Fentanyl lozenge with applicator (all strengths)
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Buccal/sublingual formulations containing fentanyl
Drugs List
Therapeutic Indications
Uses
Management of breakthrough cancer pain in patients receiving opiates
Dosage
Lozenges should be titrated to provide adequate analgesia and minimise side effects for the individual.
Adults
Prior to titration, background persistent pain should be controlled by opioid therapy and patients should not be experiencing more than 4 episodes of breakthrough pain per day.
Initial titration dose: 200micrograms, increasing if necessary by 200micrograms to 400micrograms until a single dose provides adequate analgesia.
If adequate analgesia is not obtained within 30 minutes (15 minutes after completing consumption) a second lozenge of the same strength may be administered. Maximum of two lozenges to treat any individual pain episode.
An increase to the next strength of the dose should be considered if several consecutive breakthrough pain episodes require more than one lozenge per episode.
Maintenance dose: Once an adequate titration dose is reached, patients should be maintained on this dose. Maximum of four lozenges per day.
A health professional should monitor the patient to ensure the maximum dosage is not exceeded.
Dose re-adjustment:
If more than four episodes of breakthrough pain are experienced per day, the long acting opioid dose used for persistent pain should be re-evaluated. Once the patient's persistent pain has been re-stabilised, the dose of fentanyl lozenge to treat breakthrough pain may need to be reviewed. It is imperative that any dose re-titration of any analgesic is monitored by a health professional.
In the absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.
Patients with Renal Impairment
The Renal Drug Handbook recommends the following
GFR 20 to 50ml/min: 75% of normal dose, titrate according to response.
GFR 10 to 20ml/min: 75% of normal dose, titrate according to response.
GFR less than 10ml/min: 50% of normal dose, titrate according to response.
Contraindications
Children under 16 years
Opioid-naive patients
Within 2 weeks of discontinuing MAOIs
Coma
Hereditary fructose intolerance
Severe obstructive pulmonary disease
Severe respiratory depression
Precautions and Warnings
Elderly
Family history of alcohol abuse
Family history of drug misuse
Impaired consciousness
Tobacco smoking
Adrenal insufficiency
Asthma
Bradyarrhythmia
Breastfeeding
Chronic obstructive pulmonary disease
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Head trauma
Hepatic impairment
History of alcohol abuse
History of drug misuse
History of psychiatric disorder
Hypotension
Hypovolaemia
Pregnancy
Raised intracranial pressure
Renal impairment
Respiratory depression
Diabetes: Some products may contain dextrates
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Contains glucose
Contains propylene glycol: may cause irritation
Preparation contains sucrose
Dental check-ups advisable during long-term treatment
Diabetic control may need adjustment
May cause adrenal suppression
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor patient closely during titration of dose
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with a history of alcoholism and drug abuse
Potential for drug abuse
Tolerance and dependence may occur
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction if sleep-related breathing disorders occur
Consider dose reduction or change in opioid if evidence of hyperalgesia
Increased risk of central sleep apnoea and sleep-related hypoxemia
Mucositis: absorption may be increased, consider during dose titration
Prolonged treatment may lead to dental caries
Prolonged use at high doses may result in hyperalgesia
Avoid abrupt withdrawal
Discontinue if serotonin syndrome develops
Reduce dose in elderly
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level
Advise patient of need for high oral hygiene standards
Fentanyl lozenges are not interchangeable on a microgram to microgram basis with other short-acting fentanyl products that are indicated for the use of breakthrough cancer pain.
To reduce the risk of respiratory depression and death, the product should only be given to patients stabilised on maintenance opioid therapy and this maintenance therapy must continue while the patient is taking fentanyl lozenges.
All patients require careful monitoring for signs of abuse and addiction. Monitor for signs of drug-seeking behaviours such as early prescription requests.
Repeated use may lead to Opioid Use Disorder (OUD). The risk of developing OUD is increased in patients with a personal or family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders such as depression, anxiety and personality disorders. Consider consultation with addiction specialist in patients with signs or symptoms of OUD.
