• TALVEY™ (talquetamab-tgvs)

    INDICATION AND USAGE

    TALVEY™ (talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

    This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    IMPORTANT SAFETY INFORMATION

    WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

    Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY™. Initiate TALVEY™ treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY™ until CRS resolves or permanently discontinue based on severity.

    Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur with TALVEY™. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment. Withhold or discontinue TALVEY™ based on severity.

    Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY™ is available only through a restricted program called the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS).

    CONTRAINDICATIONS: None.

    WARNINGS AND PRECAUTIONS

    Cytokine Release Syndrome (CRS): TALVEY™ can cause cytokine release syndrome, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 76% of patients who received TALVEY™ at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. Recurrent CRS occurred in 30% of patients. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule (N=153). CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose. The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward. The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

    Initiate therapy with step-up dosing and administer pre-treatment medications (corticosteroids, antihistamine, and antipyretics) prior to each dose of TALVEY™ in the step-up dosing schedule to reduce the risk of CRS. Monitor patients following administration accordingly. In patients who experience CRS, pre-treatment medications should be administered prior to the next TALVEY™ dose.

    Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care based on severity, and consider further management per current practice guidelines. Withhold TALVEY™ until CRS resolves or permanently discontinue based on severity.

    Neurologic Toxicity including ICANS: TALVEY™ can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal reactions. In the clinical trial, neurologic toxicity occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients. The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%).

    ICANS was reported in 9% of 265 patients where ICANS was collected and who received the recommended dosages. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly dosing schedule (3.7%) (N=109). The median time to onset of ICANS was 2.5 (range: 1 to 16) days after the most recent dose with a median duration of 2 (range: 1 to 22) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

    Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity; withhold or permanently discontinue TALVEY™ based on severity and consider further management per current practice guidelines. [see Dosage and Administration (2.5)].

    Due to the potential for neurologic toxicity, patients receiving TALVEY™ are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve.

    TECVAYLI® and TALVEY™ REMS: TALVEY™ is available only through a restricted program under a REMS, called the TECVAYLI® and TALVEY™ REMS because of the risks of CRS and neurologic toxicity, including ICANS.

    Further information about the TECVAYLI® and TALVEY™ REMS program is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064.

    Oral Toxicity and Weight Loss: TALVEY™ can cause oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis. In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the recommended dosages. The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%). The median time to onset of oral toxicity was 15 (range: 1 to 634) days, and the median time to resolution to baseline was 43 (1 to 530) days. Oral toxicity did not resolve to baseline in 65% of patients.

    TALVEY™ can cause weight loss. In the clinical trial, 62% of patients experienced weight loss of 5% or greater, regardless of having an oral toxicity, including 28% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. The median time to onset of Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and the median time to resolution was 50 (range: 1 to 403) days. Weight loss did not resolve in 57% of patients who reported weight loss.

    Monitor patients for signs and symptoms of oral toxicity. Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur and provide supportive care as per current clinical practice, including consultation with a nutritionist. Monitor weight regularly during therapy. Evaluate clinically significant weight loss further. Withhold TALVEY™ or permanently discontinue based on severity.

    Infections: TALVEY™ can cause infections, including life-threatening or fatal infections. Serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%), which included sepsis and COVID-19 (2.7%).

    Monitor patients for signs and symptoms of infection prior to and during treatment with TALVEY™ and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Withhold or permanently discontinue TALVEY™ as recommended, based on severity.

    Cytopenias: TALVEY™ can cause cytopenias, including neutropenia and thrombocytopenia. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received TALVEY™. The median time to onset for Grade 3 or 4 neutropenia was 22 (range: 1 to 312) days, and the median time to resolution to Grade 2 or lower was 8 (range: 1 to 79) days. The median time to onset for Grade 3 or 4 thrombocytopenia was 12 (range: 2 to 183) days, and the median time to resolution to Grade 2 or lower was 10 (range: 1 to 64) days. Monitor complete blood counts during treatment and withhold TALVEY™ as recommended, based on severity.

