FAQs2021-08-05T13:13:27+00:00

Kloxxado™ (naloxone HCl) nasal spray 8 mg FAQs

Answers to questions about Kloxxado™ (naloxone HCl) nasal spray 8 mg

Be prepared. Take action. Save lives.1 If you don’t see an answer to your Patient, Healthcare Professional, Public Health, or Savings Card question, contact us here.

Patient FAQs

Frequently asked questions about Kloxxado™

What is Kloxxado™ (naloxone HCl) nasal spray 8 mg?2021-08-05T16:04:46+00:00

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.2 Each box of Kloxxado™  contains two individually packaged single-spray devices.

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

What is the difference between Kloxxado™ and Narcan® (naloxone HCl) nasal spray 4 mg?2021-08-05T13:12:01+00:00

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.2,3 This is important because 34 percent of opioid overdose reversals involved at least 2 doses of naloxone.4

When should Kloxxado™ be used?2021-08-05T13:12:51+00:00

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.2

Signs of an opioid overdose may include:2

    • 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.2 Administer in accordance with the Instructions for Use.

How do I use Kloxxado™ nasal spray 8 mg?2021-07-30T14:52:11+00:00

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.2
  • Kloxxado™ nasal spray is for use in the nose only.2
  • Do not remove or test the Kloxxado™ nasal spray device until ready to use.2
  • Each Kloxxado™ nasal spray device contains only one dose of medicine and cannot be reused.2
  • Kloxxado™ nasal spray should be given into one nostril.2
  • If additional doses are needed, give Kloxxado™ nasal spray in the other nostril.2
  • Kloxxado™ is not a substitute for emergency medical care.2
Does Kloxxado™ only work in the nose?2021-07-09T18:41:43+00:00

Yes, Kloxxado™ nasal spray is for intranasal (in the nose/nostril) use only.2

Can I give myself Kloxxado™ nasal spray?2021-07-09T18:42:42+00:00

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™.2

How does Kloxxado™ nasal spray work?2021-07-30T14:53:23+00:00

Kloxxado™ nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.2

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.5

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.6

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.2 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.

Can I reuse Kloxxado™ nasal spray?2021-07-09T18:46:44+00:00

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.2

Will one dose of Kloxxado™ work to reverse an overdose, or will a second dose be needed?2021-07-09T18:47:11+00:00

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.2

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.2

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.2 Administer in accordance with the Instructions for Use. See Kloxxado™ Quick Instructions for Use.

Is Kloxxado™ nasal spray addictive?2021-07-09T18:47:32+00:00

Naloxone HCl has no potential for abuse or overdose. It does not work in the absence of opioids.7

What are the possible side effects from using Kloxxado™ nasal spray?2021-07-09T18:48:00+00:00

Across Kloxxado™ nasal spray’s two PK studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.2

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.2

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

Where can I get Kloxxado™ nasal spray?2021-07-09T18:48:23+00:00

Naloxone 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?2021-07-09T18:48:50+00:00

Please contact your health insurance provider to find out your coverage and co-pay requirements for Kloxxado™ nasal spray.

What are the ingredients in Kloxxado™ nasal spray?2021-07-09T18:50:30+00:00

Active ingredient: naloxone hydrochloride2

Inactive ingredients: benzalkonium chloride, disodium ethylenediaminetetraacetate, sodium chloride, hydrochloric acid and purified water.2

Kloxxado™ is not made with natural rubber latex.

How should I store Kloxxado™ nasal spray?2021-07-09T18:50:50+00:00
  • Store at room temperature 68ºF to 77ºF (20°C to 25°C).2
  • Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C).2
  • Keep Kloxxado™ nasal spray in its box until ready to use. Protect from light.2
  • Replace Kloxxado™ nasal spray before the expiration date on the box.2

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

Where can I get additional information on Kloxxado™?2021-07-09T18:51:08+00:00

Please see full Prescribing Information.

Healthcare Professional FAQs

Answers for prescribers and pharmacists

What is the difference between Kloxxado™ and Narcan® (naloxone HCl) nasal spray 4 mg?2021-08-05T13:12:01+00:00

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.2,3 This is important because 34 percent of opioid overdose reversals involved at least 2 doses of naloxone.4

Which of my patients may benefit from Kloxxado™?2021-07-09T18:54:41+00:00

Co-prescribing naloxone is recommended for your patients who are taking opioids and:7,8

  • At a high strength​ (e.g., ≥ 50MME/day)* or as a long-term therapy
  • With 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.

Who should not use Kloxxado™ (naloxone HCl) nasal spray 8 mg?2021-07-09T18:55:17+00:00

Kloxxado™ is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in Kloxxado™.2

How can I help my patients save money on Kloxxado™?2021-07-09T18:57:24+00:00

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

 

Where can I order Kloxxado™ nasal spray?2021-07-21T18:29:24+00:00

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 KloxxadoTM.

