Patient Medication Information: uses, side effects, how to take - Imdelltra
Serious warnings and precautions box
What IMDELLTRA is used for:
IMDELLTRA is a cancer medicine that contains the active substance “tarlatamab”.
IMDELLTRA is used to treat adults with small cell lung cancer (SCLC):
- that has spread throughout the lungs and/or to other parts of the body, and
- after treatment with chemotherapy that includes platinum, and it did not work or is no longer working
How IMDELLTRA works:
IMDELLTRA is a bispecific molecule that binds to DLL3 on the surface of small cell lung tumour cells and also to the surface of T cells (a type of white blood cell). IMDELLTRA works
- IMDELLTRA can cause cytokine release syndrome (CRS), which can be severe, life-threatening, or cause death. Symptoms may include fever (38°C or higher), chills, shortness of breath, trouble breathing, fast or irregular heartbeat, palpitations, low blood pressure, dizziness, headache, nausea and vomiting.
- IMDELLTRA can cause neurologic problems which can be severe, life-threatening or cause death. Symptoms may include trouble speaking or writing, memory loss, personality changes (encephalopathy), confusion, feeling disoriented or having difficulty thinking clearly (delirium), seizure, loss of balance or coordination (ataxia), weakness or numbness of arms and legs, shakiness of your hands or limbs (tremor), and headache. Some of these may be signs of a serious immune reaction called ‘immune effector cell-associated neurotoxicity syndrome’ (ICANS). These effects can occur days or weeks after you receive IMDELLTRA.
Your healthcare professional will monitor for signs and symptoms of CRS and neurological problems during treatment with IMDELLTRA. Call your doctor or get emergency help right away if you develop any of these signs and symptoms of CRS or neurologic problems at any time during your treatment with IMDELLTRA.
by attaching to these cells and bringing them together, to help your immune system target the small cell lung cancer cells.
If you have any questions about how IMDELLTRA works or why this medicine has been prescribed for you, ask your healthcare provider.
The ingredients in IMDELLTRA are:
Medicinal ingredients: tarlatamab
Non-medicinal ingredients: L-glutamic acid, Polysorbate 80, Sodium hydroxide, Sucrose
Ingredients in the IV Solution Stabilizer (IVSS), a liquid that will be used by the healthcare professional to prepare your dose of IMDELLTRA: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injection.
IMDELLTRA comes in the following dosage form(s):
Lyophilized powder for solution for intravenous infusion, 1 mg and 10 mg per vial.
Each package contains three vials: one vial of IMDELLTRA containing 1 or 10 mg powder and two vials of 7 mL IVSS.
Do not use IMDELLTRA if:
- you are allergic to tarlatamab or to any of the ingredients of IMDELLTRA. If you are not sure if you are allergic, talk to your doctor or nurse before you are given IMDELLTRA.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IMDELLTRA. Talk about any health conditions or problems you may have, including if you:
- have an infection.
- have or had problems with your nervous system.
- have or had any liver or kidney problems.
- are pregnant or plan to get pregnant.
- are breast-feeding or plan to breast-feed.
- had a recent vaccination or are going to have a vaccination. You should not receive live vaccines from 4 weeks before until 6 weeks after you are treated with IMDELLTRA.
IMDELLTRA can cause serious side effects that can be severe, life-threatening, or cause death.
These side effects include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Call your doctor or get emergency help right away if you get any of the symptoms listed above in the Serious Warning and Precautions Box. Your doctor may give you medicine to treat your side effects. Your healthcare provider will check for these problems during treatment with IMDELLTRA.
Other warnings you should know about:
Pregnancy, contraception, breastfeeding and fertility
The effects of IMDELLTRA in pregnant women are not known.
- IMDELLTRA may harm your unborn baby. Pregnancy must be ruled out before treatment with IMDELLTRA. Tell your healthcare provider if you are pregnant, think you are pregnant, or if you are planning to become pregnant.
- Tell your healthcare provider immediately if you become pregnant during treatment with IMDELLTRA. Women who are able to become pregnant must use birth control during treatment with IMDELLTRA and for 2 months after your last dose. Talk to your healthcare provider about effective methods of birth control.
- It is not known whether IMDELLTRA passes into breast milk. Do not breast-feed during treatment with IMDELLTRA and for at least 2 months after your last dose.
- The effects of IMDELLTRA on male and female fertility are not known.
Driving and Using Machines
- Do not drive, operate heavy or potentially dangerous machinery and engage in hazardous occupations or activities following IMDELLTRA infusion in case you develop neurological symptoms (such as dizziness, seizures, sleepiness, confusion, etc.) until you feel better.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with IMDELLTRA:
- It is not known which medications interact with IMDELLTRA.
How to take IMDELLTRA:
IMDELLTRA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein for 1 hour.
You will receive a smaller dose of 1 mg IMDELLTRA on Day 1.
You will receive the full treatment dose of 10 mg IMDELLTRA on Day 8, Day 15 and then every 2 weeks thereafter.
