TIDMHIK
Hikma Pharmaceuticals Plc
13 December 2017
PRESS RELEASE
Hikma launches Dihydroergotamine Mesylate Injection, USP
London, 13 December 2017 - Hikma Pharmaceuticals PLC (Hikma,
Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1
Moody's / BB+ S&P, both stable) announces that its wholly-owned
US subsidiary West-Ward Pharmaceuticals Corp. (West-Ward), has
launched Dihydroergotamine Mesylate Injection, USP, 1mg/mL.
West-Ward's Dihydroergotamine Mesylate Injection, USP is
indicated for the acute treatment of migraine headaches with or
without aura and the acute treatment of cluster headache
episodes.
According to IMS Health, US sales of Dihydroergotamine Mesylate
Injection, USP were approximately $34.8 million in the 12 months
ending October 2017.
Riad Mechlaoui, Chief Executive Officer of Injectables said, "We
are pleased to be adding Dihydroergotamine Mesylate Injection, USP
to our Injectables portfolio in the US. We have a large portfolio
of products and a pipeline of differentiated products to support
future growth."
Important safety information
Warning
Serious and/or life-threatening peripheral ischemia has been
associated with the coadministration of DIHYDROERGOTAMINE with
potent CYP 3A4 inhibitors including protease inhibitors and
macrolide antibiotics. Because CYP 3A4 inhibition elevates the
serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading
to cerebral ischemia and/or ischemia of the extremities is
increased. Hence, concomitant use of these medications is
contraindicated.
Warnings and Precautions
Dihydroergotamine Mesylate Injection, USP should not be given to
patients with ischemic heart disease (angina pectoris, history of
myocardial infarction, or documented silent ischemia) or to
patients who have clinical symptoms or findings consistent with
coronary artery vasospasm including Prinzmetal's variant
angina.
There have been reports of pleural and retroperitoneal fibrosis
in patients following prolonged daily use of injectable
Dihydroergotamine Mesylate. Rarely, prolonged daily use of other
ergot alkaloid drugs has been associated with cardiac valvular
fibrosis. Rare cases have also been reported in association with
the use of injectable Dihydroergotamine Mesylate; however, in those
cases, patients also received drugs known to be associated with
cardiac valvular fibrosis.
Dihydroergotamine Mesylate Injection, USP should not be used by
patients with documented ischemic or vasospastic coronary artery
disease. It is strongly recommended that Dihydroergotamine Mesylate
Injection, USP not be given to patients in whom unrecognized
coronary artery disease (CAD) is predicted by the presence of risk
factors (e.g., hypertension, hypercholesterolemia, smoker, obesity,
diabetes, strong family history of CAD, females who are surgically
or physiologically postmenopausal, or males who are over 40 years
of age) unless a cardiovascular evaluation provides satisfactory
clinical evidence that the patient is reasonably free of coronary
artery and ischemic myocardial disease or other significant
underlying cardiovascular disease.
The potential for adverse cardiac events exists. Serious adverse
cardiac events, including acute myocardial infarction,
life-threatening disturbances of cardiac rhythm, and death have
been reported to have occurred following the administration of
Dihydroergotamine Mesylate Injection, USP. Considering the extent
of use in patients with migraine, the incidence of these events is
extremely low.
Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other
cerebrovascular events have been reported in patients; and some
have resulted in fatalities. In a number of cases, it appears
possible that the cerebrovascular events were primary, the
Dihydroergotamine Mesylate Injection, USP having been administered
in the incorrect belief that the symptoms experienced were a
consequence of migraine, when they were not. Patients with migraine
may be at increased risk of certain cerebrovascular events (e.g.,
stroke, hemorrhage, transient ischemic attack).
Dihydroergotamine Mesylate Injection, USP, like other ergot
alkaloids, may cause vasospastic reactions other than coronary
artery vasospasm. Myocardial, peripheral vascular, and colonic
ischemia have been reported.
Dihydroergotamine Mesylate Injection, USP associated vasospastic
phenomena may also cause muscle pains, numbness, coldness, pallor,
and cyanosis of the digits. In patients with compromised
circulation, persistent vasospasm may result in gangrene or death.
Administration should be discontinued immediately if signs or
symptoms of vasoconstriction develop.
As Dihydroergotamine Mesylate Injection, USP may increase blood
pressure, it should not be given to patients with uncontrolled
hypertension. Significant elevation in blood pressure has been
reported on rare occasions in patients with and without a history
of hypertension.
Dihydroergotamine Mesylate Injection, USP 5-HT1 agonists (e.g.,
sumatriptan), ergotamine-containing or ergot-type medications or
Methysergide should not be used within 24 hours of each other.
Dihydroergotamine Mesylate Injection, USP should not be
administered to patients with hemiplegic or basilar migraine.
Dihydroergotamine Mesylate Injection, USP is contraindicated in
patients with known peripheral arterial disease, sepsis, following
vascular surgery and severely impaired hepatic or renal
function.
Administration may cause fetal harm when administered to a
pregnant woman. Dihydroergotamine possesses oxytocic properties
and, therefore, should not be administered during pregnancy. If
this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to the fetus. Dihydroergotamine Mesylate
Injection, USP should not be used by nursing mothers.
Dihydroergotamine Mesylate Injection, USP should not be used
with peripheral vasoconstrictors because the combination may cause
synergistic elevation of blood pressure.
Adverse Reactions
Serious cardiac events, including some that have been fatal,
have occurred following use of Dihydroergotamine Mesylate
injection, USP but are extremely rare. Events reported have
included coronary artery vasospasm, transient myocardial ischemia,
myocardial infarction, ventricular tachycardia, and ventricular
fibrillation. Fibrotic complications have been reported in
association with long term use of injectable Dihydroergotamine
Mesylate.
The following events derived from postmarketing experience have
been occasionally reported in patients receiving Dihydroergotamine
Mesylate Injection, USP: vasospasm, paraesthesia, hypertension,
dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash,
increased sweating, and pleural and retroperitoneal fibrosis after
long-term use of Dihydroergotamine. Extremely rare cases of
myocardial infarction and stroke have been reported. A causal
relationship has not been established.
For additional information, please refer to the Package Insert
for full prescribing information, available on
www.west-ward.com.
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate +44 (0)20 7399 2760/
Strategy and Investor Relations +44 7776 477050
Virginia Spring Investor Relations +44 (0)20 3892 4389/
Manager +44 7973 679502
West-Ward Pharmaceuticals Corp.
Keri Butler, Corporate Affairs +1 614 272 4774/ +1
and Communications 614 214 6657
FTI Consulting
Ben Atwell/ Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma Pharmaceuticals PLC is a multinational pharmaceutical
group focused on developing, manufacturing and marketing a broad
range of both branded and non-branded generic and in-licensed
products. Hikma's operations are conducted through three
businesses: 'Injectables,' 'Generics' and 'Branded,' based
primarily in the Middle East and North Africa (MENA) region, where
it is a market leader, the United States and Europe. In 2016, Hikma
achieved revenues of $1,950 million and profit attributable to
shareholders of $155 million.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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