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FENHUMA is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Fenhuma should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain. Patients can be considered opioid tolerant if they take 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.
Method of administration:
Fenhuma sublingual tablets should be administered directly under the tongue at the deepest part. Fenhuma sublingual tablets should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or sucking.
Patients should be advised not to eat or drink anything until the sublingual tablet is completely dissolved. In patients who have a dry mouth water may be used to moisten the buccal mucosa before taking Fenhuma.
Dose titration:
The object of dose titration is to identify an optimal maintenance dose for ongoing treatment of breakthrough pain episodes. This optimal dose should provide adequate analgesia with an acceptable level of adverse reactions. The optimal dose of Fenhuma will be determined by upward titration, on an individual patient basis.
Several doses are available for use during the dose titration phase. The initial dose of Fenhuma used should be 100 micrograms, titrating upwards as necessary through the range of available dosage strengths. Patients should be carefully monitored until an optimal dose is reached.
Fenhuma sublingual tablets are the generic version of the reference product of Fentanyl sublingual tablets and has demonstrated bioequivalence to the reference product. This means that Fenhuma tablets are the same as, and considered interchangeable with, the reference product.
Prescribers and patients can expect Fenhuma to produce the same clinical effect as the reference product. e. buccal tablets, lozenges, nasal sprays or other pharmaceutical forms) to Fenhuma must not occur at a 1:1 ratio because of different absorption profiles.
If patients are switched from another fentanyl containing product, a new dose titration with Fenhuma is required. The following dose regimen is recommended for titration, although in all cases the physician should take into account the clinical need of the patient, age and concomitant illness.
Undesirable effects typical of opioids are to be expected with Fenhuma; they tend to decrease in intensity with continued use. The most serious potential adverse reactions associated with opioid use are respiratory depression (which could lead to respiratory arrest), hypotension and shock.
The clinical trials of Fenhuma were designed to evaluate safety and efficacy in treating patients with breakthrough cancer pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain.
Therefore, it is not possible to definitively separate the effects of Fenhuma alone. The most frequently observed adverse reactions with Fenhuma include typical opioid adverse reactions, such as nausea, constipation, somnolence and headache.
Tabulated Summary of Adverse Reactions with Fenhuma and/or other fentanyl- containing compounds: The following adverse reactions have been reported with Fenhuma and/or other fentanyl-containing compounds during clinical studies and from post-marketing experience.
They are listed below by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥1/1,000 to <1/100; not known (cannot be estimated from available data)). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4) Drug abuse Delirium Nervous system disorders Dizziness Headache Somnolence Amnesia Parosmia Dysgeusia Tremor Lethargy Hypoaesthesia Sleep disorder Convulsion Depressed level of consciousness Loss of consciousness Eye disorders Vision blurred Cardiac disorders Tachycardia Bradycardia Vascular disorders Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Oropharyngeal pain Throat tightness Respiratory depression Gastrointestinal disorders Nausea Stomatitis Vomiting Constipation Dry mouth Mouth ulceration Gingival ulceration Lip ulceration Impaired gastric emptying Abdominal pain Dyspepsia Stomach discomfort Tongue disorder Aphthous stomatitis Swollen tongue Diarrhoea Skin and subcutaneous tissue disorders Hyperhidrosis Skin lesion Rash Pruritus allergic Pruritus Night sweats Increased tendency to bruise Urticaria Musculoskeletal and connective tissue disorders Arthralgia Musculoskeletal stiffness Joint stiffness Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Fatigue Drug withdrawal syndrome Asthenia Malaise Flushing and hot flush Peripheral oedema Pyrexia Neonatal withdrawal syndrome Drug tolerance Injury, poisoning and procedural complications Accidental overdose Fall Description of selected adverse reactions Tolerance Tolerance can develop on repeated use.
Because of the risks, including fatal outcome, associated with accidental exposure, misuse, and abuse, patients and their carers must be advised to keep Fenhuma in a safe and secure place, not accessible by others. Due to the potentially serious undesirable effects that can occur when taking an opioid therapy such as Fenhuma, patients and their carers should be made fully aware of the importance of taking Fenhuma correctly and what action to take should symptoms of overdose occur.
Before Fenhuma therapy is initiated, it is important that the patient's long-acting opioid treatment used to control their persistent pain has been stabilised. Tolerance and opioid use disorder (abuse and dependence) For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.
