Talquetamab

Talquetamab is a prescription medication used for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 and more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

• Talquetamab is available under the following different brand names: Talvey, talquetamab-tgvs.

Common side effects of Talquetamab include:

• fever
• cytokine release syndrome (CRS)
• changes in taste
• nail disorder
• musculoskeletal pain
• skin disorder
• rash
• fatigue
• weight loss
• dry mouth
• dry skin
• difficulty swallowing
• upper respiratory tract infection
• diarrhea
• low blood pressure (hypotension)
• headache
• decreased white blood cell count
• decreased hemoglobin

Serious side effects of Talquetamab include:

• mouth problems and weight loss include - changes in sense of taste, trouble swallowing, dry mouth, mouth sores
• infections
• decreased blood cell counts
• skin problems
• liver problems

Rare side effects of Talquetamab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution for SC

• 2 mg/mL (1.5-mL single-dose vial)
• 40 mg/mL (single-dose vial)

Ready-to-use SC solution

Multiple Myeloma

Adult dosage

• Hospitalize for 48 hours after all doses within the step-up dosing schedule
• All doses are based on actual body weight (ABW)
• Weekly dosing schedule
• Step-up dosing schedule
  • Day 1 (step-up dose #1): 0.01 mg/kg SC × 1 dose  
  • Day 4 (step-up dose #2): 0.06 mg/kg SC × 1 dose
  • Day 7 (first treatment dose): 0.4 mg/kg SC × 1 dose
  • Step-up dose #2 and first treatment dose: May be administered between 2 and 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for the resolution of adverse reactions
• Second treatment dose and thereafter
  • 1 week after the first treatment dose and weekly thereafter (subsequent treatment doses): 0.4 mg/kg SC every week
  • May maintain a minimum of 6 days between weekly doses
  • Continue until disease progression or unacceptable toxicity
• Biweekly dosing schedule
• Step-up dosing schedule
  • Day 1 (step-up dose #1): 0.01 mg/kg SC × 1 dose
  • Day 4 (step-up dose #2): 0.06 mg/kg SC × 1 dose
  • Day 7 (step-up dose #3): 0.4 mg/kg SC ×1 dose
  • Day 10 (first treatment dose): 0.8 mg/kg SC × 1 dose
  • Step-up doses #2 and #3: May be administered between 2 and 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions
  • Step-up dose #3: May be administered between 2 to 7 days
• Second treatment dose and thereafter
  • 2 weeks after the first treatment dose and every 2 weeks thereafter (subsequent treatment doses): 0.8 mg/kg SC every 2 weeks
  • May maintain a minimum of 12 days between biweekly doses
  • Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Talquetamab has severe interactions with no other drugs
• Talquetamab has serious interactions with no other drugs
• Talquetamab has moderate interactions with at least 47 other drugs
• Talquetamab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Talquetamab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Talquetamab?”

Cautions

• Drug available only through restricted REMS program
• based on its mechanism of action, the drug may cause fetal harm when administered to pregnant womens
• CRS
  • Can cause CRS, including life-threatening or fatal reactions
  • Clinical signs and symptoms include but are not limited to, pyrexia, hypotension, chills, hypoxia, headache, and tachycardia
  • Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC)
  • Counsel patients to seek medical attention should signs or symptoms of CRS occur
  • At the first sign of CRS, immediately evaluate the patient for hospitalization; institute treatment with supportive care based on severity, and consider further management per current practice guidelines
• Neurologic toxicity
  • Can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS)
  • The most frequent neurologic toxicities were headache, encephalopathy, sensory neuropathy, and motor dysfunction
  • ICANS onset can be concurrent with CRS, following resolution of CRS, or in the absence of CRS
  • Clinical signs and symptoms of ICANS may include but are not limited to, a confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia
  • Monitor for signs and symptoms of neurologic toxicity during treatment
  • At the first sign, including ICANS, immediately evaluate the patient and provide supportive care based on severity; withhold or permanently discontinue the drug based on severity, and consider further management per current practice guidelines
• Driving or operating machinery
  • Owing to potential neurologic toxicity, patients are at risk of a depressed level of consciousness
  • Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion, or in the event of new onset of any neurological symptoms, until symptoms resolve
• Oral toxicity and weight loss
  • Oral toxicities reported, including dysgeusia, dry mouths, dysphagia, and stomatitis
  • Can cause weight loss, regardless of having an oral toxicity
  • Monitor for signs and symptoms of oral toxicity
  • Counsel patients to seek medical attention if signs or symptoms of oral toxicity occur. and provide supportive care as per current clinical practice. including consultation with a nutritionist
  • Monitor weight regularly during therapy; evaluate clinically significant weight loss further; withhold or permanently discontinue based on the severity
• Infections
  • Can cause serious infections, including life-threatening or fatal infections
  • Monitor for signs and symptoms of infection before and during treatment, and treat appropriately
  • Administer prophylactic antimicrobials according to local guidelines
  • Withhold or consider permanent discontinuation as recommended based on the severity
• Cytopenias
  • Cytopenias reported, including neutropenia and thrombocytopenia
  • Monitor complete blood cell counts during treatment, and withhold as recommended based on severity
• Skin toxicity
  • Serious skin reactions reported, including rash, maculopapular rash, erythema, and erythematous rash
  • Monitor for skin toxicity, including rash progression
  • Consider early intervention and treatment to manage skin toxicity
  • Withhold as recommended based on the severity
• Hepatotoxicity
  • Hepatotoxicity reported
  • Liver enzyme elevation may occur with or without CRS
  • Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated
  • Withhold or consider permanent discontinuation based on the severity
• Drug interaction overview
  • CYP enzyme suppression
    • Monitor sensitive CYP substrates for toxicity or drug concentrations
    • Talquetamab causes the release of cytokines that may suppress the activity of CYP enzymes, resulting in increased exposure of CYP substrates
    • Increased exposure of CYP substrates is more likely to occur from initiation of step-up dosing up to 14 days after the first treatment dose and during and after CRS

Pregnancy and Lactation

• Based on its mechanism of action, the drug may cause fetal harm when administered to pregnant women; verify the pregnancy status of women’s reproductive potential before initiating
• Talquetamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
• Human immunoglobulin G (IgG) is known to cross the placenta; therefore, talquetamab may potentially be transmitted from the mother to the developing fetus
• There are no available data on use in pregnant women to evaluate for drug-associated risks
• No animal reproductive or developmental toxicity studies have been conducted
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 3 months after the last dose
• Lactation
  • Data are not available regarding the presence of talquetamab in human milk, its effects on breastfed children, or milk production
  • Maternal IgG is known to be present in human milk; effects of local gastrointestinal exposure and limited systemic exposure in breastfed children are unknown
  • Owing to the potential for serious adverse reactions in breastfed children, do not breastfeed during treatment and for 3 months after the last dose