathing, severe nausea and vomiting, severe diarrhea, chills/shaking, severe muscle and joint pain, and bleeding. This serious side effect is most likely to happen within 24 hours of the administration of the step-up schedule, with the risk of CRS significantly decreasing after that. Call your provider right away if you have any signs or symptoms of cytokine release syndrome so that treatment can be given.

Neurologic Toxicity, including ICANS (immune effector cell-associated neurotoxicity syndrome)

Neurological (brain) toxicities, such as aphasia (being unable to understand speech or speak normally), a change in mental status, encephalopathy (lack of blood flow and oxygen to your brain), and seizures have happened in patients who received this medication. Other neurological side effects can include headaches, neuropathy (numbness or tingling), and/or changes to your motor skills (loss of control, often of the arms or legs). Your provider will monitor you very closely for any changes in your mental status.

Infection and Low White Blood Cell Count (Lymphocytopenia/Neutropenia)

This medication can cause life-threatening infections, with or without a decrease in white blood cell counts. You may be given medications to prevent fungal and viral infections while you are taking this medication.

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. Tell your provider right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to prevent infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (those who have a cold, fever, or cough or if you live with someone with these symptoms).
• When working in your yard, wear protective clothing, including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care. Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your provider before scheduling dental appointments or procedures.
• Ask your provider before you, or someone you live with, has any vaccinations.

Electrolyte Changes

This medication can cause low levels of phosphorus in your body. Your levels will be monitored using blood tests. Do not take any supplements without first talking with your provider.

Kidney Problems

This medication can cause kidney problems, including an increased creatinine level, which your provider may monitor for using blood tests. Call your provider if you notice decreased urine output, blood in the urine, swelling in the ankles, or loss of appetite.

Headache, Muscle or Joint Pain/Aches

This medication can cause joint or muscle aches and pains, which may be treated with medications. Talk with your provider about which pain relievers you can safely take. Non-medical therapies, such as acupuncture, yoga, gentle stretching, and exercise may also help reduce this side effect.

Liver Problems

This medication can cause liver problems, which your provider may monitor for using blood tests called liver function tests (LFTs). Tell your provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen (belly), as these can be signs of liver toxicity.

Cough and Shortness of Breath

This medication can cause a new or worsening cough. It can also cause you to feel short of breath. Call your provider if these symptoms are affecting your daily life, or if you have other signs of an infection (chills, fever, sore throat). If you are having trouble breathing, call 911 right away.

Diarrhea

Your provider can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals, and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8 to 10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your provider for helpful tips on dealing with this side effect.

Nausea and/or Vomiting

Talk to your provider so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy /fatty, spicy, or acidic foods (lemons, tomatoes, oranges). Try saltines or ginger ale to lessen symptoms. Call your provider if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant while on this medication. Effective birth control is necessary for women during treatment and for 3 months after the last dose. Men should talk with their provider about the risks of fathering a child while taking this medication. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication and for 3 months after the last dose.