Eflapegrastim

What is Eflapegrastim?

• Eflapegrastim (Rolvedon) is a granulocyte colony-stimulating factor (G‑CSF) produced by covalent coupling of a human G-CSF analog (18.6 kDa) and an Fc fragment of human immunoglobulin G4 (IgG4) (49.8 kDa), both derived from recombinant E. coli, via a single 3.4 kDa polyethylene glycol linker.
• The recombinant G-CSF domain in eflapegrastim-xnst is a variant of human G-CSF with two serine substitutions at positions 17 and 65, and no additional N-terminal methionine.

What are the uses of this medicine?

• Eflapegrastim (Rolvedon) is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body.
• It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Limitations of use:

• Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

How does this medicine work?

• A long-acting, recombinant analog of the endogenous human granulocyte colony-stimulating factor (G-CSF) with hematopoietic activity.
• Similar to G-CSF, eflapegrastim binds to and activates specific cell surface receptors and stimulates neutrophil progenitor proliferation and differentiation, as well as selected neutrophil functions.
• Therefore, this agent may decrease the duration and incidence of chemotherapy-induced neutropenia.
• Eflapegrastim extends the half-life of G-CSF, allowing for administration once every 3 weeks.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a serious allergic reaction to eflapegrastim, pegfilgrastim or filgrastim products.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Eflapegrastim was approved for medical use in the United States in September 2022.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Rolvedon is a single subcutaneous injection of 13.2 mg administered once per chemotherapy cycle.
• Administer approximately 24 hours after cytotoxic chemotherapy.
• Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy.

Administration:

• Rolvedon is given as an injection under your skin (subcutaneous injection) by a healthcare provider.
• You will receive 1 injection of Rolvedon for each cycle of chemotherapy.
• You will receive your injection of Rolvedon about 24 hours after you finish receiving your chemotherapy.
• You should not receive Rolvedon for 14 days before or within 24 hours after your dose of chemotherapy.
• If you miss a dose of Rolvedon, talk to your healthcare provider about when you should receive your next dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 13.2 mg/0.6 mL solution in a single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• Rolvedon

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness
• nausea
• diarrhea
• bone pain
• headache
• fever
• decreased red blood cell count
• rash
• muscle and joint pain
• back pain

Less common, but serious side effects may include:

• Spleen rupture
• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS
• Serious allergic reactions
• Sickle cell crises
• glomerulonephritis
• leukocytosis
• thrombocytopenia
• Capillary Leak Syndrome
• Myelodysplastic syndrome and acute myeloid leukemia
• aortitis

What special precautions should I follow?

• Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products, such as Rolvedon. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
• Acute respiratory distress syndrome (ARDS) can occur in patients receiving rhG-CSF products, such as Rolvedon. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Rolvedon in patients with ARDS.
• Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products, such as Rolvedon. Permanently discontinue Rolvedon in patients with serious allergic reactions.
• Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products, such as Rolvedon. Discontinue Rolvedon if sickle cell crisis occurs.
• Glomerulonephritis has occurred in patients receiving rhG-CSF products. Evaluate and consider dose-reduction or interruption of Rolvedon if causality is likely.
• White blood cell (WBC) counts of 100 x 10 9/L or greater have been observed in patients receiving rhG-CSF products.
• Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.
• Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
• If you have breast cancer or lung cancer, when Rolvedon is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Rolvedon.
• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging findings.
• It is not known if Rolvedon passes into your breast milk.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• leukocytosis and bone pain

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdose, general supportive measures should be instituted as necessary.
• Monitor the patient for adverse reactions.

Can this medicine be used in pregnancy?

• It is not known if Rolvedon can harm your unborn baby.
• Tell your healthcare provider right away if you become pregnant during treatment with Rolvedon.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: eflapegrastim-xnst
• Inactive ingredients: citric acid monohydrate, mannitol, polysorbate 80, sodium chloride in Water for Injection. Sodium hydroxide may be used to adjust pH to 5.5 during manufacturing.

Who manufactures and distributes this medicine?

Manufactured by: Spectrum Pharmaceuticals, Inc.

Von Karman Avenue, Suite 700, Irvine, CA, USA

What should I know about storage and disposal of this medication?

• Store refrigerated at 36°F to 46°F (2°C to 8°C) in the carton to protect from light.
• Do not shake.
• Discard syringes stored at room temperature for more than 12 hours.
• Do not freeze; discard syringe if frozen.

• Dailymed label info on Eflapegrastim
• FDA Eflapegrastim

Eflapegrastim Resources
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Eflapegrastim Resources
Latest articles Most recent articles Ongoing trials	Wikipedia