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The TECVAYLI® (teclistamab-cqyv) Experience

Yellow pointer iconSAFETY OVERVIEW

TECVAYLI® 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 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 TECVAYLI®:

Cytokine Release Syndrome (CRS). Signs and symptoms of CRS may include:

Fever icon

Fever
(100.4°F or higher)

Difficulty breathing icon

Difficulty breathing

Chills icon

Chills

Dizziness icon

Dizziness or lightheadedness

Fast heartbeat icon

Fast heartbeat

Feeling anxious icon

Feeling anxious

Confusion icon

Confusion or restlessness

Headache icon

Headache

Liver enzymes icon

Increased liver enzymes in your blood

Step-up dosing may help reduce both the chance of getting CRS and the severity of it

TECVAYLI® activates your immune cells to help fight your disease. This activation can cause a serious or life-threatening side effect called Cytokine Release Syndrome (or CRS).

Your provider will give you premedication and use step-up dosing to decrease the likelihood and severity of CRS. Pretreatment medications may also be needed for doses given after a dose delay.

Green bullet point Most instances of CRS happened during the first 3 doses

Green sub bullet 42% of people taking TECVAYLI® experienced CRS after step-up dose 1, 35% after step-up dose 2, and 24% after the initial treatment dose (the third dose)

Green sub bullet Less than 3% of people taking TECVAYLI® had a first occurrence of CRS after the third dose

Green bullet point The median time to CRS occurring was 2 days (with a range of 1 to 6 days) after the most recent dose. The median amount of time that CRS lasted was 2 days (with a range of 1 to 9 days)
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Neurologic problems. Symptoms of neurologic problems with TECVAYLI® include:

Headache icon

Headache

Jerking movements icon

Jerking movements

Rigid muscles icon

Rigid muscles

Feeling restless icon

Feeling restless

Numbness icon

Numbness and tingling (feeling like "pins and needles")

Confusion icon

Confusion

Trouble speaking icon

Trouble speaking

Muscle spasms icon

Muscle spasms

Tremor icon

Tremor

Double vision icon

Double vision

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Changes in
your handwriting

Problems walking icon

Problems walking

Muscle weakness icon

Muscle weakness in your body or face

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Hearing loss

Burning icon

Burning, throbbing,
or stabbing pain

Due to the risk of CRS and neurologic symptoms, you should be hospitalized for 48 hours after all doses of TECVAYLI® that are part of the “step-up dosing schedule.” The “step-up dosing schedule” is when you receive the first 2 doses of TECVAYLI®, which are called “step-up doses,” and then you receive the first “treatment dose” of TECVAYLI®. After “step-up dose 1” of TECVAYLI®, the dose of TECVAYLI® is increased. After “step-up dose 2,” the dose is increased again when you receive the first “treatment dose” of TECVAYLI®.

Green bullet pointYour healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with TECVAYLI®, as well as other side effects and treat you as needed.

Green bullet pointDo 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 until the symptoms go away.

What are the possible side effects of TECVAYLI®?

TECVAYLI® may cause serious side effects, including:

Green bullet point See “What is the most important information I should know about TECVAYLI®?”

Green bullet point Liver problems. TECVAYLI® can cause liver problems that may lead to death. Increased bilirubin and liver enzymes in your blood are common with TECVAYLI® and can also sometimes be severe. These increases in liver enzymes can happen with or without you also having CRS. Your healthcare provider will monitor you for these problems before you start and during treatment with TECVAYLI®. Tell your healthcare provider if you develop any symptoms of a liver problem including:

Green sub bullettiredness

Green sub bulletloss of appetite

Green sub bulletpain in your right upper stomach area (abdomen)

Green sub bulletdark urine

Green sub bulletyellowing of your skin or white part of your eyes

Green bullet point Infections. Upper respiratory tract infections and pneumonia are common with TECVAYLI®. TECVAYLI® can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.

Green sub bulletYour healthcare provider will monitor you for signs and symptoms of infection before and during treatment with TECVAYLI®.

Green sub bulletYour healthcare provider may prescribe medicines for you to help prevent infections, and treat you as needed if you develop an infection during treatment with TECVAYLI®.

Green sub bulletTell your healthcare provider right away if you get a fever, chills, or any signs or symptoms of an infection.

Green bullet point Decreased white blood cell counts. Decreased white blood cell counts are common with TECVAYLI® and can also be severe. Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will check your blood cell counts before you start and during treatment with TECVAYLI®, and treat you as needed.

Green bullet point Allergic reactions and injection site reactions. TECVAYLI® can cause allergic reactions that can affect your whole body (systemic), and also cause injection site reactions.

Green sub bulletSome people taking TECVAYLI® can develop symptoms of an allergic reaction that can affect their whole body and may include fever or a swollen tongue. Get medical help right away if you develop symptoms of an allergic reaction during treatment with TECVAYLI®.

Green sub bulletInjection site reactions are common with TECVAYLI® and 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 may temporarily or permanently stop TECVAYLI® if you have any of the side effects listed above and they are severe.

The most common side effects of TECVAYLI® include:

Fever icon

Fever

Pain in joint icon

Pain in your joints and muscles, back and chest muscles, and in your arms and legs

Tiredness icon

Tiredness and
weakness

Upper respiratory problem icon

Upper respiratory tract infections and pneumonia. See "Infections" above

Nausea icon

Nausea

Headache icon

Headache

Diarrhea icon

Diarrhea

The most common severe abnormal lab test results with TECVAYLI® include:

Decreased white blood cell count icon

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.

Your healthcare team may change your treatment plan if you experience side effects.

TECVAYLI® 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.

Yellow pointer iconStarting TECVAYLI®

TECVAYLI® is a ready-to-use treatment

TECVAYLI® is given by a doctor or nurse as a subcutaneous injection under the skin, usually in your stomach area (abdomen), your thigh, or another area of your body.

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TECVAYLI® starts with what is called “step-up” dosing

Green bullet point Step-up dosing is done with TECVAYLI® to reduce the chance of getting CRS and/or experiencing neurologic problems

Green bullet point The amount of TECVAYLI® you receive will be increased from the first to second dose, and then increased again from the second to third dose

Green bullet point The amount of TECVAYLI® you receive will be based on your body weight

Green bullet point The amount given for the third dose will be the same as your ongoing weekly dose

Green bullet pointYou should be hospitalized for 48 hours after each dose given to you during the step-up dosing schedule

Step-up dosing may be administered in the hospital setting

TECVAYLI® (teclistamab-cqyv) step-up dosing schedule and weekly dosing

Step-up dose 2 and/or the first treatment dose may be given between 2 to 4 days* after the previous step-up dose so your healthcare team can manage any side effects.

*But could be given up to 7 days after the previous step-up dose. Your healthcare provider will decide the number of days to wait between your doses of TECVAYLI®.

Things to keep in mind as you start TECVAYLI®

Green bullet point Tell your doctor or healthcare provider about any medications you are currently taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements

Green bullet point Before each step-up dose and your first treatment dose of TECVAYLI®, you will receive medicines to help reduce your risk and/or lessen the severity of a serious or life-threatening side effect known as CRS

Green bullet point After your step-up doses, your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses

Green bullet point You should be hospitalized for 48 hours after administration of all doses within the TECVAYLI® step-up dosing schedule

CRS, cytokine release syndrome.

Yellow pointer iconTransitioning care

You may need to receive care at more than one treatment center as you start and continue TECVAYLI®

You should be admitted to the hospital when you start treatment with TECVAYLI®. This is where you should receive your step-up dosing schedule, so that you can be monitored for at least 48 hours after each dose to ensure you are tolerating the treatment. Once the step-up dosing schedule is complete, you will transition to receiving weekly doses of TECVAYLI®, which may be given at a different treatment facility in the outpatient setting.

Here are some tips to keep in mind during transitions in your care:

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After an initial step-up dosing schedule, you will be given TECVAYLI® weekly thereafter, possibly at a different location. Your care team can help you set up these appointments, and you may want to consider scheduling the first one before you leave the hospital. It should take place one week after your first treatment dose.

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Talk to your care team about when and where you will receive your initial step-up doses of TECVAYLI®, and where you will receive your ongoing weekly treatment doses. It is very important to have good communication with your care team. If there’s anything you’re unsure about, don’t hesitate to ask.

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To help you keep track of treatment, the Starting treatment with TECVAYLI® brochure includes a section for you to jot down each time you’re given a dose of TECVAYLI®.

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It’s also a good idea to keep track of how you’re feeling each day so that you can discuss it with your care team to help them determine whether or not you are experiencing side effects. You may also want to save important contact numbers in your phone so that you can easily get in touch with your care team if/whenever necessary.

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Remember to always carry your Patient Wallet Card so that you can be easily identified as someone receiving TECVAYLI®. You may also want to take a picture of it with your cellphone in the event that you misplace the card.

It’s important to continue with the treatment plan your doctor has prescribed during transitions of care. This can help you make the most of your TECVAYLI® treatment.

 

Once you and your doctor have decided that TECVAYLI® is right for you, Janssen has resources to help support your treatment journey.

Personalized one-on-one support

Starting and staying on track with a new medication can feel overwhelming. A Janssen Compass® Care Navigator is here to help with free personalized one-on-one support over the phone throughout your treatment journey.

You will talk to the same Care Navigator on every phone call. They will help you in 3 key areas:

  • Explore options that may help you pay for your medication
  • Learn more about your cancer and Janssen medication
  • Find resources for your practical and emotional needs while coping with cancer

Janssen Compass® is limited to education about your Janssen therapy, its administration, and/or your disease. It is intended to supplement your understanding of your therapy and is not intended to provide medical advice, replace a treatment plan from your doctor or nurse, or serve as a reason for you to start or stay on this medication.