Talquetamab Dosage

Medically reviewed by Drugs.com. Last updated on Mar 12, 2024.

Usual Adult Dose for Multiple Myeloma

WEEKLY DOSING SCHEDULE:
Step-Up Dose 1: Administer 0.01 mg/kg subcutaneously on Day 1.
Step-Up Dose 2: Administer 0.06 mg/kg subcutaneously on Day 4.
First Treatment Dose: Administer 0.4 mg/kg subcutaneously on Day 7, and then weekly thereafter.

• Step-Up Dose 2 and the First Treatment Dose may be given between 2 to 4 days or up to 7 days after the previous dose to allow for adverse reaction resolution.
• Maintain a minimum of 6 days between weekly doses.

BI-WEEKLY (EVERY 2 WEEKS) DOSING SCHEDULE
Step-Up Dose 1: Administer 0.01 mg/kg subcutaneously on Day 1.
Step-Up Dose 2: Administer 0.06 mg/kg subcutaneously on Day 4.
Step-Up Dose 3: Administer 0.4 mg/kg subcutaneously on Day 7.
First Treatment Dose: Administer 0.8 mg/kg subcutaneously on Day 10, and then every 2 weeks thereafter.

• Step-Up Dose 2 and 3 may be given between 2 to 4 days or up to 7 days after the previous dose to allow for adverse reaction resolution.
• First Treatment Dose may be given between 2 to 7 days after Step-Up Dose 3.
• Maintain a minimum of 12 days between bi-weekly doses.

RECOMMENDED PRETREATMENT MEDICATIONS DURING STEP-UP DOSING:
Administer the Following Medications 1 to 3 Hours Before Each Step-Up Dose:

• Corticosteroid: Dexamethasone 16 mg (or corticosteroid dose equivalent) given orally or intravenously
• Antihistamine: Diphenhydramine 50 mg (or equivalent) given orally or intravenously
• Antipyretic: Acetaminophen 650 mg to 1000 mg (or equivalent) given orally or intravenously

Comments:

• Dosing of this drug is based on actual body weight.
• Administer therapy in a step-up dosing schedule based on weekly or bi-weekly administration.
• Patients should be hospitalized for 48 hours after all doses within the step-up dosing schedule.
• Pretreatment medications may be required for patients who repeat doses within the step-up dosing schedule due to dose delays or for patients who experienced cytokine release syndrome (CRS).
• Dose delays and modifications may be required to manage toxicities related to this drug.
• Treatment duration: Until disease progression or unacceptable toxicity.

Use: For the treatment of adult patients 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.

• This indication is approved under accelerated approval based rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Renal Dose Adjustments

• Mild to Moderate Renal Dysfunction (CrCl 30 to 89 mL/min): No dose adjustments recommended.
• Severe Renal Dysfunction (CrCl less than 30 mL/min): Data not available; use with caution.

Liver Dose Adjustments

• Mild Liver Dysfunction (Total bilirubin at upper limit of normal [ULN] or less with AST greater than ULN, or total bilirubin greater than 1 to 1.5 times ULN with any AST): No dose adjustments recommended.
• Moderate Liver Dysfunction (Total bilirubin greater than 1.5 to less than 3 times ULN with any AST): No dose adjustments recommended.
• Severe Liver Dysfunction (Total bilirubin greater than 3 times ULN with any AST): Data not available; use with caution.

Dose Adjustments

Restarting This Drug After Dosage Delay:

• Administer pretreatment medications prior to restarting this drug and closely monitor patients.
• Evaluate risk-benefit of restarting treatment in patients experiencing dose delays greater than 28 days due to adverse reaction.

WEEKLY DOSING SCHEDULE AFTER DOSE DELAY:
Last dose: 0.01 mg/kg, and time since last dose given is more than 7 days:

• Restart dosing schedule at Step-Up Dose 1 (0.01 mg/kg).

Last dose: 0.06 mg/kg, and time from last dose administered is:

• Between 8 to 28 days: Repeat Step-Up Dose 2 (0.06 mg/kg) and continue step-up dosing schedule.
• More than 28 days: Restart dosing schedule at Step-Up Dose 1 (0.01 mg/kg).

Last dose: 0.4 mg/kg, and time from last dose administered is:

• Between 8 to 28 days: Continue dosing schedule at current treatment dose (0.4 mg/kg once weekly).
• Between 29 to 56 days: Restart dosing schedule at Step-Up Dose 2 (0.06 mg/kg).
• More than 56 days: Consider permanent discontinuation; if restarting begin with Step-Up Dose 1 (0.01 mg/kg).

