What is the safety profile of TALVEY® (talquetamab-tgvs)?

Possible side effects with TALVEY® (talquetamab-tgvs) include cytokine release syndrome (CRS) and neurologic problems

TALVEY® may cause side effects that are serious, life-threatening, or lead to death, including CRS and neurologic problems.

Call your healthcare provider or get medical help right away if you develop any of the symptoms listed below at any time during your treatment with TALVEY®.

Cytokine release syndrome (CRS) is a condition that may occur after treatment with some types of immunotherapy, like TALVEY®. CRS is caused by a large, rapid release of cytokines into the blood from immune cells affected by the immunotherapy. Cytokines are immune substances that have different actions in your body. CRS is common during treatment with TALVEY® and can also be serious or life threatening. To learn more about CRS, please see the Important Safety Information. Signs and symptoms may include:

  • fever (100.4°F or higher)
  • dizziness or lightheadedness
  • chills
  • difficulty breathing
  • feeling anxious
  • headache
  • fast heartbeat

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

  • headache
  • feeling confused
  • being less alert or aware
  • feeling disoriented
  • trouble speaking or writing
  • shaking (tremors)
  • numbness and tingling (feeling like “pins and needles”)
  • problems with walking, or loss of balance or coordination
  • feeling sleepy
  • feeling very sleepy with low energy
  • slow or difficulty thinking
  • seizures
  • muscle weakness
  • memory loss
  • burning, throbbing, or stabbing pain
  • fast eye movements that you cannot control
  • In order to reduce the risk of CRS, you will receive a step-up dosing schedule. The step-up dosing schedule is when you receive the first doses of TALVEY®, starting at a smaller dose and slowly increasing up to the full dose
  • You should be hospitalized for 48 hours after all doses that are part of the step-up dosing schedule due to the risk of CRS and neurologic problems

Patient Wallet Card

Carry this card with you at all times and show it to any healthcare provider involved in your care. This card includes important information about your TALVEY® treatment and the signs and symptoms of cytokine release syndrome and neurologic problems.

Download the cardView resources for TALVEY® patients

Select side effects seen with TALVEY®

It is important to talk to your doctor about how you are feeling throughout your treatment

The safety of TALVEY® was assessed in 339 adults during the primary analysis of MonumenTAL-1. People experienced a variety of side effects at different times in their therapy. In some cases, side effects lasted throughout their treatment. Your experience with side effects may be different from what is shown here.

Side effectExperienced byMedian* time to onsetResolved within

Oral and taste side effects may include changes in sense of taste, dry mouth, trouble swallowing, or mouth sores.

80%

of people

15 days

Some experienced onset as soon as 1 day, and some as late as 634 days.

a median* of

43 days

Some experienced resolution as soon as 1 day, and some as late as 530 days.

65% of people had oral side effects that did not resolve to the baseline.

Weight loss

62%

of people

67 days

for Grade 2 or higher

Some experienced onset as soon as 6 days, and some as late as 407 days.

Resolved for

43%

of people

who reported weight loss in a median* of 50 days.†

Some experienced resolution as soon as 1 day, and some as late as 403 days.

Skin side effects may include skin rash, raised red bumps, redness of the skin, or very dry skin that may affect the mucous membranes (such as the mouth and eyes).

62%

of people

25 days

Some experienced onset as soon as 1 day, and some as late as 630 days.

Improved for

50%

of people

in a median* of 33 days

Nail side effects are common during treatment with TALVEY® and may include changes in nail shape or color, nail bed damage, or loss of nails.

For tips on living with nail changes, see the Patient Guide.

Side effect

Oral and taste side effects may include changes in sense of taste, dry mouth, trouble swallowing, or mouth sores.

Experienced by

80% of people

Median* time to onset

15 days

Some experienced onset as soon as 6 days, and some as late as 407 days.

Resolved within

a median* of

43 days

Some experienced resolution as soon as 1 day, and some as late as 530 days.

65% of people had oral side effects that did not resolve to the baseline.