On Day 1 and Day 8, you will receive medication (such as corticosteroids) within one hour before receiving IMDELLTRA to help reduce your risk of CRS. This will be given to you by IV infusion into your vein.
On Day 1 and Day 8, you will receive fluids by IV infusion into your vein after IMDELLTRA infusion to lower the chance of side effects.
You may also receive these treatments for later doses of IMDELLTRA based on any symptoms or side effects you have.
Usual dose:
The starting dose of IMDELLTRA is 1 mg on Day 1 followed by 10 mg on Days 8, 15, and then every 2 weeks thereafter.
Your healthcare provider will regularly check your blood counts as the number of blood cells and other blood components may decrease.
Due to the risk of CRS and neurologic problems you will receive the following monitoring during treatment with IMDELLTRA:
For Cycle Day 1 and Day 8, your healthcare provider will monitor you for 6 to 8 hours from the start of the first IMDELLTRA infusion in an appropriate healthcare setting.
You should plan to stay within proximity of a healthcare facility for 24 hours from the start of each IMDELLTRA infusion on Day 1 and Day 8 and be accompanied by a caregiver.
Your healthcare provider will determine how long you should stay on IMDELLTRA.
Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with IMDELLTRA, as well as other side effects, and treat you as needed. You may be hospitalized if you develop signs or symptoms of CRS or neurologic problems during treatment with IMDELLTRA. Your healthcare provider may delay, temporarily stop or completely stop your treatment with IMDELLTRA if you develop CRS, neurologic problems, or any other side effects that are severe.
Overdose:
If you think you, or a person you are caring for, have taken too much IMDELLTRA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
It is very important to go to all of your appointments. If you miss any appointments, call your healthcare professional as soon as possible to reschedule. It is important for you to be monitored closely for side effects during treatment with IMDELLTRA.
Possible side effects from using IMDELLTRA:
These are not all the possible side effects you may have when taking IMDELLTRA. If you experience any side effects not listed here, tell your healthcare professional.
Very common (may affect more than 1 in 10 people):
- sudden and severe inflammatory syndrome with symptoms including fever, chills, low blood oxygen, headache, decreased blood pressure, nausea, or vomiting (cytokine release syndrome)
- little or no appetite (decreased appetite)
- bad taste in mouth (dysgeusia)
- fever (pyrexia)
- constipation
- low red blood cell count (anemia)
- tiredness (fatigue)
- nausea
- physical weakness or no energy (asthenia)
- low level of sodium in blood (hyponatremia)
- headache
- low levels of types of white blood cells (neutropenia, lymphopenia, neutrophil count decrease)
- shortness of breath or difficulty breathing (dyspnea)
- weight loss (weight decreased)
Common (may affect more than 1 in 100 people):
- neurologic problems (Immune effector cell-associated neurotoxicity syndrome)
- confusion (confusional state)
- shakiness of hands and limbs (tremor)
- feeling disoriented (delirium)
Uncommon (may affect up to 1 in 1000 people)
- change in normal activity of nervous system (neurotoxicity)
- seizure
- loss of balance or coordination (ataxia)
- trouble speaking, memory loss, personality changes (encephalopathy)
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Very common | |||||
| Cytokine release syndrome: fever, chills, shortness of breath, trouble breathing, fast or irregular heartbeat, palpitations, low blood pressure, dizziness, headache, nausea, vomiting | X | ||||
| Infections: fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell | X | ||||
| Common | |||||
| Immune effector cell-associated neurotoxicity syndrome (ICANS) (neurological problems): trouble speaking or writing, memory loss, personality changes (encephalopathy), confusion, feeling disoriented or having difficulty thinking clearly (delirium), seizure, loss of balance or coordination (ataxia), weakness or numbness of arms and legs, shakiness of your hands or limbs (tremor), headache | X | ||||
| Cytopenia (low white blood cell counts, low red blood cell counts and low platelet counts): chills or shivering, feeling warm, high body temperature | X | ||||
| Tumour lysis syndrome: complications occurring after treatment of a fast-growing cancer leading to a change in certain chemicals in the blood (increase potassium, uric acid, and phosphate and decreased blood levels of calcium), which may cause damage to organs, including the kidneys, heart, and liver | X | ||||
| Liver problems: tiredness, loss of appetite, pain in your right upper stomach-area (abdomen), dark urine, yellowing of your skin or the white part of your eyes | X | ||||
| Very rare | |||||
| Allergic reactions: shortness of breath or trouble breathing, pain or tightness in your chest and back, wheezing, coughing, feeling lightheaded or dizzy, rash | X | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
IMDELLTRA will be stored and managed by healthcare professionals. The information below on how to store IMDELLTRA is meant for your healthcare professional.
Unopened vials:
Store refrigerated (2°C to 8°C).
Keep in the original carton to protect from light. Do NOT freeze.
Prepared solution:
Prepared IMDELLTRA solution in the IV bag can be stored refrigerated (2°C to 8°C) for up to 7 days, or at room temperature (20°C to 25°C) for up to 8 hours.
Keep out of reach and sight of children.
If you want more information about IMDELLTRA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.amgen.ca); or by calling 1-866-502-6436.