Prab at 17:02, 22 March 2025

2025-03-22T17:02:03Z

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2025-03-17T10:19:57Z

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2025-02-10T16:18:24Z

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Deepika vegiraju at 12:48, 1 June 2023

2023-06-01T12:48:06Z

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== '''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]].

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== '''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 cell|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 ([[subcutaneou]]s 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 crisis|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 crisis|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:
* {{overdose}}
* 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|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.

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[[Category:Immunostimulants]]
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Eflapegrastim - Revision history

Prab at 17:02, 22 March 2025

Prab: CSV import

Prab: CSV import

Deepika vegiraju at 12:48, 1 June 2023