"The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, in"...
Neulasta (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.
Neulasta is provided in two presentations:
- Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).
- On-body Injector for Neulasta is supplied with a prefilled syringe containing 0.64 mL of Neulasta in solution that delivers 0.6 mL of Neulasta in solution when used with the On-body Injector for Neulasta. The syringe does not bear graduation marks and is only to be used with the On-body Injector for Neulasta.
The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the On-body Injector for Neulasta contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.
What are the possible side effects of pegfilgrastim (Neulasta)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using pegfilgrastim and call your doctor at once if you have a serious side effect such as:
- sudden or severe pain in your left upper stomach spreading up to your shoulder;
- severe dizziness, skin rash, or flushing (warmth, redness, or tingly feeling);
- rapid breathing or feeling short of breath;
- signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or...
What are the precautions when taking pegfilgrastim (Neulasta)?
Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it or to filgrastim/tbo-filgrastim; or to other medications made in a similar way (biotechnology-produced proteins using E. coli); or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, spleen problems.
If you are scheduled only for radiation therapy, pegfilgrastim may still help your body fight off infections. Discuss the risks and benefits with your doctor.
Last reviewed on RxList: 5/9/2016
This monograph has been modified to include the generic and brand name in many instances.
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