Tarlatamab

Tarlatamab is a prescription medication indicated for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

• Tarlatamab is available under the following different brand names: Imdelltra, tarlatamab-dlle.

Common side effects of Tarlatamab include:

• tiredness 
• muscle or bone pain
• fever 
• constipation
• a bad or metallic taste in the mouth 
• nausea
• decreased appetite

Serious side effects of Tarlatamab include:

• cytokine release syndrome with symptoms such as fever of 100.4°F (38°C) or higher, nausea and vomiting, low blood pressure, confusion, restlessness, or feeling anxious, tiredness, problems with balance and movement, such as trouble walking, fast heartbeat or dizziness, headache, heart, liver, or kidney problems, shortness of breath or trouble breathing, unusual bleeding or bleeding that lasts a long time
• neurologic problems include trouble speaking, memory loss, or personality changes, weakness or numbness of your arms or legs, shaking (tremors), confusion, feeling disoriented, slow thinking, or not being able to think, headache, numbness or tingling of the hands or feet, seizure, trouble sleeping, problems with walking, or loss of balance or coordination, fainting or loss of consciousness
• low blood cell counts (cytopenia)
• Infections include fever of 100.4°F (38°C) or higher, painful rash, cough, sore throat, chest pain, pain during urination, tiredness, feeling weak or generally unwell, shortness of breath
• liver problems include tiredness, dark urine, loss of appetite, yellowing of skin or the white part of the eyes, pain in the right upper stomach area (abdomen)
• allergic reactions include shortness of breath or trouble breathing, coughing, pain, or tightness in the chest and back, feeling lightheaded or dizzy, wheezing, rash

Rare side effects of Tarlatamab 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 include 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

Injection, lyophilized powder for reconstitution

• 1 mg/vial
• 10 mg/vial

Small cell lung cancer

Adult dosage

• Administer as an IV infusion over 1 hour
• Follow-step-up dosing to reduce cytokine release syndrome (CRS) incidence and severity
• Premedication with dexamethasone and post-infusion hydration is recommended during the first cycle
• After the step-up dosing schedule, administer every 2 Weeks until disease progression or unacceptable toxicity
• Step-up dosing cycle 1
  • Premedication (Days 1 and 8): 8 mg dexamethasone IV (or equivalent) within 1 hour before Tarlatamab IV infusion
  • Post Tarlatamab infusion (Days 1, 8, and 15): Administer 1 L 0.9% NaCl IV over 4-5 hours immediately after completing Tarlatamab IV infusion
• Day 1
  • 1 mg IV
    • Monitor patient from the start of infusion for 22-24 hours on Cycle 1 Day 1 and 1 Day 8 in an appropriate healthcare setting
    • Recommend that the patient remain within 1-hour of appropriate healthcare settings for a total of 48 hours from the start of the infusion, accompanied by a caregiver
• Day 8
  • 10 mg IV
    • Monitor patient from the ^{start of infusion for 22-24 hours on Cycle 1 Day 1 and 1 Day 8 in an appropriate healthcare setting}
    • ^{Recommend that the patient remain within 1-hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion, accompanied by a caregiver}
• Day 15
  • 10 mg IV
    • Observe the patient for 6-8 hours post-infusion
    • Step-up dosing cycle 2
• Days 1 and 15: 10 mg IV
  • Observe the patient for 6-8 hours post-infusion
  • Step-up dosing cycles 3 and 4
• Days 1 and 15: 10 mg IV
  • Observe patient for 3-4 hours post-infusion
  • Step-up dosing cycle 5 and thereafter
• Days 1 and 15: 10 mg IV
  • Observe patient for 2 hours post-infusion
  • Restarting after dosage delay
• Last dose administered 1 mg (Cycle 1 Day 1)
  • less than or equal to14 days: Give 10 mg IV, then resume the planned dosage schedule
  • more than 14 days: Give step-up dose 1 mg; if tolerated, increase to 10 mg 1 week later, and then resume planned dosage schedule
• Last dose administered 10 mg (Cycle 1 Day 8)
  • less than or equal to 21 days: Give 10 mg IV, then resume the planned dosage schedule
  • more than 21 days: Give step-up dose 1 mg; if tolerated, increase to 10 mg 1 week later, and then resume planned dosage schedule
• Last dose administered 10 mg (Cycle 1 Day 15 and subsequent cycles)
  • less than or equal to 28 days: Give 10 mg IV, then resume the planned dosage schedule
  • more than 28 days: Give step-up dose 1 mg; if tolerated, increase to 10 mg 1 week later, and then resume planned dosage schedule

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.

