Our treatments available for multiple myeloma from newly diagnosed to relapse/refractory

Do not receive DARZALEX^® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX^®. See below for a complete list of ingredients.

Before you receive DARZALEX^®, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of breathing problems
• have had shingles (herpes zoster)
• have ever had or might now have a hepatitis B infection as DARZALEX^® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during, and for some time after treatment with DARZALEX^®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes
• have hereditary fructose intolerance (HFI). DARZALEX^® contains sorbitol. Sorbitol is a source of fructose. People with HFI cannot break down fructose, which may cause serious side effects
• are pregnant or plan to become pregnant. DARZALEX^® may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX^®
  • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of DARZALEX^®. Talk to your healthcare provider about birth control methods that you can use during this time
  • Before starting DARZALEX^® in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program
    • The lenalidomide, pomalidomide, and thalidomide REMS have more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant
    • For males who have female partners who can become pregnant, there is information in the lenalidomide, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX^® passes into your breast milk. You should not breastfeed during treatment with DARZALEX^®. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX^®

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive DARZALEX^®?

• DARZALEX^® may be given alone or together with other medicines used to treat multiple myeloma
• DARZALEX^® will be given to you by your healthcare provider by intravenous (IV) infusion into your vein
• Your healthcare provider will decide the time between doses as well as how many treatments you will receive
• Your healthcare provider will give you medicines before each dose of DARZALEX^® and after each dose of DARZALEX^® to help reduce the risk of infusion-related reactions
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

DARZALEX^® may cause serious reactions, including:

• Infusion-related reactions. Infusion-related reactions are common with DARZALEX^®. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death can happen with DARZALEX^®. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX^® if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms: shortness of breath or trouble breathing, dizziness or lightheadedness (hypotension), cough, wheezing, heart beating faster than usual, low oxygen in the blood (hypoxia), throat tightness or irritation, runny or stuffy nose, headache, itching, high blood pressure, eye pain, nausea, vomiting, chills, fever, chest discomfort, or blurred vision
• Changes in blood tests. DARZALEX^® can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX^®. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX^®. Tell all of your healthcare providers that you are being treated with DARZALEX^® before receiving blood transfusions
• Decreases in blood cell counts. DARZALEX^® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Decreases in blood cell counts are common with DARZALEX^® but can be severe. Your healthcare provider will check your blood cell counts during treatment with DARZALEX^®. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding

The most common side effects of DARZALEX^® include cold-like symptoms (upper respiratory infection); diarrhea; constipation; decreased red blood cells; nerve damage causing tingling, numbness, or pain; tiredness; swollen hands, ankles, or feet; nausea; cough; fever; shortness of breath; feeling weak.

These are not all the possible side effects of DARZALEX^®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX^®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DARZALEX^® that is written for health professionals.

Active ingredient: daratumumab.

Inactive ingredients: may include glacial acetic acid, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, sorbitol, and water for injection.

Please click here to see the Important Product Information.

cp-109238v8

What is the most important information I should know about CARVYKTI^®?

CARVYKTI^® may cause side effects that are severe or life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:

• fever (100.4°F/38°C or higher)
• chills or shaking chills
• fast or irregular heartbeat
• difficulty breathing
• very low blood pressure
• dizziness/lightheadedness
• persistent or severe diarrhea, abdominal pain, and weight loss
• effects on your nervous system, some of which can occur days or weeks after you receive the infusion, and may initially be subtle such as:
  • feeling confused, less alert, or disoriented; having difficulty speaking or slurred speech; having difficulty reading, writing, and understanding words; memory loss
  • loss of coordination affecting movement and balance, slower movements, changes in handwriting
  • personality changes, including a reduced ability to express emotions, being less talkative, disinterested in activities, and reduced facial expression
  • tingling, numbness, and pain of hands and feet, difficulty walking, leg and/or arm weakness, and difficulty breathing
  • facial numbness, difficulty moving muscles of face and eyes

It is important that you tell your healthcare providers that you have received CARVYKTI^® and to show them your CARVYKTI^® Patient Wallet Card. Your healthcare providers may give you other medicines to treat your side effects.

