More from PegFilgrast
Other strengths and forms by Beacon Pharmaceuticals PLC
Indications & Uses
PegFilgrast is indicated for:
Pharmacology
Pegfilgrastim is a pegylated glycoprotein and a Granulocyte Colony-Stimulating Factor (G-CSF). It regulates how the bone marrow produces and releases functional neutrophils. Chemically, pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxy polyethylene glycol.
Filgrastim is a water soluble protein made of 175 amino acids, with a molecular weight of approximately 19 kilodaltons (kD). A 20 kD monomethoxy polyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. This brings the average molecular weight of pegfilgrastim to approximately 39 kD.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Pegfilgrastim for adults is a single 6 mg injection under the skin (subcutaneous), given once per chemotherapy cycle. Don't give Pegfilgrastim between 14 days before and 24 hours after cytotoxic chemotherapy. Before giving an injectable product, look at the solution for particles and discoloration, whenever the solution and container allow it. If Pegfilgrastim is discolored or has particles in it, don't give it.
NOTE: The needle cover on the single-use pre-filled syringe contains dry natural rubber (latex), so people with latex allergies should not administer this product.
Side Effects
Splenic rupture, including fatal cases, can occur after Pegfilgrastim [Pegylated Filgrastim] is given. If a patient reports pain in the left upper abdomen or in the shoulder, check for an enlarged spleen or a ruptured spleen. Acute Respiratory Distress Syndrome (ARDS) can also occur in patients receiving this medicine. A patient who develops fever and lung infiltrates, or respiratory distress, should be evaluated for ARDS. If ARDS is confirmed, the medicine should be stopped. Serious allergic reactions, including anaphylaxis, can occur too. Most of the reported events happened on the first exposure. Allergic reactions, including anaphylaxis, can come back within days after the first anti-allergic treatment has been stopped. In patients who have a serious allergic reaction, stop the medicine permanently. Don't give it to anyone with a history of serious allergic reactions to Pegfilgrastim or Filgrastim. Patients with sickle cell disorders Severe sickle cell crises can occur in patients with sickle cell disorders who receive this medicine. Severe and sometimes fatal sickle cell crises can occur in these patients when they receive Filgrastim, the parent compound of Pegfilgrastim.
Cautions & Contraindications
Warnings & Precautions
Pegfilgrastim [Pegylated Filgrastim] can cause splenic rupture, and this can be fatal. If a patient has pain in the left upper abdomen or in the shoulder, check for an enlarged spleen or a ruptured spleen. Acute Respiratory Distress Syndrome (ARDS) can also occur. Check for ARDS in any patient who develops fever, lung infiltrates or respiratory distress. If ARDS is confirmed, stop Pegfilgrastim [Pegylated Filgrastim]. Serious allergic reactions, including anaphylaxis, can happen too. In a patient who has a serious allergic reaction, stop Pegfilgrastim [Pegylated Filgrastim] permanently.
Contraindications
Pegfilgrastim must not be given to anyone who has had a serious allergic reaction to pegfilgrastim or to filgrastim in the past.
Pregnancy & Breastfeeding
Pegfilgrastim is Pregnancy Category C. No adequate and well-controlled studies have been done in pregnant women. In pregnant rabbits given cumulative doses of about 4 times the recommended human dose (based on body surface area), Pegfilgrastim was embryotoxic and increased pregnancy loss. Signs of maternal toxicity also appeared at these doses. So Pegfilgrastim should be used in pregnancy only if the likely benefit to the mother justifies the possible risk to the fetus.
Nursing Mothers: It is not known whether Pegfilgrastim passes into human milk. Other recombinant G-CSF products pass into breast milk only poorly, and G-CSF is not absorbed orally by neonates. Even so, take caution when giving it to a nursing woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Safety and effectiveness of PegFilgrast in children have not been established.
Geriatric Use: 932 patients with cancer received PegFilgrast in clinical studies. Of these, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. The doctors found no overall differences in safety or effectiveness between patients age 65 and older and younger patients.
Renal Impairment: A study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, found that renal dysfunction had no effect on the pharmacokinetics of PegFilgrast. So the dose of PegFilgrast doesn't need to be adjusted in patients with renal dysfunction.
Overdose
No one has worked out the maximum amount of PegFilgrast that can be given safely, whether as a single dose or as repeated doses. Single subcutaneous doses of 300 mcg/kg were given to 8 healthy volunteers and 3 patients with non-small cell lung cancer, and none of them had serious adverse effects. In these patients the mean maximum Absolute Neutrophil Count (ANC) was 55x109/L, with a mean maximum WBC of 67x109/L to match. The highest ANC seen in any one person was 96x109/L, and the highest WBC was 120x109/L.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Pegfilgrastim [Pegylated Filgrastim] in a refrigerator at 2 to 8°C. Don't freeze it and don't shake it. Keep it away from light.
Drug Interactions
Common questions about PegFilgrast 6 mg/0.6 ml
What is PegFilgrast 6 mg/0.6 ml SC Injection?
PegFilgrast 6 mg/0.6 ml SC Injection is a medicine that contains Pegfilgrastim [Pegylated Filgrastim]. It is made by Beacon Pharmaceuticals PLC. It belongs to the Hematopoietic drug group of medicines.
What is PegFilgrast used for?
PegFilgrast is used for: Cancer.
What are the side effects of PegFilgrast?
Splenic rupture, including fatal cases, can occur after Pegfilgrastim [Pegylated Filgrastim] is given. If a patient reports pain in the left upper abdomen or in the shoulder, check for an enlarged spleen or a ruptured spleen.
Can I take PegFilgrast during pregnancy or while breastfeeding?
Pegfilgrastim is Pregnancy Category C. No adequate and well-controlled studies have been done in pregnant women. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much PegFilgrast?
No one has worked out the maximum amount of PegFilgrast that can be given safely, whether as a single dose or as repeated doses. Single subcutaneous doses of 300 mcg/kg were given to 8 healthy volunteers and 3 patients with non-small cell lung cancer, and none of them had serious adverse effects. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store PegFilgrast?
Keep Pegfilgrastim [Pegylated Filgrastim] in a refrigerator at 2 to 8°C. Don't freeze it and don't shake it.
Can I take other medicines with PegFilgrast?
Some medicines can interact with Pegfilgrastim [Pegylated Filgrastim], for example: Sodium Chloride. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for PegFilgrast?
PegFilgrast is a prescription (Rx) medicine. Take it as your doctor advises.