Talquetamab-tgvs (Talvey™)

This medication is a bispecific GPRC5D-directed CD3 T-cell engager used to treat some forms of multiple myeloma (MM). Talquetamab-tgvs activates your T-cells (part of your immune system) by connecting the CD3 antigen (found on T cells) with GPRC5D, which is found on the surface of MM cells. The redirected T-cells kill MM cells in various ways.

How to Take Talquetamab-tgvs (Talvey™)

You will be given “pre-medications” before each step-up dose of talquetamab-tgvs. These may include a steroid, a histamine-1 (H1) receptor antagonist (such as diphenhydramine/Benadryl), and an antipyretic (such as acetaminophen/Tylenol). Some patients will need these pre-medications with every dose depending on adverse reactions and any dose delays you may need.

You will need to stay in the hospital for at least 2 days once you have completed the step-up schedule of the injection so that your care team can monitor your reaction.

TALVEY REMS

Talquetamab-tgvs is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TALVEY REMS program. This program is in place due to the risks of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS). Prescribers and pharmacies/healthcare settings must be certified with the program by enrolling and completing training. Prescribers must counsel patients on CRS and neurotoxicity and complete and provide patients with a Patient Wallet Card to carry with them at all times.

Possible Side Effects of Talquetamab-tgvs

There are a number of things you can do to manage the side effects of talquetamab-tgvs. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Cytokine Release Syndrome (CRS)

Cytokine release syndrome (CRS) can occur. T cells are activated by this medication, causing them to release many cytokines. The cytokines cause an inflammatory response in the body. This reaction, if left untreated, can be very dangerous. Signs and symptoms may be fever, having a hard time breathing, chills, low blood pressure, fast heart rate, headache, and higher levels of liver enzymes in your blood. Your care team will monitor you closely for CRS while you are on therapy with talquetamab-tgvs. You should call your provider right away if you have any signs or symptoms of CRS so that treatment can be started.

Neurologic Toxicity including ICANS

Neurological (brain) toxicities, such as aphasia (being unable to understand speech or speak normally), a change in mental status, and seizures have happened in patients who received this medication. Other neurological side effects can include headaches, encephalopathy (damage or disease of the brain), neuropathy (numbness or tingling), and/or changes to your motor skills (loss of control, often of the arms or legs). Your care team will be monitoring you very closely for any changes in your mental status.

Infection and Low White Blood Cell Count (Lymphocytopenia/Neutropenia)

This medication can cause life threatening infections, with or without a decrease in white blood cell counts.

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care. Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Mouth Ulcers (Mucositis)

Certain cancer treatments can cause sores or soreness in your mouth and/or throat. This can make it hard to swallow, eat, and drink. Notify your oncology care team if your mouth, tongue, inside of your cheek or throat becomes white, ulcerated or painful. Performing regular mouth care can help prevent or manage mouth sores. If mouth sores become painful, your doctor or nurse can recommend a pain reliever.

• Brush with a soft-bristle toothbrush or cotton swab twice a day.
• Avoid mouthwashes that contain alcohol. A baking soda and/or salt with warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon of salt in an eight-ounce glass of warm water) is recommended 4 times daily.
• If your mouth becomes dry, eat moist foods, drink plenty of fluids (6-8 glasses), and suck on sugarless hard candy.
• Avoid smoking and chewing tobacco, drinking alcoholic beverages and citrus juices.

Decrease in Appetite or Taste Changes

This medication can affect your appetite and how foods taste.

Nutrition is an important part of your care. Cancer treatment can affect your appetite, and in some cases the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Nail and Skin Changes

This medication can affect your fingernails/toenails. Your fingernails/toenails may:

• Become dark, brittle or fall off.
• Start to soften with a small dent in the middle of the nail.
• Crack along the cuticles.
• Have pitting or ridging.

Keep your fingernails and toenails clean and dry. You may use nail polish, but do not wear fake nails (gels, acrylics, overlay). If any nails fall off, clean the nail bed well with soap and water and cover with a band aid.
You may notice dry skin or changes in the color or tone of your skin. Your skin may be more sensitive to the sun, which can result in severe sunburn or rash. Some patients reported having hand-foot syndrome while on this medication. If you notice the heels of your feet or palms of your hands becoming red, swollen, or blistered, call your care team. You may also have thickening of the skin of your heels and/or palms.

Rash

Some patients may develop redness, a flat rash, acne, scaly skin, red itchy bumps, swelling, or blisters. Use an alcohol-free moisturizer on your skin and lips; avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Be sure to notify your oncology care team of any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Xerostomia (Dry Mouth)

This medication can cause xerostomia, also known as dry mouth. Xerostomia can be uncomfortable and can affect your speech, swallowing and dental health. Ways to manage this side effect include:

• Perform frequent oral hygiene with toothpaste containing fluoride.
• Floss once a day, if your care team says you can.
• Chew sugar free gum or suck on sugar free candy to stimulate saliva production.
• Rinse your mouth frequently to keep the mouth moist.
• Speak to your providers about over the counter and prescription gels and rinses that act as saliva replacement.

Speak to your provider if this side effect continues to be a problem.

Muscle or Joint Pain/Aches and Headache

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Weight loss

Patients reported losing weight while on this medication. Weigh yourself every day. Report any weight loss to your provider right away. Your care team will help with ways to keep the weight on, including talking with a nutritionist.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (phosphate, magnesium, sodium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary for women during treatment and for at least 3 months after treatment. Even if your menstrual cycle stops, you could still be fertile and conceive. You should not breastfeed while receiving this medication and for 3 months after your last dose.