Community Group FAQs

Community Frequently Asked Questions2024-03-22T12:15:14-04:00

Community Group 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.‡

* 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

Why is a higher dose important for my community?2023-08-22T16:10:45-04:00

Overdose deaths appear to have accelerated during the COVID-19 pandemic, reaching 81,230 between June 2019 and May 2020, primarily driven by illicitly manufactured synthetic opioids.* A higher dose of naloxone may be required to revive a patient due to the stronger effect of illicitly manufactured fentanyl.†‡ 78% of overdose reversal attempts with Narcan® Nasal Spray involved ≥2 sprays.‡ The frequency of naloxone multi-dosing has been increasing.§

* Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic. Centers for Disease Control and Prevention website. Available at: https://emergency.cdc.gov/han/2020/han00438.asp. 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
§ Geiger et. al. 2019, “Who Receives Naloxone from Emergency Medical Services? Characteristics of Calls and Recent Trends,” Substance Abuse, 41:3, 400-407.

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

Does Hikma offer public access pricing?2023-05-26T16:15:37-04:00

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

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

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.

Does Hikma also offer injectable naloxone?2024-03-22T11:48:25-04:00

Yes. If you are a government entity, please reach out to communityhealth@hikma.com for more information. If you’re a non-profit community group, we encourage you to reach out to Remedy Alliance, who we have partnered with to support harm reduction programs looking for injectable naloxone.

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.

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