LONDON, Aug. 15,
2024 /PRNewswire/ -- Hikma Pharmaceuticals
PLC (Hikma), the multinational pharmaceutical company,
announces the shelf-life extension of KLOXXADO®
(naloxone HCl) nasal spray 8mg from 24 to 36 months.
KLOXXADO® packaging has been updated with 36-month
dating, starting with product manufactured in March 2024.
KLOXXADO® contains twice as much naloxone per
spray as Narcan® Nasal Spray 4mg in a
ready-to-use nasal spray to reverse the effects of opioid overdose,
providing an important treatment option in addressing the overdose
epidemic.1,2
Naloxone has long been recognized as an important, safe and
effective treatment in the fight against opioid
overdose.3 With the increasing prevalence of illicitly
manufactured synthetic opioids, organizations including the
CDC,4 the American Medical
Association5 and others have noted that a higher
dose of naloxone may be required to revive a patient experiencing
poisoning from illicit fentanyl or other opioids. As a ready-to-use
nasal spray that contains twice as much naloxone per spray than
Narcan® Nasal Spray 4mg,
KLOXXADO® provides an important lifesaving
treatment option.1,2
"The shelf-life extension is good news for frontline responders
and the thousands of people who carry KLOXXADO® and who
may need to use it at a moment's notice to reverse an overdose,"
said Dr. Hafrun Fridriksdottir, President, Hikma Generics. "We
have a role to play in the fight against illicit fentanyl and as we
approach International Overdose Awareness Day on August 31st, it's gratifying that we
are supplying an important medicine that can save lives and help
address the deadly overdose epidemic."
About Naloxone
Naloxone hydrochloride is a medicine that rapidly reverses an
opioid overdose. It can quickly restore normal breathing in someone
experiencing an opioid overdose and should be given to any person
who shows signs of an opioid overdose or when an opioid overdose is
suspected.6
KLOXXADO® is indicated for the emergency
treatment of known or suspected opioid overdose, as manifested by
respiratory and/or central nervous system depression, for adult and
pediatric patients.1 KLOXXADO® is not a
substitute for emergency medical
care.1 KLOXXADO® is intended for
immediate administration as emergency therapy in settings where
opioids may be present.1
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.
Enquiries
Hikma Pharmaceuticals USA
Media:
Steve Weiss
+1 732 788 8279
uscommunications@hikma.com
About Hikma
Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated
BBB-/stable S&P and BBB-/positive Fitch)
Hikma helps put better health within reach every day for
millions of people around the world. For more than 45 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 North America, 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 9,100
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
KLOXXADO®️ is a registered trademark of Hikma
Pharmaceuticals USA Inc.
NARCAN® is a registered trademark of Emergent Operations
Ireland Limited.
Important Safety Information for KLOXXADO®
(naloxone HCl) Nasal Spray 8
mg
Contraindications
Hypersensitivity to naloxone
hydrochloride or to any of the other ingredients
Warnings and Precautions
- Use KLOXXADO® right away if you suspect an
opioid overdose emergency, even if you are not sure, because an
opioid overdose emergency can cause severe injury or death. Signs
and symptoms of an opioid overdose emergency may include:
-
- Unusual sleepiness; you are not able to awaken the person with
a loud voice or by rubbing firmly on the middle of their chest
(sternum).
- Breathing problems, including slow or shallow breathing in
someone difficult to awaken or who looks like they are not
breathing.
- The black circle in the center of the colored part of the eye
(pupil) is very small (sometimes called "pinpoint pupils") in
someone difficult to awaken.
- Family members, caregivers or other people who may have to use
KLOXXADO® in an opioid overdose emergency should
know where KLOXXADO® is stored and how to give
KLOXXADO® before an opioid overdose emergency
happens.
- Get emergency medical help right away after using the first
dose of KLOXXADO®. Rescue breathing or CPR
(cardiopulmonary resuscitation) may be needed while waiting for
emergency medical help.
- The signs and symptoms of an opioid overdose emergency can
return after KLOXXADO® is given. If this happens,
give another dose after 2 to 3 minutes, using a new
KLOXXADO® device, alternating nostrils, and watch
the person closely until emergency medical help arrives.
- Do not use KLOXXADO® if you are allergic to
naloxone hydrochloride or any of the ingredients in
KLOXXADO®.