BI-WEEKLY (EVERY 2 WEEKS) DOSING SCHEDULE AFTER DOSE DELAY:
Last dose: 0.01 mg/kg, and time since last dose given is more than 7 days:

• Restart dosing schedule at Step-Up Dose 1 (0.01 mg/kg).

Last dose: 0.06 mg/kg, and time from last dose administered is:

• Between 8 to 28 days: Repeat Step-Up Dose 2 (0.06 mg/kg) and continue step-up dosing schedule
• More than 28 days: Restart dosing schedule at Step-Up Dose 1 (0.01 mg/kg).

Last dose: 0.4 mg/kg, and time from last dose administered is:

• Between 8 to 28 days: Repeat Step-Up Dose 3 (0.4 mg/kg) and continue step-up dosing schedule.
• Between 29 to 56 days: Restart dosing schedule at Step-Up Dose 2 (0.06 mg/kg).
• More than 56 days: Consider permanent discontinuation; if restarting begin with Step-Up Dose 1 (0.01 mg/kg).

Last dose: 0.8 mg/kg, and time from last dose administered is:

• Between 15 to 28 days: Continue dosing schedule at current treatment dose (0.08 mg/kg).
• Between 29 to 56 days: Restart dosing schedule at Step-Up Dose 3 (0.4 mg/kg).
• More than 56 days: Consider permanent discontinuation; if restarting begin with Step-Up Dose 1 (0.01 mg/kg).

Adverse Reaction Dose Modifications:
CYTOKINE RELEASE SYNDROME (CRS):
If CRS is suspected, withhold therapy and institute appropriate treatment.
Grade 1:

• Withhold doses until CRS resolves and administer pretreatment medications prior to the next dose.

Grade 2:

• Withhold doses until CRS resolves, administer pretreatment medications prior to the next dose, and hospitalize the patient for 48 hours following the next dose.

Grade 3:

• First Occurrence with Duration Less than 48 Hours: Withhold doses until resolution and provide supportive therapy (may include intensive care); then, administer pretreatment medications prior to the next dose and hospitalize the patient for 48 hours following the next dose.
• Recurrent Grade 3 CRS or Grade 3 CRS lasting 48 hours or longer: Permanently discontinue drug and provide supportive therapy.

Grade 4:

• Discontinue the drug permanently and provide supportive therapy, which may include intensive care.

NEUROLOGIC TOXICITY:
Grade 1:

• Withhold doses until neurologic toxicity symptoms resolve or stabilize.

Grade 2; Grade 3 (First Occurrence):

• Withhold doses until neurologic toxicity improve to Grade 1 or less and provide supportive therapy.

Grade 3 (Recurrent) or Grade 4:

• Discontinue the drug permanently and provide supportive therapy, which may include intensive care.

IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS):
Grade 1:

• Withhold therapy until ICANS resolves, monitor neurologic symptoms, and consider neurology evaluation.
• Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.

Grade 2

• Withhold therapy until ICANS resolves, monitor neurologic symptoms, and consider neurology evaluation.
• Administer dexamethasone 10 mg (or corticosteroid dose equivalent) intravenously every 6 hours. Continue until resolution to Grade 1 or less, then taper.
• Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
• Hospitalize patient for 48 hours following the next dose.

Grade 3 (First Occurrence):

• Withhold therapy until ICANS resolves, monitor neurologic symptoms, and consider neurology evaluation.
• Administer dexamethasone 10 mg (or corticosteroid dose equivalent) intravenously every 6 hours. Continue until resolution to Grade 1 or less, then taper.
• Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
• Provide supportive therapy, which may include intensive care.
• Hospitalize patient for 48 hours following the next dose.

Grade 3 (Recurrent):

• Permanently discontinue this drug, monitor neurologic symptoms, and consider neurology evaluation.
• Administer dexamethasone 10 mg (or corticosteroid dose equivalent) intravenously every 6 hours. Continue until resolution to Grade 1 or less, then taper.
• Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
• Provide supportive therapy, which may include intensive care.

Grade 4:

• Permanently discontinue this drug, monitor neurologic symptoms, and consider neurology evaluation.
• Administer dexamethasone 10 mg (or corticosteroid dose equivalent) intravenously every 6 hours. Continue until resolution to Grade 1 or less, then taper.
• May alternatively administer methylprednisolone 1000 mg intravenously once a day for 2 or more days.
• Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
• Provide supportive therapy, which may include intensive care.

ORAL TOXICITY AND WEIGHT LOSS:
Grades 1 to 2:

• Provide supportive care and consider withholding doses if not responsive.

Grade 3:

• Withhold doses until resolution to Grade 1 or better, and provide supportive care.

Grade 4:

• Permanently discontinue therapy with this drug.

INFECTIONS:
All Grades:

• Withhold doses in the step-up phase in patients until infection resolves.

