talquetamab

High Alert

Relapsed or refractory multiple myeloma in patients who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: edema, hypotension, tachycardia

Derm: dry skin, erythema, nail disorder, pruritus, rash

F and E: hyponatremia, hypophosphatemia

GI: ↑liver enzymes, constipation, diarrhea, dry mouth, dysphagia, hepatotoxicity, hypoalbuminemia, nausea, stomatitis

Hemat: anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia

Local: injection site reactions

Metab: ↓appetite, weight loss

MS: pain

Neuro: ageusia, dysgeusia, encephalopathy, fatigue, headache, motor dysfunction, neuropathy, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS)

Resp: cough, dyspnea, hypoxia

Misc: chills, cytokine release syndrome (CRS), fever, infection

Drug-drug:

May suppress activity of CYP450 drug-metabolizing enzymes (especially after first dose on Day 1 and up to 14 days after the first treatment dose and during/after onset of cytokine release syndrome); careful monitoring of CYP450 substrates is recommended.

Solution for SUBQ injection: 2 mg/mL; 40 mg/mL

Weekly Dosing Schedule

SUBQ (Adults ): Day 1 (step-up dose 1): 0.01 mg/kg as single dose; Day 4 (step-up dose 2): 0.06 mg/kg as single dose; Day 7 (1st treatment dose): 0.4 mg/kg as single dose; Weekly dosing schedule: 0.4 mg/kg administered 1 wk after first treatment dose and then once weekly; continue until disease progression or unacceptable toxicity.

Biweekly Dosing Schedule

SUBQ (Adults ): Day 1 (step-up dose 1): 0.01 mg/kg as single dose; Day 4 (step-up dose 2): 0.06 mg/kg as single dose; Day 7 (step-up dose 3): 0.4 mg/kg as single dose; Day 10 (1st treatment dose): 0.8 mg/kg as single dose; Biweekly dosing schedule: 0.8 mg/kg administered 2 wk after first treatment dose and then every 2 wk; continue until disease progression or unacceptable toxicity.

Talvey

Acts as a T-cell engager, binding to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D expressed on the surface of multiple myeloma cells, resulting in facilitated lysis of malignant cells.

Therapeutic effects:

Slowed progression of multiple myeloma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, T-cell engagers

Absorption: 59% absorbed following SUBQ administration.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Metabolized into small peptides by catabolic pathways. Excretion pathway unknown.

Half-Life: 8–12 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	2–3 days	unknown

Explain purpose and side effects of talquetamab. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests will be needed.
Advise patient to notify health care professional if signs and symptoms of infusion-related reactions (shortness of breath, cough, chills, nausea) occur within 24 hr of start of infusion.
Inform patient to seek treatment for signs and symptoms of neurologic toxicity (difficulty waking, confusion, anxiety, agitation, dizziness, weakness, seizures, shaking, stiffness, difficulty concentrating or speaking, hallucinations) or CRS (fever, chills, fast HR, low BP, joint aches, muscle aches, headache, dizziness, nausea, vomiting, trouble breathing).
Instruct patient to notify health care professional promptly if signs and symptoms of infection (fever, sore throat, cough, sinus pain, lower back or side pain, difficult or painful urination) occur. Caution patient to avoid crowds and persons with known infections.
Instruct patient to inspect oral mucosa for dryness, redness, and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Consult health care professional if pain interferes with eating. Stomatitis pain treatment may require opioid analgesics.
Inform the patient to report signs or symptoms of liver toxicity (tiredness, nausea, upper abdominal pain, yellowing of skin or eyes, dark urine, light-colored stools).
Advise patient to report skin rash, extreme itchiness, or weight loss.
May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness during and for 48 hr after step-up dosing and with new onset of any neurologic toxicity.
Advise patient to stay hydrated; side effects can include diarrhea, nausea, and vomiting.
Advise patient to avoid live vaccines during therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during treatment and for 3 mo after last dose. Advise patient to notify health care professional if pregnancy is suspected or planned and to avoid breastfeeding during therapy.

tal-KWE-ta-mab

NDC Code

57894- Janssen Biotech, Inc.
- 57894-469- TALVEY
  - 57894-469-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-469-01) / 1.5 mL in 1 VIAL, SINGLE-DOSE

57894- Janssen Biotech, Inc.
- 57894-470- TALVEY
  - 57894-470-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-470-01) / 1 mL in 1 VIAL, SINGLE-DOSE

63552- Patheon Manufacturing Services LLC
- 63552-199-
  - 63552-199-00- 120 VIAL, SINGLE-DOSE in 1 CASE (63552-199-00) / 1.5 mL in 1 VIAL, SINGLE-DOSE

64406- Biogen Inc.
- 64406-540-
  - 64406-540-01- 10 kg in 1 BOTTLE (64406-540-01)

65267- Janssen Pharmaceutical Sciences Unlimited Company
- 65267-901-
  - 65267-901-00- 10 L in 1 BOTTLE (65267-901-00)

65267- Janssen Pharmaceutical Sciences Unlimited Company
- 65267-901-
  65267-901-01- 1 L in 1 BOTTLE (65267-901-01)

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