Zynyts

Zynyts

Zynyts

What is Zynyz?

Zynyz is a programmed death receptor-1 (PD-1)-blocking antibody (also called an immune checkpoint inhibitor) that works on immune T cells by binding to the PD-1 protein to prevent interaction with PD-L1, a protein that is commonly found on some cancer cells.

When an immune cell's PD-1 protein interacts with a cancer cell's PD-L1 protein, the cancer cell is considered healthy and is left alone. By blocking interaction with PD-1, Zynyz removes the “brakes” of the immune system, allowing for a more effective attack on cancer cells.

What is Zynyz used for?

Zynyz is used to treat adult patients with a type of skin cancer called Merkel cell carcinoma that is metastatic (the cancer has spread to other parts of the body) or recurrent locally advanced (the cancer has returned).

Merkel cell carcinoma (MCC) is a rare and aggressive type of skin cancer that usually appears as a painless, reddish-purple skin nodule on the head, neck, and arms on sun-exposed skin. MCC is typically a fast-growing cancer with a high metastasis rate, meaning it can spread quickly to other parts of the body.

Zynyz was approved under the US FDA's accelerated approval program for the treatment of Merkel cell carcinoma based on tumor response rate and duration of response (DOR). Further approval may require additional clinical trials to confirm clinical benefit.

It is not known whether this medicine is safe and effective in children.

Important information

Zynyz is a medicine that can treat Merkel cell carcinoma by acting on your immune system. It can cause your immune system to attack normal organs and tissues in any area of ​​your body, interfering with how they function. These problems can sometimes become serious or life-threatening and result in death. You can have more than one of these problems at the same time. These problems can occur at any time during treatment or even after your treatment has ended.

Call or consult your doctor immediately if you experience any new or worsening signs or symptoms, including:

Lung problems.

• Husten
• Kurzatmigkeit
• Brustschmerzen

Intestinal problems.

• Durchfall (weicher Stuhl) oder häufigerer Stuhlgang als gewöhnlich
• Stuhl, der schwarz, teerig oder klebrig ist oder Blut oder Schleim enthält
• starke Schmerzen oder Druckempfindlichkeit im Magenbereich

Liver problems.

• Gelbfärbung Ihrer Haut oder des Weißen Ihrer Augen
• starke Übelkeit oder Erbrechen
• Schmerzen auf der rechten Seite Ihres Magenbereichs (Abdomen)
• dunkler Urin (teefarben)
• Es kommt häufiger zu Blutungen oder Blutergüssen als normal

Problems with the hormonal glands.

• Kopfschmerzen, die nicht verschwinden oder ungewöhnliche Kopfschmerzen
• Lichtempfindlichkeit des Auges
• Augenprobleme
• schneller Herzschlag
• vermehrtes Schwitzen
• extreme Müdigkeit
• Gewichtszunahme oder Gewichtsverlust
• sich stärker hungrig oder durstig fühlen als gewöhnlich
• häufiger als gewöhnlich urinieren
• Haarausfall
• frieren
• Verstopfung
• Deine Stimme wird tiefer
• Schwindel oder Ohnmacht
• Stimmungs- oder Verhaltensänderungen, wie verminderter Sexualtrieb, Reizbarkeit oder Vergesslichkeit

Kidney problems.

• Verringerung Ihrer Urinmenge
• Blut in Ihrem Urin
• Schwellung Ihrer Knöchel
• Appetitverlust

Skin problems.

• Ausschlag
• Juckreiz
• Blasenbildung oder Abblättern der Haut
• schmerzhafte Wunden oder Geschwüre in Mund, Nase, Rachen oder Genitalbereich
• Fieber oder grippeähnliche Symptome
• geschwollene Lymphknoten

Problems can also occur in other organs and tissues.These are not all of the signs and symptoms of immune system problems that may occur during treatment with this medicine. Call your doctor immediately if you experience any new or worsening signs or symptoms, including:

