Takeda launches CINRYZE™ in India, the first C1-I NH for prophylaxis in hereditary angioedema patients
·
CINRYZE™ is plasma-derived C1-I NH approved for
routine prevention (prophylaxis), short-term prevention or pre-procedure
prevention, and acute attacks of HAE.
·
Among adult HAE patients, 51% miss at least one day
of work (mean 3.3 days), 44% students miss at least one day of school (mean 1.9
days) and 59% miss at least one day of leisure activities (mean 2.7 days) as
result of their most recent HAE attacks.[1]
·
With strong clinical evidence, CINRYZE™ is proven
to reduce the frequency and severity of attacks with fixed dosing regimen.
New Delhi, January 2023: Takeda
Biopharmaceuticals India Private Limited (formerly known as Baxalta Bioscience
India Pvt. Ltd.), a global values-based, R&D-driven biopharmaceutical
leader launched CINRYZE™ an innovative injectable prescription medicine
for the treatment of hereditary angioedema (HAE) patients. With eight years of global
clinical experience proving efficacy and safety, CINRYZE™ has the potential to
mark a breakthrough in the episodic treatment, short and long-term prophylaxis
for HAE. Moreover, CINRYZE™ is the pioneer C1 esterase inhibitor (C1-I NH)
approved by the FDA & EMA for the symptomatic management of HAE and for preventing
future angioedema attacks.[2]
CINRYZE™ is indicated in India for:
a.
Routine prevention (prophylaxis) of angioedema
attacks in adults, adolescents and children 6 years of age and above with HAE[3].
b.
Treatment of angioedema attacks and pre-procedure
prevention of angioedema attacks in adults, adolescents and children 2 years of
age and above with HAE [3].
Speaking at the launch, Serina Fischer, General Manager, Takeda
Biopharmaceuticals India Private Limited said, “At Takeda, we are
committed to bringing innovative treatment to fulfil the unmet medical needs
across our core therapy areas. We are confident that the launch of Cinryze will
bridge the gap in the treatment of HAE patients in India. The launch furthers
our commitment towards rare diseases patients in India.”
Sony Paul, Franchise Head, Rare Diseases, Takeda Biopharmaceuticals India Private Limited added, “As per
data, there are likely to be more than 30,000[4] undiagnosed patients at present in the country.
These patients are suffering due to the lack of diagnosis and treatment.
With the launch of Cinryze, our aim is to treat acute attacks of HAE and
prevent future HAE attacks by prophylactic regime improving
the quality of life of HAE patients.”
Hereditary Angioedema (HAE) is a rare genetic condition that causes
swelling in different parts of the body like limbs, face, abdomen, and larynx [5,6]. HAE is caused by a mutation in the gene which produce
protein called the C1 esterase inhibitor leading to its reduced level or compromised
functioning. [6] Symptoms of HAE often present in childhood, and
while attacks can occur at any age, early onset may predict a more severe
disease course [6]. Attacks often occur in children without a clear
trigger,[5] and may affect a child’s participation in school,
activities, and sports, which can leave them feeling socially isolated [7,8].
It can be life-threatening in severe cases in which the swelling attacks can
manifest in the larynx (voice box), or trachea (windpipe) [5,6].
The disease is usually identified by recurrent episodes of fluid
accumulation outside the blood vessels, causing rapid swelling of body tissues.
The symptoms of HAE could be like an allergic reaction; however, the potential outcome
could be life-threatening in case of HAE. Due to the lack of awareness among
healthcare professionals, HAE is highly underdiagnosed in the country.
Takeda Biopharmaceuticals India Private Limited (formerly known as
Baxalta Bioscience India Private Limited) is a part of Takeda Pharmaceutical
Company Limited's group of companies headquartered in Japan. The company
focuses on immunology, genetic diseases, haematology, oncology and
gastrointestinal portfolios in the country. As a global leader in
pharmaceuticals, Takeda has been focusing on driving comprehensive research to
support the development of effective and innovative treatments in the company’s
chosen therapy areas.
HAE, hereditary angioedema; QoL, Quality of
life; FDA, Food and Drug Administration; EMA, European Medicines Agency
References:
1.
Lumry WR, Castaldo AJ, Vernon MK, et al. The humanistic burden of
hereditary angioedema: Impact on health-related quality of life, productivity,
and depression. Allergy Asthma Proc. 2010;31:407-14.
2.
Cinryze®. USFDA PI. March
2022. Cinryze®. SmPC EMA. October 2020
3.
CINRYZE®. Indian PI. Feb 2022.
4.
Jindal AK, Bishnoi A, Dogra S.
Hereditary Angioedema: Diagnostic Algorithm and Current Treatment Concepts.
Indian Dermatology Online Journal. 2021;12(6): 796-804.
https://doi.org/10.4103/idoj.idoj_398_21
5.
Cicardi M, Bork K, Caballero T, et al.
Evidence-based recommendations for the therapeutic management of angioedema
owing to hereditary C1 inhibitor deficiency: consensus report of an
International Working Group. Allergy. 2012; 67(2):147-157.
6.
Zuraw
BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
7.
Read N, Lim E, Tarzi MD, et al. Patient hereditary
angioedema: a survey of UK service provision and patient experience. Clin Exp
Immunol 2014; 178:473-88.
8.
Mendivil J, Murphy R, Cruz
Mdl, et al. Clinical characteristics and burden of illness in patients with
hereditary angioedema: findings from a multinational patient survey. Orphanet Journal of Rare Diseases. 2021 (16).
9.
Savarese L, Bora M, Falco RD, et al. Emotional
processes and stress in children affected by hereditary angioedema with
C1-inhibitor deficiency: a multicenter, prospective study Orphanet J Rare Dis.
