ZYNYZ 25 mg/mL
retifanlimab-dlwr · INJECTION · Incyte Corporation
ZYNYZ is a injection containing retifanlimab-dlwr at 25 mg/mL, taken intravenous. Manufactured by Incyte Corporation.
Key Facts
- Brand Name
- ZYNYZ
- Generic Name
- retifanlimab-dlwr
- NDC Code (Product)
50881-006- Manufacturer
- Incyte Corporation
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761334
- Drug Class
- Programmed Death Receptor-1 Blocking Antibody [EPC]
- Marketing Start
- 03/22/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). ( 1.2 ) 1.1 Squamous Cell Carcinoma of the Anal Canal ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ZYNYZ, as a single agent, is indicated for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum‑based chemotherapy. 1.2 Merkel Cell Carcinoma ZYNYZ is indicated for the treatment of adult pat…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer ZYNYZ as an intravenous infusion over 30 minutes after dilution ( 2.3 ): For Squamous Cell Carcinoma of the Anal Canal (SCAC), in combination with carboplatin and paclitaxel, or as a single agent ( 2.1 ): 500 mg every 4 weeks, or 375 mg every 3 weeks For Merkel Cell Carcinoma (MCC) ( 2.1 ): 500 mg every 4 weeks See full prescribing information for dosage modifications for adverse reactions ( 2.2 ) and preparation and administration instructions. ( 2.3 ) 2.1 Recommended Dosage The recommended dosages of ZYNYZ are provided in Table 1. Administer ZYNYZ as an intravenous infusion after dilution, over 30 minutes, as recommended [see Dosage and Administration ( 2.3 )] . Table 1: Recommended Dosage of ZYNYZ Indication Recommended Dosage of ZYNYZ Duration of Treatment Combination Therapy Refer to the Prescribing Information for the agents administered in combination with ZYNYZ for recommended dosing information, as appropriate. Adult patients with inoperable locally recurrent or metastatic SCAC in combination with carboplatin and paclitaxel 500 mg every 4 weeks or 375 mg every 3 weeks Until disease progression, unacceptable toxicity, or up to 12 month…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling. Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions ( 5.1 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.2 )] Complications of Allogeneic HSCT [see Warnings and Precautions ( 5.3 )] ZYNYZ in Combination with Carboplatin and Paclitaxel In patients with SCAC, the most common (≥ 20%) adverse reactions are fatigue, peripheral neuropathy, nausea, alopecia, diarrhea, musculoskeletal pain, constipation, hemorrhage, rash, vomiting, decreased appetite, pruritus, and abdominal pain. ( 6.1 ) ZYNYZ as a Single Agent In patients with SCAC, the most common (≥ 10%) adverse reactions are fatigue, musculoskeletal pain, diarrhea, non-urinary tract infections, perineal pain, hemorrhage, urinary tract infection, rash, nausea, decreased appetite, constipation, abdominal pain, dyspnea, pyrexia, vomiting, cough, pruritus, hypothyroidism, headache, and decreased weight. ( 6.1 ) In patients with MCC, the most common (≥ 10%) adverse reactions are musculoskeletal pain, fatigue, pruritus, diarrhea, rash, pyrexia, nausea, and constipation. ( 6.1 ) To report SUSPECTED ADVERS…
Frequently Asked Questions
What is ZYNYZ used for?
ZYNYZ contains retifanlimab-dlwr. It is a injection taken intravenous. Consult your doctor for specific uses.
Is ZYNYZ a controlled substance?
ZYNYZ is not classified as a controlled substance by the DEA.
What is the generic name for ZYNYZ?
The generic name for ZYNYZ is retifanlimab-dlwr. There are no other listed brand versions of retifanlimab-dlwr.
What is the NDC code for ZYNYZ 25 mg/mL?
The NDC (National Drug Code) for ZYNYZ 25 mg/mL is 50881-006, listed by Incyte Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)