How do I report negative side effects or adverse events?2021-07-09T18:58:11+00:00

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?2021-07-09T18:58:37+00:00

Yes.9

What is the FDA-approved indication for Kloxxado™ (naloxone HCl) nasal spray 8 mg?2021-07-09T18:59:00+00:00

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.2

Kloxxado™ is intended for immediate administration as emergency therapy in settings where opioids may be present.2 is not a substitute for emergency medical care.2

What side effects or adverse events are most commonly reported with Kloxxado™?2021-07-09T18:59:48+00:00

Across Kloxxado™ nasal spray’s two PK studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.2

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.2

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

My patient may be misusing opioids. What else should I be aware of?2021-07-09T19:00:39+00:00

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.10 In these situations, your patient may not be able to tell the difference between a true prescription opioid and a counterfeit medication.11

Overdoses on illicitly manufactured synthetic opioids may require more naloxone to reverse the overdose.10 It is important that your patient understand opioid safety, including having enough naloxone and knowing how to administer it.

Public Health FAQs

Answers for harm reduction specialists, first responders and members of community groups.

What is the difference between Kloxxado™ and Narcan® (naloxone HCl) nasal spray 4 mg?2021-08-05T13:12:01+00:00

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.2,3 This is important because 34 percent of opioid overdose reversals involved at least 2 doses of naloxone.4

Why is a higher dose important for my community?2021-07-09T19:03:14+00:00

Overdose deaths appear to have accelerated during the COVID-19 pandemic, reaching 81,230 from June 2019 to May 2020, primarily driven by illicitly manufactured synthetic opioids.12 A higher dose of naloxone may be required to revive a patient due to the stronger effect of illicitly manufactured fentanyl.13 34% of overdose reversal attempts with Narcan® Nasal Spray involved ≥2 sprays.4 The frequency of naloxone multi-dosing has been increasing.14

Who should not use Kloxxado™ (naloxone HCl) nasal spray 8 mg?2021-07-09T18:55:17+00:00

Kloxxado™ is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in Kloxxado™.2

Does Hikma offer public access pricing?2021-07-09T19:06:07+00:00

Yes! Please contact us if you’re interested in placing a bulk order of KloxxadoTM.

Where can I order Kloxxado™ nasal spray?2021-07-21T18:29:24+00:00

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 KloxxadoTM.

How do I report negative side effects or adverse events?2021-07-09T18:58:11+00:00

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?2021-07-09T18:58:37+00:00

Yes.9

What is the FDA-approved indication for Kloxxado™ (naloxone HCl) nasal spray 8 mg?2021-07-09T18:59:00+00:00

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.2

Kloxxado™ is intended for immediate administration as emergency therapy in settings where opioids may be present.2 is not a substitute for emergency medical care.2

What side effects or adverse events are most commonly reported with Kloxxado™?2021-07-09T18:59:48+00:00

Across Kloxxado™ nasal spray’s two PK studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.2

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.2

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

KloxxadoTM Savings Card FAQs

What is the Kloxxado™ Savings Card?2021-07-09T19:10:57+00:00

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?2021-07-09T19:10:46+00:00

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?2021-07-21T16:57:13+00:00

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?2021-07-09T19:11:56+00:00

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?2021-07-09T19:12:28+00:00

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

How do I activate my Kloxxado™ Savings Card?2021-07-09T19:12:49+00:00

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?2021-07-09T19:13:32+00:00

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

References

  1. FDA 2019, “Having Naloxone on Hand Can Save a Life During an Opioid Overdose,” https://www.fda.gov/consumers/consumer-updates/having-naloxone-hand-can-save-life-during-opioid-overdose, Accessed May 3, 2021.
  2. KLOXXADO™ (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
  3. NARCAN® (naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent BioSolutions, Inc., 2020
  4. Avetian et. al. 2018, “Use of naloxone nasal spray 4mg in the community setting: a survey of use by community organizations,” Current Medical Research and Opinion, 34(4):573-576.
  5. White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
  6. NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.
  7. CDC 2016, “CDC Guideline for Prescribing Opioids for Chronic Pain,” https://www.cdc.gov/drugoverdose/pdf/Guidelines_At-A-Glance-a.pdf, Accessed May 3, 2021.
  8. HHS 2018, “Naloxone The Opioid Reversal Drug that Saves Lives,” https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf, Accessed May 3, 2021.
  9. 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.
  10. Emergency.cdc.gov: HAN Archive – 00438 | Health Alert Network (HAN) 2020, https://emergency.cdc.gov/han/2020/han00438.asp, Accessed May 3, 2021.
  11. Sutter et. al., 2017, “Fatal Fentanyl: One Pill Can Kill”, Academic Emergency Medicine, 24:106-113.
  12. CDC 2021, “Save Lives Now,” https://www.cdc.gov/drugoverdose/pubs/featured-topics/save-lives-now.html, Accessed July 1, 2021
  13. Emergency.cdc.gov: HAN Archive – 00384 | Health Alert Network (HAN) 2015, https://emergency.cdc.gov/han/han00384.asp, Accessed May 3, 2021
  14. Geiger et. al. 2019, “Who Receives Naloxone from Emergency Medical Services? Characteristics of Calls and Recent Trends,” Substance Abuse, 41:3, 400-407.
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Important Safety Information About KLOXXADO™️ (naloxone HCl) Nasal Spray 8 mg

Contraindications