Names and pronunciation
(tek-LIS-tuh-mab) Tecvayli
PDF page 1416
Loading InternPractice…
Drug reference
(tek-LIS-tuh-mab) Tecvayli
PDF page 1416
Func. class.: Antineoplastic
PDF page 1416
Chem. class.: Bispecific B-cell matu- ration antigen ACTIONS: It is a T-cell antibody that binds to the receptor expressed on the surface of T cells to the B-cell antigen (BCMA) expressed on the surface of multiple myeloma cells
PDF page 1416
USES: Relapsed multiple myeloma; available only through restricted pro- gram (Tecvayli REMS)
PDF page 1416
CONTRAINDICATIONS: Hypersensitivity Precautions: Anemia, contraception requirements, pregnancy, infection, neutropenia, requires a specialized care setting, requires an experienced clinician
PDF page 1416
Black Box Warning: Cytokine release syn- drome, neurotoxicity, restricted program only
PDF page 1416
SIDE EFFECTS CNS: Fever, fatigue, headache, Gillian Barre syndrome, encephalopathy, sei- zures, peripheral neuropathy CV: Hypotension/hypertension, edema MS: MS pain, bone pain GI: Nausea, increased LFTs, diarrhea, constipation, anorexia, vomiting, hepatic failure HEMA: Lymphopenia, neutropenia, hypo- albuminemia, thrombocytopenia INTEG: Injection site reaction META: Hypophosphatemia, hyponatre- mia, hypocalcemia SYST: Cytokine release syndrome, infection
PDF page 1416
INTERACTIONS Decreased CYP enzyme activity, toxicity; monitor for toxicity and adjust the dose as needed for CYP substrates, especially during the first 2 wk
PDF page 1416
DOSAGE AND ROUTES Adult: SUBCUT Step-up dosing day 1 0.06 mg/kg; day 4 0.3 mg/kg; day 7 first treatment 1.5 mg/kg; thereafter weekly 1.5 mg/kg
PDF page 1416
Available forms: Injection 30 mg/3 mL (10 mg/mL), 153 mg/1.7 mL (90 mg/ mL) single-dose vial
PDF page 1416
Administer: • Prior to each dose corticosteroid (PO/ IV dexamethasone 16 mg); histamine-1 (H1) receptor antagonist (PO/IV diphen- hydramine 50 mg or equivalent); anti- pyretics acetaminophen (650-1000 mg or equivalent) • Remove from refrigerator and let warm at room temperature for 15 min • Withdraw needed amount after swirl- ing gently • The appropriate injection volume is based on vial concentration, patient weight, and type of dose
PDF page 1416
Assess: • For injection site pain, swelling, red- ness—usually occur after 2 injections (4-5 days); use cold compress to relieve pain/swelling • Infections (fever, flulike symptoms, dyspnea, change in urination, redness/ swelling around any wounds), stop treat- ment if some serious infections occur • Blood dyscrasias: CBC, differential pe- riodically • Lab: LFTs, serum Ig concentrations will be drawn, and neurologic status will be reviewed periodically
PDF page 1416
Evaluate: • Therapeutic response: Lessened spread of multiple myeloma
PDF page 1416
CLINICAL CONSIDERATIONS
PDF page 1416
Patient and caregiver information: • Cytokine release syndrome: discuss signs/symptoms (fever, hypoxia, chills, hy- potension, sinus tachycardia, headache, elevated liver enzymes). Advise patients to immediately contact their health care pro- vider if they experience any of these signs/ symptoms • Advise patients that hospitalization will be required × 48 hr after administration of all doses within the step-up dosing schedule • Hepatotoxicity: advise patient to report dark urine, yellowing eyes, skin, fatigue, anorexia, right upper abdominal pain • Not to take any live virus vaccines dur- ing treatment • To report signs of infection, allergic reaction, immediately • To advise all health care professionals of Rx, OTC, herbals, supplements taken • Pregnancy/breastfeeding: To advise health care professional if pregnancy is planned or suspected or if breastfeeding, not to breastfeed or become pregnant during or for 5 mo after last dose, use effective contraception; that a pregnancy test may be done prior to starting treat- ment • This product is available through a re- stricted program, Tecvayli REMS, that each patient is given a Tecvayli Patient Wallet Card that they should carry with them at all times and show to all of their health care providers. This card describes signs/symptoms of CRS and neurologic toxicity, which, and if experienced, the patient should seek medical attention im- mediately
PDF pages 1416, 1417
PHARMACOKINETICS Bioavailability 72%
PDF page 1416