WARNING

Talquetamab-tgvs injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). Inform your physician if you believe you may currently have an infection of any kind, or if you have an inflammatory condition. To avoid this response, your doctor could advise you to take specific drugs before to getting talquetamab-tgvs injection. Inform your doctor right once if you get any of the following symptoms during or following your injection: Fever, chills, an irregular or fast heartbeat, dyspnea, shortness of breath, coughing, restlessness, confusion, anxiety, headache, dizziness, lightheadedness, headache pain, shaking, diarrhea, nausea, vomiting, fatigue, or weakness.

Immunological effector cell-associated neurotoxicity syndrome (ICANS), a potentially fatal or extremely severe reaction affecting the central nervous system, can result from talquetamab-tgvs injection. Inform your physician if you suffer from memory loss, seizures, or strokes now or in the past. As soon as you notice any of the following symptoms, let your doctor know: headache; uneasiness; disorientation; loss of consciousness; seizures; uncontrollably jerking or shaking a part of the body; double vision; hearing loss; difficulty speaking or writing; difficulty moving; spasms or tightness in the muscles; pain that burns, throbs, or stabs; or numbness.

While receiving a dosage of talquetamab-tgvs injection, you may have CRS, or central nervous system responses; however, these reactions may also happen thereafter. While they can happen at any point during therapy, these responses are more frequent after the talquetamab-tgvs injection’s first three doses. at order to ensure that you are not experiencing a harmful medication reaction, a doctor or nurse will closely monitor you at a hospital or medical facility during your injections and for 48 hours following at least your first three doses of talquetamab-tgvs injection.

Talquetamab-tgvs is only accessible through a restricted program known as the TECVAYLI and TALVEY REMS because to the dangers of CRS and ICANS. You will be enrolled in the program by your doctor. Only specific pharmacies registered with TECVAYLI and TALVEY REMS carry talquetamab-tgvs. If you have any questions regarding how to fill your prescription, speak with your pharmacist or doctor.

Remember to keep all of your doctor’s and the laboratory’s appointments. To monitor how your body is reacting to the talquetamab-tgvs injection, your doctor may prescribe specific tests.

When you start treatment with talquetamab-tgvs injectable and every time you refill your prescription, you will get the manufacturer’s patient information sheet (Medication Guide) from your doctor or pharmacist. If you have any questions, make sure to approach your pharmacist or doctor after thoroughly reading the material.

Discuss the potential risks of talquetamab-tgvs injection with your physician.

Why is this medication prescribed?

Bone marrow cancers known as multiple myeloma that have reappeared or did not respond to at least four previous therapies are treated with talquetamab-tgvs. Talquetamab-tgvs belongs to the group of drugs known as bispecific T-cell engager antibodies. It functions by eradicating cancerous cells.

How should this medicine be used?

In a medical facility, a doctor or nurse will administer talquetamab-tgvs subcutaneously, or beneath the skin, as a solution (liquid). Usually, it is administered on days 1, 4, 7, and 10 and then every two weeks from there on, or on days 1, 4, 7, and 10. Most likely, your doctor will put you on a low dosage of talquetamab-tgvs and then progressively raise it to make sure you can tolerate the drug.

Depending on how you respond to the drug and any adverse effects you encounter, your doctor may decide to increase your dosage or discontinue your talquetamab-tgvs injectable treatment. Discuss your feelings with your physician while you go through treatment.

Other uses for this medicine

Ask your doctor or pharmacist for more information if you think this medicine could be recommended for something else.

What special precautions should I follow?

Regarding special precautions for talquetamab-tgvs injectable, it’s crucial to follow the healthcare provider’s instructions and adhere to the recommended guidelines. Here are some general precautions associated with talquetamab-tgvs injectable:

• If you have an allergy to any of the ingredients in talquetamab-tgvs injectable, other medications, or talquetamab-tgvs itself, let your doctor and pharmacist know. For an ingredient list, consult the Medication Guide or ask your pharmacist.
• Inform your physician and pharmacist about all of the vitamins, nutritional supplements, herbal items, prescription and over-the-counter drugs, and vitamins you now take or intend to take.
• Inform your physician if you have an infection, liver illness, low blood cell counts (leukopenia, neutropenia, anemia), or any of these conditions.
• Inform your physician if you intend to get pregnant or are already pregnant. Before beginning talquetamab-tgvs injectable medication, a pregnancy test is required. During the three months following your last dosage of talquetamab-tgvs injection and during your therapy, you should use birth control to avoid getting pregnant. Consult your physician about available birth control options. Contact your doctor if you become pregnant while taking the talquetamab-tgvs injectable. The fetus may suffer from talquetamab-tgvs injection.
• Inform your physician if you are nursing a child. For three months following your last dosage and throughout your therapy, do not breastfeed.
• It should be noted that talquetamab-tgvs may induce vertigo or disorientation. Till you are certain of how this medication will affect you, do not operate machinery or drive a car.