Before you receive CARVYKTI^®, tell your healthcare provider about all your medical conditions, including if you have:

• Current or past neurologic problems (such as seizures, stroke, new or worsening memory loss)
• Lung or breathing problems
• Heart problems
• Liver problems
• Kidney problems
• A recent or active infection
• Low blood counts

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive CARVYKTI^®?

• CARVYKTI^® is made from your own white blood cells, so your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis). The procedure can take 3 to 6 hours and may need to be repeated.
• Your white blood cells are sent to a manufacturing center to make CARVYKTI^®. It takes about 4-5 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
• While CARVYKTI^® is being made, you may get other medicines to treat the multiple myeloma. This is so your multiple myeloma does not get worse.

Before you get CARVYKTI^®, your healthcare provider will give you chemotherapy for 3 days to prepare your body.

Thirty to 60 minutes before you are given CARVYKTI^®, you may be given other medicines. These may include:

• medicines for an allergic reaction (antihistamines)
• medicines for fever (such as acetaminophen)

When your CARVYKTI^® is ready, your healthcare provider will give CARVYKTI^® to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of CARVYKTI^® will be given in one infusion bag. The infusion usually takes approximately 30-60 minutes.

After getting CARVYKTI^®, you will be monitored at the certified healthcare facility where you received your treatment for at least 7 days after the infusion.

You should plan to stay close to the location where you received your treatment for at least 2 weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur. You may be hospitalized if you develop serious side effects until your side effects are under control and it is safe for you to leave the hospital.

Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving CARVYKTI^®?

• Avoid driving for at least 2 weeks after you get CARVYKTI^®
• You must not be given certain vaccines called live vaccines for some time before and after CARVYKTI^® treatment. Talk to your healthcare provider if you need to have any vaccinations
• Do not donate blood, organs, tissues, or cells for transplantation

What are the possible or reasonably likely side effects of CARVYKTI^®?

The most common side effects of CARVYKTI^® include:

• fever (100.4°F/38°C or higher), chills
• dizziness/lightheadedness
• headache, muscle or joint pain, feeling very tired
• altered mental state, confusion
• infections
• low levels of antibodies (immunoglobulins) in the blood
• cough, being short of breath
• diarrhea, nausea, decreased appetite, constipation
• fast or irregular heartbeat
• problems with blood clotting

In a study comparing CARVYKTI^® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI^® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI^® and after treatment with CARVYKTI^®. The reasons for death were progression of multiple myeloma and side effects of the treatment.

CARVYKTI^® can cause a very common side effect called cytokine release syndrome, or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or lightheadedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any of these other symptoms after receiving CARVYKTI^®.

CARVYKTI^® can increase the risk of life-threatening infections, including COVID-19, that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

CARVYKTI^® can cause various neurologic side effects, some of which may be severe or fatal. Symptoms include but are not limited to confusion, disorientation, loss of consciousness, seizures, difficulty speaking, reading or writing, tremor, slower movements, changes in personality, depression, tingling and numbness of hands and feet, leg and arm weakness, and facial numbness.

CARVYKTI^® can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]), which may make you feel weak or tired, or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.

CARVYKTI^® can cause serious gastrointestinal side effects, including severe or persistent diarrhea or ruptured bowel, which can be life-threatening and may lead to death. Tell your healthcare provider right away if you develop diarrhea, abdominal pain, weight loss, fever, chills, or any signs or symptoms of an infection.

CARVYKTI^® may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.

Having CARVYKTI^® in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.

These are not all the possible side effects of CARVYKTI^®. Call your healthcare provider if you have any side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI^®.

cp-258861v9

What is the most important information I should know about TECVAYLI?

TECVAYLI can cause side effects that are serious, life-threatening or cause death, including cytokine release syndrome (CRS) and neurologic problems.