A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. , major depression). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. Patients should be advised to contact their physician if these signs occur.
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
1. Contraindicated in opioid naive patients. 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl in United Kingdom.
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All patients must start therapy with a single 100 microgram sublingual tablet. If adequate analgesia is not obtained within 15-30 minutes of administration of a single sublingual tablet, a supplemental (second) 100 microgram sublingual tablet may be administered.
If adequate analgesia is not obtained within 15-30 minutes of the first dose an increase in dose to the next highest tablet strength should be considered for the next episode of breakthrough pain (Refer to figure below). Dose escalation should continue in a stepwise manner until adequate analgesia with tolerable adverse reactions is achieved.
The dose strength for the supplemental (second) sublingual tablet should be increased from 100 to 200 micrograms at doses of 400 micrograms and higher. This is illustrated in the schedule below. No more than two (2) doses should be administered for a single episode of breakthrough pain during this titration phase.
FENHUMA TITRATION PROCESS Strength (micrograms) of first sublingual tablet per episode of breakthrough pain Strength (micrograms) of supplemental (second) sublingual tablet to be taken 15-30 minutes after first tablet, if required 100 100 200 100 300 100 400 200 600 200 800 - If adequate analgesia is achieved at the higher dose, but undesirable effects are considered unacceptable, an intermediate dose (using the 100 microgram sublingual tablet where appropriate) may be administered.
During titration, patients can be instructed to use multiples of 100 microgram tablets and/or 200 microgram tablets for any single dose. No more than four (4) tablets should be used at any one time. The efficacy and safety of doses higher than 800 micrograms have not been evaluated in clinical studies in patients.
In order to minimise the risk of opioid–related adverse reactions and to identify the appropriate dose, it is imperative that patients be monitored closely by health professionals during the titration process. During titration patients should wait at least 2 hours before treating another episode of breakthrough pain with Fenhuma.
Maintenance therapy:
Once an appropriate dose has been established, which may be more than one tablet, patients should be maintained on this dose and should limit consumption to a maximum of four Fenhuma doses per day. During the maintenance period patients should wait at least 2 hours before treating another episode of breakthrough pain with Fenhuma.
Dose re-adjustment:
If the response (analgesia or adverse reactions) to the titrated Fenhuma dose markedly changes, an adjustment of dose may be necessary to ensure that an optimal dose is maintained. If more than four episodes of breakthrough pain are experienced per day over a period of more than four consecutive days, then the dose of the long acting opioid used for persistent pain should be re-evaluated.
If the long acting opioid or dose of long acting opioid is changed the Fenhuma dose should be re-evaluated and re-titrated as necessary to ensure the patient is on an optimal dose. It is imperative that any dose re-titration of any analgesic is monitored by a health professional.
4).
Discontinuation of therapy:
Fenhuma should be discontinued immediately if the patient […]
Drug dependence Repeated use of Fenhuma can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Respiratory Depression In common with all opioids, there is a risk of clinically significant respiratory depression associated with the use of Fenhuma.
g. myasthenia gravis) because of the risk of further respiratory depression, which could lead to respiratory failure. Increased intracranial pressure Fenhuma should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of hyperkapnia, such as those showing evidence of raised intracranial pressure, reduced consciousness, coma or brain tumours.
In patients with head injuries, the clinical course may be masked by the use of opioids. In such a case, opioids should be used only if absolutely necessary. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Cardiac disease Fentanyl may produce bradycardia. Fentanyl should be used with caution in patients with previous or pre-existing bradyarrhythmias. Elderly, cachectic or debilitated population Data from intravenous studies with fentanyl suggest that older patients may have reduced clearance, a prolonged half-life and they may be more sensitive to the active substance than younger patients.
Older, cachectic, or debilitated patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary. Impaired hepatic or renal function Fenhuma should be administered with caution to patients with liver or kidney dysfunction, especially during the titration phase.
The use of Fenhuma in patients with hepatic or renal impairment may increase the bioavailability of fentanyl and decrease its systemic clearance, which could lead to accumulation and increased and prolonged opioid effects. Hypovolaemia and hypotension Care should be taken in treating patients with hypovolaemia and hypotension.
Use in patients with mouth wounds or mucositis Fenhuma has not been studied in patients with mouth wounds or mucositis. There may be a risk of increased systemic drug exposure in such patients and therefore extra caution is recommended during dose titration.
Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with fentanyl. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.
When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased […]