Linvoseltamab

Linvoseltamab is used to treat adults with multiple myeloma who have had at least 4 treatment regimens and their cancer has come back or did not respond to a previous treatment.

Linvoseltamab is only available through a special program. You must be registered in the program and understand the risks and benefits of linvoseltamab.

Linvoseltamab may also be used for other purposes not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Read the Patient Wallet Card about serious side effects and learn what symptoms to watch for. Keep the card with you at all times.

Linvoseltamab is given as an infusion into a vein by a healthcare provider.

You will need to stay in the hospital for 24 hours after some doses of linvoseltamab. Talk with your doctor if you have any questions.

Your doctor will determine the right treatment schedule for you.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep using these medicines for as long as your doctor has prescribed. Your doctor will monitor you for these side effects.

You will need frequent medical tests and your cancer treatments may be delayed or discontinued based on the results.

Call your doctor if you have symptoms of neurological problems such as headache, agitation, tiredness, confusion, hallucinations, problems with thinking or memory, unusual muscle problems or pain, numbness and tingling, seizures, walking difficulties, handwriting or speech changes.

Tell your medical caregivers if you have symptoms of a serious side effect, such as fever, chills, trouble breathing, vomiting, or severe tiredness.

Tell your doctor if you have or have ever had:

• low white blood cell (WBC) counts;
• an active or recent infection; or
• abnormal liver function tests.

May harm an unborn baby. Do not use if you are pregnant. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using linvoseltamab and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using linvoseltamab, and for at least 3 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or if you have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Linvoseltamab may cause serious side effects. Call your doctor at once if you have:

• neurological problems--headache, jerking muscle movements, rigid muscles, feeling restless, numbness and tingling, confusion, problems speaking, muscle spasms, tremors, double vision, changes in handwriting, problems walking, muscle weakness in your body or face, hearing loss, burning, throbbing, or stabbing pain;
• signs of infection or low white blood cell counts--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding, shortness of breath, chest pain, painful urination, mouth sores, skin sores, cough; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of linvoseltamab may include:

• muscle or bone pain;
• cough with or without mucus;
• nausea, diarrhea;
• tiredness or weakness;
• headache;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• fever, chills, chest pain, feeling short of breath; or
• abnormal blood tests (low white and red blood cell counts).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Multiple Myeloma:

Step-Up Dosing: -Day 1 (step-up dose 1): 5 mg via IV infusion over 4 hours as a single dose-Day 8 (step-up dose 2): 25 mg via IV infusion over 4 hours as a single dose-Day 15 (first treatment dose): 200 mg via IV infusion over 4 hours as a single doseWeekly Dosing: -One week after Day 15 (second treatment dose): 200 mg via IV infusion over 1 hour as single dose-Weeks 4 to 13: 200 mg via IV infusion over 30 minutes once a week (for a total of 10 treatment doses)Biweekly Dosing: -Week 14 and thereafter: 200 mg via IV infusion over 30 minutes every 2 weeksMonthly Dosing: -Week 24 or after: 200 mg via IV infusion over 30 minutes every 4 weeks only if a very good partial response (VGPR) or better is achieved/maintained at or after Week 24 AND after at least 17 doses of 200 mg. Comments:-Carefully review the dosing tables/recommendations in the manufacturer product information before administration. -Administer as an IV infusion according to the step-up schedule to reduce the incidence/severity of cytokine release syndrome (CRS). -For patients without CRS, the infusion duration can be reduced for subsequent doses as recommended by the manufacturer; for patients who experienced CRS with a previous dose, the infusion duration should be maintained at the duration of the previous infusion. -Weekly doses should be given at least 5 days apart; biweekly doses should be at least 10 days apart; every 4-week doses should be at least 24 days apart.-Pretreatment medications are recommended to reduce the risk of CRS and infusion-related reactions (IRR). -Duration of therapy: Until disease progression or unacceptable toxicity.Use: For the treatment of relapsed or refractory multiple myeloma in patients who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Call your doctor for guidance if you miss an appointment for your linvoseltamab injection.

In a medical setting, an overdose will be treated promptly.

Do not drive or engage in hazardous activities for 48 hours after receiving certain doses of linvoseltamab or until any neurological symptoms have resolved. Your reactions may be affected.

Other drugs may affect linvoseltamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.