Talvey
Talvey (talquetamab or talquetamab-tgvs) is a cancer medication used to treat multiple myeloma that has come back or doesn’t improve after at least four other treatments. As a bispecific antibody, it helps your immune system find and destroy cancer cells. It’s given as a shot under the skin either once a week or once every two weeks by a healthcare professional in a clinic or hospital. Common side effects include fever, changes in taste, nail problems, and a serious condition called cytokine release syndrome (CRS).
What is Talvey (talquetamab)?
What is Talvey (talquetamab) used for?
- Relapsed and refractory multiple myeloma in adults who've already tried at least four other therapies
How Talvey (talquetamab) works
Talvey (talquetamab) is a bispecific T-cell engager (BiTE), which is a type of monoclonal antibody that’s designed to bind to two different targets.
One side of the antibody attaches to G protein–coupled receptor class C group 5 member D (GPRC5D), a protein on cancer cells (as well as other healthy cells in your body), while the other side binds to CD3, a protein on T-cells in your immune system. By connecting these two cells, Talvey (talquetamab) brings T-cells close to the cancer cells, helping the immune system attack and destroy the cancer cells.
Drug facts
Side effects of Talvey (talquetamab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low white blood cells (up to 90%)
- Fever (83%)
- Cytokine release syndrome (76%)
- Changes in taste (70%)
- Low platelets (62%)
- Nail problems (50%)
- Higher liver enzymes (up to 49%)
- Blood electrolyte changes (up to 44%)
- Muscle pain (43%)
- Rash (38%)
- Tiredness (37%)
- Weight loss (35%)
- Dry mouth (34%)
- Dry skin (30%)
- Trouble swallowing (23%)
- Upper respiratory tract infection (22%)
- Diarrhea (21%)
- Low blood pressure (21%)
- Headache (21%)
Less Common Side Effects
- Injection site reactions
- Nausea
- Chills
- Pain
- Swelling
- Mouth sores
- Constipation
- Itchiness
- COVID-19
- Fungal infection
- Movement problems
- Lower appetite
- Cough
- Trouble breathing
- Fast heartbeat
Talvey (talquetamab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome (CRS): Fever, trouble breathing, chills, dizziness, fast heartbeat, headache, feeling anxious
- Nervous system problems: headache, numbness, dizziness, confusion, sleepiness, trouble speaking or writing, shaking, muscle weakness, pain, seizures
- Serious infection: fever, body aches, chills, feeling very tired or weak, very fast heartbeat, cough, chest pain, shortness of breath, rash, sore throat
The following Talvey (talquetamab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in taste
- Dry mouth
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain or trouble swallowing
- Pain, redness, or swelling with sores inside the mouth or throat
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
- Weight loss
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Talvey (talquetamab)
Pros
- Works in a more specific, targeted way than traditional chemotherapy
- Given as a brief injection under the skin
- Recommended treatment option for people with multiple myeloma
Cons
- Need to stay in the hospital for 2 days after each step-up dose and first full dose
- Can cause serious side effects like CRS and nervous system problems
- Might cause taste changes and weight loss
Pharmacist tips for Talvey (talquetamab)
- Talvey (talquetamab) can cause cytokine release syndrome (CRS), a serious reaction where your immune system becomes overly activated. Let your oncologist know right away if you have symptoms like fever, chills, headache, trouble breathing, nausea, vomiting, or tiredness.
- To lower your risk of CRS, you’ll need to take premedications like dexamethasone, diphenhydramine, and acetaminophen 1 to 3 hours before your Talvey (talquetamab) step-up doses.
- Talvey (talquetamab) is given as an injection under your skin, usually in your stomach. Sometimes, it can be injected into your thigh or another area.
- Your Talvey (talquetamab) dose depends on your weight, and you might need more than one injection per dose. If you have any redness or swelling at the injection site, your oncologist might recommend using an ice pack to manage it.
- If you pause Talvey (talquetamab) treatment, you might need to restart the step-up dosing process. Depending on how long the pause was, you might just need just one step-up dose, or have to start over completely.
- Talvey (talquetamab) can cause dizziness, confusion, and sleepiness, especially during step-up dosing. To stay safe, avoid driving or using heavy machinery during step up dosing and for two days after.
- If your temperature reaches 100.4°F or higher, it means you have a fever. Call your oncologist or get medical help right away. A fever while taking Talvey (talquetamab) could be serious since it might mean you have an infection or it could be an early warning sign of CRS.
- Talvey (talquetamab) can sometimes irritate your liver. Get your regular blood tests during treatment to check your liver health. If you have stomach pain, yellowing of the skin, or yellowing around the whites of your eyes, call your care team right away.
- Talvey (talquetamab) is only available through a restricted program called the TECVAYLI and TALVEY REMS. You’ll receive a Patient Wallet Card, which you should carry with you at all times and show to all your healthcare professionals. This card lists signs of CRS and nervous system problems.