Grade 3:

• Withhold doses during the treatment phase until infection improves to Grade 1 or better within 28 days.

Grade 4:

• Consider permanent discontinuation of this drug; if not, withhold subsequent doses (i.e., doses administered after step-up dosing schedule) until adverse reaction improves to Grade 1 or better.

CYTOPENIAS:
Absolute Neutrophil Count (ANC) Less Than 0.5 x 10(9)/L:

• Withhold doses until ANC is 0.5 x 10(9)/L or greater

Febrile Neutropenia:

• Withhold doses until ANC 1 x 10(9)/L or greater, and fever resolves

Hemoglobin Less Than 8 g/dL:

• Withhold doses until hemoglobin is 8 g/dL or greater

Platelet Count Less Than 25,000/mcL OR Platelet Count Between 25,000 to 50,000/mcL With Bleeding:

• Withhold doses until platelet count is 25,000/mcL or greater, and no evidence of bleeding

SKIN REACTIONS:
Grade 3 to 4:

• Withhold doses until adverse reaction improves to Grade 1 or baseline

OTHER NON-HEMATOLOGIC ADVERSE REACTIONS:
Grade 3:

• Withhold doses until adverse reaction improves to Grade 1 or baseline

Grade 4:

• Consider permanent discontinuation of this drug; if not, withhold subsequent doses (i.e., doses administered after step-up dosing schedule) until adverse reaction improves to Grade 1 or less.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for talquetamab. It includes a communication plan, elements to assure safe use, and implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:

• CYTOKINE RELEASE SYNDROME (CRS): CRS, including life-threatening or fatal reactions, can occur in patients receiving this drug. Initiate treatment with step-up dosing to reduce the risk of CRS. Withhold this drug until the CRS resolves or permanently discontinue based on severity.
• NEUROLOGIC TOXICITY: Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious life threatening or fatal reactions, can occur in patients receiving this drug. Monitor patients for signs or symptoms of neurologic toxicity during treatment. Withhold or permanently discontinue this drug based on severity of reactions.
• REMS: This drug is only available through a restricted program called the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy (REMS).

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous injection into the abdomen (preferred injection site), or alternatively into other subcutaneous tissue at other sites (e.g., thigh)
• Do not inject into tattoos, scars, or areas where skin is compromised (bruised, tender, red, or hardened).
• Separate multiple injections by at least 2 cm.

Storage requirements:

• Store refrigerated at 2C to 8C (36F to 46F) in original carton to protect from light.
• Do not freeze.
• Prepared dosing syringe(s): Store at 2C to 8C (36F to 46F) or at room temperature 15C to 30C (59F to 86F) for a maximum of 24 hours. Discard the syringe(s) after 24 hours if not used.

Preparation techniques:

• Refer to manufacturer reference tables for total dose based on actual body weight, injection volume, and number of vials required.
• Do not dilute vial(s) prior to administration and do not combine vials of different concentrations.
• Inspect vials prior to use and do not use if discolored, cloudy, or if foreign particles are present.
• Prior to administration, bring vial to ambient room temperature for at least 15 minutes; do not warm any other way.
• Gently swirl vial for 10 seconds to mix; do not shake product.
• If dose is greater than 2 mL, divide equally into multiple syringes.

General:

• This drug should only be administered by a qualified healthcare professional with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and neurologic toxicity, including ICANS.

Monitoring:

• Neurological: Assess patients for signs and symptoms of neurologic toxicity, including ICANS.
• Gastrointestinal: Monitor for signs and symptoms of oral toxicity and associated weight loss.
• Immunological: Evaluate patients for signs and symptoms of CRS.
• Hematological: Monitor complete blood counts and assess for cytopenias.
• Hepatic: Assess for liver toxicity by monitoring liver enzymes and total bilirubin at baseline and during treatment.
• Infectious: Evaluate patient for infection prior to and during treatment.

Patient advice:

• Read the FDA-approved patient labeling (Medication Guide).
• Discuss the signs and symptoms of CRS, neurological toxicity, and ICANS with patients, and counsel the to seek medical attention if identified.
• Advise patients that they should be hospitalized for 48 hours after administration of all doses within the step-up dosing schedule.
• Alert patients to refrain from driving or operating heavy machinery during step-up dosing, 48 hours after completion of step-up dosing, and in the event of new-onset neurological symptoms.
• Inform patients that they will be given a Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers.
• Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur.
• Advise patients that they may experience weight loss and to report weight loss.
• Advise females of reproductive potential of the risk to the fetus and to use effective contraception during treatment and for 3 months after the last dose.
• Inform patients that breastfeeding is not advised during treatment or for 3 months after last dose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer