Pegtima® (pegfilgrastim)

A biologic indicated for the treatment of autoimmune and inflammatory diseases, offering high efficacy and a favorable safety profile.

Pegtima®

Active Ingredient: Pegfilgrastim

Indications for Pegfilgrastim

Pegtima® contains the active ingredient pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacterium called E. coli. It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.

Pegtima® is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count accompanied by fever), which may be caused by the use of cytotoxic chemotherapy (medications that rapidly destroy developing cells). White blood cells are important because they help your body fight infections.

These cells are sensitive to the effects of chemotherapy, which may cause their number to decrease in your body. If the number of white blood cells falls to a low level, there may not be enough of these cells in the body to fight bacteria, and you may be at increased risk of infection.

Concentration:

Each 0.6 mL prefilled syringe contains:
Pegfilgrastim…………………………………………………………….6 mg

Excipients: acetic acid, sorbitol, polysorbate 20, sodium hydroxide, and water for injection.

Pegfilgrastim consists of filgrastim (recombinant methionyl human G-CSF) with a 20 kDa polyethylene glycol (PEG) molecule covalently bound to the N-terminal methionine residue. Filgrastim is produced by recombinant DNA technology in E. coli (K12).

Presentation:

Box containing 1 prefilled syringe with 0.6 mL of injectable solution containing 6 mg of pegfilgrastim.

SUBCUTANEOUS USE
ADULT USE

Contraindications:

Do not use Pegtima® if you are allergic to pegfilgrastim, filgrastim, proteins derived from E. coli, or any other ingredient in this medication.

This medication is contraindicated for individuals under 18 years of age.

Specifications

Type of medication:

Biological - growth factor (pegylated).

Mechanism of Action:

RHG-CSF.

Therapeutic Area:

Onco-Hematology.

Prescription needed?

Sold by prescription only.
Restricted to healthcare establishments.

Storage conditions:

Store refrigerated at 2°C to 8°C. Do not freeze. Keep the syringe in the original carton to protect it from light. Do not shake.

Administration route:

Subcutaneous (SC). Adult use.

M.S. Registration: 1.4531.0001.001-8

10 MG/ML SOL INJ CT SER VD TRANS PREENC X 0.6 ML