Rolvedon Side Effects

Generic name: eflapegrastim

Medically reviewed by Drugs.com. Last updated on Sep 24, 2024.

Note: This document provides detailed information about Rolvedon.

Applies to eflapegrastim: subcutaneous solution Side Effects associated with eflapegrastim. Some dosage forms listed on this page may not apply specifically to the brand name Rolvedon.

Applies to eflapegrastim: subcutaneous solution.

Precautions

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

Check with your doctor right away at the first sign of an infection, including fever, chills, cough, sore throat, or unusual tiredness or weakness.

Check with your doctor right away if you are having pain in the upper left part of your stomach or at the tip of the left shoulder. This could be a symptom of a serious side effect with the spleen.

Check with your doctor right away if you develop a fever, chest pain or tightness, 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, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

This medicine may cause kidney problems. Call your doctor right away if you have swelling in your face or ankles, blood in the urine, or decrease in how much or how often you urinate.

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 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 have 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 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.

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.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests (eg, bone tests) may be affected by this medicine.

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:

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:

For healthcare professionals

Applies to eflapegrastim: subcutaneous solution.

General adverse events

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]

Gastrointestinal

• Very common (10% or more): Abdominal pain (17%), diarrhea (40%), nausea (52%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (25%)^[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]

See also:

Further information

Rolvedon 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