ADAKVEO 10 MGML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CRIZANLIZUMAB

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

B06AX01

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

CRIZANLIZUMAB 10 MG/ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

المجال العلاجي:

CRIZANLIZUMAB

الخصائص العلاجية:

ADAKVEO is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

تاريخ الترخيص:

2021-12-15

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
ADAKVEO
® 10 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
ACTIVE INGREDIENT
Each 1 ml contains 10 mg crizanlizumab.
Each vial contains 10 ml.
Inactive and allergenic ingredients: see section 2 “Important
information about
some of the ingredients in the medicine” and section 6 “Further
information”.
READ THIS 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 doctor 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 THIS MEDICINE INTENDED FOR?
Adakveo is indicated to reduce the frequency of vasoocclusive crises
(VOCs)
in adults and pediatric patients aged 16 years and older with sickle
cell
disease.
THERAPEUTIC GROUP: Monoclonal antibodies (mAbs)
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
• you are sensitive (allergic) to the active ingredient
crizanlizumab or to any
of the additional ingredients contained in the medicine (see section
6).
SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE
Before treatment with Adakveo, tell the doctor about your medical
condition,
including if you are pregnant or breastfeeding.
ADAKVEO MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
• INFUSION-RELATED REACTIONS. INFUSION-RELATED REACTIONS MAY OCCUR
DURING OR WITHIN 24 HOURS OF RECEIVING AN INFUSION OF ADAKVEO. The
doctor may slow down, temporarily stop, or completely stop the Adakveo
infusion if you have an infusion-related reaction. You may continue to
receive
Adakveo at a slower infusion rate and the doctor may give you certain
medicines before the infusion to lower the risk of getting an
infusion-related
reaction. The doctor should monitor you for signs and symptoms of
infusion-
related reactions and treat the s

خصائص المنتج

ADA API Nov22 V2 USPI Sep 2022
FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
ADAKVEO
®
10 mg/mL concentrate for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 10 mg
crizanlizumab.
One vial of 10 ml contains 100 mg crizanlizumab.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion, I.V
4
INDICATIONS AND USAGE
ADAKVEO
®
is indicated to reduce the frequency of vaso-occlusive crises (VOCs)
in adults and pediatric patients aged
16 years and older with sickle cell disease.
5
DOSAGE AND ADMINISTRATION
5.1
RECOMMENDED DOSAGE
Administer ADAKVEO 5 mg/kg by intravenous infusion over a period of 30
minutes at Week 0, Week 2, and every
4 weeks thereafter.
If a dose is missed, administer ADAKVEO as soon as possible.
If ADAKVEO is administered within 2 weeks after the missed dose,
continue dosing according to the patient's original
schedule.
If ADAKVEO is administered more than 2 weeks after the missed dose,
continue dosing every 4 weeks thereafter.
ADAKVEO may be given with or without hydroxyurea.
5.2
PREPARATION AND ADMINISTRATION
ADAKVEO should be prepared and administered by a healthcare
professional.
Preparation
•
Use aseptic technique to prepare the solution for infusion.
•
Calculate the dose (mg) and the total volume (mL) of ADAKVEO solution
required, and the number of ADAKVEO
vials needed based on the patient’s actual body weight.
o
Prepare 5 mg of ADAKVEO per kg of actual body weight.
•
Calculate the volume of ADAKVEO to be used according to the following
equation:
Volume
(
mL
)
=
patient′s
body weight
(
kg
)
x prescribed dose
�
5 mg
kg
�
concentration of ADAKVEO
�
10 mg
mL
�
Dilution
Dilute ADAKVEO in 0.9% Sodium Chloride Injection, USP or 5% Dextrose
Injection, USP to a total volume of 100 mL
for intravenous infusion as follows:
ADA API Nov22 V2 USPI Sep 2022
1.
Obtain the number of vials required. One vial is needed for every 10
mL of ADAKVEO.
2.
Bring vials to room temperature for a maximum of 4 ho