Fulphila Side Effects
Generic name: pegfilgrastim
Note: This document provides detailed information about Fulphila.
Applies to pegfilgrastim: subcutaneous solution Side Effects associated with pegfilgrastim. Some dosage forms listed on this page may not apply specifically to the brand name Fulphila.
Applies to pegfilgrastim: subcutaneous solution.
Precautions
It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If you or your child have left upper stomach pain or shoulder tip pain, contact your doctor right away. This could be a symptom of a serious side effect with the spleen.
Check with your doctor right away at the first sign of any infection such as fever, chills, cough, sore throat, or redness, swelling, or pain around a cut or sore.
Check with your doctor right away if you or your child develop a fever, chest pain or tightness, fast breathing, or trouble breathing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).
This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.
You should not use this medicine for 14 days before and up to 24 hours after you receive cancer medicines.
If you are receiving this medicine via the On-body Injector (OBI) for Neulasta®:
- Tell your doctor if you have an allergy to acrylic adhesives.
- Keep the injector at least 4 inches away from electrical equipment, such as cell or cordless phones, microwaves, and other appliances.
- Do not use hot tubs or saunas while you are wearing the injector. Do not expose the injector to sunlight. Do not sleep on the injector. Call your doctor if the injector comes off before or during a dose.
- Keep the injector dry at least 3 hours before the dose is scheduled to start. This will help you notice any leaks. Call your doctor if the bandage becomes wet or the medicine is dripping.
- The injector is programmed to deliver your dose about 27 hours after it is placed on your skin. It will take about 45 minutes for the dose to be given. Avoid activities, such as driving and traveling, that may interfere with the injector 1 hour before the dose starts, while it is being given, and for at least 1 hour afterward. You must have a caregiver nearby for your first dose.
- You should avoid airport X-ray scans and request a manual pat down instead.
- You should avoid sleeping on the OBI for Neulasta® or applying pressure on the OBI for Neulasta®. Doing so may prevent the OBI from working properly.
- You should avoid getting body lotions, creams, oils, and cleaning agents near the OBI for Neulasta® as these products may loosen the adhesive that holds the OBI into your body.
This medicine may cause kidney problems. Call your doctor right away if you or your child has swelling in the face or ankles, blood in the urine, or decrease in how much or how often you urinate.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor right away if you or your child has black or tarry stools, bleeding gums, blood in the urine or stools, pinpoint red spots on the skin, or unusual bleeding or bruising after receiving this medicine.
This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.
This medicine may cause blood or bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer. Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may cause aortitis (inflammation of the aorta, the largest artery in the body). Check with your doctor right away if you have fever, stomach pain, unusual tiredness or weakness, or back pain.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, bone tests).
Serious side effects of Fulphila
Along with its needed effects, pegfilgrastim (the active ingredient contained in Fulphila) 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:
More common side effects
- chills
- cough
- fever
- sore throat
- ulcers, sores, or white spots in the mouth
Rare side effects
- bluish lips or skin
- pain, left upper abdomen or shoulder
- tightness in the chest
- trouble breathing
Incidence not known
- 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
- blisters in the skin
- blood in the urine or stools
- chest pain
- cloudy urine
- decrease in how much or how often you urinate
- difficulty with swallowing
- dizziness
- fainting or lightheadedness
- fast heartbeat
- flushing or redness of the skin
- hives or welts, skin rash
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- nausea
- painful or difficult urination
- pinpoint red spots on the skin
- sores on the skin
- stomach pain
- swelling of the hands, ankles, feet, or lower legs
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusually warm skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking pegfilgrastim:
Symptoms of overdose
- bone pain
- chest pain
- difficult or labored breathing
- eye pain
- general feeling of illness
- headache
Other side effects of Fulphila
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 side effects
- belching
- change in sense of taste
- constipation
- cracked lips
- diarrhea
- hair loss or thinning of the hair
- heartburn
- indigestion
- joint pain
- lack or loss of strength
- loss of appetite
- muscle soreness
- swelling or inflammation of the mouth
- trouble sleeping
- vomiting
- weakness, generalized
- weight loss
Incidence not known
- body produces substance that can bind to drug making it less effective or cause side effects
For healthcare professionals
Applies to pegfilgrastim: subcutaneous solution.
General adverse events
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]
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References
1. (2002) "Product Information. Neulasta (pegfilgrastim)." Amgen
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
Frequently asked questions
- What are biosimilar drugs and how do they compare to biologics?
- What is the difference between Fulphila and Neulasta?
- How is Fulphila injected / administered?
- Is Fulphila a chemo drug?
- What is the difference between Udenyca and Fulphila?
- What does cbqv stand for in pegfilgrastim?
- What biosimilars have been approved in the United States?
- What is the difference between Udenyca and Neulasta?
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Further information
Fulphila 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.