dm+d
24118511000001107
Refrigerated Storage
LonquexTeva Pharma
Teva Pharma
Lonquex
Pre-filled syringe 6 mg lipegfilgrastim in 0.6 ml solution
In the event of an inadvertent temperature excursion the following data may be used:
Lonquex may be removed from the refrigerator and stored below 25 °C for a maximum single period of up to 3 days. Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Reduce expiry date to 3 days (from date of excursion) if exposed to the condition stated above.
13 October 2020
London MI Service
New Medicines
LonquexChemotherapy-induced neutropenia in children
Information
Lonquex
Licence extension / variation
Teva
Teva
Development and Regulatory status
None
Recommended for approval (Positive opinion)
None
Jun 22CHMP recommends a change to the indications for Lonquex to permit use in children aged 2 years and older (previously only licensed for use in adults). The proposed revised indication is use “in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)” [1].
Category
un-glycosylated recombinant methionyl human G-CS
Neutropenia means a low neutrophil count. The normal range for neutrophils is 2.5-7.5 x 109/L. Moderate neutropenia is defined as neutrophil count of 0.5-1.0 x 109/L. Severe neutropenia is a count of <0.5 x 109/L.
Chemotherapy-induced neutropenia in children
Subcutaneous injection