Oncology Drug Reference Sheet: Talquetamab-Tgvs

DRUG INFORMATION
Classification	Immunotherapy; bispecific T-cell engager/bispecific antibody
Mechanism of Action	Binds to the GPRC5D receptor on multiple myeloma cells and nonmalignant plasma cells and to CD3 on T cells, which results in cytokine release and leads to lysis of multiple myeloma cells
Indication	Adults 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
ADMINISTRATION
Dosing, Frequency, and Duration	Weekly Dosing
	Day			Dose
	1			Step-up dose 1: 0.01 mg/kg
	4			Step-up dose 2: 0.06 mg/kg
	7			First treatment dose: 0.4 mg/kg
	One week after the first treatment dose and weekly thereafter (minimum of six days between doses)			0.4 mg/kg
	Every Two Weeks Dosing
	Day			Dose
	1			Step-up dose 1: 0.01 mg/kg
	4			Step-up dose 2: 0.06 mg/kg
	7			Step-up dose 3: 0.4 mg/kg
	10			First treatment dose: 0.8 mg/kg
	Two weeks after the first treatment dose and every two weeks thereafter (minimum of 12 days between doses)			0.8 mg/kg
Route	Subcutaneous injection
Safe Handling	Talquetamab-tgvs is a potentially hazardous drug per the National Institute for Occupational Safety and Health definition because of its embryo-fetal toxicity. Follow safe handling precautions.
ADVERSE REACTIONS
Decreased lymphocytes, neutrophils, white blood cells, and hemoglobin Nail disorders, skin disorders, rash, and xerosis Dry mouth, dysgeusia, dysphagia, diarrhea, and decreased weight Pyrexia, fatigue, musculoskeletal pain, hypotension, and headache Upper respiratory tract infection Cytokine release syndrome (CRS)
WARNINGS
Black box warnings: CRS and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS)
Other warnings: oral toxicity and weight loss, serious infections, cytopenias, skin toxicity, hepatotoxicity, and embryo-fetal toxicity
NURSING CONSIDERATIONS
Pretreatment	Verify patients’ pregnancy status and monitor complete blood cell counts, liver enzymes, bilirubin, and weight at baseline and regularly throughout treatment. Administer premedications (corticosteroid, antihistamine, and antipyretic) one to three hours prior to each dose in the step-up dosing schedule Talquetamab-tgvs is available only through a risk evaluation and mitigation strategy (REMS) program; provide patients with a wallet card at the start of their treatment.
Administration	The abdomen is the preferred injection site, but other subcutaneous sites may be used. Divide doses greater than 2 ml equally between multiple syringes and inject them separately at least 2 cm apart.
Post-treatment	Skin reactions include rash, maculo-papular rash, erythema, and erythematous rash; conduct regular skin assessments. Oral toxicities include dysgeusia, dry mouth, dysphagia, and stomatitis; refer patients to a dietician depending on severity. In the drug’s clinical trial, 76% of patients developed CRS; the median time to onset was 27 hours after administration, most commonly after step-up dose 1 or 2. In the clinical trial, 55% of patients developed neurologic toxicity; the median time to onset of ICANS was 2.5 days after administration.   All step-up doses require hospitalization for 48 hours after administration.
PATIENT EDUCATION
Report fever or signs of infection, neurologic symptoms (e.g., dizziness, confusion, changes in consciousness), shortness of breath, jaundice, dark urine, abdominal pain, trouble swallowing, weight loss, mouth sores, skin changes, and loss of appetite. Delayed onset of CRS or ICANS is possible; seek immediate evaluation if you develop symptoms. Avoid pregnancy and breastfeeding during treatment and for four months after your final dose. Refrain from driving and operating heavy or potentially dangerous machinery during and for 48 hours after a step-up dose schedule or until any new-onset neurologic toxicity symptoms resolve. Carry a wallet card at all times and present it to all healthcare providers.
RESOURCES
Patient Resources	U.S. Food and Drug Administration medication guide  Branded product patient-facing website
Healthcare Professional Resources	Package insert  Patient assistance  Product website  CRS Huddle Card ICANS Huddle Card Drug Development Huddle Card
Other Resources	National Cancer Institute drug information  REMS

Note. Talquetamab-tgvs (Talvey^®) and teclistamab-cqyv (Tecvayli^®) are lookalike/sound alike drugs. Both are indicated for the treatment of adult patients with relapsed or refractory multiple myeloma but are distinct drugs with different mechanisms of action, dosing, and safety profiles. Consult the package insert for full drug information.