Hikma Pharmaceuticals participates in naloxone training event with U.S. Congressman Buddy Carter ahead of National Fentanyl Awareness and Prevention Day
Hikma Pharmaceuticals participated in a naloxone training event with U.S. Congressman Buddy Carter ahead of National Fentanyl Awareness and Prevention Day. The event, held at Groves High School in Savannah, Georgia, marks Hikma's milestone of donating over 600,000 doses of naloxone in the past three years. Hikma is working with government officials and the White House Office of National Drug Control Policy to expand access to naloxone, a vital tool for reversing overdoses.
Hikma manufactures multiple forms of naloxone, including generic injectable vials, prefilled syringes, and KLOXXADO® (naloxone 8mg) intranasal spray. The company's Hikma Community Health initiative partners with frontline organizations to expand naloxone access through donations, partnerships, and awareness programs. Hikma also provides a Co-Pay Assistance Program for KLOXXADO® to increase accessibility and reduce out-of-pocket costs.
Hikma Pharmaceuticals ha partecipato a un evento di formazione sul naloxone con il congressista americano Buddy Carter in preparazione per la Giornata Nazionale di Sensibilizzazione e Prevenzione sul Fentanil. L'evento, tenutosi presso il Groves High School a Savannah, in Georgia, segna il traguardo di Hikma di aver donato oltre 600.000 dosi di naloxone negli ultimi tre anni. Hikma sta collaborando con funzionari governativi e l'Ufficio della Casa Bianca per il Controllo Nazionale delle Droghe per espandere l'accesso al naloxone, uno strumento fondamentale per invertire le sovradosi.
Hikma produce diverse forme di naloxone, inclusi fiale iniettabili generiche, siringhe pre-riempite e KLOXXADO® (naloxone 8mg) spray intranasale. L'iniziativa Hikma Community Health collabora con organizzazioni in prima linea per ampliare l'accesso al naloxone tramite donazioni, partenariati e programmi di sensibilizzazione. Hikma fornisce anche un Programma di Assistenza al Co-Payment per KLOXXADO® per aumentare l'accessibilità e ridurre i costi a carico dei pazienti.
Hikma Pharmaceuticals participó en un evento de capacitación sobre naloxona con el congresista estadounidense Buddy Carter, en preparación para el Día Nacional de Concientización y Prevención del Fentanilo. El evento, realizado en el Groves High School en Savannah, Georgia, marca el hito de Hikma de haber donado más de 600,000 dosis de naloxona en los últimos tres años. Hikma está trabajando con funcionarios del gobierno y la Oficina de Política Nacional de Control de Drogas de la Casa Blanca para expandir el acceso a la naloxona, una herramienta vital para revertir las sobredosis.
Hikma fabrica múltiples formas de naloxona, incluyendo viales inyectables genéricos, jeringas precargadas y KLOXXADO® (naloxona 8mg) aerosol intranasal. La iniciativa Hikma Community Health se asocia con organizaciones en la primera línea para ampliar el acceso a la naloxona a través de donaciones, asociaciones y programas de concientización. Hikma también ofrece un Programa de Asistencia para Co-Pagos para KLOXXADO® para aumentar la accesibilidad y reducir los costos de bolsillo.
Hikma Pharmaceuticals는 미국 하원의원인 Buddy Carter와 함께 나록손 교육 행사에 참여했으며, 이는 국립 펜타닐 인식 및 예방의 날을 앞둔 것입니다. 조지아주 사바나의 Groves High School에서 열린 이 행사는 Hikma가 지난 3년 동안 600,000회 이상의 나록손을 기부한 이정표가 되었습니다. Hikma는 정부 관계자 및 백악관 약물 통제 정책 사무소와 협력하여 나록손 접근성을 확대하고 있으며, 이는 과다복용을 되돌리는 데 중요한 도구입니다.
Hikma는 일반 주사 바이알, 미리 채워진 주사기 및 KLOXXADO® (나록손 8mg) 비강 스프레이 등 여러 형태의 나록손을 제조하고 있습니다. Hikma Community Health 이니셔티브는 선도적인 조직과 협력하여 기부, 파트너십 및 인식 프로그램을 통해 나록손 접근성을 확대하고 있습니다. Hikma는 또한 KLOXXADO®의 접근성을 높이고 개인 부담 비용을 줄이기 위한 공동 지불 지원 프로그램을 제공합니다.
Hikma Pharmaceuticals a participé à un événement de formation sur la naloxone avec le député américain Buddy Carter, à l'approche de la Journée nationale de sensibilisation et de prévention contre le fentanyl. L'événement, qui s'est tenu au Groves High School à Savannah, en Géorgie, marque un jalon pour Hikma avec plus de 600 000 doses de naloxone données au cours des trois dernières années. Hikma travaille avec des responsables gouvernementaux et le Bureau de la politique nationale de contrôle des drogues de la Maison Blanche pour élargir l'accès à la naloxone, un outil essentiel pour inverser les overdoses.