    Skin Toxicity: TALVEY™ can cause serious skin reactions, including rash, maculo-papular rash, erythema, and erythematous rash. In the clinical trial, skin reactions occurred in 62% of patients, with grade 3 skin reactions in 0.3%. The median time to onset was 25 (range: 1 to 630) days. The median time to improvement to grade 1 or less was 33 days.

    Monitor for skin toxicity, including rash progression. Consider early intervention and treatment to manage skin toxicity. In the clinical trial, supportive care included topical steroids (15%). Oral steroid tapers (4.4%) were typically administered for Grade 3 skin reactions. Withhold or permanently discontinue TALVEY™, based on severity.

    Hepatotoxicity: TALVEY™ can cause hepatotoxicity. Elevated ALT occurred in 33% of patients, with grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred in 31% of patients, with grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients. Liver enzyme elevation can occur with or without concurrent CRS.

    Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TALVEY™ or consider permanent discontinuation of TALVEY™, based on severity [see Dosage and Administration (2.5)].

    Embryo-Fetal Toxicity: Based on its mechanism of action, TALVEY™ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TALVEY™ and for 3 months after the last dose.

    Adverse Reactions: The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache.

    The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased.

    Please read full Prescribing Information, including Boxed WARNING, for TALVEY™.

    cp-394174v2

    INDICATION
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf

Helping Patients Afford TALVEY™

Downloadable Forms
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JCP
Hover on a document on the left for a quick document preview
 
 
 

Helping Patients Afford TALVEY™

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking TALVEY™. Download a summary of affordability options or see a full list of options below.

Select your patient’s coverage status for relevant resources. 

For Patients with Commercial or Private Insurance

Janssen CarePath Savings Program for TALVEY™
Eligible patients pay as little as
$5
per dose
Your eligible patients with commercial or private insurance pay as little as $5 per dose for their TALVEY™ medication

There is a limit to savings each year. Savings may apply to co-pay, co-insurance, or deductible. Program does not cover the cost to give patients their treatment.

Patients may participate without sharing their income information.

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 your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).

Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Savings Program Savings Program Only
Provider Portal Provider Portal
Sign Patients Up for the Savings Program and Get a Savings Card
 
 
View Savings Program Transactions
 
 
Requires Business Associate Agreement/Patient Authorizations
 
 
Get Benefits Investigations
 
 
Get Prior Authorization Support
 
 
Create Medical Necessity and Exception Letters
 
 
Request Exceptions and Appeals Information
 
 
View Patient Dashboard
 
 
Get Timely Notifications
 
 
24-hour Online Access to Your Account
 
 
Get Started with the Option That Works Best for You and Your Patients
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Savings Program
  • Sign Patients Up for the Savings Program and Get a Savings Card

Sign Up for the Savings Program Only

Provider Portal
  • Sign Patients Up for the Savings Program and Get a Savings Card
  • View Savings Program Transactions
  • Requires Business Associate Agreement/Patient Authorizations
  • Get Benefits Investigations
  • Get Prior Authorization Support
  • Create Medical Necessity and Exception Letters
  • Request Exceptions and Appeals Information
  • View Patient Dashboard
  • Get Timely Notifications
  • 24-hour Online Access to Your Account

Create a Provider Portal Account

In addition to the Janssen CarePath Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Independent Co-Pay Assistance Foundations
Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help your patients.

Additional Affordability Support from Janssen

Patient assistance is available if your patient has commercial, employer-sponsored, or government coverage that does not fully meet their needs. Your patient may be eligible to receive their Janssen medication free of charge for up to one year if they meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfo.com or call 833-742-0791.

For Patients with Government Coverage

Even if your patients have government coverage like Medicare, we can identify programs that may help them afford their medications. Here are some independent programs that may be right for them.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Independent Co-Pay Assistance Foundations
Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help your patients.

