LONDON, June 15,
2023 /PRNewswire/ -- Hikma Pharmaceuticals
PLC (Hikma), the multinational pharmaceutical company,
has launched Dobutamine Injection, USP, in a 250mg/20mL vial
in the US. With this launch, Hikma's growing US portfolio of
sterile injectable medicines now exceeds 150 products spanning a
wide range of therapeutic areas and dosage forms.
"Our portfolio of more than 150 injectable medicines has
expanded by more than 50 percent over the last three
years1, driven by customer needs, an expansion of our
capabilities and product offerings, and the continued recognition
of Hikma as a reliable, high-quality supplier of sterile
injectable medicines," said Riad Mishlawi, President, Injectables,
Hikma. "As a top-three supplier of generic injectable medicines by
volume in the US2, we are proud of the important role we
play in the US health care system. We are committed to further
growing our portfolio and capabilities and continuing to supply
essential medicines to US hospitals, doctors, and patients."
In addition to its growing US portfolio, Hikma now markets
approximately 30 sterile injectable medicines in Canada, with plans to launch up to 13
additional products this year. The Company has also launched Hikma
503B, a new sterile compounding
business focused on providing high-quality, ready-to-administer
injectable medications that are customized to the specific needs of
patients in the US.
About Dobutamine Injection, USP
Dobutamine Injection, USP has been launched in the US and
is indicated when parenteral therapy is necessary for inotropic
support in the short-term treatment of adults with cardiac
decompensation due to depressed contractility resulting either from
organic heart disease or from cardiac surgical procedures.
According to IQVIA, US sales of Dobutamine Injection, USP, in
250mg/20mL were approximately $2
million in the 12 months ending April 2023.
Enquiries
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Hikma
Pharmaceuticals PLC
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Susan
Ringdal
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+44 (0)20 7399 2760/
+44 7776 477050
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EVP, Strategic Planning
and Global Affairs
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uk-investors@hikma.uk.com
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Steve Weiss
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+1 732 788
8279
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David Belian
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+1 848 254
4875
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US Communications and
Public Affairs
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uscommunications@hikma.com
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About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated
BBB-/stable S&P and BBB-/stable Fitch)
Hikma helps put better health within reach every day for
millions of people 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 are 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
8,800 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
This product has been approved for marketing in
the United States by the US
FDA. This product approval does not confer the right on
Hikma, or any other party, to market this product outside
the United States.
Important Safety Information for Dobutamine Injection,
USP, in 250mg/20mL:
CONTRAINDICATIONS
Dobutamine is contraindicated in patients with idiopathic
hypertrophic subaortic stenosis and in patients who have shown
previous manifestations of hypersensitivity to dobutamine.
WARNINGS & PRECAUTIONS
- Increase in Heart Rate or Blood Pressure: Dobutamine may cause
a marked increase in heart rate or blood pressure, especially
systolic pressure. Approximately 10% of adult patients in clinical
studies have had rate increases of 30 beats/minute or more, and
about 7.5% have had a 50 mm Hg or greater increase in systolic
pressure. Usually, reduction of dosage promptly reverses these
effects. Because dobutamine facilitates atrioventricular
conduction, patients with atrial fibrillation are at risk of
developing rapid ventricular response. In patients who have atrial
fibrillation with rapid ventricular response, a digitalis
preparation should be used prior to institution of therapy with
dobutamine. Patients with preexisting hypertension appear to face
an increased risk of developing an exaggerated pressor
response.
- Ectopic Activity: Dobutamine may precipitate or exacerbate
ventricular ectopic activity, but it rarely has caused ventricular
tachycardia.
- Hypersensitivity: Reactions suggestive of hypersensitivity
associated with administration of dobutamine including skin rash,
fever, eosinophilia, and bronchospasm, have been reported
occasionally.
- Dobutamine contains sodium metabisulfite, a sulfite that may
cause allergic-type reactions, including anaphylactic symptoms and
life-threatening or less severe asthmatic episodes, in certain
susceptible people. The overall prevalence of sulfite sensitivity
in the general population is unknown and probably low. Sulfite
sensitivity is seen more frequently in asthmatic than in
nonasthmatic people.
- During the administration of dobutamine, as with any
adrenergic agent, ECG and blood pressure should be continuously
monitored. In addition, pulmonary wedge pressure and cardiac output
should be monitored whenever possible to aid in the safe and
effective infusion of dobutamine.
- Hypovolemia should be corrected with suitable volume expanders
before treatment with dobutamine is instituted.
- No improvement may be observed in the presence of marked
mechanical obstruction, such as severe valvular aortic
stenosis.
- Usage Following Acute Myocardial Infarction - Clinical
experience with dobutamine following myocardial infarction has been
insufficient to establish the safety of the drug for this use.
There is concern that any agent that increases contractile force
and heart rate may increase the size of an infarction by
intensifying ischemia, but it is not known whether dobutamine does
so.
- Laboratory Tests - Dobutamine, like other ß2-agonists,
can produce a mild reduction in serum potassium concentration,
rarely to hypokalemic levels. Accordingly, consideration should be
given to monitoring serum potassium.
