KLOXXADO^® contains twice as much naloxone per spray as Narcan^® (naloxone HCl) 4mg nasal spray, in a ready-to- use format to reverse the effects of opioid overdose.Since launching KLOXXADO^® in 2021, Hikma has donated the lifesaving medicine to harm reduction groups, community organizations and others across the US. With the help of more than 40 donation partners, KLOXXADO^® has been distributed for free in places it can have the biggest impact, including music festivals, downtowns and schools.

“Since its launch two years ago, KLOXXADO^® has quickly become an essential tool for those on the front lines working to reverse opioid overdoses and save lives,” said Brian Hoffmann, President, Hikma Generics. “We are working closely with our partners across the country to ensure the more than 375,000 doses of KLOXXADO^® that have now been donated are reaching those who need it most, including patients, health care providers, first responders, harm reduction groups and others. As the opioid overdose epidemic continues, we are committed to expanding access to KLOXXADO^®, and all forms of naloxone that Hikma manufactures, to meet the urgent needs of US patients and communities.”

As the US FDA, the White House Office of National Drug Control Policy and others have noted, naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths, and expanding access to all forms of naloxone is one of the top ways to address the overdose crisis.

In addition to KLOXXADO^®, Hikma manufactures multiple injectable formulations of naloxone, and – through its Hikma Community Health™ initiative – has partnered with non-profits and harm reduction organizations across the US to help expand access to its entire naloxone portfolio, including by:

• Donating 50,000 vials of injectable naloxone in 2021 to members of the Opioid Safety and Naloxone Network Buyers Club (now called Remedy Alliance/For The People) to help ease a shortage of the medicine facing non-profit harm reduction programs in the US.

• Furthering its partnership with Remedy Alliance through a first-of-its-kind agreement for Hikma to provide a private label, discounted naloxone injectable medicine specifically for the harm reduction community. As covered in The Washington Post, this partnership ensures supply and price are no longer barriers to this opioid overdose antidote to hundreds of harm reduction groups nationwide.

• Ensuring widespread access to KLOXXADO^® by providing a Co-Pay Assistance Program for eligible individuals, further increasing access and decreasing out-of-pocket costs to this life-saving medication.

• Partnering with State Government and Community Programs to expand access to our naloxone portfolio and continuing to provide generic medications for the treatment of substance use disorder to patients and health care providers.

Per prescribing information of KLOXXADO^® and NARCAN^®

KLOXXADO^®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.

NARCAN^® is a registered trademark of Emergent Operations Ireland Limited.

Hikma Community Health™ is a trademark of Hikma Pharmaceuticals USA Inc.

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 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 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.

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