Adrenal insufficiency has been reported with opioid use, as opioid may influence the gonadal or the hypothalamic-pituitary-adrenal axes. Changes in serum prolactin, plasma cortisol and testosterone levels have been shown with the use of opioids. If adrenal insufficiency is suspected, gradually wean patient off opioid treatment until adrenal function is recovered. Continue with corticosteroid treatment until adrenal function has recovered and opioid treatment can commence.
Central sleep apnoea and sleep-related hypoxemia has been reported with opioid use in a dose-dependent fashion. Consider dose reduction in patients presenting with central sleep apnoea.
Pregnancy and Lactation
Pregnancy
Use fentanyl lozenges with caution during pregnancy.
The manufacturer recommends only using fentanyl lozenges if necessary. At the time of writing, human data is limited but animal studies have shown reproductive toxicity. Risks are currently unknown.
Lactation
Use fentanyl lozenges with caution during breastfeeding.
The manufacturer suggests fentanyl lozenges should not be used when breastfeeding and not to restart treatment until 5 days after the last administration of fentanyl. Lactmed suggests limiting maternal intake of fentanyl by providing pain relief via non narcotic analgesics.
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). This medicine may be subject to police testing and has specified maximum blood levels for driving.
When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.
Counselling
Advise patients that the fentanyl lozenge should be placed in the mouth against the cheek and moved around the mouth using the applicator.
Advise patients that the fentanyl lozenge should be sucked not chewed and consumed over a 15 minute period.
Patients and their carers must be instructed that fentanyl lozenges contain an active substance in an amount that can be fatal to a child. Patients and their carers must be instructed to keep all units out of the reach of children and to discard of open units and fentanyl products no longer required, appropriately.
Advise patients that fentanyl may impair their ability to perform hazardous tasks. They should be advised not to drive or operate machinery if they experience somnolence, dizziness, blurred or double vision during treatment.
Advise patients of the need to maintain high oral hygiene standards. Dental check-ups are advisable during long-term treatment as prolonged treatment may lead to dental caries.
Advise patients grapefruit products may increase plasma levels.
Advise patients the effects are potentiated by CNS depressants (including alcohol).
Side Effects
Abdominal pain
Abnormal thinking
Abnormal vision
Accidental injury
Addiction
Adrenal insufficiency
Anaphylactic reaction
Anorexia
Anxiety
Apnoea
Asthenia
Bleeding (application site)
Bleeding gums
Bradycardia
Circulatory depression
Circumoral paraesthesia
Confusion
Constipation
Convulsions
Dependence
Depersonalisation
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dyspepsia
Dyspnoea
Emotional lability
Enlarged abdomen
Euphoria
Fatigue
Flatulence
Flushing
Gait abnormality
Hallucinations
Headache
Hot flushes
Hyperaesthesia
Hypersensitivity reactions
Hypotension
Ileus
Inco-ordination
Increase in dental caries
Insomnia
Irritation at application site
Loss of consciousness (transient)
Malaise
Mouth ulcers
Muscle rigidity
Myoclonus
Nausea
Oedema
Opioid use disorder
Pain
Paraesthesia
Peripheral oedema
Pharyngeal oedema
Pruritus
Psychological dependence
Pyrexia
Rash
Respiratory depression
Sedation
Shock
Sleep apnoea
Slurred speech
Somnolence
Stomatitis
Sweating
Taste disturbances
Tongue disorder
Tremor
Urinary retention
Urticaria
Vasodilation
Vertigo
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last full review date: May 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Actiq 200 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.
Summary of Product Characteristics: Actiq 400 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.
Summary of Product Characteristics: Actiq 600 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.
Summary of Product Characteristics: Actiq 800 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.
Summary of Product Characteristics: Actiq 1200 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.
Summary of Product Characteristics: Actiq 1600 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.
Summary of Product Characteristics: Cynril Lozenges. Fontus Health Ltd. Revised March 2019.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 10 May 2019
New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 10 May 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 May 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.