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Overview: Lynozyfic is injected by a health care provider into a blood vessel to treat certain people with multiple myeloma. Common side effects include blood disorders, muscle or joint pain, nausea, diarrhea, and tiredness. Lynozyfic is only available through a special program, from certain pharmacies, and to certain people. You should carry the Lynozyfic Patient Wallet Card with you all the time. This card helps health care providers watch for and treat serious side effects that may happen while you are using Lynozyfic.

Uses

What is Lynozyfic used for?

Lynozyfic (linvoseltamab-gcpt) is commonly used to treat certain people with multiple myeloma, which is a type of blood cancer.

Lynozyfic may also be used for other conditions as determined by your health care provider.

How does Lynozyfic work (mechanism of action)?

Lynozyfic helps your immune system fight multiple myeloma. It seems to work by connecting two different types of cells in your body. The medicine attaches to a protein, called B-cell maturation antigen (BCMA), on the multiple myeloma cells. It also engages or attaches to special markers on T cells, called CD3 receptors. T cells help fight infections and cancer, including multiple myeloma. By connecting these two cells together, Lynozyfic helps your immune system find and attack the multiple myeloma cells.

How is Lynozyfic supplied (dosage forms)?

Lynozyfic is available in an injectable form that is given by a health care provider.

How should I store Lynozyfic?

Lynozyfic is usually given by a health care provider in a hospital. You will not store it at home.

Side Effects

What are the most common side effects of Lynozyfic?

The most common side effects of Lynozyfic are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Blood disorders (see below)
  • Muscle or joint pain
  • Cytokine release syndrome (see below)
  • Cough
  • Infections in the nose, throat, or lungs, including pneumonia (see below)
  • Diarrhea or nausea
  • Tiredness
  • Headache
  • Shortness of breath

There may be other side effects of Lynozyfic that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Lynozyfic?

While less common, the most serious side effects of Lynozyfic are described below, along with what to do if they happen.

Severe Allergic Reactions. Lynozyfic may cause allergic reactions, which can be serious. Stop using Lynozyfic and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cytokine Release Syndrome (CRS).Lynozyfic can cause a dangerous and sometimes life-threatening problem called cytokine release syndrome. CRS occurs when your immune system responds too much to medicines or infection. CRS may happen right away or several days after you get Lynozyfic. Get emergency help if you have any of the following symptoms of CRS. 

  • Fever, chills, or shaking
  • Fast or racing heart
  • Dizziness or feeling lightheaded
  • Trouble breathing
  • Severe nausea, vomiting, or diarrhea
  • Severe headache

Neurologic Problems. Lynozyfic can cause nervous system problems, including a condition called immune effector cell-associated neurotoxicity syndrome (ICANS). Get emergency help if you have any of the following symptoms.

  • Headache
  • Confusion
  • Seizures
  • Balance problems
  • Trouble talking or walking
  • Feeling very sleepy, sluggish, or disoriented
  • Pain, burning, tingling, numbness, or weakness

Decreased Alertness or Confusion. Lynozyfic can affect your alertness and cause confusion. Do not drive or do other activities that require alertness for at least 48 hours after each new dose of Lynozyfic, or after any dose until these symptoms go away.

Blood Disorders. Lynozyfic can cause blood disorders, such as low white blood cell levels, including lymphocytopenia and neutropenia, as well as anemia. Neutropenia, especially if you also have a fever (called febrile neutropenia), can sometimes be severe. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection, including serious infections. Keep all of your appointments, including those for lab work, while you are using Lynozyfic. 

Infections. Lynozyfic can increase your risk of infections, including serious infections. Keep all appointments, including those for lab work, while you are using Lynozyfic. Follow any recommendations from your health care provider about how to prevent or treat infections. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Coughing, or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Weakness or tiredness
  • Sore throat or mouth or throat sores
  • Swollen lymph nodes

Progressive Multifocal Leukoencephalopathy (PML). People using Lynozyfic may get a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop using Lynozyfic and call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • A hard time walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Lynozyfic. Keep all appointments, including those for lab work, while you are using Lynozyfic. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Lynozyfic?

Allergies to Ingredients. People who are allergic to any of the following should not use Lynozyfic.

  • Linvoseltamab-gcpt
  • Lynozyfic
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Lynozyfic.

What should I know about Lynozyfic before using it?

Lynozyfic is usually given as an infusion into a vein (IV) by a health care provider in a hospital. You will likely stay in the hospital for at least 24 hours after the first couple of doses of Lynozyfic. This is so you can be watched closely for serious side effects. See the Side Effects section for more details. 

Lynozyfic is only available through a special program, from certain pharmacies, and to certain people. It is important that you keep all of your appointments, including labs or other testing, while using Lynozyfic. You should get a Lynozyfic Patient Wallet Card. Carry it with you at all times and show it to all of your health care providers. This card lets health care providers know that you are using Lynozyfic. It also describes symptoms of possible serious side effects that need to be treated right away. If you have any questions about this program, you can go to www.LynozyficREMS.com or call 855-212-6391.

What should I tell my health care provider before using Lynozyfic?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Lynozyfic is right for you.

In particular, make sure that you discuss any of the following.

Infection. Tell your health care provider if you have an infection before receiving Lynozyfic. Lynozyfic may increase your risk of infections.

Other Medicines and Supplements. Lynozyfic may interact with other medicines and supplements. Before using Lynozyfic, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Lynozyfic may cause harm to an unborn baby. If you can get pregnant, you should use effective birth control while using Lynozyfic and for 3 months after your last dose. If you get pregnant or think you might be pregnant while using Lynozyfic, tell your health care provider right away.

Breastfeeding. It is not known if Lynozyfic passes into breast milk. You should not breastfeed while using Lynozyfic and for 3 months after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Lynozyfic.

How can I get more information about Lynozyfic?

For more information about Lynozyfic, you can visit the drugmaker’s website at www.lynozyfic.com or call them at 844-746-4363.

Interactions

Does Lynozyfic interact with foods or drinks?

There are no known interactions between Lynozyfic and foods or drinks.

It is unknown if drinking alcohol will affect Lynozyfic, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. 

Does Lynozyfic interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. 

Lynozyfic may alter the blood levels of many other medicines. These interactions may be more likely to happen if you are having a side effect known as cytokine release syndrome (see the Side Effects section for more details) and while your dose is being increased and for up to 2 weeks after you reach the dose you will use long-term. Tell your health care provider about all medicines that you take or have recently taken.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Lynozyfic?

If you or someone else has used too much Lynozyfic, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Lynozyfic?

Lynozyfic is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving Lynozyfic as scheduled.

If you miss an appointment to get your Lynozyfic dose, call to make another appointment as soon as possible.