Side Effects You May Experience During IMDELLTRA (tarlatamab) Treatment
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What is IMDELLTRA™ (tarlatamab-dlle)?
IMDELLTRA™ is a prescription medicine used to treat extensive-stage small cell lung cancer (ES-SCLC) . It is used when the cancer has spread throughout the lung or to other parts of the body and has not responded to platinum-containing chemotherapy or that chemotherapy has stopped working . It is not known whether IMDELLTRA™ is safe and effective in children.
For complete information about IMDELLTRA™, click here.
Serious Side Effects to Watch for During Treatment
IMDELLTRA™ may cause serious or life-threatening side effects. These include cytokine release syndrome (CRS) and neurological problems .
Cytokine Release Syndrome (CRS)
CRS develops when the immune system overreacts to immunotherapy. During IMDELLTRA™ treatment, it is common and may be serious/life-threatening .
Seek emergency medical help if any of the following symptoms occur:
- Fever: 38 °C (100.4 °F) or higher
- Low blood pressure
- Fatigue
- Fast/irregular heartbeat, palpitations, dizziness
- Headache
- Shortness of breath or difficulty breathing
- Nausea or vomiting
- Confusion, restlessness, anxiety
- Loss of balance/coordination (ataxia), difficulty walking
- Heart, liver or kidney problems
- Unusual or prolonged bleeding
Because of the risk of CRS, IMDELLTRA™ treatment starts with step-up doses and your medical team will monitor you closely during this process.
Neurological Problems
IMDELLTRA™ may cause serious/life-threatening neurological side effects. Symptoms may develop days or weeks after receiving the drug .
Contact your doctor immediately if any of these symptoms develop:
- Difficulty speaking, memory loss, personality changes (encephalopathy)
- Confusion, disorientation, slowed thinking
- Seizure
- Loss of balance, difficulty walking
- Weakness or numbness in the arms/legs
- Tremor (hands/legs)
- Headache
- Tingling, numbness in the hands/feet
- Sleep problems
- Fainting or loss of consciousness
- General weakness, lack of energy
Because of these risks, your doctor will monitor you on days 1 and 8 of cycle 1 after the infusion starts for 22–24 hours at an appropriate healthcare facility. In addition, for 48 hours from the start of the infusion, you are advised to remain within 1 hour of this facility and have a caregiver with you.
Low Blood Cell Counts (Cytopenia)
Low blood cell counts during treatment with IMDELLTRA™ are common and may be serious .
- Low white blood cells (neutropenia): increases infection risk
- Low red blood cells (anemia): causes fatigue and shortness of breath
- Low platelets (thrombocytopenia): may cause bruising and bleeding problems
Infections
IMDELLTRA™ may cause serious and life-threatening infections.
Symptoms:
- Fever of 38 °C or higher
- Cough
- Chest pain
- Fatigue
- Shortness of breath
- Painful rash
- Sore throat
- Pain when urinating
- General weakness
Liver Problems
IMDELLTRA™ may increase liver enzymes and bilirubin. These increases may occur with or without CRS.
Symptoms:
- Fatigue
- Loss of appetite
- Pain in the upper right abdomen
- Dark urine
- Yellowing of the skin or eyes
Allergic Reactions
IMDELLTRA™ may cause serious allergic reactions.
Symptoms:
- Shortness of breath or difficulty breathing
- Chest and back pain or tightness
- Wheezing
- Cough
- Dizziness, fainting
- Rash
Most Common Side Effects
The most common side effects of IMDELLTRA™ include:
- Fatigue
- Fever
- Bad or metallic taste in the mouth
- Decreased appetite
- Muscle or bone pain
- Constipation
- Nausea
Important Safety Information
What is the most important information I should know about IMDELLTRA™?
IMDELLTRA™ may cause serious side effects, including:
Cytokine Release Syndrome (CRS)
CRS is common during IMDELLTRA™ treatment and may be serious/life-threatening . Seek emergency help if any of the following symptoms develop:
- Fever of 38 °C (100.4 °F) or higher
- Low blood pressure
- Fatigue
- Fast heartbeat or dizziness
- Headache
- Shortness of breath or difficulty breathing
- Nausea and vomiting
- Confusion, restlessness, anxiety
- Difficulty walking, balance problems
- Heart, liver or kidney problems
- Prolonged bleeding
Because of CRS risk, IMDELLTRA™ is given according to a step-up dosing schedule :
- Day 1: low dose
- Days 8 and 15: full dose
- Afterward: full dose every 2 weeks
- Step-up dosing is repeated if a dose is delayed
- IV drugs that reduce CRS risk are given on days 1 and 8
- Additional fluids and supportive treatments are given with the first 3 doses
Neurological Problems
IMDELLTRA™ can, even days/weeks later, cause serious neurological side effects. Your doctor will refer you to a neurologist if needed.
Tell your doctor immediately if these symptoms occur:
- Difficulty speaking, memory loss, personality change
- Confusion, slowed thinking
- Seizure
- Loss of balance, difficulty walking
- Weakness or numbness in the arms/legs
- Tremor
- Headache
- Tingling in the hands/feet
- Sleep problems
- Fainting
- General weakness
On days 1 and 8, 22–24 hours of hospital observation are provided. For 48 hours, you should remain within 1 hour of the hospital and a caregiver is recommended.
Monitoring Schedule
- Cycle 1, days 1 and 8: 22–24 hours of observation
- Day 15 and cycle 2: 6–8 hours of observation
- Cycles 3–4: 3–4 hours of observation
- Cycle 5 onward: 2 hours of observation
Treatment may be temporarily interrupted or discontinued depending on the severity of side effects.
Pregnancy and Breastfeeding
- Pregnancy test before treatment
- Effective contraception during treatment and for 2 months afterward
- Do not breastfeed for 2 months after the last dose
What should I avoid while taking IMDELLTRA™?
If you experience dizziness, confusion or tremor, do not drive or operate heavy machinery and avoid risky activities.
Side Effect Monitoring
Your doctor will use blood tests during treatment to monitor your liver, infections and blood cell counts regularly. If needed, the drug may be interrupted or discontinued.
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