Additional Affordability Support from Janssen

Patient assistance is available if your patient has commercial, employer-sponsored, or government coverage that does not fully meet their needs. Your patient may be eligible to receive their Janssen medication free of charge for up to one year if they meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfo.com or call 833-742-0791.

For Patients with No Insurance Coverage

If your patients need help with drug costs, we can identify programs that may help them afford their medications.

Here are some programs that are not offered by Janssen. Each program has its own eligibility rules.

Take a look and see which ones may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help your patients.

Uninsured Patients May Be Eligible for Additional Support

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. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Janssen CarePath Savings Program for TALVEY™
Eligible patients pay as little as
$5
per dose
Your eligible patients with commercial or private insurance pay as little as $5 per dose for their TALVEY™ medication

There is a limit to savings each year. Savings may apply to co-pay, co-insurance, or deductible. Program does not cover the cost to give patients their treatment.

Patients may participate without sharing their income information.

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 your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).

Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Savings Program Savings Program Only
Provider Portal Provider Portal
Sign Patients Up for the Savings Program and Get a Savings Card
 
 
View Savings Program Transactions
 
 
Requires Business Associate Agreement/Patient Authorizations
 
 
Get Benefits Investigations
 
 
Get Prior Authorization Support
 
 
Create Medical Necessity and Exception Letters
 
 
Request Exceptions and Appeals Information
 
 
View Patient Dashboard
 
 
Get Timely Notifications
 
 
24-hour Online Access to Your Account
 
 
Get Started with the Option That Works Best for You and Your Patients
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Savings Program
  • Sign Patients Up for the Savings Program and Get a Savings Card

Sign Up for the Savings Program Only

Provider Portal
  • Sign Patients Up for the Savings Program and Get a Savings Card
  • View Savings Program Transactions
  • Requires Business Associate Agreement/Patient Authorizations
  • Get Benefits Investigations
  • Get Prior Authorization Support
  • Create Medical Necessity and Exception Letters
  • Request Exceptions and Appeals Information
  • View Patient Dashboard
  • Get Timely Notifications
  • 24-hour Online Access to Your Account

Create a Provider Portal Account

In addition to the Janssen CarePath Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help your patients.

Additional Affordability Support from Janssen

Patient assistance is available if your patient has commercial, employer-sponsored, or government coverage that does not fully meet their needs. Your patient may be eligible to receive their Janssen medication free of charge for up to one year if they meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfo.com or call 833-742-0791.

Uninsured Patients May Be Eligible for Additional Support

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. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Important Safety Information For

  • TALVEY™

    INDICATION AND USAGE

    TALVEY™ (talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

    This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    IMPORTANT SAFETY INFORMATION

    WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

    Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY™. Initiate TALVEY™ treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY™ until CRS resolves or permanently discontinue based on severity.

    Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur with TALVEY™. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment. Withhold or discontinue TALVEY™ based on severity.

    Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY™ is available only through a restricted program called the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS).

    CONTRAINDICATIONS: None.

    WARNINGS AND PRECAUTIONS

    Cytokine Release Syndrome (CRS): TALVEY™ can cause cytokine release syndrome, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 76% of patients who received TALVEY™ at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. Recurrent CRS occurred in 30% of patients. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule (N=153). CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose. The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward. The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

    Initiate therapy with step-up dosing and administer pre-treatment medications (corticosteroids, antihistamine, and antipyretics) prior to each dose of TALVEY™ in the step-up dosing schedule to reduce the risk of CRS. Monitor patients following administration accordingly. In patients who experience CRS, pre-treatment medications should be administered prior to the next TALVEY™ dose.

    Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care based on severity, and consider further management per current practice guidelines. Withhold TALVEY™ until CRS resolves or permanently discontinue based on severity.

    Neurologic Toxicity including ICANS: TALVEY™ can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal reactions. In the clinical trial, neurologic toxicity occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients. The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%).