Hikma fabrique plusieurs formes de naloxone, y compris des flacons injectables génériques, des seringues préremplies et un KLOXXADO® (naloxone 8mg) spray intranasal. L’initiative Hikma Community Health collabore avec des organisations de première ligne pour élargir l’accès à la naloxone grâce à des dons, des partenariats et des programmes de sensibilisation. Hikma propose également un programme d'assistance au co-paiement pour KLOXXADO® afin d'augmenter l'accessibilité et de réduire les coûts à la charge des patients.
Hikma Pharmaceuticals nahm an einer Naloxon-Schulung mit dem US-Kongressabgeordneten Buddy Carter im Vorfeld des Nationalen Fentanyl-Bewusstseins- und Präventionstags teil. Die Veranstaltung, die in der Groves High School in Savannah, Georgia, stattfand, markiert den Meilenstein von Hikma, über 600.000 Dosen Naloxon in den letzten drei Jahren gespendet zu haben. Hikma arbeitet mit Regierungsvertretern und dem Büro für nationale Drogenkontrollpolitik des Weißen Hauses zusammen, um den Zugang zu Naloxon zu erweitern, einem wichtigen Mittel zur Umkehrung von Überdosierungen.
Hikma stellt verschiedene Formen von Naloxon her, darunter generische Injektionsfläschchen, vorbefüllte Spritzen und KLOXXADO® (Naloxon 8mg) intranasales Spray. Die Hikma Community Health-Initiative arbeitet mit Organisationen an vorderster Front zusammen, um den Zugang zu Naloxon durch Spenden, Partnerschaften und Sensibilisierungsprogramme zu erweitern. Hikma bietet außerdem ein Co-Pay-Hilfsprogramm für KLOXXADO® an, um die Zugänglichkeit zu erhöhen und die Eigenkosten zu senken.
- Donated over 600,000 doses of naloxone in the past three years
- Manufactures multiple forms of naloxone, including KLOXXADO® intranasal spray
- Partnered with Remedy Alliance to provide discounted naloxone injectable medicine for harm-reduction programs
- Offers Co-Pay Assistance Program for KLOXXADO® to increase accessibility
- None.
Hikma's participation is part of its ongoing partnership with
The
These actions build on Hikma's long-standing commitment to working with government officials, health care providers, non-profit organizations and the public health community to ensure naloxone is widely accessible to all who can benefit from it. For more than 20 years, Hikma has been working with communities across the
"Naloxone training events like Congressman Carter's help build understanding of this vital tool that individuals, families, first responders and communities can quickly use to reverse overdoses and save lives, and we are proud to support efforts to expand availability of this essential medicine," said Dr. Hafrun Fridriksdottir, President of Hikma's Generics business. "As a
Earlier this summer, Rep. Carter introduced a resolution to recognize National Fentanyl Prevention and Awareness Day on Aug. 21. This is one of the many important actions he's taken to expand access to naloxone including legislation to have the life-saving medicine in schools and calling for it to be available in the
"Naloxone should be in every medicine cabinet in America and as accessible as fire extinguishers. As our nation battles a fentanyl poisoning and opioid overdose epidemic, it is critical that we continue to provide community resources and support to save lives. Thank you to Hikma for participating in this important training and making sure GA-01 has the tools and knowledge necessary to keep our loved ones safe," said Rep. Buddy Carter.
Hikma manufactures multiple forms of naloxone including generic injectable vials and prefilled syringes made in
Through its Hikma Community Health initiative, Hikma is partnering with those on the frontlines of the overdose public health emergency across the US to help expand access to naloxone, including by:
- Donating more than 600,000 doses of KLOXXADO® and injectable naloxone 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.
- Donating 50,000 vials of injectable naloxone in 2021 to members of Remedy Alliance – a leading supplier of naloxone to harm-reduction programs in the US – to help ease a nationwide shortage.
- Furthering our partnership with Remedy Alliance by providing the first and only private label, discounted naloxone injectable medicine made 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.2
- 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.
- Participating in awareness days and training events with community partners like Facing Fentanyl and This Must Be the Place and meeting with government leaders like ONDCP Director Dr. Rahul Gupta and many members of Congress and state officials.
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About Hikma
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Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the
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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
1 https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2024/20240515.htm
2 https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ebf0f833-c1c0-487c-8f29-01fa8c61b6cb&type=display
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SOURCE Hikma Pharmaceuticals USA Inc.
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