Body

Summary of resources to help you pay for TECVAYLI® [PDF]

Change your coverage
 

The following program is affiliated with Janssen.

Janssen CarePath Savings Program for TECVAYLI®

If you are eligible, you may be able to lower your out-of-pocket medication costs for TECVAYLI®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. With the Janssen CarePath Savings Program for TECVAYLI®, eligible patients pay $5 for each dose for your medication costs, with a $26,000 maximum program benefit each calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give you your injections.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 877-CarePath (877-227-3728).

See program requirements

To enroll in the Janssen CarePath Savings Program

Visit MyJanssenCarePath.com to create an online account, check your eligibility, enroll in the Savings Program, manage your Savings Program benefits, and receive timely alerts and program updates.

Express Enrollment

If you only want to check your eligibility and enroll in the Janssen CarePath Savings Program, use Express Enrollment at MyJanssenCarePath.com/express. There is a "Print a Card" feature to provide you with a Savings Program card. You will not have a Janssen CarePath account and will not be able to view and manage your Savings Program benefits.

Or call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

The following program is affiliated with Janssen.

Janssen CarePath Savings Program for TECVAYLI®

If you are eligible, you may be able to lower your out-of-pocket medication costs for TECVAYLI®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. With the Janssen CarePath Savings Program for TECVAYLI®, eligible patients pay $5 for each dose for your medication costs, with a $26,000 maximum program benefit each calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give you your injections.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 877-CarePath (877-227-3728).

See program requirements

To enroll in the Janssen CarePath Savings Program

Visit MyJanssenCarePath.com to create an online account, check your eligibility, enroll in the Savings Program, manage your Savings Program benefits, and receive timely alerts and program updates.

Express Enrollment

If you only want to check your eligibility and enroll in the Janssen CarePath Savings Program, use Express Enrollment at MyJanssenCarePath.com/express. There is a "Print a Card" feature to provide you with a Savings Program card. You will not have a Janssen CarePath account and will not be able to view and manage your Savings Program benefits.

Or call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Back

IMPORTANT SAFETY INFORMATION
  • Minimize
  • Expand
  • Full Screen
  • Return to Website

What is TECVAYLI™ (teclistamab-cqyv)?

TECVAYLI™ is a prescription medicine to treat adults with multiple myeloma who:

  • have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and
  • their cancer has come back or did not respond to prior treatment

TECVAYLI™ is approved based on patient response. Data are not yet available to show if TECVAYLI™ improves survival or symptoms.

It is not known if TECVAYLI™ is safe and effective in children.

IMPORTANT SAFETY INFORMATION

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

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 (100.4°F or higher)
  • difficulty breathing
  • chills
  • dizziness or lightheadedness
  • fast heartbeat
  • feeling anxious
  • confusion or restlessness
  • headache
  • increased liver enzymes in your blood

Neurologic problems. Symptoms of neurologic problems with TECVAYLI™ include:

  • headache
  • jerking movements
  • rigid muscles
  • feeling restless
  • numbness and tingling (feeling like “pins and needles”)
  • confusion
  • trouble speaking
  • muscle spasms
  • tremor
  • double vision
  • changes in your handwriting
  • problems walking
  • muscle weakness in your body or face
  • hearing loss
  • 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™.
    • “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.
    • Your healthcare provider will decide when you will receive “step-up dose 2” and your first “treatment dose”.
      • “Step-up” dose 2 may be given between 2 to 4 days after “step-up” dose 1, or up to 7 days after “step-up” dose 1 if you have certain side effects with TECVAYLI™.
      • Your first “treatment dose” may be given between 2 to 4 days after “step-up” dose 2, or up to 7 days after “step-up” dose 2 if you have certain side effects with TECVAYLI™.
    • Your healthcare provider will decide the number of days to wait between your doses of TECVAYLI™ as well as how many treatments you will receive.
    • If your dose of TECVAYLI™ is delayed for any reason, you may need to repeat the “step-up dosing schedule” to receive TECVAYLI™.
    • Before each “step-up” dose and your first “treatment dose” of TECVAYLI™ 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 during treatment with TECVAYLI™, as well as other side effects and treat you as needed.
  • 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 until the symptoms go away.

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

You will receive a TECVAYLI™ Patient Wallet Card from your healthcare provider. Carry the TECVAYLI™ Patient Wallet Card with you at all times and show it to all of your healthcare providers. The TECVAYLI™ 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 TECVAYLI™ Patient Wallet Card. You may need to be treated in a hospital.

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

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 about TECVAYLI™” 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 are the possible side effects of TECVAYLI™?

TECVAYLI™ may 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 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:
  • tiredness
  • loss of appetite
  • pain in your right upper stomach area (abdomen)
  • dark urine
  • yellowing of your skin or white part of your eyes
  • 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.
    • Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with TECVAYLI™.
    • Your 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™.
    • 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. 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.
  • Allergic reactions and injection site reactions. TECVAYLI™ can cause allergic reactions that can affect your whole body (systemic), and also cause injection site reactions.
    • Some people taking TECVAYLI™ can develop symptoms of an allergic reaction that can affect your 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™.
    • Injection 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
  • pain in your joints and muscles, back and chest muscles, and in your arms and legs
  • tiredness and weakness
  • upper respiratory tract infections and pneumonia. See “Infections” above.
  • nausea
  • headache
  • diarrhea

The most common severe abnormal lab 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-324738v2