TAKHZYRO

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Lanadelumab 150 mg/mL;  

Disponible desde:

Takeda New Zealand Limited

Dosis:

300 mg/2mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Lanadelumab 150 mg/mL   Excipient: Citric acid monohydrate Dibasic sodium phosphate dihydrate Histidine Polysorbate 80 Sodium chloride Water for injection

tipo de receta:

Prescription

indicaciones terapéuticas:

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angiodema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years or older.

Resumen del producto:

Package - Contents - Shelf Life: Syringe, glass, - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Vial, glass, single dose, 2 mL type 1 with chlorobutyl rubber stopper - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light

Fecha de autorización:

2019-06-04

Ficha técnica

NEW ZEALAND DATA SHEET
TAKHZYRO V4 (CCDS V5)
1
1 PRODUCT NAME
TAKHZYRO 300 mg/2 mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanadelumab 300 mg/2 mL
Each pre-filled syringe or vial contains 300 mg of lanadelumab in 2 mL
(150 mg per mL) solution.
Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA technology.
_Excipient with known effect: _
Each mL of solution contains 3.45 mg (0.150 mmol) of sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for injection.
The solution is colourless to slightly yellow, appearing either clear
or slightly opalescent. It has a pH
of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
TAKHZYRO is indicated for routine prevention of recurrent attacks of
hereditary angioedema (C1-
esterase-inhibitor deficiency or dysfunction) in patients aged 12
years and older.
4.2
Dose and method of administration
TAKHZYRO therapy should be initiated under supervision of a physician
experienced in the care of
patients with hereditary angioedema (HAE).
Dose
The recommended starting dose is 300 mg lanadelumab every 2 weeks. In
patients who are stably
attack free on treatment, a dose reduction of 300 mg lanadelumab every
4 weeks may be
considered, especially in patients with low weight.
_Special populations _
Elderly:
Limited information is available on patients above 65 years of age.
Available data indicates that no
dose adjustment is required for patients above 65 years of age.
Hepatic impairment:
No studies have been conducted in patients with hepatic impairment.
Renal impairment:
No studies have been conducted in patients with renal impairment.
Paediatric population:
The safety and efficacy of TAKHZYRO in children aged <12 years has not
been established and
therefore treatment in children aged <12 years is not recommended.
NEW ZEALAND DATA SHEET
TAKHZYRO V4 (CCDS V5)
2
Method of administration
TAKHZYRO is administered subcutaneo