Talquetamab-tgvs (subcutaneous)

Talquetamab-tgvs (subcutaneous)

Talquetamab-tgvs (subcutaneous) Subcutaneous route (solution)

Warning: Cytokine release syndrome and neurological toxicity, including immune effector cell-associated neurotoxicity syndrome

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, may occur in patients receiving talquetamab-tgvs. Initiate talquetamab-tgvs with gradual dosing to reduce the risk of CRS. Withhold talquetamab-tgvs until CRS resolves or discontinue treatment permanently depending on severity.

Talquetamab-tgvs can cause neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), as well as serious, life-threatening or fatal reactions. Monitor patients during treatment for signs and symptoms of neurological toxicity, including ICANS, and treat promptly. Withhold or permanently discontinue talquetamab TGVs based on severity.

Due to the risk of CRS and neurological toxicity, including ICANS, talquetamab-tgvs is only available through a restricted program called TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).

Uses for talquetamab-tgvs

This medicine is only available through a restricted distribution program called the Tecvayli™ and Talvey™ REMS (Risk Evaluation and Mitigation Strategy) program.

Before using talquetamab-tgvs

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the association between age and the effects of talquetamab TGVS injection in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of talquetamab-tgvs injection in the elderly.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your doctor if you are taking other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Schwere Infektion – mit Vorsicht anwenden. Kann diesen Zustand verschlimmern.

Proper use of talquetamab-tgvs

Cancer treatment medications are very powerful and can have many side effects. Before you receive this medicine, make sure you understand all of the risks and benefits. It is important that you work closely with your doctor during treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given as an injection under the skin, usually in the stomach or thigh.

It is very important that you understand the Tecvayli™ and Talvey™ REMS program requirements and familiarize yourself with the Tecvayli™ and Talvey™ Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you don't have one.

You will receive this medicine on a weekly or biweekly (every 2 weeks) “stepped dosing schedule.” Weekly dosing schedule: You will receive this medicine on days 1 and 4, followed by the first dose of treatment on day 7. After you receive your first dose of treatment, this medicine is usually given once a week. Biweekly dosing schedule: You will receive this medicine on days 1, 4, and 7, followed by the first dose of treatment on day 10. After you receive your first dose of treatment, this medicine is usually given every two weeks. Your doctor will ask you to stay for 48 hours after you receive the dose increase.

You may also be given other medicines (e.g. allergy medicines, fever medicines, steroids) 1 to 3 hours before this medicine is given to prevent unwanted reactions to the injection.

Missed dose

This medicine must be administered on a fixed schedule. If you miss a dose, call your doctor, home health care provider, or treatment clinic for instructions.

Precautions when using talquetamab-tgvs

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests are required to check for adverse effects.

Using this medicine during pregnancy may harm your unborn baby. If you are a woman who can become pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of contraception to prevent pregnancy during treatment and for 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor immediately.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These can be life-threatening and require immediate attention. Tell your doctor immediately if you experience restlessness, back pain, blurred vision, burning, throbbing or stabbing pain, coma, confusion, double vision, drowsiness, agitation, fever, chills, hallucinations, headache, hearing loss, irritability or twitching movements, mood or mental changes, muscle cramps, nausea, lightheadedness, dizziness, fainting, stiff muscles, seizures, Rash, stiff neck, tremor, trouble breathing, difficulty speaking, unusual tiredness or weakness, or vomiting.

Ask your doctor for a patient card. This card lists the symptoms of cytokine release syndrome and nervous system problems. Always carry the card with you during treatment. You must show the card to any doctor treating you.

This medicine may cause oral problems and weight loss. Contact your doctor immediately if you experience changes or loss of taste, difficulty swallowing, dry mouth, or swelling or soreness in your mouth.

This medicine can cause serious infections. Contact your doctor immediately if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, and pain or difficulty urinating.

This medicine reduces the number of some types of blood cells in your body. This can cause bleeding or infection more easily. To alleviate these problems, avoid being around sick or infected people. Wash your hands often. Avoid strenuous sports or other situations where you could suffer bruises, cuts or injuries. Brush your teeth gently and floss. Be careful when using sharp objects such as razors and fingernail clippers.

