Teclistamab

Teclistamab is a prescription medication used for the treatment of relapsed or refractory multiple myeloma in adults who have received more than 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

• Teclistamab is available under the following different brand names: Tecvayli

Common side effects of Teclistamab include:

• fever
• cytokine release syndrome
• musculoskeletal pain
• injection site reactions (redness, bruising, infection, discomfort, inflammation, swelling, a hard lump, and rash)
• fatigue
• upper respiratory tract infection
• nausea
• headache
• pneumonia
• diarrhea
• decreased white blood cells
• decreased hemoglobin
• decreased platelets

Serious side effects of Teclistamab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• confusion
• restlessness
• rapid heart rate
• bluish skin
• chills
• low blood pressure
• irregular heart rate
• headache
• elevated liver enzymes
• difficulty with coordination
• trouble walking
• muscle weakness
• twitching
• muscle spasm
• numbness and tingling in the hands and feet
• memory loss
• difficulty to concentrate
• personality change 
• seizure
• weakness in the arms or legs
• fatigue
• difficulty speaking and swallowing
• little or no urination
• shortness of breath
• mouth sores
• sore throat

Rare side effects of Teclistamab 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, loss of coordination, feeling 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 as a result 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 and pediatric dosage

Injectable solution

• 10 mg/mL ([30 mg/3 mL]; 3-mL single-dose vials)
• 90 mg/mL ([153 mcg/1.7 mL]; 1.7-mL single-dose vials)

Multiple Myeloma

Adult dosage

• Administer pretreatment medications 1–3 hours before each step-up dose to reduce the risk of cytokine release syndrome (CRS)
• Day 1 (step-up dose 1): 0.06 mg/kg subcutaneous * 1 dose
• Day 4 (step-up dose 2): 0.3 mg/kg subcutaneous * 1 dose; may give 2–4 days after step-up dose 1 or up to 7 days after step-up dose 1 to allow adverse reactions to resolve
• Day 7 (first treatment dose): 1.5 mg/kg subcutaneous * 1 dose; may give 2–4 days after step-up dose 2 or up to 7 days after step-up dose 2 to allow adverse reactions to resolve
• Subsequent treatment doses
  • Pretreatment medications may be required prior to administration of subsequent doses for patients who repeated doses within the step-up schedule following a dose delay or who experienced CRS following a prior dose
  • One week after the first treatment dose and weekly thereafter: 1.5 mg/kg subcutaneous once weekly
• Dosing frequency after achieving and maintaining complete response for more than 6 months
  • May decrease dosing frequency to biweekly (every 2 weeks) in patients who have achieved and maintained a complete response or better for a minimum of 6 months
  • 1.5 mg/kg SC every 2 weeks

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, health care provider, or pharmacist first.

• Teclistamab has severe interactions with no other drugs
• Teclistamab has serious interactions with no other drugs
• Teclistamab has moderate interactions with at least 29 drugs
• Teclistamab 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, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hepatotoxicity, including fatalities reported; monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated
• Neutropenia and febrile neutropenia reported; monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines; monitor with neutropenia for signs of infection
• Based on its mechanism of action, fetal harm may occur when administered to pregnant women
• Hypersensitivity
  • May cause both systemic administration-related reactions and local injection-site reactions; withhold or consider permanent discontinuation of therapy based on the severity
  • May cause systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue
  • Injection-site reactions occurred reported
• CRS
  • May cause CRS, including life-threatening or fatal reactions
  • Median time to onset of CRS was 2 days after the most recent dose with a median duration of 2 days
  • Clinical signs and symptoms of CRS included fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated AST/ALT
  • Initiate therapy according to a step-up dosing schedule to reduce the risk of CRS
  • Premedicate to reduce the risk of CRS and monitor the following administration
  • At the first sign of CRS, immediately evaluate for hospitalization
  • Administer supportive care based on severity and consider further management per current practice guidelines
• Neurologic toxicity
  • Serious or life-threatening neurologic toxicity, including ICANS may occur
  • Median time to onset of ICANS was 4 days after the most recent dose with a median duration of 3 days
  • Reported clinical manifestations were a confusional state and dysgraphia
  • Onset of ICANS can be concurrent with CRS, following the resolution of CRS, or in the absence of CRS
  • Monitor for signs and symptoms of neurologic toxicity during treatment
  • At the first sign of neurologic toxicity, including ICANS, immediately evaluate and provide supportive therapy based on the severity
  • Due to the potential for neurologic toxicity, treated patients are at risk of a depressed level of consciousness
  • Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of the step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves
• Infections
  • Severe, life-threatening, or fatal infections reported
  • Monitor for signs and symptoms of infection before and during treatment and treat appropriately
  • Administer prophylactic antimicrobials according to guidelines
  • Monitor immunoglobulin levels during treatment and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis
• REMS
  • Available only through a restricted program under a REMS called Tecvayli REMS
  • Notable requirements of REMS include the following:
  • Prescribers must be certified with the program by enrolling and completing training
  • Prescribers must counsel treated patients about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with Patient Wallet Card
  • Pharmacies and healthcare settings that dispense must be certified with the REMS program and must verify prescribers are certified through the REMS program
  • Wholesalers and distributors must only distribute to certified pharmacies or healthcare settings
  • Further information about the Tecvayli REMS program is available at www.TECVAYLIREMS.com or by telephone at 1-855-810-8064
• Drug interaction overview
  • May cause the release of cytokines that may suppress the activity of CYP enzymes, resulting in increased exposure of CYP substrates
  • Highest risk of drug-drug interaction is expected to occur from initiating a step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS
  • Monitor for toxicity or concentrations of CYP substrates where minimal concentration changes may lead to serious adverse reactions
  • Adjust the dose of concomitant CYP substrate drug as needed

Pregnancy and Lactation

• Based on the mechanism of action, fetal harm may occur when administered to pregnant women
• There are no available data on use in pregnant women
• No animal reproductive or developmental toxicity studies conducted
• Teclistamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
• Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab may potentially transmit from the mother to the developing fetus
• Advise women of the potential risk to the fetus
• Verify the pregnancy status of women of reproductive potential before initiating
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 5 months after the final dose
• Lactation
  • There are no data on the presence of teclistamab in human milk, its effect on breastfed children, or milk production
  • Maternal IgG is known to be present in human milk
  • Advise patients not to breastfeed during treatment and for 5 months after the final dose