Fentanyl
Indications
- Moderate-to-severe pain
- Breakthrough pain (lozenge, for patients with cancer pain on maintenance opioid analgesic)
Adverse effects
Following adverse effect are specific to Fentanyl. See Opioid analgesic adverse effects for full list of adverse effects.
More common
- Rash, erythema, skin irritation (patch)
- Itch (patch)
- May have a lower incidence of nausea, vomiting and constipation than other opioids
Dose
Doses will vary widely depending on the indication, eg acute or chronic pain, and previous analgesic requirements.
Titrate dose according to response and sedation score. Monitor cardiorespiratory status of patient closely, particularly with repeated parenteral doses in opioid-naive individuals.
Acute pain (dose ranges for opioid-naïve patients)
SC
- Start at the lower end of the dosage range (25-50 micrograms every 2 hours as required) and titrate according to response.
Transdermal preparation (patch)
- Do not use fentanyl patch in opioid-naive patients
- Base dose on previous 24-hour opioid requirement; calculate equivalent 24-hour transdermal fentanyl dose if necessary
- It may be appropriate to stabilise the patient on fentanyl SC infusion, and then convert to the patch
- Use 1 patch every 3 days. Adjust dose according to response, no more frequently than every 3 days if analgesia is insufficient
SC infusion
- Base dose on previous 24‑hour opioid requirement; calculate equivalent 24‑hour fentanyl dose
Lozenge for breakthrough pain (over 18 years)
- Application via buccal mucosa
- Initially 200 micrograms. Repeat once only (if analgesia is inadequate 30 minutes after starting first lozenge)
- Dose titration - if a single lozenge is inadequate for several episodes of breakthrough pain, use the next dosage strength
- The aim is to relieve an episode of breakthrough pain with a single lozenge. Usually allow at least 4 hours between doses. If >4 breakthrough doses are required per day adjust the regular baseline opioid dose
Sublingual/buccal tablet for breakthrough pain (over 18 years)
- Place tablet under tongue or against cheek
- Initially 100 micrograms. Repeat once only (if analgesia is inadequate 30 minutes after starting first tablet)
- Dose titration - if a single tablet is inadequate for several episodes of breakthrough pain, use the next dosage strength
- The aim is to relieve an episode of breakthrough pain with a single tablet. Usually allow at least 4 hours between doses. If >4 breakthrough doses are required per day, adjust the regular baseline opioid dose.
Dose equivalence
- For analgesic effect, 100 to 150 micrograms fentanyl SC is approximately equivalent to 10 mg morphine IM/SC
- See product information in TGA for dose conversion in patch. As an example, the 12 micrograms/hour patch is approximately equivalent to 30-45 mg oral morphine daily. This dose equivalence should be used only to convert from oral morphine to fentanyl patch.
Patient advice
Transdermal preparation (patch)
- Write the date and time of application on the patch with permanent marker, then apply it to dry, hairless, non-irritated skin on the upper part of your body or upper arm. Do not apply straight after a hot bath or shower; wait until skin is cool and dry. Do not use if patch is damaged or cut. Check the patch is still attached on the days between patch changes.
- Remove after 3 days (72 hours) and put a new patch on a different place. Make sure you know how to dispose of patches safely.
- When wearing the patch, do not allow it to come into contact with direct sources of heat such as electric blankets, heat pads, heat lamps, saunas or hot baths.
- After removing a patch, avoid exposing that area of skin to the sun for 2 days as it may be more sun-sensitive.
Lozenge
- Place lozenge in the mouth against the cheek and move it around the mouth using the applicator. Let it dissolve over 15 minutes. Do not chew.
- Take particular care to ensure good dental hygiene as the lozenge contains sugar.
Buccal/sublingual tablet
- Allow tablets to dissolve; do not swallow
- Analgesic effect occurs rapidly but is short acting
Precautions (fentanyl specific)
Renal
- Evidence suggests that fentanyl has no active or toxic metabolites and may be used in renal impairment.
Bradyarrhythmias
- May be exacerbated
Dry mouth, diabetes
- Each lozenge contains approximately 2 g glucose
Serotonin toxicity
- Treatment with, or within 14 days of, a Monoamine Oxidase Inhibitor (MAOI) is contraindicated due to the risk of serotonin toxicity.
- Treatment with other drugs that may contribute to serotonin toxicity may increase likelihood; avoid combinations or monitor clinical course carefully.
Practice considerations
Transdermal preparation (patch)
Do not use patch for postoperative and other acute pain situations because of the risk of life-threatening respiratory depression; it has a delayed onset and prolonged duration of action; rapid and safe dose titration is not possible
Takes about 24–72 hours to reach maximum effect; steady state concentration may not be reached until the second patch is applied; wean other analgesics slowly after first patch is applied
When switching from an oral opioid, apply the first fentanyl patch at the same time as the last dose of a 12 hour controlled release product OR 12 hours after the last dose of a 24 hour controlled release product
Patch is generally effective for 72 hours; however, adult patients with pain that regularly occurs before the next dose is due may sometimes need to apply a new patch every 48 hours
Plasma concentration slowly falls after patch removal (eg concentration is halved after about 22–25 hours); monitor for adverse effects for at least 24 hours after removal of patch
Heat increases the release of fentanyl from patch; avoid exposure to external heat sources (including heated blanket, hot baths), monitor for increased adverse effects if a fever develops
Deaths have occurred in children accidentally exposed to patches, therefore ensure the patient/carer understands:
- how to store and dispose of patches safely (approximately 30–50% of original amount of fentanyl remains in the patch after 3 days of use)
- that the patch must always be firmly attached
Subcutaneous
- SC fentanyl infusion may be used as an alternative to SC morphine in palliative care patients who develop morphine intolerance; the larger volumes of fentanyl required may necessitate more frequent changes of the SC infusion site
- SC sufentanil (available under the SAS) may be used as an alternative to SC fentanyl for palliative care as a smaller volume of infusion is required
Lozenge
- Fentanyl lozenges may be used for breakthrough pain in cancer patients already stabilised on an opioid
- About 25% of the fentanyl is absorbed rapidly through the buccal mucosa and pain relief begins after 5–10 minutes; the rest of the drug is swallowed and absorbed more slowly, giving peak plasma concentration at 20–40 minutes
- Any partly used lozenges should be returned to the pharmacy for safe disposal
- There is no dose equivalence between fentanyl lozenges and other opioid products (including fentanyl patches)
Sublingual/buccal tablets
- Fentanyl tablets may be used for breakthrough pain in cancer patients already stabilised on an opioid
- Pain relief begins after 5-10 minutes and lasts for 1-2 hours
- There is no dose equivalence between fentanyl sublingual/buccal tablets and other opioid products (including fentanyl patches)
Available brands
Fentanyl lozenges 200, 400, 600, 800, 1200, 1600 mcg
- Actiq®
Fentanyl transdermal patch
12, 25, 50, 75, 100 mcg/hr q3days
- Denpax®
- Fenpatch®
- Dutran®
- Durogesic®
- Fentanyl Sandoz®
Fentanyl sublingual/buccal tablets
100, 200, 400, 600, 800 mcg
- Abstral®; Fentora®