2018;13:115;
10.
Castaldo AJ, Jervelund C,
Corcoran D, et al. Assessing the cost and quality-of-life impact of
on-demand–only medications for adults with hereditary angioedema. Allergy
Asthma Proc. 2021;42:108-17.
ABBREVIATED PRESCRIBING INFORMATION
CINRYZE™ 500 IU powder
C1 esterase inhibitor (human)
Qualitative
and Quantitative Composition: Each
single use powder vial contains 500 International Units (IU) of C1 inhibitor
(human) produced from the plasma of human donors, Trisodium citrate dihydrate
14.7 mg, sodium chloride 20.5 mg, L-valine 10.3mg, L-analine 6mg, L-theronine
23.5 mg and sucrose 100mg. Clinical Particulars: Therapeutic indications:
Treatment of angioedema attacks in adults, adolescents and children 2 years of
age and above with hereditary angioedema (HAE). Pre-procedure prevention of
angioedema attacks in adults, adolescents and children 2 years of age and above
with hereditary angioedema (HAE). Routine prevention (prophylaxis) of
angioedema attacks in adults, adolescents and children 6 years of age and above
with hereditary angioedema (HAE). Posology and Method of Administration: CINRYZE™
therapy is for intravenous route only. Patients may also administer CINRYZE™
after training under the guidance of health care professional. The
reconstituted product should be inspected fir particulate matter prior to
administration (do not infuse if particles are seen). The reconstituted product
should be administered by intravenous injection at a rate of 1 ml per minute. Treatment
of angioedema attacks: Adult & adolescents (12 to 17 years old): 1000
IU of CINRYZE™ at the first sign of the onset of an angioedema attack. A second
dose of 1000 IU may be administered if the patient has not responded adequately
after 60 minutes. For children 2 to 11 years who weigh > 25 kg: 1000
IU of CINRYZE™ at the first sign of the onset of an angioedema attack. A second
dose of 1000 IU may be administered if the patient has not responded adequately
after 60 minutes. For children 2 to 11 years who weigh between 10-25 kg: 500
IU of CINRYZE™ at the first sign of the onset of an angioedema attack. A second
dose of 500 IU may be administered if the patient has not responded adequately
after 60 minutes. Pre procedure Prevention of angioedema attacks. Adult
& adolescents (12 to 17 years old): 1000 IU of CINRYZE™ within 24 hours
before a medical, dental or surgical procedure. For children 2 to 11 years
who weigh > 25 kg: 1000 IU of CINRYZE™ within 24 hours before a medical,
dental or surgical procedure. For children 2 to 11 years who weigh between
10-25 kg: 500 IU of CINRYZE™ within 24 hours before a medical, dental or
surgical procedure. Routine prevention of angioedema attacks. Adults and
adolescents (12 to 17 years old): 1000 IU of CINRYZE™ every 3 or 4 days for
routine prevention against angioedema attacks. Doses up to 2,500 IU every 3 to
4 days may be considered based on individual patient response. Children 6 to
11 years of age: 500 IU of CINRYZE™ every 3 or 4 days for routine
prevention against angioedema attacks. Doses up to 1000 IU every 3 to 4 days
may be considered based on individual patient response. Contraindications: CINRYZE™
is contraindicated in patients who have manifested life-threatening immediate
hypersensitivity reactions, including anaphylaxis to the product.
Special
warnings and precautions for use.
Thrombotic events: Thrombotic events have been reported in patients receiving
CINRYZE™, and patients with known risk factors should be monitored closely.
Transmissible Agents: Standard C is made from the human blood, and it may carry
a risk of transmitting infective agents. Hyper-sensitivity: Hypersensitivity
reactions may have symptoms like angioedema attacks. Interaction with other
drugs: No interaction studies have been conducted. Fertility, Pregnancy,
and Lactation Pregnancy: It is not known that CINRYZE™ when administered to
a pregnant women can harm fetus or can affect reproduction capacity. CINRYZE™
should be given to pregnant women only when clearly indicated. It is not known
whether CINRYZE™ is excreted in human milk, and caution must be exercised when
it is administered during lactation. Effects on Ability to Drive and Use
Machines: Based upon the clinical data currently available, CINRYZE™ has a
minor influence on the ability to drive and use machines. Undesirable
Effects: The very common adverse reactions following CINRYZE™ infusion
include headache and nausea. The common adverse reactions include
hypersensitivity,
dizziness, rash, erythema,
pruritus, injection site reactions and pyrexia. The uncommon adverse reactions
include hot flush, phlebitis, venous burning and venous thrombosis. Storage
and handling instructions: Do not store above 25°C. Do not freeze. Store in
the original package in order to protect from light. After reconstitution use
the reconstituted product immediately. If immediate use is not possible,
chemical and physical in use stability has been demonstrated for 3 hours at
room temperature (150C -250C) For storage conditions after reconstitution of
the medicinal product.
Manufactured
by:
Takeda Manufacturing Austria
AG, Industriestrasse 67,1221 Vienna, Austria
Name and
Address of Imported and Marketed by :
Baxalta Bioscience India Pvt.
Ltd,
Khasra No. 1/24, 25, 3/1/1,
Gala No. 1A-1F, 2A-2E,
3B-3E and 4A-4E, Warehouse No.
1, Sector-76,
Hasanpur Darbaripur, Gurgaon,
Haryana India
Suspected Adverse Reactions
should be reported at: AE.India@takeda.com.
Consumer Care No: 00080 0050
4087
Date of Preparation of the
API: November 2022
Based on India PI-Date of
revision of text: Feb 2022
Further information is
available on request.
C-APROM/IN/CIN/0011
###
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