TAKHZYRO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LANADELUMAB

Available from:

TAKEDA ISRAEL LTD

ATC code:

B06AC05

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

LANADELUMAB 150 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

SHIRE PHARMACEUTICALS IRELAND LIMITED , IRELAND

Therapeutic area:

LANADELUMAB

Therapeutic indications:

Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE)in patients aged 2 years and older.

Authorization date:

2020-01-09

Patient Information leaflet

Takhzyro_PFS_171021
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
TAKHZYRO
Solution for subcutaneous injection in a pre-filled syringe
COMPOSITION:
ACTIVE INGREDIENT AND ITS QUANTITY: lanadelumab 300 mg/2 ml.
INACTIVE INGREDIENTS: see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your 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 to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Takhzyro is intended for use in adults and adolescents aged 12 years
and older to prevent angioedema
attacks in patients with hereditary angioedema (HAE).
THERAPEUTIC GROUP: Other hematological agents, medicines used for
hereditary angioedema.
WHAT HEREDITARY ANGIOEDEMA (HAE) IS
HAE is an inherited condition which runs in families. With this
condition your blood does not contain
enough of a protein called 'C1 inhibitor', or C1 inhibitor does not
work properly. This leads to too high
level of 'plasma kallikrein', which in turn produces higher levels of
bradykinin in your blood. Too high
levels of bradykinin lead to symptoms of HAE like swelling and pain in
the,
•
hands and feet
•
face, eyelids, lips or tongue
•
voice-box (larynx), which may cause difficulty breathing
•
genitals
HOW TAKHZYRO WORKS
Takhzyro is a type of protein that blocks the activity of plasma
kallikrein. This helps to reduce the
amount of bradykinin in your bloodstream and prevents symptoms of HAE.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
you are sensitive (allergic) to the active ingredient – lanadelumab,
or to any of the other ingredients
of this medicine (see the list of inactive ingredients in section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
•
Talk to your docto

Summary of Product characteristics

1
Takhzyro_SPC_171021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TAKHZYRO
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One unit (vial or pre-filled syringe) contains 300 mg of lanadelumab*
in 2 mL solution.
*
Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Solution for injection in pre-filled syringe.
The solution is colourless to slightly yellow, appearing either clear
or slightly opalescent.
The solution 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 (HAE)
in patients aged 12 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be initiated under the supervision of a
physician experienced in the
management of patients with hereditary angioedema (HAE).
Posology
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.
TAKHZYRO is not intended for treatment of acute HAE attacks (see
section 4.4)
_Missed doses _
If a dose of TAKHZYRO is missed, the patient should be instructed to
administer the dose as soon as
possible ensuring at least 10 days between doses.
Special populations
_ _
_Elderly _
2
Takhzyro_SPC_171021
Age is not expected to affect exposure to lanadelumab. No dose
adjustment is required for patients
above 65 years of age (see section 5.2).
_Hepatic impairment _
No studies have been conducted in patients with hepatic impairment.
Hepatic impairment is not
expected to affect exposure to lanadelumab. No dose adjustment is
required in patients with hepatic
impairment (see section 5.2).
_ _
_Renal impairment _
No studies have been conducted in patients with severe rena