    ICANS was reported in 9% of 265 patients where ICANS was collected and who received the recommended dosages. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly dosing schedule (3.7%) (N=109). The median time to onset of ICANS was 2.5 (range: 1 to 16) days after the most recent dose with a median duration of 2 (range: 1 to 22) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

    Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity; withhold or permanently discontinue TALVEY™ based on severity and consider further management per current practice guidelines. [see Dosage and Administration (2.5)].

    Due to the potential for neurologic toxicity, patients receiving TALVEY™ are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve.

    TECVAYLI® and TALVEY™ REMS: TALVEY™ is available only through a restricted program under a REMS, called the TECVAYLI® and TALVEY™ REMS because of the risks of CRS and neurologic toxicity, including ICANS.

    Further information about the TECVAYLI® and TALVEY™ REMS program is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064.

    Oral Toxicity and Weight Loss: TALVEY™ can cause oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis. In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the recommended dosages. The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%). The median time to onset of oral toxicity was 15 (range: 1 to 634) days, and the median time to resolution to baseline was 43 (1 to 530) days. Oral toxicity did not resolve to baseline in 65% of patients.

    TALVEY™ can cause weight loss. In the clinical trial, 62% of patients experienced weight loss of 5% or greater, regardless of having an oral toxicity, including 28% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. The median time to onset of Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and the median time to resolution was 50 (range: 1 to 403) days. Weight loss did not resolve in 57% of patients who reported weight loss.

    Monitor patients for signs and symptoms of oral toxicity. Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur and provide supportive care as per current clinical practice, including consultation with a nutritionist. Monitor weight regularly during therapy. Evaluate clinically significant weight loss further. Withhold TALVEY™ or permanently discontinue based on severity.

    Infections: TALVEY™ can cause infections, including life-threatening or fatal infections. Serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%), which included sepsis and COVID-19 (2.7%).

    Monitor patients for signs and symptoms of infection prior to and during treatment with TALVEY™ and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Withhold or permanently discontinue TALVEY™ as recommended, based on severity.

    Cytopenias: TALVEY™ can cause cytopenias, including neutropenia and thrombocytopenia. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received TALVEY™. The median time to onset for Grade 3 or 4 neutropenia was 22 (range: 1 to 312) days, and the median time to resolution to Grade 2 or lower was 8 (range: 1 to 79) days. The median time to onset for Grade 3 or 4 thrombocytopenia was 12 (range: 2 to 183) days, and the median time to resolution to Grade 2 or lower was 10 (range: 1 to 64) days. Monitor complete blood counts during treatment and withhold TALVEY™ as recommended, based on severity.

    Skin Toxicity: TALVEY™ can cause serious skin reactions, including rash, maculo-papular rash, erythema, and erythematous rash. In the clinical trial, skin reactions occurred in 62% of patients, with grade 3 skin reactions in 0.3%. The median time to onset was 25 (range: 1 to 630) days. The median time to improvement to grade 1 or less was 33 days.

    Monitor for skin toxicity, including rash progression. Consider early intervention and treatment to manage skin toxicity. In the clinical trial, supportive care included topical steroids (15%). Oral steroid tapers (4.4%) were typically administered for Grade 3 skin reactions. Withhold or permanently discontinue TALVEY™, based on severity.

    Hepatotoxicity: TALVEY™ can cause hepatotoxicity. Elevated ALT occurred in 33% of patients, with grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred in 31% of patients, with grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients. Liver enzyme elevation can occur with or without concurrent CRS.

    Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TALVEY™ or consider permanent discontinuation of TALVEY™, based on severity [see Dosage and Administration (2.5)].

    Embryo-Fetal Toxicity: Based on its mechanism of action, TALVEY™ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TALVEY™ and for 3 months after the last dose.

    Adverse Reactions: The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache.

    The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased.

    Please read full Prescribing Information, including Boxed WARNING, for TALVEY™.

    cp-394174v2

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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IMPORTANT SAFETY INFORMATION