ADVERSE REACTIONS
Increased Heart Rate, Blood Pressure, and Ventricular Ectopic
Activity - A 10- to 20-mm increase in systolic blood pressure
and an increase in heart rate of 5 to 15 beats/minute have been
noted in most patients (see WARNINGS regarding exaggerated
chronotropic and pressor effects). Approximately 5% of patients
have had increased premature ventricular beats during infusions.
These effects are dose related.
Hypotension - Precipitous decreases in blood pressure
have occasionally been described in association with dobutamine
therapy. Decreasing the dose or discontinuing the infusion
typically results in rapid return of blood pressure to baseline
values. In rare cases, however, intervention may be required and
reversibility may not be immediate.
Reactions at Sites of Intravenous Infusion - Phlebitis
has occasionally been reported. Local inflammatory changes have
been described following inadvertent infiltration. Isolated cases
of cutaneous necrosis (destruction of skin tissue) have been
reported.
Miscellaneous Uncommon Effects - The following adverse
effects have been reported in 1% to 3% of patients: nausea,
headache, anginal pain, nonspecific chest pain, palpitations, and
shortness of breath.
Isolated cases of thrombocytopenia have been reported.
Administration of dobutamine, like other catecholamines, can
produce a mild reduction in serum potassium concentration, rarely
to hypokalemic levels (see PRECAUTIONS).
DRUG INTERACTIONS
Animal studies indicate that dobutamine may be ineffective if
the patient has recently received a ß-blocking drug. In such a
case, the peripheral vascular resistance may increase.
Preliminary studies indicate that the concomitant use of
dobutamine and nitroprusside results in a higher cardiac output
and, usually, a lower pulmonary wedge pressure than when either
drug is used alone.
There was no evidence of drug interactions in clinical studies
in which dobutamine was administered concurrently with other drugs,
including digitalis preparations, furosemide, spironolactone,
lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine,
atropine, heparin, protamine, potassium chloride, folic acid, and
acetaminophen.
USE IN SPECIFIC POPULATIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility -
Studies to evaluate the carcinogenic or mutagenic potential of
dobutamine, or its potential to affect fertility, have not been
conducted.
Pregnancy–Teratogenic Effects - Reproduction studies
performed in rats at doses up to the normal human dose (10
mcg/kg/min for 24 h, total daily dose of 14.4 mg/kg), and in
rabbits at doses up to twice the normal human dose, have revealed
no evidence of harm to the fetus due to dobutamine. There are,
however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of
human response, this drug should be used during pregnancy only if
clearly needed.
Labor and Delivery - The effect of dobutamine on labor
and delivery is unknown.
Nursing Mothers - It is not known whether this drug is
excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when dobutamine is administered
to a nursing woman. If a mother requires dobutamine treatment,
breastfeeding should be discontinued for the duration of the
treatment.
Pediatric Use - Dobutamine has been shown to increase
cardiac output and systemic pressure in pediatric patients of every
age group. In premature neonates, however, dobutamine is less
effective than dopamine in raising systemic blood pressure without
causing undue tachycardia, and dobutamine has not been shown to
provide any added benefit when given to such infants already
receiving optimal infusions of dopamine.
Geriatric Use - Of the 1893 patients in clinical studies
who were treated with dobutamine, 930 (49.1%) were 65 and older. No
overall differences in safety or effectiveness were observed
between these and younger subjects. Other reported clinical
experience has not identified differences in responses between the
elderly and younger patients, but greater sensitivity of some older
individuals cannot be ruled out.
In general, dose selection for an elderly patient should be
cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or drug therapy.
DOSAGE AND ADMINISTRATION
Note - Do not add dobutamine to 5% Sodium Bicarbonate
Injection or to any other strongly alkaline solution. Because of
potential physical incompatibilities, it is recommended that
dobutamine not be mixed with other drugs in the same solution.
Dobutamine should not be used in conjunction with other agents or
diluents containing both sodium bisulfite and ethanol.
Preparation and Stability - At the time of
administration, dobutamine must be further diluted in an IV
container to at least a 50 mL solution using one of the following
intravenous solutions as a diluent: 5% Dextrose Injection, 5%
Dextrose and 0.45% Sodium Chloride Injection, 5% Dextrose and 0.9%
Sodium Chloride Injection, 10% Dextrose Injection, Isolyte® M with
5% Dextrose Injection, Lactated Ringer's Injection, 5% Dextrose in
Lactated Ringer's Injection, Normosol®-M in D5-W, 20% Osmitrol® in
Water for Injection, 0.9% Sodium Chloride Injection, or Sodium
Lactate Injection. Intravenous solutions should be used within 24
hours.
Recommended Dosage - Infusion of dobutamine should be
started at a low rate (0.5 to1mcg/kg/min) and titrated at intervals
of a few minutes, guided by the patient's response, including
systemic blood pressure, urine flow, frequency of ectopic activity,
heart rate and (whenever possible) measurements of cardiac output,
central venous pressure, and/or pulmonary capillary wedge pressure.