• Cytokine Release Syndrome (CRS). Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:

• Neurologic problems. Tell your healthcare provider or get medical help right away if you develop any signs and symptoms of neurologic problems, including:

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with TECVAYLI and treat you as needed. Your healthcare provider may temporarily stop or completely stop your treatment with TECVAYLI if you develop CRS or neurologic problems.

• TECVAYLI is available only through the TECVAYLI and TALVEY^® Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.

If you have any questions about TECVAYLI, ask your healthcare provider.

See “What are the possible side effects of TECVAYLI?” for more information about side effects.

Before you receive TECVAYLI, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or plan to become pregnant. TECVAYLI may harm your unborn baby.
  • Your healthcare provider should do a pregnancy test before you start treatment with TECVAYLI.
  • You should use effective birth control (contraception) during treatment and for 5 months after your last dose of TECVAYLI.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with TECVAYLI.
• are breastfeeding or plan to breastfeed. It is not known if TECVAYLI passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of TECVAYLI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive TECVAYLI?

• TECVAYLI will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen), your thigh or another area of your body may be injected.
• See “What is the most important information I should know” at the beginning of this Important Safety Information for information about how you will receive TECVAYLI.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with TECVAYLI.

What should I avoid while receiving TECVAYLI?

Do not drive or operate heavy or dangerous machinery during and for 48 hours after your TECVAYLI step-up dosing schedule is completed, or at any time during treatment with TECVAYLI if you develop new neurologic symptoms such as dizziness, confusion, tremors, sleepiness, or any other symptoms that impair your consciousness, until the symptoms go away. See “What is the most important information I should know about TECVAYLI?” for more information about signs and symptoms of neurologic problems.

What are the possible side effects of TECVAYLI?

TECVAYLI can cause serious side effects, including:

• See “What is the most important information I should know about TECVAYLI?”
• Liver problems. TECVAYLI can cause liver problems that may cause death. Increases in liver enzymes can happen with or without CRS. Tell your healthcare provider if you develop any symptoms of a liver problem including:

• Infections. TECVAYLI can cause bacterial and viral infections that are severe, life-threatening, or that may cause death.
  • Your healthcare provider may prescribe medicines to help prevent infections and treat you as needed if you develop an infection during treatment with TECVAYLI.
  • Tell your healthcare provider right away if you get a fever, chills or any signs or symptoms of an infection.
• Decreased white blood cell counts. Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
• Allergic reactions and injection site reactions.
  • Allergic reactions: can include fever, rash, swollen tongue, or trouble breathing. Get medical help right away if you develop any symptoms of an allergic reaction during treatment with TECVAYLI.
  • Injection site reactions: can include redness, heat, swelling, bruising, bacterial skin infection (cellulitis), discomfort, blood collection under the skin at the injection site (hematoma), and rash. Tell your healthcare provider if you develop any severe injection site reactions.

Your healthcare provider will check your liver enzymes and white blood cell counts before you start and during your treatment with TECVAYLI.

Your healthcare provider will monitor you for signs and symptoms of these serious side effects during treatment and may temporarily or permanently stop TECVAYLI if you develop severe side effects.

The most common side effects of TECVAYLI when used alone include:

The most common side effects of TECVAYLI when used with daratumumab and hyaluronidase-fihj

include:

The most common severe abnormal blood test results with TECVAYLI include: decreased white blood cells, red blood cells, and platelets.

These are not all the possible side effects of TECVAYLI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI.

cp-324738v8

What is the most important information I should know about TALVEY^®?

TALVEY^® may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.

