Healthcare Professional FAQs

Healthcare Frequently Asked Questions2024-03-22T12:12:06-04:00

Healthcare Professional FAQs

What is the difference between Kloxxado® and Narcan® (naloxone HCl) nasal spray 4 mg?2023-07-15T11:14:27-04:00

Kloxxado® contains 8 mg of naloxone per spray, whereas Narcan® only contains 4 mg of naloxone per spray.*† Both products come with two devices per box, so with Kloxxado® you’re getting twice as much naloxone per box.*† This is important because 78 percent of opioid overdose reversals involved at least 2 doses of naloxone.‡

See Comparison of Kloxxado® and Other Naloxone Offerings ›

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† NARCAN® (naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent BioSolutions, Inc., 2020
‡ Abdelal R, Banerjee A, Carlberg-Racich S, Darwaza N, Ito D, Shoaff J, Epstein J. Real-World Study of Multiple Naloxone Administration for Opioid Overdose Reversal Among Bystanders. JMCP. 2021;27(10-a):S54

Which of my patients may benefit from Kloxxado®?2023-08-30T20:24:56-04:00

Co-prescribing naloxone is recommended for your patients who are taking opioids and meet any of the following criteria:

  • Taking opioids at a high strength​ (e.g., ≥ 50MME/day)* or as a long-term therapy†
  • Taking a benzodiazepine†
  • Have certain respiratory conditions, like COPD or sleep apnea†
  • Have a mental health disorder†
  • Have a history of overdose or substance use disorder, including PWUD and patients in recovery†
  • Are likely to observe an overdose among family, friends, or caregivers​†

Download the Kloxxado® Co-RX Guide for more details.

* Your state PDMP may have built-in tools to help you assess a patient’s MME-associated risks.
† Naloxone: The Opioid Reversal Drug that Saves Lives. US Department of Health and Human Services website. Available at: https://www.hhs.gov/system/files/naloxone-coprescribing-guidance.pdf. Accessed June 25, 2023.

Who should not use Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-17T07:25:16-04:00

Kloxxado® is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in Kloxxado®.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

Where can I order Kloxxado® nasal spray?2023-05-26T16:15:37-04:00

Please contact your nearest wholesaler or call Hikma Specialty USA Inc. Customer Service at 1-877-259-6893. Contact us if you’re interested in placing a bulk order of Kloxxado®.

How do I report negative side effects or adverse events?2023-05-26T16:15:37-04:00

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Is Kloxxado® FDA-approved?2023-07-17T07:27:10-04:00

Yes.*

* FDA 2021, “FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose,” https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose, Accessed May 3, 2021.

What is the FDA-approved indication for Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-17T07:29:33-04:00

Kloxxado® (naloxone HCl) nasal spray 8 mg is an opioid antagonist 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.*

Kloxxado® is intended for immediate administration as emergency therapy in settings where opioids may be present.*

Kloxxado® is not a substitute for emergency medical care.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

What side effects or adverse events are most commonly reported with Kloxxado®?2023-08-22T16:17:18-04:00

Across Kloxxado® nasal spray’s two pharmacokinetics (PK) studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.*

Risks include: Risk of Recurrent Respiratory & CNS Depression; Risk of limited efficacy with partial agonists or mixed agonist/antagonists; Precipitation of severe opioid withdrawal; Risk of CV effects.*

For more information, please see the full Prescribing Information and Important Safety Information.

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

My patient may be misusing opioids. What else should I be aware of?2023-07-17T07:36:16-04:00

If a patient misusing opioids obtains opioids from anywhere other than a pharmacy, they are at risk of acquiring counterfeit medications that contain illicitly manufactured synthetic opioids.* In these situations, your patient may not be able to tell the difference between a true prescription opioid and a counterfeit medication.*

Overdoses on illicitly manufactured synthetic opioids may require more naloxone to reverse the overdose.†‡ It is important that your patient understand opioid safety, including having enough naloxone and knowing how to administer it.

* One Pill Can Kill Fake Pills Fact Sheet. US Drug Enforcement Agency website. Available at: https://www.dea.gov/sites/default/files/2022-12/DEA-OPCK_FactSheet_December_2022.pdf. Accessed June 25, 2023.
† Naloxone DrugFacts. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugfacts/naloxone. Accessed June 25, 2023.
‡ Abdelal R, Banerjee A, Carlberg-Racich S, Darwaza N, Ito D, Shoaff J, Epstein J. Real-World Study of Multiple Naloxone Administration for Opioid Overdose Reversal Among Bystanders. JMCP. 2021;27(10-a):S54.

