NUCALA SOLUTION FOR INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MEPOLIZUMAB

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

L04AC06

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MEPOLIZUMAB 100 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)

Therapeutic area:

MEPOLIZUMAB

Therapeutic indications:

Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientsChronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.Eosinophilic Granulomatosis with Polyangiitis (EGPA)Nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Authorization date:

2021-08-19

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
NUCALA SOLUTION FOR INJECTION
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Mepolizumab 100 mg/ml
Each 1 mL pre-filled pen contains 100 mg of mepolizumab.
For a list of inactive and allergenic ingredients in the preparation,
see section 2 –
“Important information about some of the ingredients of the
medicine” and section 6
“Further information“.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is used for the treatment of:
→ adult patients with SEVERE EOSINOPHILIC ASTHMA that does not
respond to other
treatments, in combination with additional medicines.
→ adult patients with SEVERE CHRONIC RHINOSINUSITIS WITH NASAL
POLYPS (CRSWNP),
for whom corticosteroid treatment and surgery within the past ten
years did not
provide adequate control of the disease.
The medicine is given together with intranasal corticosteroids.
→ adult patients with EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS
(EGPA) –
Churg-Strauss Syndrome.
→ adult patients with HYPEREOSINOPHILIC SYNDROME (HES) that is not
adequately
controlled, with no secondary non-hematological cause. The medicine is
given
together with other medicines.
THERAPEUTIC GROUP
Monoclonal antibody, medicines for obstructive airway diseases.
Nucala
Solution
for
Injection
contains
the
active
ingredient
MEPOLIZUMAB,
a
monoclonal antibody
, a type of protein designed to recognize a specific target
substance in the body.
Mepolizumab, the active ingredient in Nucala Solution for Injection,
blocks a protein
called interleukin-5. By blocking the activity of th

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Nucala solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nucala solution for injection in pre-filled pen
Each 1 ml pre-filled pen contains 100 mg of mepolizumab.
Mepolizumab is a humanised monoclonal antibody produced in Chinese
hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
A clear to opalescent, colourless to pale yellow to pale brown
solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe eosinophilic asthma
Nucala is indicated as an add-on treatment for severe refractory
eosinophilic asthma in adult patients.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Nucala is indicated as an add-on therapy with intranasal
corticosteroids for the treatment of adult
patients with severe CRSwNP for whom therapy with corticosteroids and
surgery in the last 10 years
do not provide adequate disease control.
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Nucala is indicated for the treatment of adult patients with
eosinophilic granulomatosis with
polyangiitis (EGPA).
Hypereosinophilic syndrome (HES)
Nucala is indicated as an add-on treatment for adult patients with
inadequately controlled
hypereosinophilic syndrome without an identifiable non-haematologic
secondary cause (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nucala should be prescribed by physicians experienced in the diagnosis
and treatment of severe
refractory eosinophilic asthma, CRSwNP, EGPA or HES.
Posology
_ _
_Severe eosinophilic _
_asthma _
_Adults _
The recommended dose of mepolizumab is 100 mg administered
subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. The need for continued
therapy should be considered at
least on an annual basis as determined by physician assessment of the
patient’s disease severity and
level of control of exacerbations
.
_CRSwNP _
_ _
_Adults _
_ _
The recommended dose of mepolizumab is 100 mg