Leitlinien & Arzneimittelsicherheit

HOS-098112 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reaction (AR) seen with naloxone administration is nausea (frequency very common). Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them. Tabulated list of adverse reactions The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience. ARs are listed below by system organ class and frequency. Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as very common: (≥ 1/10); common: (≥ 1/100, < 1/10); uncommon: (≥ 1/1,000, < 1/100); rare: (≥ 1/10,000, < 1/1,000) very rare: (< 1/10,000); not known (cannot be estimated from the available data). Immune system disorders Very rare: Hypersensitivity, Anaphylactic shock Nervous system disorders Common Dizziness, Headache Uncommon Tremor Cardiac disorders Common Tachycardia Uncommon Arrhythmia, Bradycardia Very rare Cardiac fibrillation, Cardiac arrest Vascular disorders Common Hypotension, Hypertension Respiratory, thoracic and mediastinal disorders Uncommon Hyperventilation Very rare Pulmonary oedema Gastrointestinal disorders Very common Nausea 5 Common Vomiting Uncommon Diarrhoea, Dry mouth Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis Very rare Erythema multiforme General disorders and administration site conditions Uncommon Drug withdrawal syndrome (in patients dependent on opioids) Description of selected adverse reactions Drug withdrawal syndrome Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia. Behavioural changes including violent behaviour, nervousness and excitement may also be observed. Vascular disorders In reports on intravenous/intramuscular naloxone: hypotension, hypertension, cardiac arrhythmia (including ventricular tachycardia and fibrillation) a

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HOS-098108 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098107 · has-indication-information · PDF-Seite 2

Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and over. Nyxoid is not a substitute for emergency medical care.

HOS-098110 · has-interaction-information · PDF-Seite 4

Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists. When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in some individuals. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described, more typically when naloxone is used post-operatively (see sections 4.4 and 4.8). Administration of Nyxoid may decrease the analgesic effects of opioids used primarily to provide pain relief, due to its antagonist properties (see section 4.4). When administering naloxone to patients who have received buprenorphine as an analgesic, complete analgesia may be restored. It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses. However, reversal of respiratory depression caused by buprenorphine is limited.

HOS-098111 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no adequate data from the use of naloxone in pregnant women. Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3). The potential risk for humans is unknown. Nyxoid should not be used during pregnancy unless the clinical condition of the woman requires treatment with naloxone. In pregnant women who have been treated with Nyxoid, the fetus should be monitored for signs of distress. In opioid dependent pregnant women, naloxone administration can cause withdrawal symptoms in newborn infants (see section 4.4). Breast-feeding It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone. However, as naloxone is practically not orally bioavailable its potential to affect a breast-fed infant is negligible. Caution should be exercised when naloxone is administered to a breast-feeding mother but there is no need to discontinue breast-feeding. Breast-fed babies from mothers who have been treated with Nyxoid should be monitored to check for sedation or irritability. Fertility No clinical data on effects of naloxone on fertility are available, however data from rat studies (see section 5.3) indicate no effects.

HOS-098109 · has-warning-information · PDF-Seite 3

Instructing patients / users on the proper use of Nyxoid Nyxoid should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established. Patients or any other person who might be in a position to administer Nyxoid must be instructed in its proper use and the importance of seeking medical assistance. Nyxoid is not a substitute for emergency medical care and may be used instead of intravenous injection, when intravenous access is not immediately available. Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting. Therefore, the prescriber should take appropriate steps to ensure that the patient and/or any other person who might be in a position to administer Nyxoid thoroughly understands the indications and use of Nyxoid. The prescriber should describe the symptoms which allow presumptive diagnosis of central nervous system (CNS) / respiratory depression, the indication and the instructions for use with the patient and / or person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event. This should be performed in accordance with the educational guidance for Nyxoid. Monitoring of the patient for a response Patients who respond satisfactorily to Nyxoid must be closely monitored. The effect of some opioids can be longer than the effect of naloxone, which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required. Opioid withdrawal syndrome Receiving Nyxoid can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome (see section 4.8). Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when Nyxoid is administered. Effectiveness of naloxone Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs, respiration should be mechanically assisted. Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects. 3 Paediatric population Opioid withdrawal may be life-threatening in neonates if not recognised and properly treated and may include the following signs

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