Can Kloxxado® reverse an overdose on illicitly manufactured fentanyl or fentanyl analogs?2023-07-21T16:46:31-04:00

Kloxxado® contains 8 mg of naloxone HCl, a medicine that can reverse the effects of opioids including fentanyl and fentanyl analogs.*† Overdoses on illicitly manufactured fentanyl may require more naloxone to reverse.‡ This is why it is important to carry Kloxxado®, which contains twice as much naloxone as Narcan® (naloxone HCl) Nasal Spray 4 mg.*§

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† Stop Overdose – Naloxone. CDC, https://www.cdc.gov/stopoverdose/naloxone/index.html, Accessed 2023 0622.
‡ Naloxone. National Institutes of Health. Accessed March 26, 2021. https://www.drugabuse.gov/publications/drugfacts/naloxone.
§ NARCAN® (naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent BioSolutions Inc., 2020.

How can I help my patients save money on Kloxxado®?2024-03-22T11:47:59-04:00

Learn more about the Kloxxado® Savings Card for eligible patients.

 

Savings Card FAQs

What is the Kloxxado® Savings Card?2024-03-22T11:47:59-04:00

The Kloxxado® Savings Card helps eligible patients save money on their Kloxxado® (naloxone HCl) nasal spray 8 mg prescription. With the Kloxxado® Savings Card eligible patients can receive Kloxxado® for as little as $0* per box, up to 2 boxes per redemption, up to 4 boxes per month.

*Maximum value of $40 per box. The Kloxxado® Savings Card is not Health Insurance. See eligibility and restrictions.

How can I get a Kloxxado® Savings Card?2024-03-22T11:47:59-04:00

Take the Kloxxado® Savings Card with your prescription for Kloxxado® (naloxone HCl) nasal spray 8 mg to your pharmacist and pay as little as $0* per box, up to 2 boxes per redemption, up to 4 boxes per month. No activation is necessary. See eligibility and restrictions.

*Maximum value of $40 per box. The Kloxxado® Savings Card is not Health Insurance. See eligibility and restrictions..

Who is eligible for the Kloxxado® Savings Card?2024-03-22T11:47:59-04:00

Patients may be eligible if they are covered by commercial insurance and insurance does not cover the full cost of the prescription. No other purchase is necessary. This offer is not Health Insurance. No substitutions permitted.

This Kloxxado® Savings Card is not transferable. You are not eligible if you are enrolled in any state or federally funded healthcare program including, but not limited to, Medicare, Medicare Part D, Medicaid (including Medicaid managed care), Medigap, VA, FEHB, DOD, TRICARE or a state pharmacy assistance program. In addition, you must be 18 years or older and a legal resident of the US or Puerto Rico. Offer void where prohibited by law, taxed or restricted. May not be used with any other discount, trial offer, or other offer. Hikma Specialty USA Inc. reserves the right to rescind, revoke, or amend this program without notice. Participation in this program confirms that this offer is consistent with your insurance coverage, if any, and that you will report the value received if required by your insurance provider. By using this card, you certify that you understand and will comply with the terms and conditions. For questions, please call 1-877-259-6893, 8 am-7 pm ET, Monday-Friday. Other conditions may apply.

How do I use the Kloxxado® Savings Card?2024-03-22T11:47:59-04:00

Present your Kloxxado® Savings Card to the pharmacist along with a valid prescription for Kloxxado® (naloxone HCl) nasal spray 8 mg.

 

What if my pharmacy is unable to process my Kloxxado® Savings Card?2024-03-22T11:47:59-04:00

Please call customer service at 1-877-259-6893.

How do I activate my Kloxxado® Savings Card?2024-03-22T11:48:00-04:00

No activation is necessary. Simply download and print your Kloxxado® Savings Card and take it to your pharmacist along with your prescription for Kloxxado® (naloxone HCl) nasal spray 8 mg. See eligibility and restrictions.

How long can I use my Kloxxado® Savings Card?2024-03-22T11:48:00-04:00

You may continue to use your card for as long as you are eligible or until the Savings Card program is terminated.

Don’t see an answer to your question? Contact us

Important Safety Information About 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228.

This website is intended for U.S. audiences
Customer Service: Phone 1-877-259-6893 | Email

© Hikma Specialty USA Inc. All rights reserved.
NARCAN® is a registered trademark of Emergent Operations Ireland Limited.

KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
The brand statement “Better Health. Within Reach. Every Day.” is a registered trademark of Hikma Pharmaceuticals PLC.

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June 2023

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Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications