Patient & Caregiver FAQs

Frequently Asked Questions2024-03-22T12:12:58-04:00

Patient FAQs

What is Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-15T10:36:33-04:00

Kloxxado® is a nasal spray that contains a single spray with 8 mg of naloxone HCl.* Kloxxado® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of Kloxxado® contains two individually packaged single-spray devices.*

Always carry Kloxxado® with you in case of an opioid emergency.

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

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.‡

* 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

When should Kloxxado® be used?2023-07-15T10:54:47-04:00

Use Kloxxado® nasal spray right away if you think there are signs of an opioid overdose emergency.* Get emergency medical help right away after giving the first dose of Kloxxado® nasal spray, even if the person wakes up.*

Signs of an opioid overdose may include:*

    • unusual sleepiness and 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

Get emergency medical help right away in any case of known or suspected overdose.

Kloxxado® is not a substitute for emergency medical care.* Administer in accordance with the Instructions for Use.

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

How do I use Kloxxado® nasal spray 8 mg?2023-07-15T10:49:57-04:00

Read the Kloxxado® Quick Instructions for Use for detailed information about how to administer Kloxxado®.

Remember:

  • Use Kloxxado® nasal spray exactly as prescribed by your healthcare provider.*
  • Kloxxado® nasal spray is for use in the nose only.*
  • Do not remove or test the Kloxxado® nasal spray device until ready to use.*
  • Each Kloxxado® nasal spray device contains only one dose of medicine and cannot be reused.*
  • Kloxxado® nasal spray should be given into one nostril.*
  • If additional doses are needed, give Kloxxado® nasal spray in the other nostril.*
  • Kloxxado® is not a substitute for emergency medical care.*

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

Does Kloxxado® only work in the nose?2023-07-15T10:53:03-04:00

Yes, Kloxxado® nasal spray is for intranasal (in the nose/nostril) use only.*

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

Can I give myself Kloxxado® nasal spray?2023-07-15T10:59:08-04:00

No, treatment of suspected opioid overdose is usually performed by someone other than the affected person. This is why you should tell the people around you where you keep Kloxxado®.*

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

How does Kloxxado® nasal spray work?2023-07-15T10:57:12-04:00

Kloxxado® nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*

Opioids work by attaching to specific receptors found in the brain and in the nervous system.† This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.†

Naloxone, the active ingredient in Kloxxado®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*‡

Get emergency medical help right away in any case of known or suspected overdose emergency. Kloxxado® nasal spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the Kloxxado® Quick Instructions for Use.

Each device is a single dose.* If an additional dose is needed, you must use another device.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
‡ NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.

Can I reuse Kloxxado® nasal spray?2023-07-15T11:00:53-04:00

No, you cannot reuse Kloxxado® nasal spray.* Each device is single-use, single-dose only.* It is intended to be sprayed once, in a nostril, and then discarded.*

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

Will one dose of Kloxxado® work to reverse an overdose or will a second dose be needed?2023-05-26T16:16:07-04:00

A second dose of Kloxxado® nasal spray may be necessary. One dose of naloxone may not be enough to reverse the effects of an opioid overdose that involves strong opioids. Or, sometimes, the naloxone dose can wear off before the opioids—necessitating another dose.*

Emergency medical services (EMS) should be called immediately after administering the first dose and will hopefully arrive before a second dose is needed. But if help hasn’t arrived, bystanders can administer additional doses of Kloxxado® nasal spray every 2 to 3 minutes in alternating nostrils if the patient doesn’t respond, responds insufficiently or relapses back into respiratory depression.*

Get emergency medical help right away in any cases of known or suspected overdose emergency. Kloxxado® nasal spray is not a substitute for emergency medical care.* Administer in accordance with the Instructions for Use. See Kloxxado® Quick Instructions for Use.

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

Is Kloxxado® nasal spray addictive?2023-07-15T11:08:13-04:00

Naloxone HCl has no potential for abuse or overdose. It does not work in the absence of opioids.*†

* Stop Overdose/Frequently Asked Questions about Naloxone. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stopoverdose/naloxone/faq.html. 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.

What are the possible side effects from using Kloxxado® nasal spray?2023-09-15T14:08:25-04:00

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.

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.

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

Where can I get Kloxxado® nasal spray?2023-08-22T16:00:11-04:00

Kloxxado® is a prescription medicine. Kloxxado® nasal spray is available at your local pharmacy with a prescription from your doctor. Ask your doctor if a prescription for naloxone is right for you.

Organizations wishing to order Kloxxado® nasal spray:

Contact us if you’re interested in placing a bulk order of Kloxxado®. Public access pricing is available.

