Note: This document contains side effect information about eflapegrastim. Some dosage forms listed on this page may not apply to the brand name Rolvedon.
Applies to eflapegrastim: subcutaneous solution.
Serious side effects of Rolvedon
Along with its needed effects, eflapegrastim (the active ingredient contained in Rolvedon) 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 eflapegrastim:
More common
- Black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- bone pain
- pain in the arms or legs
- pale skin
- pinpoint red spots on the skin
- stomach pain
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Back pain
- blue lips, fingernails, or skin
- blurred vision
- change in the amount of urine
- chest pain or tightness
- chills
- cloudy or bloody urine
- cough
- difficult or fast breathing
- difficulty swallowing
- dizziness
- eye pain
- fainting or lightheadedness
- fast heartbeat
- feeling of fullness
- fever
- fever sores on the skin
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- lower back or side pain
- nausea
- nervousness
- pain spreading to the left shoulder
- painful or difficult urination
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- slow or fast heartbeat
- sore throat
- sores, welts, or blisters
- swelling of the hands, ankles, feet, or lower legs
- ulcers or white spots on the lips or in the mouth
Other side effects of Rolvedon
Some side effects of eflapegrastim 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
- Decreased appetite
- diarrhea
- feeling of warmth
- muscle or joint pain
- redness of the face, neck, arms and occasionally, upper chest
Incidence not known
- 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
For Healthcare Professionals
Applies to eflapegrastim: subcutaneous solution.
Dermatologic
Very common (10% or more): Rash (25%)[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (17%), diarrhea (40%), nausea (52%)[Ref]
General
This drug was clinically studied in patients with early-stage breast cancer. The most common adverse reactions, occurring with a frequency of 20% or greater, were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain. Four percent of patients reported permanent discontinuation of this drug due to an adverse reaction.[Ref]
Hematologic
Very common (10% or more): Anemia (25%), flushing (10%), thrombocytopenia (14%)[Ref]
Local
Very common (10% or more): Local administration reactions (11%)[Ref]
Metabolic
Very common (10% or more): Decreased appetite (19%)[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (21%), back pain (20%), bone pain (38%), myalgia (22%)[Ref]
Other
Very common (10% or more): Fatigue (58%), pain (12%), pain in extremity (11%), peripheral edema (18%), pyrexia (28%)[Ref]
Respiratory
Very common (10% or more): Dyspnea (16%), cough (15%)[Ref]
Nervous system
Very common (10% or more): Dizziness (16%), headache (29%)[Ref]
