Lonquex

Company: Teva Pharmaceuticals Ireland.
Legal category: Prescription. High Tech. Sport permitted. Additional monitoring required.
Active ingredient: Lipegfilgrastim 6mg/0.6ml.
Description: Solution for injection in pre-filled syringe.
Presentation: 1, €824.16.
Indication: Reduction in duration of neutropenia and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia and myelodysplastic syndromes).
Pharmacology: Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol molecule via a carbohydrate linker. It is a sustained duration form of filgrastim due to decreased renal clearance. Filgrastim is a recombinant methionyl human granulocyte colony stimulating factor [G CSF]). Human G CSF regulates the production and release of functional neutrophils from bone marrow.
Dosage: Adult: One 6mg subcutaneous injection (into abdomen, upper arm or thigh) for each chemotherapy cycle 24 hours after cytotoxic chemotherapy. Elderly: As per adults. Children: Up to 17 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substance or any of the excipients. Pregnancy, lactation.
Special precautions: May cause reversible thrombocytopenia; monitor platelet count and haematocrit regularly. Leukocytosis may occur; perform a white blood cells (WBC) count at regular intervals; if WBC counts exceed 50 x 10⁹/l after the expected nadir, discontinue immediately. Increased haematopoietic activity of bone marrow may be associated with transient positive bone imaging findings. Do not use in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia. Take care to distinguish diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia. Splenomegaly and splenic rupture, including fatal cases, reported following use of G CSF or derivatives; carefully monitor spleen size. Consider splenic rupture if left upper abdominal pain or shoulder tip pain reported. Pulmonary adverse reactions, particularly interstitial pneumonia, reported. Acute respiratory distress syndrome may occur; consider discontinuation. Caution in patients with sickle cell anaemia. Hypokalaemia may occur; monitor serum potassium level in patients at increased risk. Evaluate further if patient fails to respond to treatment. Contains sorbitol.
Drug interactions: Administer 24 hours after cytotoxic chemotherapy. Chemotherapy associated with delayed myelosuppression (not evaluated).
Adverse drug reactions: Thrombocytopenia, hypokalaemia, headache, skin reactions, musculoskeletal pains, chest pain.
Full prescribing information and references available from Teva Pharmaceuticals Ireland. Telephone: 1800 201700.