• Tarlatamab has no noted severe interactions with any other drugs
• Tarlatamab has no noted serious interactions with any other drugs
• Tarlatamab has no noted moderate interactions with any other drugs
• Tarlatamab has no noted minor interactions with any 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 Tarlatamab?”

Long-Term Effects

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

Cautions

• Cytokine release syndrome (CRS)
  • Can cause CRS including serious or life-threatening reactions
  • Most events (43%) occurred after the first dose
  • Clinical signs and symptoms include pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting
  • Potentially life-threatening complications may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC)
  • Administer following recommended step-up dosing and administer concomitant medications before and after Cycle 1
  • Closely monitor patients for signs and symptoms of CRS during treatment
  • At first sign of CRS, immediately discontinue the infusion, evaluate the patient for hospitalization, and institute supportive care based on the severity
  • Withhold or permanently discontinue based on severity
• Neurologic toxicity including ICANS
  • Can cause serious or life-threatening neurologic toxicity, including ICANS
  • The most frequent neurologic toxicities were headache, peripheral neuropathy, dizziness, insomnia, muscular weakness, delirium, syncope, and neurotoxicity
  • Most patients experienced ICANS following cycle 2 day 1
  • Onset of ICANS can be concurrent with CRS, following resolution of CRS, or in absence of CRS
  • Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery
• Cytopenias
  • Can cause cytopenias including neutropenia, thrombocytopenia, and anemia
  • Monitor for signs and symptoms of cytopenias
  • Perform complete blood counts before initiating, before each dose, and as clinically indicated
  • Based on severity, temporarily withhold, or permanently discontinue
• Infections
  • Can cause serious infections, including life-threatening and fatal infections
  • Monitor for signs and symptoms of infection before and during treatment and treat as clinically indicated
  • Withhold or permanently discontinue based on severity
• Hepatotoxicity
  • Can cause hepatotoxicity
  • Monitor liver enzymes and bilirubin before treatment, before each dose, and as clinically indicated
  • Withhold or permanently discontinue based on severity
• Hypersensitivity
  • Can cause severe hypersensitivity reactions
  • Clinical signs and symptoms may include but are not limited to, rash and bronchospasm
  • Monitor for signs and symptoms of hypersensitivity during treatment and manage as clinically indicated
  • Withhold or consider permanent discontinuation based on severity
• Embryo-fetal toxicity
  • Based on its mechanism of action, may cause fetal harm when administered during pregnancy
• Drug interaction overview
  • CYP substrates
  • Caution
    • Tarlatamab causes transient release of cytokines that may suppress CYP450 enzymes and may result in an increased exposure of concomitant CYP substrates during and up to 14 days after occurrence of cytokine release syndrome

Pregnancy and Lactation

• Based on its mechanism of action may cause fetal harm when administered during pregnancy
• Data are unavailable regarding use in pregnant women to inform a drug-associated risk
• In an animal reproduction study, a murine surrogate molecule administered IV to pregnant mice crossed the placental barrier
• Tarlatamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
• Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, Tarlatamab has the potential to be transmitted to the developing fetus
• Advise women of potential fetal risk
• Verify pregnancy status of women of reproductive potential before initiating
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 2 months after the last dose
• Lactation
  • Data are unavailable on the presence of Tarlatamab in human milk, its effects on breastfed children, or milk production
  • Maternal IgG is known to be present in human milk
  • The effects of local gastrointestinal exposure and limited systemic exposure in breastfed children to Tarlatamab are unknown
  • Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment and for 2 months after last dose