Lonquex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lipegfilgrastim 10 mg/mL;  ;  

Available from:

Teva Pharma (New Zealand) Limited

Dosage:

6 mg/0.6mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Lipegfilgrastim 10 mg/mL     Excipient: Acetic acid Polysorbate 20 Sodium hydroxide Sorbitol Water for injection

Prescription type:

Prescription

Therapeutic indications:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Type1 0.6mL, with stainless steel 29G needle and bromobutyl stopper + needle guard safety device - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 days not refrigerated stored at or below 25°C protect from light

Authorization date:

2017-05-01

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Lonquex
®
6mg/0.6mL SOLUTION FOR INJECTION
Lonquex
®
is the Teva Pharmaceuticals Ltd. trademark for lipegfilgrastim (rbe),
a long-acting form of
recombinant human granulocyte colony-stimulating factor (G-CSF).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use pre-filled syringe of Lonquex
®
contains 6 mg of lipegfilgrastim in 0.6 mL solution. Each
mL of solution for injection contains 10 mg of lipegfilgrastim.
Lipegfilgrastim is derived from human G-CSF cells expressed by
recombinant DNA technology.
The potency of this medicinal product should not be compared to the
potency of another pegylated or
non-pegylated protein of the same therapeutic class.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Lonquex
®
is a sterile, clear, colourless, preservative-free aqueous liquid for
subcutaneous (SC)
administration, presented in a 1 mL prefilled syringe
CAS Registry Number: 1117844-87-7.
Pharmacotherapeutic group: Immunostimulants, Colony stimulating
factors,
ATC code: L03AA14
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lonquex
®
is indicated for reduction in the duration of neutropenia and the
incidence of febrile
neutropenia in adult patients treated with cytotoxic chemotherapy for
malignancy (with the exception of
chronic myeloid leukaemia and myelodysplastic syndromes).
Lonquex
®
Data Sheet V2.0
16 August 2019 _ _
_ _
Page 1 of 19_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
Lonquex
®
treatment should be initiated and supervised by physicians experienced
in oncology or
haematology.
To assess a patient’s haematologic status and ability to tolerate
myelosuppressive chemotherapy, a
complete blood count and platelet count should be obtained before
chemotherapy is administered.
The recommended dosage of Lonquex
®
is a single subcutaneous injection of 6 mg administered once
per chemotherapy cycle.
DOSAGE
One 6 mg dose of Lonquex
®
(a single pre-filled syringe of Lonquex
®
) is recommended for each
chemotherapy cycle, given approximately