Abstral^®

FENTANYL CITRATE

Abstral^® is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain. Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain.*¹

Adverse Events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse Events should also be reported to Kyowa Kirin International UK NewCo Ltd, known as Grünenthal Meds on +44 (0)1896 664000, email PVUK@grunenthalmeds.com

Click here to download the Abstral^® prescribing and adverse event reporting information.

Prescribing Information Abstral® (fentanyl (as citrate)) Sublingual Tablets

Please refer to the full Summary of Product Characteristics before prescribing.

Name: Abstral sublingual tablets.

Active Ingredient: 100mcg, 200mcg, 300mcg, 400mcg, 600mcg or 800mcg fentanyl (as citrate).

Indication

Management of breakthrough pain (BTP) in adult patients using opioid therapy for chronic cancer pain.

Dosage and administration

Administer directly under the tongue, and allow to dissolve without chewing, sucking or swallowing the tablet.

Adults;

Initially 100mcg, titrating upwards as necessary with close monitoring to establish an appropriate dose. Patients should wait at least 2 hours before treating another episode of breakthrough pain and take no more than 4 doses/day. Abstral should be discontinued immediately if BTP episodes cease. Treatment for the persistent background pain should be kept as prescribed. If discontinuation of all opioid therapy is required, closely monitor to avoid the possibility of abrupt withdrawal effects.

Elderly and patients with renal and hepatic impairment;

Take particular care during titration and monitor for signs of fentanyl toxicity.

Children and adolescents;

Must not be used in patients under 18 years of age.

Adverse effects

The most serious adverse effects include respiratory depression, hypotension and shock. The most frequent adverse reactions include nausea, constipation, somnolence, headache, dizziness, dyspnoea, stomatitis, vomiting, dry mouth, hyperhidrosis and fatigue. Other serious but uncommon adverse reactions include hypersensitivity, tachycardia, bradycardia, hypotension, depressed level of consciousness, loss of consciousness and drug withdrawal syndrome. Coma is also known to occur. Cheyne Stokes respiration has been observed in cases of fentanyl overdose. Prescribers should consult the summary of product characteristics for further details of side effects.

Precautions

Abstral should be used with caution in patients with previous or pre-existing bradyarrythmias; care should be taken in treating patients with hypovolaemia and hypotension. Abstral must be kept out of sight and reach of children. Ensure patients and carers use correctly and know what to do in case of overdose.

Before starting Abstral, ensure long-acting opioid treatment for persistent pain is stable. Dependence may develop upon repeated administration of opioids. Repeated use of Abstral may lead to Opioid Use Disorder (abuse and dependence) Take care during dose titration in patients with COPD or at risk of respiratory depression. Administer with extreme caution in patients susceptible to the intracranial effects of hyperkapnia.

Opioids may mask the clinical course in patients with head injuries. Use with caution in patients with mouth wounds or mucositis. Monitor use carefully in elderly, cachectic and debilitated patients, and patients with liver or kidney dysfunction. A potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs. Discontinue Abstral if serotonin syndrome is suspected. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep related hypoxaemia.

Interactions

Use with caution if given concomitantly with CYP3A4 inhibitors and/or inducers, other CNS depressants, alcohol or partial opioid agonists/antagonists. Co-administration of a serotoninergic agent, such as a Selective Serotonin Reuptake Inhibitor, a Serotonin Norepinephrine Reuptake Inhibitor or a Monoamine Oxidase Inhibitor, may increase the risk of serotonin syndrome. Concomitant use of other CNS depressants, such as other morphine derivatives (analgesics and antitussives), general anaesthetics, gabapentinoids (gabapentin and pregabalin), skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics (i.e., benzodiazepines), hypnotics, antipsychotics, clonidine, and related substances may produce increased CNS depressant effects, increased risk of sedation, respiratory depression, hypotension, coma and death because of additive CNS depressant effect. Not recommended for use in patients who have received an MAOI within 14 days

Pregnancy: Fentanyl should only be used during pregnancy when clearly necessary. Do not use during labour and delivery.

Lactation: Fentanyl should not be used by breastfeeding women.

Contraindications

Hypersensitivity to any of the ingredients; opioid-naïve patients; severe respiratory depression or severe obstructive lung conditions. Treatment of acute pain other than BTP. Patients being treated with medicinal products containing sodium oxybate

Further information available on request from the Marketing Authorisation Holder.
Legal classification: CD POM. Date of prescribing information: October 2022.

Adverse event reporting information

For the United Kingdom

Marketing Authorisation Holder: Kyowa Kirin Ltd., Galabank Business Park, Galashiels, Scotland TD1 1QH, UK.

Pack Sizes & NHS cost: Abstral 100-400mcg 10 tablets: £49.99. Abstral 100-800mcg 30 tablets: £149.70.

Marketing Authorisation Numbers: PL 16508/0030-35.

Adverse Events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse Events should also be reported to Kyowa Kirin International UK NewCo Ltd, known as Grünenthal Meds on +44 (0)1896 664000, email PVUK@grunenthalmeds.com

For the Republic of Ireland

Marketing Authorisation Holder: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands.

Pack Sizes: Abstral 100-400mcg 10 tablets. Abstral 100-800mcg 30 tablets.

Marketing Authorisation Numbers: PA2288/004/002/002-007.

Adverse Events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse Events should also be reported to Kyowa Kirin International UK NewCo Ltd, known as Grünenthal Meds on +44 (0)1896 664000, email PVUK@grunenthalmeds.com

Abstral^® (fentanyl (as citrate)) is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain. Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain. Please note not all medicines containing opioids are authorised for all types of pain indication. Refer to the summary of product characteristics before prescribing. For advice on the responsible use of opioids, including those indicated for other types of pain, please click here

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References

1. Abstral^® Summary of Product Characteristics 10-2022.

KKI/INT/ABS/0011 November 2023