Pegfilgrastim Kamada

/ Kamada

Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or hematology.
Posology
One 6 mg dose (a single pre-filled syringe) of Pegfilgrastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
See prescribing information for full details.

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

Hypersensitivity to the active substance or to any of the excipients

Pulmonary adverse events
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of acute respiratory distress syndrome (ARDS). In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given.
Glomerulonephritis
Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended.
Capillary leak syndrome
Capillary leak syndrome has been reported after G-CSF administration and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
Splenomegaly and splenic rupture

Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim. Therefore, spleen size should be carefully monitored (e.g., clinical examination, ultrasound). A diagnosis of splenic rupture should be
considered in patients reporting left upper abdominal pain or shoulder tip pain.
Myelodysplastic syndrome and acute myeloid leukemia in breast and lung cancer patients
In the post-marketing observational study setting, pegfilgrastim in conjunction with chemotherapy and/or radiotherapy has been associated with development of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in breast and lung cancer patients. Monitor patients treated in these settings for signs and symptoms of MDS/AML.
Sickle cell anemia
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
Hypersensitivity
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim. Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Aortitis
Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
See prescribing information for full details.

Very common: headache, nausea, bone pain.
Common: thrombocytopenia, leukocytosis, musculoskeletal pain (myalgia), arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain), injection site pain, noncardiac chest pain.
See prescribing information for full details.

Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.

Pregnancy: There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Pegfilgrastim is not recommended during pregnancy and
in women of childbearing potential not using contraception.
Lactation: There is insufficient information on the excretion of pegfilgrastim /metabolites in human milk, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Single doses of 300 µg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.