Side effect

Weight loss

Experienced by

62% of people

Median* time to onset

67 days

for Grade 2 or higher

Some experienced onset as soon as 6 days, and some as late as 407 days.

Resolved for

43% of people

who reported weight loss in a median* of 50 days.†

Some experienced resolution as soon as 1 day, and some as late as 403 days.

Side effect

Skin side effects may include skin rash, raised red bumps, redness of the skin, or very dry skin that may affect the mucous membranes (such as the mouth and eyes).

Experienced by

62% of people

Median* time to onset

25 days

Some experienced onset as soon as 1 day, and some as late as 630 days.

Improved for

50% of people

in a median* of 33 days

Side effect

Nail side effects are common during treatment with TALVEY® and may include changes in nail shape or color, nail bed damage, or loss of nails.

For tips on living with nail changes, see the Patient Guide.

How can I manage possible side effects?

Explore ways to manage some of these side effects.

Learn more

You are now viewing data from the longer-term analysis

The following information is from a longer-term analysis of the clinical trial for TALVEY® where data continued to be collected for up to 3 years. These data were collected after the primary analysis and include 375 adults treated with TALVEY®. This information is not included in the current full Prescribing Information.

Of the 375 people in the longer-term analysis, less than 10% of people discontinued treatment due to side effects. A select set of these side effects is provided below.‡

Select the ? for more details on the side effect.

Side effectOccurred inLed to discontinuation of TALVEY® in
Weight decrease?
40.5% of people1.1% of people
Altered sense of taste?
72.8% of people0.8% of people
Rash?
39.5% of people0.5% of people
Skin disorders?
43.7% of people0.5% of people
Dry skin?
35.5% of people0.3% of people
Dry mouth35.2% of people0% of people
Difficulty swallowing23.7% of people
Nail disorder?
57.3% of people
Itching of the skin24.3% of people

Below are key reminders of the limitations of the data you just reviewed:

The safety data from this longer-term analysis are not included in the current full Prescribing Information. These data were collected after the conclusion of the primary analysis of MonumenTAL-1 and included additional patients that were enrolled during the longer-term follow-up.

Data were collected from the newly enrolled people and additional data continued to be collected for the original primary analysis participants. No conclusions should be drawn from these data.

These are not all the possible side effects of TALVEY®. Call your healthcare team for medical advice if you are experiencing any side effects.

Other possible side effects with TALVEY®

Talk to your healthcare provider right away if you develop any signs or symptoms of these side effects.

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:

  • Fever of 100.4°F (38°C) or higher
  • Chills
  • Cough
  • Chest pain
  • Tiredness
  • Shortness of breath
  • Painful rash
  • Sore throat
  • Pain during urination
  • Feeling weak or generally unwell

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.

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:

  • Tiredness
  • Loss of appetite
  • Pain in your right upper stomach-area (abdomen)
  • Dark urine
  • Yellowing of your skin or the white part of your eyes

Problems with pregnancy

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®. Your healthcare provider should do a pregnancy test before you start treatment with TALVEY®. Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after their last dose of TALVEY®.

Most common side effects with TALVEY®

  • Fever
  • Changes in your sense of taste
  • Nail problems
  • Muscle or joint pain
  • Rash
  • Feeling very tired
  • Weight loss
  • Dry mouth
  • Very dry skin that may affect the mucous membranes (such as the mouth and eyes)
  • Difficulty swallowing
  • Infected nose, sinuses, or throat (cold)
  • Diarrhea
  • Low blood pressure
  • Headache

*The median is the time at which half the people had their side effects improve or resolve.

†Weight loss did not resolve in 57% of patients who had reported it.

‡Median follow-up for MonumenTAL-1 cohorts: TCR-naïve Q2W was >30 months; TCR-exposed was >28 months; TCR-naïve QW was >37 months.

HCP, healthcare provider; QW, once weekly; Q2W, every 2 weeks; REMS, Risk Evaluation and Mitigation Strategy; TCR, T-cell redirection.