LONDON, Sept. 17, 2019 /PRNewswire/ -- 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
"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
"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
- 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
- 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.
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:
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.,
- 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
- 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.
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
Patient Counseling Information should be shared with the
patient prior to administration.
information, please refer to the Package
Insert for full prescribing
information, available on
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.
Hikma Pharmaceuticals USA Inc.
Eatontown, NJ 07724 USA
Document identification number: WW40002
1 Hikma Pharmaceuticals USA Inc. was formerly known as West-Ward
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