PEG-Filastin Injection (6 mg/0.6 ml)

Indications

Patients With Cancer Receiving Myelosuppressive Chemotherapy: Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Pegfilgrastim is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Patients With Hematopoietic Subsyndrome Of Acute Radiation Syndrome: Pegfilgrastim is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation

Therapeutic Class

Hematopoietic drug

Pharmacology

Pegfilgrastim is a covalent conjugate of filgrastim and monomethoxypolyethylene glycol which binds to specific cell surface receptors of haematopoietic cells, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Dosage & Administration

Cancer patients receiving Myelosuppressive Chemotherapy: The recommended dosage of Pegfilgrastim is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. For pediatric patients weight less than 10 kg is 0.1 mg (0.01 ml)/kg, 10-20 kg is 0.15 ml, 21-30 kg is 0.25 ml & 31-44 kg is 0.4 ml. Do not administer Pegfilgrastim between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Hematopoietic Subsyndrome of Acute Radiation Syndrome: The recommended dose of Pegfilgrastim is two doses of 6 mg each, administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy) & the second dose one week after the first dose. For dosing in pediatric patients weighing less than 45 kg, refer to Myelosuppressive Chemotherapy dosing system.

Interaction

No formal drug interaction studies between Pegfilgrastim and other drugs have been performed.

Contraindications

Do not administer Pegfilgrastim to patients with a history of serious allergic reactions to Pegfilgrastim or Filgrastim.

Side Effects

Bone or musculoskeletal pain, hypersensitivity reactions (e.g. urticaria, skin rash, angioedema, erythema, flushing, dyspnoea, hypotension, cutaneous vasculitis, SC tissue disorders), splenomegaly, glomerulonephritis, leukocytosis, pulmonary AR (e.g. interstitial pneumonia; pulmonary oedema, infiltrates and fibrosis).

Pregnancy & Lactation

Pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Pegfilgrastim should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Lactation: It is not known whether Pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.

Precautions & Warnings

Mifepristone & Misoprostol combination should not give to anyone else. Administration must be under the supervision of a qualified physician. The combination of Mifepristone & Misoprostol has been prescribed for the patients specific condition, it may not be the correct treatment for another patients, and may be dangerous to the other women if she is or were to become pregnant. Any intrauterine device (IUD) should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation. Patients who have an ongoing pregnancy at last visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA (Manual vaccum Aspiration) is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Overdose Effects

The maximum amount of Pegfilgrastim that can be safely administered has not been determined.

Storage Conditions

Pegfilgrastim should be stored at 2-8° C & avoid shaking before injection. Don’t store it at room temperature for more than 48 hours. Do not administer this product if discoloration or particulates are observed.