TIDMHIK
Hikma Pharmaceuticals Plc
17 September 2019
London, 17 September 2019 - Hikma Pharmaceuticals PLC (Hikma,
Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated
Ba1/stable Moody's and BB+/positive S&P) the multinational
pharmaceutical company, has launched a new prefilled syringe
capability in the US through its affiliate, Hikma Pharmaceuticals
USA Inc.(1) The first Hikma medicine available in prefilled syringe
form is Heparin Sodium Injection, USP, 5000 Units/mL.
"Medical professionals are always in need of tools that help
them improve the speed, safety and accuracy of patient care and
that is why Hikma is excited to launch our prefilled syringe
capability," said Dan Motto, Hikma's EVP of Commercial &
Business Development, US Injectables. "Our Heparin Sodium Injection
prefilled syringes are ready-to-administer and will help hospitals,
pharmacists, doctors and nurses treat patients faster, more easily
and with reduced risk. This is another example of how Hikma is
using its capabilities as a leading generic pharmaceutical company
to serve the growing needs of US medical professionals and their
patients."
"Hikma is continuously expanding its broad and deep portfolio of
essential injectable medicines" said Riad Mishlawi, President,
Hikma Injectables. "We have made significant investments in our US
manufacturing capabilities to bring this new prefilled syringe
capability to market, and Heparin is the first of many important
medicines we will deliver in this form."
Heparin Sodium Injection is indicated for:
-- Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
-- Prevention of postoperative deep venous thrombosis and
pulmonary embolism in patients undergoing major abdominothoracic
surgery or who, for other reasons, are at risk of developing
thromboembolic disease;
-- Atrial fibrillation with embolization;
-- Treatment of acute and chronic consumptive coagulopathies
(disseminated intravascular coagulation);
-- Prevention of clotting in arterial and cardiac surgery;
-- Prophylaxis and treatment of peripheral arterial embolism;
-- Anticoagulant use in blood transfusions, extracorporeal
circulation, and dialysis procedures
Hikma is the third largest US supplier of generic injectable
medicines by volume, with a growing portfolio of over 100 products.
Today one in every six injectable generic medicines used in US
hospitals is a Hikma product.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global 477050
Affairs uk-investors@hikma.com
Steven Weiss +1 732 720 2830/ +1 732 788 8279
Senior Director, Communications sweiss@hikma.com
and Public Affairs
(1) Hikma Pharmaceuticals USA Inc. was formerly known as
West-Ward Pharmaceuticals Corp
About Hikma
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
more than 40 years, we've been creating high-quality medicines and
making them accessible to the people who need them. Headquartered
in the UK, we're a global company with a local presence across the
United States (US), the Middle East and North Africa (MENA) and
Europe, and we use our unique insight and expertise to transform
cutting-edge science into innovative solutions that transform
people's lives. We're committed to our customers, and the people
they care for, and by thinking creatively and acting practically,
we provide them with a broad range of branded and non-branded
generic medicines. Together, our 8,400 colleagues are helping to
shape a healthier world that enriches all our communities. We are a
leading licensing partner, and through our venture capital arm, are
helping bring innovative health technologies to people around the
world. For more information, please visit www.hikma.com.
Important Safety Information for Heparin Sodium Injection, USP,
5000 Units/mL:
CONTRAINDICATIONS
The use of Heparin Sodium Injection is contraindicated in
patients with the following conditions:
-- History of heparin-induced thrombocytopenia and
heparin-induced thrombocytopenia and thrombosis;
-- Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions).
-- In whom suitable blood coagulation tests, e.g., the whole
blood clotting time, partial thromboplastin time, etc., cannot be
performed at appropriate intervals (this contraindication refers to
full-dose heparin; there is usually no need to monitor coagulation
parameters in patients receiving low-dose heparin);
-- An uncontrolled active bleeding state, except when this is
due to disseminated intravascular coagulation.
WARNINGS & PRECAUTIONS
The following warnings and precautions should be taken when
administering Heparin Sodium Injection, USP:
-- Do not use Heparin Sodium Injection as a "catheter lock
flush" product. Fatal hemorrhages have occurred in pediatric
patients due to medication errors in which 1 mL Heparin Sodium
Injection vials were confused with 1 mL "catheter lock flush"
vials.
-- Avoid using heparin in the presence of major bleeding, except
when the benefits of heparin therapy outweigh the potential
risks.
-- Hemorrhage can occur at virtually any site in patients
receiving heparin. Fatal hemorrhages have occurred. Use heparin
sodium with caution in disease states in which there is increased
risk of hemorrhage.
-- Heparin-induced thrombocytopenia (HIT) is a serious
antibody-mediated reaction. HIT may progress to the development of
venous and arterial thromboses, a condition referred to as
heparin-induced thrombocytopenia with thrombosis (HITT). Thrombotic
events may also be the initial presentation for HITT. These serious
thromboembolic events include deep vein thrombosis, pulmonary
embolism, cerebral vein thrombosis, limb ischemia, stroke,
myocardial infarction, mesenteric thrombosis, renal arterial
thrombosis, skin necrosis, gangrene of the extremities that may
lead to amputation, and possibly death. HIT or HITT can occur up to
several weeks after the discontinuation of heparin therapy.
-- Thrombocytopenia in patients receiving heparin has been
reported at frequencies up to 30%. It can occur 2 to 20 days
(average 5 to 9) following the onset of heparin therapy. Monitor
thrombocytopenia of any degree closely.
-- When using a full dose heparin regimen, adjust the heparin
dose based on frequent blood coagulation tests. If the coagulation
test is unduly prolonged or if hemorrhage occurs, discontinue
heparin promptly. Periodic platelet counts and hematocrits are
recommended during the entire course of heparin therapy, regardless
of the route of administration.
-- Resistance to heparin is frequently encountered in fever,
thrombosis, thrombophlebitis, infections with thrombosing
tendencies, myocardial infarction, cancer, in postsurgical
patients, and patients with antithrombin III deficiency.
-- Patients with documented hypersensitivity to heparin should
be given the drug only in clearly life-threatening situations.
Because Heparin Sodium Injection is derived from animal tissue, it
should be used with caution in patients with a history of
allergy.
ADVERSE REACTIONS
The following adverse reactions have been reported: hemorrhage,
heparin-induced thrombocytopenia (HIT) and heparin-induced
thrombocytopenia and thrombosis (HITT), thrombocytopenia, heparin
resistance, and hypersensitivy.
The following postmarketing adverse reactions have been
reported: hemorrhage, heparin-induced thrombocytopenia (HIT) and
heparin-induced thrombocytopenia and thrombosis (HITT) including
delayed onset cases, local irritation (erythema, mild pain,
hematoma or ulceration may follow deep subcutaneous (intrafat)
injection), histamine-like reactions (site of injection or necrosis
of skin during subcutaneous injection), hypersensitivity (chills,
fever, urticaria, asthma, rhinitis, lacrimation, headache, nausea
and vomiting, and anaphylactoid reactions including shock, itching
and burning, especially on the plantar side of the feet),
significant elevations of aminotransferases (aspartate
aminotransferase (AST) and alanine aminotransferase (ALT)),
osteoporosis following long-term administration of high doses of
heparin, cutaneous necrosis after systemic administration,
suppression of aldosterone synthesis, delayed transient alopecia,
priapism, and rebound hyperlipemia on discontinuation of
heparin.
Patient Counseling Information should be shared with the patient
prior to administration.
For additional information, please refer to the Package Insert
here
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7014808d-cec9-4b2c-8eb5-940493e356ab
for full prescribing information, available on www.hikma.com.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or
call 1-800-FDA-1088.
Manufactured by:
Hikma Pharmaceuticals USA Inc.
Eatontown, NJ 07724 USA
Document identification number: WW40002
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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