Zynyz Side Effects

Generic name: retifanlimab

Medically reviewed by Drugs.com. Last updated on Jul 30, 2024.

Note: This document provides detailed information about Zynyz.

Applies to retifanlimab: intravenous solution Side Effects associated with retifanlimab. Some dosage forms listed on this page may not apply specifically to the brand name Zynyz.

Applies to retifanlimab: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Colitis (swelling of the colon or bowel) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

This medicine may cause serious kidney problems (eg, nephritis, kidney failure). Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sores or ulcers on the skin, mouth or lips, or swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.

Pancreatitis (swelling of the pancreas) may occur while you are receiving this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Tell your doctor right away if you have changes in your eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving this medicine.

Serious side effects of Zynyz

Along with its needed effects, retifanlimab (the active ingredient contained in Zynyz) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking retifanlimab:

Other side effects of Zynyz

Some side effects of retifanlimab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to retifanlimab: intravenous solution.

General adverse events

The most common adverse reactions occurring in 10% of patients or greater included fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.

Serious adverse reactions occurred in 22% of patients treated with this drug; the most common serious adverse reactions included fatigue, arrhythmia, and pneumonitis occurring in 2% of patients or greater.^[Ref]

Cardiovascular

• Common (1% to 10%): Arrythmia
• Uncommon (less than 1%): Myocarditis, pericarditis, vasculitis, atrial fibrillation^[Ref]

Dermatologic

• Very common (10% or more): Pruritus (18%), various rashes including rash, dermatitis, dermatitis bullous, rash erythematous, rash maculo-papular, rash papular, and rash pruritic (11%)
• Frequency not reported: Exfoliative dermatitis^[Ref]

Immune-mediated skin reactions with this drug occurred in 8% of patients.

Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1) blocking antibodies.^[Ref]

Endocrine

• Very common (10% or more): Hypothyroidism (10%)
• Common (1% to 10%): Hyperthyroidism
• Uncommon (less than 1%): Adrenal insufficiency, hypophysitis, thyroiditis, Type 1 diabetes mellitus, hypoparathyroidism^[Ref]

Thyroiditis can present with or without endocrinopathy; hypothyroidism can follow hyperthyroidism.

Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts; hypophysitis can cause hypopituitarism.^[Ref]

Gastrointestinal

• Very common (10% or more): Increased lipase (30%), increased amylase (19%), diarrhea (15%), nausea (10%)
• Common (1% to 10%): Colitis
• Uncommon (less than 1%): Pancreatitis, gastritis, duodenitis
• Frequency not reported: Cytomegalovirus colitis^[Ref]

Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1 blocking antibodies.^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (38%), decreased lymphocytes (29%), decreased neutrophils (13%), decreased leukocytes (12%)
• Uncommon (less than 1%): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), immune thrombocytopenic purpura^[Ref]

Hepatic

• Very common (10% or more): Increased aspartate aminotransferase (23%), increased alanine aminotransferase (21%)
• Common (1% to 10%): Hepatitis^[Ref]

Immunologic

• Common (1% to 10%): Anti-drug antibodies (ADAs)
• Uncommon (less than 1%): Sarcoidosis, solid organ transplant rejection, systemic inflammatory response^[Ref]

ADAs occurred in 2.9% of patients on this drug; the significance is not clearly understood.^[Ref]

Local

• Uncommon (0.1% to 1%): Infusion-related reactions^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain including arthralgia, back pain, bone pain, pain in extremity, neck pain, and myalgia (22%)
• Uncommon (less than 1%): Myositis/polymyositis, rhabdomyolysis, arthritis, polymyalgia rheumatica, eosinophilic fasciitis, polyarthritis^[Ref]

Nervous system

• Uncommon (less than 1%): Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy, demyelinating polyneuropathy, radiculopathy^[Ref]

Ocular

• Uncommon (less than 1%): Uveitis, iritis, retinal detachment, visual impairments including blindness^[Ref]

Oncologic

• Uncommon (less than 1%): Disease progression of chronic lymphocytic leukemia^[Ref]

Other

• Very common (10% or more): Fatigue including asthenia (28%), decreased sodium (23%), increased alkaline phosphatase (20%), pyrexia (10%)
• Common (1% to 10%): Decreased potassium, increased calcium
• Frequency not reported: Allogeneic hematopoietic stem cell transplantation (HSCT) complications^[Ref]

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.

Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).^[Ref]

Renal

• Common (1% to 10%): Nephritis
• Uncommon (less than 1%): Renal failure^[Ref]

Respiratory

• Common (1% to 10%): Pneumonitis
• Uncommon (less than 1%): Lung disorders^[Ref]

In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in those who have received prior thoracic radiation.^[Ref]

See also:

Frequently asked questions

• What are monoclonal antibodies?

Further information

Zynyz side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer