Pegfilgrastim

Incompatible with NaCl solutions.

Hypersensitivity (including anaphylaxis) to pegfilgrastim or filgrastim.

Patient with sickle cell trait or disease, pre-malignant or malignant myeloid conditions, recent history of pulmonary infiltrates or pneumonia. Not indicated for use in chronic myeloid leukaemia, myelodysplastic syndrome or mobilisation of peripheral blood progenitor cells for haematopoietic stem cell transplantation. Some available brands (e.g. pegfilgrastim-jmdb [Fulphila^®], pegfilgrastim-pbbk [Fylnetra^®], pegfilgrastim-apgf [Nyvepria^®], pegfilgrastim-fpgk [Stimufend^®], pegfilgrastim-cbqv [Udenyca^®], pegfilgrastim-bmez [Ziextenzo^®]) are approved by US Food and Drug Administration as biosimilars to the reference biological, pegfilgrastim (Neulasta^®). Biosimilar agents are not interchangeable with pegfilgrastim; instead, they are considered therapeutic alternatives (refer to local product-specific recommendations). Pregnancy and lactation.

Significant: Serious allergic reactions (including anaphylaxis); aortitis, thrombocytopenia, leucocytosis, anaemia; glomerulonephritis; splenomegaly, acute respiratory distress syndrome (ARDS), interstitial pneumonia; myelodysplastic syndrome and acute myeloid leukaemia (particularly in breast and lung cancer patients).
Cardiac disorders: Chest pain.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Inj site pain.
Musculoskeletal and connective tissue disorders: Bone pain, myalgia, arthralgia, pain in extremity, back pain, neck pain.
Nervous system disorders: Headache.
Potentially Fatal: Severe sickle cell crisis, capillary leak syndrome. Rarely, splenic rupture, Stevens-Johnson syndrome.

Monitor CBC with differential and platelet count before and as clinically indicated. Assess for signs or symptoms of allergic reactions, aortitis, capillary leak syndrome, acute respiratory distress syndrome and splenic rupture.

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, pegfilgrastim must be administered at least 24 hours after cytotoxic chemotherapy administration. Concomitant use with 5-fluorouracil or other antimetabolites may potentiate myelosuppression.

May interfere with bone imaging studies resulting in transient positive bone imaging changes.

Description:
Mechanism of Action: Pegfilgrastim, a biosynthetic haematopoietic agent, is a covalent conjugate of filgrastim and monomethoxypolyethylene glycol. It binds to specific cell surface receptors, thereby stimulating the production, maturation, and activation of neutrophils and increasing their migration and cytotoxicity.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 16-120 hours.
Excretion: Mainly via binding to neutrophils. Elimination half-life: 15-80 hours.

Store between 2-8°C. Do not freeze. Protect from light. Do not shake.

Các tác nhân tạo máu / Trị liệu chăm sóc nâng đỡ

L03AA13 - pegfilgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.

Amgen New Zealand Limited. Neulastim Solution for Injection data sheet 18 November 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 23/09/2024.

Anon. Pegfilgrastim. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/09/2024.

Brayfield A, Cadart C (eds). Pegfilgrastim. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2024.

Joint Formulary Committee. Pegfilgrastim. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2024.

Neulasta 6 mg Solution for Injection (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/09/2024.

Neulasta Injection (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2024.

Neulasta Pre-filled Syringes 6 mg/0.6 mL (Amgen Biopharmaceuticals Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/09/2024.

Pegfilgrastim. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/09/2024.