Is Kloxxado® nasal spray covered by insurance?2023-07-15T11:11:54-04:00

Kloxxado® is covered by many health insurance plans, including most Medicaid programs. Contact your insurance provider to learn more. You can also download a Kloxxado® Savings Card and pay as little as $0* (up to $40 savings for eligible patients) for Kloxxado® nasal spray.

* Maximum value of $40 per box, up to 2 boxes per redemption, up to 4 boxes per month. No activation is necessary. See eligibility and restrictions.

What are the ingredients in Kloxxado® nasal spray?2023-07-15T11:16:46-04:00

Active ingredient: naloxone hydrochloride*

Inactive ingredients: benzalkonium chloride, disodium ethylenediaminetetraacetate, sodium chloride, hydrochloric acid and purified water.*

Kloxxado® is not made with natural rubber latex.*

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

How should I store Kloxxado® nasal spray?2023-07-15T11:20:26-04:00
  • Store at room temperature 68°F to 77°F (20°C to 25°C).*
  • Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C).*
  • Keep Kloxxado® nasal spray in its box until ready to use. Protect from light.*
  • Replace Kloxxado® nasal spray before the expiration date on the box.*

Keep Kloxxado® nasal spray and all medicines out of the reach of children.*

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

Where can I get additional information on Kloxxado®?2023-05-26T16:15:37-04:00

Please see full Prescribing Information.

Someone I know may be misusing opioids. Where can I learn more?2023-07-15T11:21:38-04:00

If you or someone you love is at risk for misusing opioids, resources and help are available. Find information about substance use disorder treatment options on findtreatment.gov, a product of the Substance Abuse and Mental Health Services Administration.  Connect with harm reduction resources near you at harmreduction.org, the official website of the National Harm Reduction Coalition.

What happens if you give Kloxxado® to someone who is not on opioids?2023-07-15T11:23:14-04:00

Naloxone, the medicine in Kloxxado®, works only if a person has opioids in their system.*† It has no effect if opioids are not present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 5, 2023.

Do I need a prescription to get Kloxxado®?2023-06-02T09:06:18-04:00

Kloxxado® is a prescription medication available at retail pharmacies across the U.S. Talk to your doctor to find out if Kloxxado® is right for you.

How do I talk to my doctor about Kloxxado®?2023-07-21T13:46:25-04:00

The idea of discussing the risks of opioid overdose may be uncomfortable, but your doctor is ready for it. If you think there is a risk for you or your family, talk to your doctor about a Kloxxado® prescription.

Remember, you may be at higher risk of accidental overdose if you take opioids and:

  • Also take a benzodiazepine*
  • Have or are recovering from substance use disorder*
  • You may be in situations where illicit substances are present
  • Have a respiratory condition like COPD or sleep apnea*
  • Have a mental health disorder*

* Opioids/Risks and How to Reduce Them. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/opioids/patients/reduce-risks.html. Accessed June 23, 2023

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.

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?2024-07-29T12:51:19-04:00

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 1-800-631-2174, 8 am-5 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?2024-07-29T02:09:01-04:00

Please call customer service at 1-800-631-2174.

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.

Opioid & Fentanyl FAQs

What is Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-15T10:36:33-04:00

Kloxxado® is a nasal spray that contains a single spray with 8 mg of naloxone HCl.* Kloxxado® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of Kloxxado® contains two individually packaged single-spray devices.*

Always carry Kloxxado® with you in case of an opioid emergency.

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

How does Kloxxado® nasal spray work?2023-07-15T10:57:12-04:00

Kloxxado® nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*

Opioids work by attaching to specific receptors found in the brain and in the nervous system.† This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.†

Naloxone, the active ingredient in Kloxxado®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*‡

Get emergency medical help right away in any case of known or suspected overdose emergency. Kloxxado® nasal spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the Kloxxado® Quick Instructions for Use.

Each device is a single dose.* If an additional dose is needed, you must use another device.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
‡ NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.

What are the possible side effects from using Kloxxado® nasal spray?2023-09-15T14:08:25-04:00

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.

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.

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

Someone I know may be misusing opioids. Where can I learn more?2023-07-15T11:21:38-04:00

If you or someone you love is at risk for misusing opioids, resources and help are available. Find information about substance use disorder treatment options on findtreatment.gov, a product of the Substance Abuse and Mental Health Services Administration.  Connect with harm reduction resources near you at harmreduction.org, the official website of the National Harm Reduction Coalition.

What happens if you give Kloxxado® to someone who is not on opioids?2023-07-15T11:23:14-04:00

Naloxone, the medicine in Kloxxado®, works only if a person has opioids in their system.*† It has no effect if opioids are not present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 5, 2023.

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

Contraindications