Talvey Side Effects

Generic name: talquetamab

Medically reviewed by Drugs.com. Last updated on Oct 16, 2023.

Note: This document contains side effect information about talquetamab. Some dosage forms listed on this page may not apply to the brand name Talvey.

Applies to talquetamab: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Warning: Cytokine Release Syndrome and Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity SyndromeCytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving talquetamab-tgvs. Initiate talquetamab-tgvs treatment with step-up dosing to reduce the risk of CRS. Withhold talquetamab-tgvs 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 talquetamab-tgvs. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue talquetamab-tgvs based on severity.Because of the risk of CRS and neurologic toxicity, including ICANS, talquetamab-tgvs is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).

Serious side effects of Talvey

Along with its needed effects, talquetamab (the active ingredient contained in Talvey) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking talquetamab:

More common

Agitation
back pain
being forgetful
blurred vision
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain
chills
coma
confusion
confusion as to time, place, or person
cough or hoarseness
diarrhea
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
ear congestion
fainting
fast, pounding, or irregular heartbeat or pulse
fever or chills
hallucinations
headache
holding false beliefs that cannot be changed by fact
increased sensitivity to pain
increased sensitivity to touch
irritability
itching of the vagina or genitals
lightheadedness
loss of memory
loss of smell
loss of voice
lower back or side pain
mood or mental changes
muscle or bone pain
muscle spasms
nausea
nerve pain
painful or difficulty urination
problems with memory
rapid or irregular heartbeat
rash with flat lesions or small raised lesions on the skin
seizures
shakiness in the legs, arms, hands, or feet
sneezing
sore throat
stiff muscles
stiff neck
stuffy or runny nose
sweating
swelling
thick, white vaginal discharge with mild or no odor
tingling in the hands and feet
trembling and shaking of the hands or feet
trouble breathing
unsteadiness or awkwardness
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
vomiting
weakness in arms, hands, legs, or feet
weight loss
white patches in the mouth or throat or on the tongue
white patches with diaper rash

Less common

Black, tarry stools
pale skin
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising

Incidence not known

Bleeding gums
burning, throbbing, or stabbing pain
dark urine
double vision
hearing loss
jerking movements
pinpoint red spots on the skin
rigid muscles
stomach pain, severe
trouble speaking
yellow eyes or skin

Other side effects of Talvey

Some side effects of talquetamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change or loss of taste
constipation
decreased appetite
difficulty swallowing
dry mouth
loss of sense of taste
reduced or lessening or loss of sense of taste
swelling or inflammation of the mouth

For Healthcare Professionals

Applies to talquetamab: subcutaneous solution.

General

The most common adverse reactions occurring in 20% of patients or greater included 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 occurring in 30% of patients or greater included lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased.

Serious adverse events occurred in 47% of patients and fatal adverse events occurred in 3.2% of patients who received this drug in clinical trials.^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (21%), tachycardia (11%)

Dermatologic

-Nail disorder included: Koilonychia, nail bed disorder, nail cuticle fissure, nail discoloration, nail disorder, nail dystrophy, nail hypertrophy, nail pitting, nail ridging, nail toxicity, onychoclasis, onycholysis and onychomadesis

-Skin disorders included: Palmar-plantar erythrodysesthesia syndrome, palmoplantar keratoderma, skin discoloration, skin exfoliation and skin fissures.

-Rash included: Dermatitis, dermatitis acneiform, dermatitis contact, dermatitis exfoliative, dermatitis exfoliative generalized, erythema, exfoliative rash, rash, rash erythematous, rash macular, rash maculo papular, rash papular, rash pruritic, rash pustular, rash vesicular and stasis dermatitis.

-Xerosis included: Dry eye, dry skin and xerosis.

Very common (10% or more): Nail disorder (50%), skin disorder (41%), rash (38%), xerosis (30%), pruritus (19%)

Gastrointestinal

Very common (10% or more): Oral toxicity (up to 80%), dysgeusia (70%), dry mouth (34%), dysphagia (23%), diarrhea (21%), stomatitis (18%), nausea (18%), constipation (16%), oral disorder (12%)

-Dysgeusia included: Ageusia, dysgeusia, hypogeusia and taste disorder

-Stomatitis included: Cheilitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, tongue discomfort, tongue erythema, tongue edema and tongue ulceration

-Oral disorder included: Oral disorder, oral dysesthesia, oral mucosal exfoliation, oral toxicity and oropharyngeal pain

Hepatic

Very common (10% or more): Alanine aminotransferase increased (33%), aspartate aminotransferase increased (31%)

Hematologic

Very common (10% or more): Lymphocyte count decreased (90%), white blood cell decreased (73%), hemoglobin decreased (67%), neutrophil count decreased (64%), platelet count decreased (62%), albumin decreased (66%)

Immunologic

Very common (10% or more): Cytokine release syndrome (76%), anti-drug antibodies (up to 25%)

Local

Very common (10% or more): Injection site reaction (13%)

Metabolic

Very common (10% or more): Weight decreased (up to 62%), phosphatase decreased (49%), alkaline phosphate decreased (44%), gamma-glutamyl transferase increased (38%), potassium decreased (31%), sodium decreased (31%), appetite decreased (19%)

Musculoskeletal

Very common (10% or more): Musculoskeletal pain which included dysarthria, dysgraphia, dysmetria, dysphonia, gait disturbance, muscle atrophy, muscle spasms, muscular weakness and tremor (43%)

Nervous system

Very common (10% or more): Neurologic toxicity (55%), headache (21%), encephalopathy (15%), sensory neuropathy (14%), motor dysfunction (10%)

Common (1% to 10%): Immune effector cell-associated neurotoxicity syndrome

-Encephalopathy included: Agitation, altered state of consciousness, amnesia, aphasia, bradyphrenia, confusional state, delirium, depressed level of consciousness, disorientation, encephalopathy, hallucination, lethargy, memory impairment, mood altered, restlessness, sleep disorder and somnolence.

-Sensory neuropathy included: Dysesthesia, hyperesthesia, hypoesthesia, hypoesthesia oral, immune-mediated neuropathy, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy, sciatica and vestibular neuronitis

Other

Very common (10% or more): Pyrexia (83%), fatigue (37%), chills (19%), pain (18%), edema (14%), bacterial infection including sepsis (19%), COVID-19 (11%), fungal infection (10%)

Common (less than 10%): Viral infection

-Bacterial infection including sepsis also included: Bacteremia, bacterial prostatitis, carbuncle, cellulitis, citrobacter infection, clostridium difficile colitis, clostridium difficile infection, cystitis escherichia, cystitis klebsiella, diverticulitis, enterobacter bacteremia, Escherichia pyelonephritis, escherichia sepsis, folliculitis, gastroenteritis escherichia coli, helicobacter gastritis, human ehrlichiosis, klebsiella bacteremia, klebsiella sepsis, moraxella infection, otitis media acute, pitted keratolysis, pneumococcal sepsis, pneumonia, pneumonia streptococcal, pseudomonal bacteremia, pyuria, renal abscess, salmonella sepsis, sepsis, septic shock, skin infection, staphylococcal bacteremia, staphylococcal infection, staphylococcal sepsis, streptococcal bacteremia, tooth abscess, tooth infection, urinary tract infection enterococcal, and urinary tract infection pseudomonal.

-Fungal infection included: Body tinea, candida infection, ear infection fungal, esophageal candidiasis, fungal infection, fungal sepsis, fungal skin infection, genital candidiasis, onychomycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, tinea pedis, vulvovaginal candidiasis, and vulvovaginal mycotic infection.