In reported trials, the optimal infusion rates have varied from
patient to patient, usually 2 to 20 mcg/kg/min but sometimes
slightly outside of this range. On rare occasions, infusion rates
up to 40 mcg/kg/min have been required to obtain the desired
effect. Rates of infusion (mL/h) for dobutamine concentrations of
500 mcg/mL, 1000 mcg/mL, and 2000 mcg/mL necessary to attain
various delivery rates of dobutamine (mcg/kg/min) for patients of
different weights are given in the tables below.
Concentrations of up to 5,000 mcg/mL have been administered to
humans (250 mg/50 mL). The final volume administered should be
determined by the fluid requirements of the patient.
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration,
whenever solution and container permit.
OVERDOSAGE
Overdoses of dobutamine have been reported rarely. The following
is provided to serve as a guide if such an overdose is
encountered.
Signs and Symptoms - Toxicity from dobutamine is usually
due to excessive cardiac ß-receptor stimulation. The duration of
action of dobutamine is generally short (T1/2= 2 minutes) because
it is rapidly metabolized by catechol-0-methyltranferase. The
symptoms of toxicity may include anorexia, nausea, vomiting,
tremor, anxiety, palpitations, headache, shortness of breath, and
anginal and nonspecific chest pain. The positive inotropic and
chronotropic effects of dobutamine on the myocardium may cause
hypertension, tachyarrhythmias, myocardial ischemia, and
ventricular fibrillation. Hypotension may result from
vasodilation.
Treatment - To obtain up-to-date information about the
treatment of overdose, a good resource is your certified Regional
Poison Control Center. Telephone numbers of certified poison
control centers are listed in the Physicians' Desk Reference
(PDR). In managing overdosage, consider the possibility of
multiple drug overdoses, interaction among drugs, and unusual drug
kinetics in your patient.
The initial actions to be taken in a dobutamine overdose are
discontinuing administration, establishing an airway, and ensuring
oxygenation and ventilation. Resuscitative measures should be
initiated promptly. Severe ventricular tachyarrhythmias may be
successfully treated with propranolol or lidocaine. Hypertension
usually responds to a reduction in dose or discontinuation of
therapy.
Protect the patient's airway and support ventilation and
perfusion. If needed, meticulously monitor and maintain, within
acceptable limits, the patient's vital signs, blood gases, serum
electrolytes, etc.
If the product is ingested, unpredictable absorption may occur
from the mouth and the gastrointestinal tract. Absorption of drugs
from the gastrointestinal tract may be decreased by giving
activated charcoal, which, in many cases, is more effective than
emesis or lavage; consider charcoal instead of or in addition to
gastric emptying. Repeated doses of charcoal over time may hasten
elimination of some drugs that have been absorbed. Safeguard the
patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal
hemoperfusion have not been established as beneficial for an
overdose of dobutamine.
INDICATIONS AND USAGE
Dobutamine is indicated when parenteral therapy is necessary for
inotropic support in the short-term treatment of adults with
cardiac decompensation due to depressed contractility resulting
either from organic heart disease or from cardiac surgical
procedures. Experience with intravenous dobutamine in controlled
trials does not extend beyond 48 hours of repeated boluses and/or
continuous infusions.
Whether given orally, continuously intravenously, or
intermittently intravenously, neither dobutamine nor any other
cyclic-AMP-dependent inotrope has been shown in controlled trials
to be safe or effective in the long-term treatment of congestive
heart failure. In controlled trials of chronic oral therapy with
various such agents, symptoms were not consistently alleviated, and
the cyclic-AMP-dependent inotropes were consistently associated
with increased risk of hospitalization and death. Patients with
NYHA Class IV symptoms appeared to be at particular risk.
HOW SUPPLIED/STORAGE AND HANDLING
Dobutamine Injection, USP, 20 mL single dose vial contains
dobutamine hydrochloride, equivalent to 250 mg dobutamine per 20
mL; ten vials per carton. NDC 0143-9141-10.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room
Temperature].
ENDING INFORMATION
For additional information, please refer to the
Package Insert for full prescribing
information, available
on www.hikma.com.
To report SUSPECTED ADVERSE REACTIONS, contact Hikma
Pharmaceuticals USA Inc. at
1-877-845-0689 or FDA at 1-800 FDA-1088
or www.fda.gov/medwatch.
Manufactured by:
HIKMA FARMACÊUTICA (PORTUGAL),
S.A.
Estrada do Rio da Mó, 8, 8A e 8B
–
Fervença – 2705-906 Terrugem SNT, PORTUGAL
Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922 USA
Document Identification Number: HK-2200-v1
1
https://www.hikma.com/newsroom/article-i3630-hikma-launches-100th-injectable-medicine-in-us-with-introduction-of-vancomycin-hydrochloride-for-injection-usp/
2 Source: IQVIA MAT April 2023,
generic injectable volumes by eaches, excluding branded generics
and Becton Dickinson
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SOURCE Hikma Pharmaceuticals USA Inc.