- Avoid breastfeeding while taking Talvey (talquetamab) and for 3 months after the last dose. It’s not known if this medication passes into breast milk, but it could potentially harm a nursing infant.
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Risks and warnings for Talvey (talquetamab)
Talvey (talquetamab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
Talvey (talquetamab) can cause a serious reaction called cytokine release syndrome (CRS), which can be life-threatening. This happens when your immune system overreacts to the medication. Common symptoms include fever, low blood pressure, chills, trouble breathing, headache, and fast heart rate. In severe cases, CRS can lead to heart problems, lung problems, organ failure, or blood clotting problems.
CRS most often happens after step-up doses, which is why you need to stay in the hospital for two days after those doses so your care team can monitor you closely. To lower your risk, your care team will give you dexamethasone, diphenhydramine, and acetaminophen 1 to 3 hours before your step-up doses. Call your oncologist right away if you notice any signs of CRS. If CRS happens, your treatment might need to be paused or stopped depending on how severe it is.
Serious nervous system problems
Some people taking Talvey (talquetamab) developed nervous system problems. These can be mild, like numbness in the fingers or headache, or serious, like a condition called immune effector-cell associated neurotoxicity syndrome (ICANS). In clinical studies, most ICANS cases happened within 2 days after a dose and lasted around 2 days. Tell your care team immediately if you have symptoms like confusion, trouble speaking, shakiness, sleepiness, trouble writing, or seizures. ICANS can happen at the same time as CRS, after CRS, or on its own.
Since Talvey (talquetamab) can cause drowsiness or trouble staying alert, avoid driving or using heavy machinery during step-up dosing and for 2 days after. And if you develop new nervous system symptoms, wait until they go away before driving or operating machinery.
Mouth problems and weight loss
Talvey (talquetamab) might cause mouth problems such as dry mouth, changes in taste, difficulty swallowing, and mouth sores. These symptoms can develop at any time, but for most people they began within the first 15 days of treatment and took over a month to get better, though they didn’t fully go away for some people. Some people also experienced weight loss. In some cases, weight loss didn’t go away, even after treatment stopped.
Your oncologist will monitor your weight and check for mouth problems during treatment. If you notice mouth pain, trouble eating, or significant weight loss, tell your care team right away. They might recommend you meet with a dietician to help manage these problems.
Infections
Talvey (talquetamab) can cause serious infections, including bacterial infections and sepsis. Multiple myeloma already weakens your immune system, and Talvey (talquetamab) can lower it even more, making it harder for your body to fight infections. Your oncologist might prescribe antibiotics to help prevent infections. Contact your care team right away if you have any signs or symptoms of infection such as fever, body aches, chills, or cough.
Low blood cell counts
Talvey (talquetamab) commonly causes low blood cell counts. Low white blood cells make it harder to fight infections and low platelets raise your risk of bleeding. If you have any unexplained bruising, blood in your urine, blood in your stool, or nosebleeds contact your care team right away. Your oncologist will check your blood counts regularly during treatment. If your blood cell levels drop too much, they might pause or stop Talvey (talquetamab).
Skin problems
Some people taking Talvey (talquetamab) developed skin reactions, including rash, redness, and irritation. These rashes are usually not severe, but you should still tell your oncologist if you notice any symptoms. In clinical trials, skin reactions typically started around 25 days after treatment began and took about a month to improve. If a severe rash develops, you might need to pause treatment until it gets better.
Serious liver problems
Talvey (talquetamab) can cause you to have high liver enzymes, which is a sign of liver irritation. Your oncologist will monitor your liver using blood tests, because most of the time you won’t notice any symptoms or feel differently when your liver is irritated. But if you do have sudden stomach pain, yellowing of the skin, or yellowing of the eyes, contact your care team right away. If your lab tests are abnormal, you might need to pause taking Talvey (talquetamab) while your oncologist looks into it.
Harm to unborn baby
Based on the way Talvey (talquetamab) works, it might cause harm to an unborn baby. If you’re able to get pregnant, use birth control while taking this medication and for 3 months after the last dose. Let your oncologist know if you’re pregnant or thinking about becoming pregnant while taking Talvey (talquetamab).
Talvey (talquetamab) dosage
Typical dosage for Talvey (talquetamab)
The recommended dose follows a step-up schedule. Each dose is given as an injection under the skin, starting with a low dose and increasing to the highest dose. The dose is based on your weight.
There are two schedule options:
-
Once a week
- Day 1: 0.01 mg/kg; Day 4: 0.06 mg/kg; Day 7: 0.4 mg/kg
- Then, once a week at 0.4 mg/kg.
-
Once every two weeks
- Day 1: 0.01 mg/kg; Day 4: 0.06 mg/kg; Day 7: 0.4 mg/kg; Day 10: 0.8 mg/kg
- Then, once every two weeks at 0.8 mg/kg.
What are alternatives to Talvey (talquetamab)?
Talvey (talquetamab) images
