Description
Tarlatamab-dlle injection is used to treat extensive stage small cell lung cancer (ES-SCLC) that has spread throughout the lung or to other parts of the body in patients who have received other cancer medicines (eg, platinum) that did not work well.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tarlatamab-dlle injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tarlatamab-dlle injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection—Use with caution. May make this condition worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 1 hour. Your treatment schedule is divided into cycles that are usually 28 days long.
You will receive this medicine on a "step-up dosing schedule." This means you will receive a smaller dose on Day 1 of your first treatment cycle. Then, you will receive the full treatment dose on Day 8 and Day 15 of Cycle 1. You will receive your full dose every 2 weeks after Day 15 of Cycle 1.
Your doctor will ask you to stay in a medical facility during treatment with this medicine:
- For 22 to 24 hours on Day 1 and Day 8 of Cycle 1 doses.
- For 6 to 8 hours on Day 15 of Cycle 1 and Cycle 2 doses.
- For 3 to 4 hours on Cycle 3 and Cycle 4 doses.
- For 2 hours on Cycle 5 and later doses.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your may also receive extra fluids and other medicines (eg, steroid medicine) within 1 hour before or immediately after starting treatment with this medicine.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 2 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, confusion, double vision, drowsiness, restlessness, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may cause serious infections. Avoid being near people who are sick or have infections. Wash your hands often. Check with your doctor right away if you have a fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a fast heartbeat, skin itching, rash, or redness, swelling of the face, throat, or tongue, or trouble breathing or swallowing.
This medicine may cause dizziness, confusion, sleepiness, or tremors. Do not drive or do anything else that could be dangerous during treatment with this medicine until you know how this medicine affects you.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Bladder pain
- blood in the stools
- bloody or cloudy urine
- blurred vision
- bruising
- burning, numbness, tingling, or painful sensations
- chest pain, discomfort, or tightness
- confusion
- cough
- coughing or vomiting blood
- diarrhea
- difficult, burning, o painful urination
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- frequent urge to urinate
- headache
- lower back or side pain
- muscle or body pain
- nausea
- new loss of taste or smell
- pale skin
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- swelling of the face, fingers, feet, or lower legs
- trembling and shaking of the hands
- trouble breathing
- trouble sleeping
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weakness in the arms, hands, legs, or feet
- weight gain
Less common
- Coma
- confusion as to time, place, or person
- decreased urine output
- ear congestion
- hallucinations
- holding false beliefs that cannot be changed by fact
- increased thirst
- loss of voice
- muscle cramps
- seizures
- unusual excitement, nervousness, or restlessness
Rare
- Anxiety
- blue lips, fingernails, or skin
Incidence not known
- Black, tarry stools
- bleeding gums
- dark urine
- loss of appetite
- pinpoint red spots on the skin
- stomach pain, severe
- trouble swallowing
- ulcers, sores, or white spots in the mouth
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Arm or leg pain
- back pain
- bone pain
- change in taste
- constipation
- difficulty in moving
- joint pain or swelling
- muscle aches, cramps, or stiffness
- neck pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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