It’s important to note that the information provided here is general and may not cover all aspects of your individual treatment plan. Always follow the guidance provided by your healthcare team, and consult with them for personalized advice based on your specific health status and the latest information available.

What special dietary instructions should I follow?

In general, specific dietary restrictions related to talquetamab-tgvs may not be typical. However, it’s important to maintain a healthy and balanced diet to support overall well-being. If your healthcare provider provides specific dietary recommendations or restrictions based on your individual health status, be sure to follow them.

What should I do if I forget a dose?

If you forget a dose of talquetamab-tgvs, contact your healthcare provider or treatment team immediately for guidance. They will provide instructions on whether the missed dose can be administered later or if any adjustments are needed. It’s crucial not to alter the dosing schedule or try to make up for a missed dose without consulting your healthcare provider.

What side effects can this medication cause?

Talquetamab-tgvs injectable can cause various side effects, and it’s important to be aware of these potential reactions. However, it’s crucial to note that not everyone will experience the same side effects, and some individuals may not experience any side effects at all. Additionally, the severity of side effects can vary from person to person. If you are prescribed talquetamab-tgvs injectable, your healthcare provider will monitor your response to the medication and help manage any side effects. Here are some common side effects associated with talquetamab-tgvs injectable:

• • Fever
  • Fatigue
  • Chills
  • Pain
  • Swelling
  • Nausea
  • Constipation or diarrhea
  • Nail discoloration
  • Dry skin
  • Muscle and bone pain
  • Decreased appetite

Certain adverse effects may be dangerous. Call your doctor right away or seek emergency medical attention if you encounter any of the following symptoms:

• Fever, chills, weakness, cough, shortness of breath, or sore throat
• Dry mouth, difficulty swallowing, altered or loss of taste, or sores in the mouth
• Rash or redness of skin, dry skin or itching
• Feeling of racing heart
• Yellowing of skin or whites of eyes, dark urine or lower abdominal pain

Talquetamab-tgvs may cause weight loss. Talk to your doctor about the risks of taking this medication.

It’s important to note that the specific side effects can vary from person to person, and the information provided here is based on general observations with similar therapies. Additionally, ongoing clinical trials and real-world experience may provide more detailed and updated information on the safety profile of Talquetamab-tgvs.

Always consult with your healthcare provider for the most accurate and current information regarding the side effects and safety considerations associated with Talquetamab-tgvs, as well as personalized guidance based on your individual health status.

What should I know about storage and disposal of this medication?

Storage and Disposal of talquetamab-tgvs:

Storage:

• Talquetamab-tgvs is likely to be stored by healthcare professionals, typically in a healthcare facility or pharmacy setting.
• If you are provided with a home-use version or have any specific instructions for storage, follow the guidelines provided by your healthcare provider or pharmacist.

Disposal:

• Proper disposal of medical waste is crucial. If you have unused talquetamab-tgvs or items used in its administration (such as syringes or vials), follow the disposal instructions provided by your healthcare provider, pharmacist, or local waste management regulations.

In case of emergency/overdose

• In case of an emergency or suspected overdose, contact your local emergency services immediately.
• It is important to have contact information for your healthcare provider or the prescribing clinic readily available.
• Be prepared to provide information about the medication, the dosage, and any symptoms or reactions observed.

What other information should I know?

• Inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking, as well as any allergies or medical conditions you have.
• Attend all scheduled medical appointments and follow-up visits as recommended by your healthcare provider.
• Report any side effects or unexpected reactions to your healthcare provider promptly.

Remember, the information provided here is general, and the specifics can vary based on individual circumstances and the latest medical guidelines. Always follow the guidance provided by your healthcare team and refer to the medication’s prescribing information for the most accurate details. If you have specific questions or concerns about talquetamab-tgvs, discuss them with your healthcare provider.