PDlasta® is the prolonged form of Filgrastim produced by Pooyesh Darou Biopharmaceutical Company.
PDlasta® is supplied as 6 mg / 0.6 mL prefilled syringes for subcutaneous (SC) injection.
PDlasta® same as Filgrastim, is a Colony Stimulating Factor.
PDlasta® is used for Reduction the duration of neutropenia and the occurrence of febrile neutropenia which can be caused by the use of cytotoxic chemotherapy agents.
PDlasta® (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim), which is similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body, and monomethoxypolyethylene glycol. It belongs to a group of proteins called cytokines.
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 Escherichia 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.
Both Filgrastim and pegfilgrastim are Colony Stimulating Factors that act on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. Despite the same mechanism of action, Pegfilgrastim has reduced renal clearance which results in prolonged persistence.
- After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
- The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
- Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
- The serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).
The usual dose is one 6 mg subcutaneous injection using a pre-filled syringe per chemotherapy cycle and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Some of the common side effects of PDlasta® are listed below:
- Bone pain, and general aches and pains in the joints and muscles. Your doctor will tell you what you can take to ease the bone pain.
- Nausea and headaches.
- Swelling in the arms or legs
- Pain and redness at the site of the injection.
- Hard stools (constipation). Drinking more liquids, working out, or adding fiber to your diet may help. Talk with your doctor about a stool softener or laxative.
Drugs such as lithium may potentiate the release of neutrophils; patients receiving lithium and PDlasta® should have more frequent monitoring of neutrophil counts.
Laboratory monitoring: Complete blood count and platelet count should be obtained prior to chemotherapy. Regular monitoring count of platelets and hematocrit is recommended.
Other monitoring parameters: fever, pulmonary infiltrates, respiratory distress, left upper abdominal pain, shoulder tip pain, or splenomegaly. Monitor for sickle cell crisis (in patients with sickle cell anemia).