Talvey Side Effects

Generic name: talquetamab

Medically reviewed by Drugs.com. Last updated on Nov 20, 2024.

Note: This document provides detailed information about Talvey Side Effects associated with talquetamab. Some dosage forms listed on this page may not apply specifically to the brand name Talvey.

Applies to talquetamab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Subcutaneous route (solution)

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 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 side effects

• 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 side effects

• 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 side effects

• 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 adverse events

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

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

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.

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.

Respiratory

• Very common (10% or more): Upper respiratory tract infection (22%), cough (17%), dyspnea (11%), hypoxia (10%)

Frequently asked questions

• What’s the difference between Tecvayli and Talvey?

Further information

Talvey side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer