Drug information on Grafeel PFS (300mcg/mL) (Filgrastim) from Dr. Reddy's Laboratories

Medical Condition(s) for which Grafeel PFS (300mcg/mL) may be prescribed

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•  Most Common: Mild to moderate bone and muscle pain and allergic reaction.

•  Central Nervous System: Dizziness, fatigue and headache.

•  Skin: Rash, hair loss, inflammation of blood vessels in the skin, Sweet's syndrome, redness or swelling at the site of injection.

•  Gastrointestinal: Nausea, vomiting, mouth ulcer, constipation, loss of appetite, sore throat and diarrhea.

•  Respiratory: Shortness of breath, trouble breathing and wheezing.

•  ENT: Nosebleed.

♦ •  Musculoskeletal: Decreased bone density.

•  Potentially Fatal: Pulmonary infiltrates leading to respiratory failure or acute respiratory distress syndrome and rupture of the spleen.

Adult: SC/IV: The recommended dose is 5 to 10 mcg/kg/day for 4-7 days.

It comes as a solution for injection, administered by a healthcare provider into the vein or under the skin.

Hypersensitivity.

• Caution should be exercised in patients with history of blood cancer, sickle-cell disease; bone disease, withdraw treatment if there are signs of pulmonary infiltrate, fluid retention or heart failure, pregnancy and breastfeeding.

• Monitor complete blood count, bone density in patients with osteoporosis (long-term treatment).

• Regular examination of structure and functions of bone-marrow cells should be done in severe congenital neutropenia.

Do not stop this medication without your healthcare provider's advice.

Injection: Refrigerate at 2-8°C. Do not freeze. Keep this medication in an airtight container, and out of reach of children.

♦ Safety Labeling Changes Approved By FDA