This medicine can cause serious liver problems. Consult your doctor immediately if you experience clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, rash, stomach pain or tenderness, swelling of the feet or lower legs, or unusual symptoms such as fatigue or weakness, or yellow eyes or skin.

This medicine can cause serious skin reactions (e.g. rash, maculopapular rash, erythema and erythematous rash). Contact your doctor immediately if you experience hot flashes, redness of the skin, rash with flat or small raised lesions on the skin, or unusually warm skin.

This medicine may cause dizziness, confusion, sleepiness, or tremor. Do not drive or do other activities that could be dangerous during and for 48 hours after taking this medicine until you know how this medicine affects you.

Side effects of talquetamab-tgvs

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Agitation
• Rückenschmerzen
• vergesslich sein
• verschwommene Sicht
• Körperschmerzen oder Schmerzen
• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Kribbeln, Kribbeln oder Kribbeln
• Brustschmerzen
• Schüttelfrost
• Koma
• Verwirrung
• Verwirrung hinsichtlich Zeit, Ort oder Person
• Husten oder Heiserkeit
• Durchfall
• Schwindel
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• Schläfrigkeit
• verstopfte Ohren
• Ohnmacht
• schneller, hämmernder oder unregelmäßiger Herzschlag oder Puls
• Fieber oder Schüttelfrost
• Halluzinationen
• Kopfschmerzen
• falsche Überzeugungen vertreten, die nicht durch Tatsachen geändert werden können
• erhöhte Schmerzempfindlichkeit
• erhöhte Berührungsempfindlichkeit
• Reizbarkeit
• Juckreiz der Vagina oder Genitalien
• Benommenheit
• Gedächtnisverlust
• Geruchsverlust
• Verlust der Stimme
• Schmerzen im unteren Rücken oder an der Seite
• Stimmungsschwankungen oder mentale Veränderungen
• Muskel- oder Knochenschmerzen
• Muskelkrämpfe
• Brechreiz
• Nervenschmerzen
• Schmerzen oder Schwierigkeiten beim Wasserlassen
• Probleme mit dem Gedächtnis
• schneller oder unregelmäßiger Herzschlag
• Hautausschlag mit flachen oder kleinen erhabenen Läsionen auf der Haut
• Anfälle
• Zittern in den Beinen, Armen, Händen oder Füßen
• niesen
• Halsentzündung
• Muskelkater
• steifer Hals
• verstopfte oder laufende Nase
• Schwitzen
• Schwellung
• dicker, weißer Vaginalausfluss mit mildem oder keinem Geruch
• Kribbeln in den Händen und Füßen
• Zittern und Zittern der Hände oder Füße
• Atembeschwerden
• Unsicherheit oder Unbeholfenheit
• ungewöhnliche Aufregung, Nervosität oder Unruhe
• ungewöhnliche Müdigkeit oder Schwäche
• Erbrechen
• Schwäche in Armen, Händen, Beinen oder Füßen
• Gewichtsverlust
• weiße Flecken im Mund, Rachen oder auf der Zunge
• Weiße Flecken mit Windeldermatitis

Less common

• Schwarzer, teeriger Stuhl
• blasse Haut
• Geschwüre, Wunden oder weiße Flecken im Mund
• ungewöhnliche Blutungen oder Blutergüsse

Incident not known

• Zahnfleischbluten
• brennender, pochender oder stechender Schmerz
• dunkler Urin
• Doppeltsehen
• Schwerhörigkeit
• ruckartige Bewegungen
• Punktgenaue rote Flecken auf der Haut
• starre Muskeln
• Magenschmerzen, stark
• Schwierigkeiten beim Sprechen
• gelbe Augen oder Haut

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Geschmacksveränderung oder Geschmacksverlust
• Verstopfung
• verminderter Appetit
• Schluckbeschwerden
• trockener Mund
• Verlust des Geschmackssinns
• verminderter oder verminderter oder Verlust des Geschmackssinns
• Schwellung oder Entzündung des Mundes

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Available dosage forms:

• Lösung

Therapeutic class: Antineoplastic agent

Pharmacological class: Talquetamab

More information