Talvey contains the active ingredient talquetamab-tgvs, which is a bispecific GPRC5D-directed CD3 T-cell engager. It is available as a sterile, preservative-free injection for subcutaneous administration in single-dose vials of 3 mg or 40 mg. Key inactive ingredients include edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, and sucrose.

How should I use this medication?

This medication is injected under the skin. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

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):

• Diarrhea
• Dry skin
• Fatigue
• Skin rash

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection
• An unusual or allergic reaction to talquetamab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

This medication may affect how other medications work. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells.

Carry the Patient Wallet Card with you at all times. Show it to all members of your care team. It describes the signs and symptoms of severe side effects you may have while taking this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 3 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 3 months after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 3 months after the last dose.

What are the most serious risks of this medication?

This medication can cause a serious side effect called cytokine release syndrome. Your care team will monitor you closely. Tell your care team right away if you feel faint or lightheaded or have fever, fatigue, loss of appetite, nausea, headache, shortness of breath, or a fast or irregular heartbeat.

This medication may affect the brain and nervous system. Talk to your care team right away if you have confusion, dizziness, tremors, trouble speaking, weakness, or pain, tingling, or numbness in the hands or feet. Some side effects can be severe. Call emergency services if you have seizures or trouble staying awake.