- KLOXXADO® can cause sudden and severe opioid
withdrawal, the symptoms of which may include body aches, diarrhea,
increased heart rate, fever, runny nose, sneezing, goosebumps,
sweating, yawning, nausea or vomiting, nervousness, restlessness or
irritability, shivering or trembling, stomach cramps, weakness and
increased blood pressure.
- In infants under 4 weeks old who have been receiving opioids
regularly, sudden opioid withdrawal may be life-threatening if not
treated the right way. Signs and symptoms include: seizures, crying
more than usual, and increased reflexes.
- Tell your doctor about all of your medical conditions before
using KLOXXADO®, including if you have heart problems,
are pregnant or plan to become pregnant, are breastfeeding or plan
to breastfeed.
- Tell your doctor about all of the medicines you take, including
prescription and over-the-counter medicines, drugs, vitamins and
herbal supplements.
Side Effects
The following serious side effect is
discussed in the full Prescribing Information for
KLOXXADO®:
- Sudden and Severe Opioid Withdrawal
Symptoms of sudden and severe opioid withdrawal resulting from
the use of KLOXXADO® in someone regularly using
opioids include: body aches, diarrhea, increased heart rate, fever,
runny nose, sneezing, goosebumps, sweating, yawning, nausea or
vomiting, nervousness, restlessness or irritability, shivering or
trembling, stomach cramps, weakness and increased blood
pressure.
Infants may have seizures, cry more than normal and have increased
reflexes.
Some people may become aggressive after abrupt reversal of opioid
overdose.
In two clinical studies, a total of 47 healthy adult volunteers
were exposed to a single dose of KLOXXADO®, one spray in
one nostril. Side effects were reported in two subjects for each of
the following: abdominal pain, asthenia, dizziness, headache, nasal
discomfort, and presyncope.
These are not all of the possible side effects of
KLOXXADO®. Contact your doctor for medical advice about
side effects.
Pregnancy, Infancy and Breastfeeding, Children
Tell
your doctor if you are pregnant or plan to become pregnant. If you
are pregnant and opioid dependent, use of
KLOXXADO® may cause withdrawal symptoms in you and
your unborn baby. A healthcare provider should monitor you and your
unborn baby right away after you use KLOXXADO®.
There is no information regarding the presence of naloxone in human
milk, the effects of naloxone on the breastfed infant or on milk
production.
If the primary concern is an infant at risk of an overdose,
consider whether other naloxone-containing products may be more
appropriate.
KLOXXADO® nasal spray is safe and effective in
children for known or suspected opioid overdose.
Dosage and Administration
Do not attempt to prime or
test-fire the device. Each KLOXXADO® Nasal Spray
contains only 1 dose of medicine and cannot be reused. Read the
"instructions for use" at the end of the Prescribing Information
and Medication Guide for detailed information about the right way
to use KLOXXADO® Nasal Spray.
Storage and Handling
Store
KLOXXADO® at room temperature between 68°F to 77°F
(20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or
above 104°F (40°C). Do not freeze KLOXXADO®. Keep
KLOXXADO® in its box until ready to use. Protect
from light. Replace KLOXXADO® before the expiration
date on the box. Keep KLOXXADO® and all medicines
out of the reach of children.
For more information, please see the full Prescribing
Information and Medication Guide, which you can find on our website
at www.kloxxado.com.
- To report an adverse event or product complaint, please contact
us at us.hikma@primevigilance.com or call 1-877-845-0689
or 1-800-962-8364.
- Adverse events may also be reported to the FDA directly at
1-800-FDA-1088 or www.fda.gov/medwatch.
Distributed by: Hikma
Specialty USA Inc., Columbus, OH 43228.
Document Identification Number: HK-2667-v1
1
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ebf0f833-c1c0-487c-8f29-01fa8c61b6cb&type=display
2
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a0ebc83d-2892-40de-bc0a-775ce90b30db&type=display
3 https://pubmed.ncbi.nlm.nih.gov/28722939/
4
https://archive.cdc.gov/#/details?url=https://emergency.cdc.gov/han/2020/han00438.asp
5
https://apnews.com/article/opioids-business-health-government-and-politics-8263d4b147b3c6b104346b4ca31c28a3
6
https://nida.nih.gov/publications/drugfacts/naloxone
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SOURCE Hikma Pharmaceuticals USA Inc.