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

Applies to pegfilgrastim: subcutaneous solution.

Serious side effects of Nyvepria

Along with its needed effects, pegfilgrastim (the active ingredient contained in Nyvepria) 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 immediately if any of the following side effects occur while taking pegfilgrastim:

Rare

• Chills
• cough
• eye pain
• fever
• general feeling of illness
• headache
• sore throat
• unusual tiredness

Incidence not known

• Back pain
• black, tarry stools
• bleeding gums
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bloody or cloudy urine
• blue lips, fingernails, or skin
• chest pain
• decrease or increase in the amount of urine
• difficult or fast breathing
• dry, red, hot, or irritated skin
• fainting or lightheadedness
• fast heartbeat
• feeling of fullness
• fever sores or blisters on the skin
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• lower back or side pain
• nausea
• painful or difficult urination
• pain spreading to the left shoulder
• pinpoint red spots on the skin
• redness of the skin
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swelling of the eyelids, face, lips, hands, or feet
• swollen glands
• trouble breathing or swallowing
• unusual bleeding or bruising
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking pegfilgrastim:

Symptoms of overdose

• Bone pain
• chest pain or tightness
• difficult or labored breathing
• swelling

Other side effects of Nyvepria

Some side effects of pegfilgrastim 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

• Bone, arm, or leg pain

For Healthcare Professionals

Applies to pegfilgrastim: subcutaneous solution.

General

The most commonly reported side effects included bone pain, skeletal pain, medullary bone pain, and spontaneously reversible mild to moderate lactate dehydrogenase elevations.^[Ref]

Musculoskeletal

Very common (10% or more): Bone pain (up to 31%), skeletal pain (up to 27%), medullary bone pain (up to 26%)

Common (1% to 10%): Arthralgia, back pain, extremity pain, limb pain, musculoskeletal pain, myalgia, neck pain, polyarthralgia, polymyalgia^[Ref]

Metabolic

Very common (10% or more): Spontaneously reversible mild to moderate lactate dehydrogenase elevations (up to 18%), spontaneously reversible mild to moderate alkaline phosphatase elevations (up to 11%), spontaneously reversible mild to moderate uric acid elevations (up to 11%)

Common (1% to 10%): Spontaneously reversible severe uric acid elevations

Frequency not reported: Anorexia^[Ref]

Other

Common (1% to 10%): Fever, non-cardiac chest pain, pain, pyrexia

Frequency not reported: Fatigue, generalized weakness, mucositis^[Ref]

Dermatologic

Common (1% to 10%): Alopecia, contact dermatitis

Uncommon (0.1% to 1%): Acute febrile dermatosis, cutaneous vasculitis, erythema/generalized erythema, pruritus, skin rash, Sweet's syndrome, urticaria^[Ref]

Hematologic

Common (1% to 10%): Leukocytosis, thrombocytopenia

Uncommon (0.1% to 1%): Asymptomatic splenomegaly, fatal splenic rupture, sickle cell crisis, splenic rupture, splenomegaly/enlarged spleen

Frequency not reported: Granulocytopenia, neutropenic fever^[Ref]

Local

Common (1% to 10%): Application site reactions, injection site pain

Uncommon (0.1% to 1%): Injection site erythema, injection site reactions

Postmarketing reports: Application site bruise, application site discomfort, application site hemorrhage, local skin reactions^[Ref]

Gastrointestinal

Common (1 to 10%): Diarrhea, nausea

Frequency not reported: Abdominal pain, constipation, dyspepsia, stomatitis, vomiting^[Ref]

Immunologic

Common (1% to 10%): Influenza, preexisting binding antibodies^[Ref]

Cardiovascular

Common (1% to 10%): Chest pain

Uncommon (0.1% to 1%): Capillary leak syndrome, flushing, hypotension

Rare (0.01% to 0.1%): Aortitis

Frequency not reported: Peripheral edema^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Dizziness, taste perversion^[Ref]

Ocular

Common (1% to 10%): Periorbital edema^[Ref]

Respiratory

Uncommon (0.1% to 1%): Acute respiratory distress syndrome (ARDS), dyspnea, fatal ARDS, interstitial pneumonia, pulmonary adverse reactions, pulmonary edema, pulmonary fibrosis, pulmonary infiltrates, respiratory failure^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylaxis, angioedema, hypersensitivity reactions/hypersensitivity-type reactions, serious allergic reactions

Frequency not reported: Allergies to acrylics

Postmarketing reports: Allergic reactions, allergic-type reactions, anaphylactic reactions^[Ref]

Hepatic

Uncommon (0.1% to 1%): Transient elevations in ALT, transient elevations in AST, transient elevations in liver function tests^[Ref]

Renal

Uncommon (0.1% to 1%): Glomerulonephritis^[Ref]

Oncologic

Frequency not reported: Potential for tumor growth stimulatory effects on malignant cells^[Ref]

Psychiatric

Frequency not reported: Insomnia^[Ref]