• Brustschmerzen, unregelmäßiger Herzschlag, Kurzatmigkeit oder Schwellung der Knöchel
• Verwirrtheit, Schläfrigkeit, Gedächtnisprobleme, Stimmungs- oder Verhaltensänderungen, steifer Nacken, Gleichgewichtsstörungen, Kribbeln oder Taubheitsgefühl in Armen oder Beinen
• Doppeltsehen, verschwommenes Sehen, Lichtempfindlichkeit, Augenschmerzen, Veränderungen des Sehvermögens
• anhaltende oder starke Muskelschmerzen oder -schwäche, Muskelkrämpfe
• niedrige rote Blutkörperchen, Blutergüsse

Infusion reactions, which can sometimes be serious.Signs and symptoms of infusion reactions may include:

• Schüttelfrost oder Zittern
• Juckreiz oder Ausschlag
• Spülung
• Kurzatmigkeit oder pfeifende Atmung
• Schwindel
• Ich habe das Gefühl, ohnmächtig zu werden
• Fieber
• Rücken- oder Nackenschmerzen

Rejection of a transplanted organ.Your doctor should tell you what signs and symptoms you should report and monitor for, depending on the type of organ transplant you received.

Complications, including graft-versus-host disease, in people who have had a bone marrow transplant (stem cell transplant) that uses donor (allogeneic) stem cells.These complications can be serious and lead to death. These complications may occur if you have had a transplant before or after treatment with Zynyz. Your doctor will monitor you for these complications.

Prompt medical treatment can help prevent these problems from getting worse.

Your doctor will check you for these problems during your treatment. Your doctor may want to treat you with corticosteroids or hormone replacement medications. Your doctor may also need to delay or stop treatment if you experience serious side effects.

Before you get Zynyz

Before you start treatment, tell your doctor about all your medical conditions, including if you:

• Probleme mit dem Immunsystem wie Morbus Crohn, Colitis ulcerosa oder Lupus haben
• eine Organtransplantation erhalten haben
• eine Stammzelltransplantation mit Spenderstammzellen (allogen) erhalten haben oder planen, diese zu erhalten.
• wenn Ihr Brustbereich einer Strahlenbehandlung unterzogen wurde
• wenn Sie an einer Erkrankung leiden, die Ihr Nervensystem beeinträchtigt, wie z. B. Myasthenia gravis oder Guillain-Barré-Syndrom

pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. Zynyz may harm your unborn baby.

Women who can become pregnant:

• Ihr Arzt sollte vor Beginn der Behandlung einen Schwangerschaftstest durchführen.
• Sie sollten während Ihrer Behandlung und für 4 Monate nach Ihrer letzten Dosis eine wirksame Verhütungsmethode anwenden. Sprechen Sie mit Ihrem Arzt über Verhütungsmethoden, die Sie in dieser Zeit anwenden können.
• Informieren Sie sofort Ihren Arzt, wenn Sie während der Behandlung schwanger werden oder vermuten, schwanger zu sein.

Breastfeeding

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known whether Zynyz passes into breast milk.

Do not breast-feed during treatment and for 4 months after the last dose.

What other medications affect Zynyz?

Tell your doctor about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

How do I get Zynyz?

Your doctor will give you Zynyz into your vein through an intravenous line (IV) over 30 minutes.

Zynyz is usually given every 4 weeks. Your doctor will decide how many treatments you need.

Your doctor will do blood tests to check for side effects.

If you miss an appointment, call your doctor as soon as possible to reschedule your appointment.

Dosage information

Usual adult dose for Merkel cell carcinoma

500 mg as an intravenous infusion over 30 minutes every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.

Use: For the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

Zynyz side effects

Zynyz can cause serious side effects. See Important Information.

The most common side effects include:

• Müdigkeit
• Muskel- und Knochenschmerzen
• Juckreiz
• Durchfall
• Ausschlag
• Fieber
• Brechreiz

These are not all possible side effects. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

General information about using Zynyz safely and effectively

Sometimes medications are prescribed for purposes other than those listed in the medication guide. If you would like more information, contact your doctor. You can ask your doctor for information intended for healthcare professionals.

What ingredients does Zynyz contain?

Active ingredient:Retifanlimab-dlwr
Inactive ingredients:Glacial acetic acid, polysorbate 80, sodium acetate, sucrose and water for injections.

References

1. Zynyz-Produktetikett

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