Call your healthcare provider or get medical help right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with TALVEY^®:

Cytokine Release Syndrome (CRS). CRS is common during treatment with TALVEY^® and can also be serious or life-threatening, or lead to death. Signs and symptoms of CRS may include:

Neurologic problems. Symptoms of neurologic problems with TALVEY^® may include:

• Due to the risk of CRS and neurologic problems, you should be hospitalized for 48 hours after all doses of TALVEY^® that are part of the “step-up dosing schedule.” The “step-up dosing schedule” is when you receive the first 2 or 3 doses of TALVEY^®, which are smaller “step-up” doses, and also the first full “treatment dose” of TALVEY^®.
• TALVEY^® is given weekly or every 2 weeks. Your healthcare provider will decide the number of days to wait between your doses of TALVEY^® as well as how many treatments you will receive.
  • If you receive TALVEY^® weekly, “Step-up dose 1” is given on day 1 of treatment. “Step-up dose 2” is usually given on day 4 of treatment. The first “treatment dose” is usually given on day 7 of treatment.
  • If you receive TALVEY^® every 2 weeks, “Step-up dose 1” is given on day 1 of treatment. “Step-up dose 2” is usually given on day 4 of treatment. “Step-up dose 3” is usually given on day 7 of treatment. The first “treatment dose” is usually given on day 10 of treatment.
• If your dose of TALVEY^® is delayed for any reason, you may need to repeat the “step-up dosing schedule” to receive TALVEY^®.
• Before each “step up” dose of TALVEY^®, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.
• Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems as well as other side effects, and treat you as needed.

TALVEY^® is available only through the TECVAYLI^® and TALVEY^® Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.

You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.

Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital.

• If you have any questions about TALVEY^®, ask your healthcare provider.
• Your healthcare provider may temporarily stop or completely stop your treatment with TALVEY^® if you develop CRS, neurologic problems, or any other side effects that are severe.

See “What are the possible side effects of TALVEY^®?” for more information about side effects.

Before you receive TALVEY^®, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or plan to become pregnant. TALVEY^® may harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with TALVEY^®.

• are breastfeeding or plan to breastfeed. It is not known if TALVEY^® passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of TALVEY^®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive TALVEY^®?

• TALVEY^® will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in the stomach area (abdomen). TALVEY^® may also be injected into your thigh or another area of your body.
• See “What is the most important information I should know about TALVEY^®?” at the beginning of the Medication Guide for information about how you will receive TALVEY^®.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What should I avoid while receiving TALVEY^®?

Do not drive, operate heavy machinery, or do other dangerous activities during and for 48 hours after your TALVEY^® “step-up dose” is completed or at any time during treatment with TALVEY^®, if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms of neurologic problems until your symptoms go away.

See “What is the most important information I should know about TALVEY^®?” for more information about signs and symptoms of CRS and neurologic problems.

What are the possible side effects of TALVEY^®?

TALVEY^® may cause serious side effects, including:

• See “What is the most important information I should know about TALVEY^®?”
• Mouth problems and weight loss. Tell your healthcare provider or get medical help right away if you develop any of the following symptoms of mouth problems:

Your healthcare provider will monitor you for these symptoms and will monitor your weight during treatment with TALVEY^®. Tell your healthcare provider if you lose weight during treatment with TALVEY^®.

• Infections. TALVEY^® can cause serious infections that can be life-threatening and may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with TALVEY^®. Tell your healthcare provider right away if you get or develop any signs or symptoms of infection during treatment with TALVEY^®, including:

• Decreased blood cell counts. Decreased blood cell counts are common during treatment with TALVEY^® and can also be severe. Your healthcare provider will check your blood cell counts during treatment with TALVEY^®. Tell your healthcare provider if you get any symptoms of infection or unusual bleeding or bruising.
• Skin problems. Skin problems are common during treatment with TALVEY^® and can also be serious. Tell your healthcare provider if you get skin problems such as skin rash, raised red bumps, or redness of the skin.
• Liver problems. Abnormal liver tests can happen during treatment with TALVEY^®. Your healthcare provider will do blood tests before and during treatment with TALVEY^® to check your liver. Tell your healthcare provider if you develop any of the following symptoms of liver problems:

The most common side effects of TALVEY^® include:

The most common severe abnormal lab test results with TALVEY^® include decreased white blood cells and red blood cells. These are not all the possible side effects of TALVEY^®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read full Prescribing Information, including Boxed Warning, for TALVEY^®.

cp-394175v3