PecFent · 4.4 Special warnings and precautions for use · 1

HOS-154871 · has-adverse-reaction-information · PDF-Seite 9

Summary of the safety profile Typical opioid adverse reactions are to be expected with PecFent. Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose. However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be monitored for these. The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain. Therefore it is not possible to definitively separate the effects of PecFent alone. Tabulated list of adverse reactions The following adverse reactions have been reported with PecFent and/or other fentanyl-containing compounds during clinical studies and post marketing experience (frequencies defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data)). Common Uncommon Unknown Infections and Pneumonia infestations Nasopharyngitis Pharyngitis Rhinitis Immune system Hypersensitivity disorders Metabolism and Anorexia nutrition disorders Dehydration Hyperglycaemia Decreased appetite 9  Common Uncommon Unknown Psychiatric disorders Disorientation Delirium Insomnia Abnormal dreams Drug dependence HallucinationConfusional (addiction) state Drug abuse Depression Paranoia

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HOS-154867 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients without maintenance opioid therapy as there is an increased risk of respiratory depression. Severe respiratory depression or severe obstructive lung conditions. Treatment of acute pain other than breakthrough pain. Patients being treated with medicinal products containing sodium oxybate.

HOS-154866 · has-indication-information · PDF-Seite 2

PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

HOS-154869 · has-interaction-information · PDF-Seite 7

Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3). The treatment of sodium oxybate should be discontinued before start of treatment with PecFent. Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when PecFent is given concurrently with medicinal products that affect CYP3A4 activity. Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of PecFent. The concomitant use of PecFent with strong CYP3A4 inhibitors (e.g. 7 ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression. Patients receiving PecFent concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time. Dose increase should be undertaken with caution. CNS depressants The concomitant use of other central nervous system depressants, including other opioids, antitussives or substitution treatments, H1 antihistamines, barbiturates, anxiolytics (i.e., benzodiazepines), antipsychotics, clonidine, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, gabapentinoids (gabapentin and pregabalin) sedating antihistamines and alcohol may produce increased CNS depressant effects, increased risk of sedation, respiratory depression, hypotension, coma, and death because of additive CNS depressant effect. The lowest effective dose of sedative medicines should be used and duration of concomitant use should be limited (see section 4.4). Serotoninergic medicinal products: Coadministration of fentanyl with a serotoninergic medicinal product, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition. PecFent is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within the previous 14 days because severe and unpredictable potentiation by MAO inhibi

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HOS-154870 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. PecFent should not be used during pregnancy unless clearly necessary. Following long-term treatment, fentanyl may cause withdrawal in the new-born infant. It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the foetus. If PecFent is administered, an antidote for the child should be readily available. 8 Breastfeeding Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breast-feeding should not be restarted until at least 5 days after the last administration of fentanyl. Fertility There are no clinical data on the effects of fentanyl on fertility.

HOS-154868 · has-warning-information · PDF-Seite 5

Because of the risks, including fatal outcome, associated with accidental exposure, misuse, and abuse, patients and their carers must be advised to keep PecFent in a safe and secure place, not accessible by others. Patients and their carers must be instructed that PecFent contains an active substance in an amount that can be fatal to a child. In order to minimise the risks of opioid-related adverse reactions and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process. It is important that the long acting opioid treatment used to treat the patient’s persistent pain has been stabilised before PecFent therapy begins. Hyperalgesia As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered. A fentanyl dose reduction or discontinuation of fentanyl treatment or treatment review may be indicated. 5 Respiratory depression There is a risk of clinically significant respiratory depression associated with the use of fentanyl. Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients is reduced. The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5). Chronic pulmonary disease In patients with chronic obstructive pulmonary diseases, fentanyl may cause more serious adverse reactions. In these patients, opioids may decrease respiratory drive and increase airway resistance. Increased intracranial pressure PecFent should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of patients with a head injury and should be used only if clinically warranted. Cardiac disease Fentanyl may produce bradycardia. PecFent should, therefore, be used with caution in patients with previous or pre-existing bradyarrhythmias. Impaired hepatic or renal function In addition, PecFent should be administered with caution to patients with hepatic or renal impairment. The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not

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