Note: This document contains side effect information about retifanlimab. Some dosage forms listed on this page may not apply to the brand name Zynyz.

Applies to retifanlimab: intravenous solution.

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:

More common

• Back pain
• black, tarry stools
• blistering, peeling, or loosening of the skin
• bone pain
• chest pain
• chills
• constipation
• cough
• depressed mood
• diarrhea
• dizziness
• dry skin and hair
• fainting
• fast or irregular heartbeat
• feeling cold
• fever
• hair loss
• hoarseness or husky voice
• itching
• joint pain
• muscle cramps and stiffness
• nervousness
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• sensitivity to heat
• slowed heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain or loss

Less common

• Bloody or cloudy urine
• dark urine
• drowsiness
• general feeling of discomfort or illness
• headache
• light-colored stools
• nausea and vomiting
• stomach cramps
• swelling of the face, feet, or lower legs
• thickening of bronchial secretions
• upper right abdominal or stomach pain
• watery or bloody diarrhea
• yellow eyes and skin

Rare

• Anxiety
• bleeding gyms
• bloating
• blurred vision
• burning feeling in the chest or stomach
• chest discomfort or tightness
• chest pain, possible moving to the left arm, neck, or shoulder
• confusion
• constipation
• darkening of the skin
• decreased amount of urine
• difficulty in breathing, chewing, swallowing, or talking
• difficulty in moving
• double vision
• drooping eyelids
• dry mouth
• eye pain or redness
• flushing
• fruit-like breath odor
• heavier menstrual periods
• inability to move the arms and legs
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• indigestion
• irritability
• joint pain, swelling, or redness
• loss of appetite
• loss of consciousness
• lower back or side pain
• mental depression
• muscle aches or cramps
• nosebleeds
• numbness or tingling in the fingers, face, or feet
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• redness, soreness, or itching skin
• seizures
• sensitivity to light
• skin rash
• stiff neck or back
• stomach pain, discomfort, or upset
• sudden numbness and weakness in the arms and legs
• sweating
• tearing
• tenderness in the stomach area
• throbbing pain

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:

More common

• Lack or loss of strength
• pain in the arms or legs

For Healthcare Professionals

Applies to retifanlimab: intravenous solution.

General

-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

-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]

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]

Endocrine

-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]

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]

Gastrointestinal

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

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]

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

-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]

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]

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]