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  • Fenta SL
    / Rafa


    Active Ingredient
    Fentanyl 67, 133, 267, 400, 533, 800 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Sublingual Tablet

    30 X 67 mcg

    not in the basket chart 66856

    Sublingual Tablet

    30 X 133 mcg

    not in the basket chart 66862

    Sublingual Tablet

    30 X 267 mcg

    not in the basket chart 66860

    Sublingual Tablet

    30 X 400 mcg

    not in the basket chart 66857

    Sublingual Tablet

    30 X 533 mcg

    not in the basket chart 66859

    Sublingual Tablet

    30 X 800 mcg

    not in the basket chart 66858

    Related information


    Dosage

    Physicians should keep in mind the potential of abuse of fentanyl.
    Patients should be instructed not to use two different formulations of fentanyl concurrently for the treatment of breakthrough pain, and to dispose of any fentanyl product prescribed for BTP when switching to Fenta SL. The number of tablet strengths available to the patients at any time should be minimised to prevent confusion and potential overdose.
    Fenta SL should be administered directly under the tongue at the deepest part. Fenta SL 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.
    After 30 minutes, if remnants from the Fenta SL tablet remain, they may be swallowed.
    In patients who have a dry mouth, water may be used to moisten the buccal mucosa before taking Fenta SL.
    The tablet should not be stored once removed from the blister package as the tablet integrity can not be guaranteed and a risk of accidental exposure to a tablet can occur. Patients should be advised to keep Fenta SL in a locked storage space.
    Dose Titration: Before patients are titrated with Fenta SL, it is expected that their background persistent pain will be controlled by use of opioid therapy and that they are typically experiencing no more than 4 episodes of breakthrough pain per day.
    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 Fenta SL 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 Fenta SL used should be 133 micrograms, titrating upwards as necessary through the range of available dosage strengths.
    Patients should be carefully monitored until an optimal dose is reached. Switching from other fentanyl containing products to Fenta SL 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 Fenta SL 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.
    All patients must start therapy with a single 133 micrograms sublingual tablet. If adequate analgesia is not obtained within 15-30 minutes of administration of a single tablet, a supplemental (second) 133 micrograms tablet may be administered. If treatment of a breakthrough pain episode requires more than one dosage unit, an increase in dose to the next higher available strength should be considered (Refer to figure below). Dose escalation should continue in a stepwise manner until adequate analgesia is achieved. The dose strength for the supplemental (second) tablet should be increased from 133 to 267 micrograms at dose of 533 micrograms. This is illustrated in the schedule below. No more than two (2) tablets should be administered for a single episode of breakthrough pain during this titration phase.
    If adequate analgesia is achieved at the higher dose, but undesirable effects are considered unacceptable, an intermediate dose may be administered (using the 67 micrograms or 133 micrograms tablet).
    Doses higher than 800 micrograms have not been evaluated in clinical studies.
    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.
    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 Fenta SL doses per day.
    Dose re-adjustment: If the response (analgesia or adverse reactions) to the titrated Fenta SL 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 consistently experienced per day, 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 Fenta SL 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.
    Discontinuation of therapy: Fenta SL should be discontinued immediately if the patient no longer experiences breakthrough pain episodes. The treatment for the persistent background pain should be kept as prescribed.
    If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor in order to manage the risk of abrupt withdrawal effects.
    Use in elderly patients: Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity.
    Use in patients with renal and hepatic impairment: Patients with kidney or liver dysfunction should be carefully observed for signs of fentanyl toxicity during the Fenta SL titration phase.
    Use in paediatric population: Fenta SL is not indicated for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.


    Indications

    Fenta SL is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
    BTP 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.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Patients without maintenance opioid therapy as there is an increased risk of respiratory depression. Simultaneous use of monoamine-oxidase (MAO) inhibitors, or within 2 weeks after the cessation of the use of MAO inhibitors. Severe respiratory depression or severe obstructive lung conditions. Treatment of acute pain other than breakthrough pain.


    Special Precautions

    Patients and their carers must be instructed that Fenta SL contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children and non-patients at all times.
    In order to minimise the risks of opioid-related undesirable effects 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 Fenta SL therapy begins and that the patient continues to be treated with the long acting opioid treatment whilst taking Fenta SL.
    As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl. Particular caution should be used when titrating Fenta SL in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Fenta SL may further decrease respiratory drive to the point of respiratory failure.
    Fenta SL 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 a patient with a head injury and should be used only if clinically warranted.
    Cardiac disease: Fentanyl may produce bradycardia. Fentanyl should be used with caution in patients with previous or preexisting bradyarrhythmias.
    Serotonin Syndrome: Caution is advised when Fenta SL is coadministered with drugs that affect the serotoninergic neurotransmitter systems.
    See prescribing information for full details.


    Side Effects

    Typical opioid side effects are to be expected with Fenta SL. Frequently, these will cease or decrease in intensity with continued use of the 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 closely monitored for these.
    The most frequently observed adverse reactions include: nausea, vomiting, constipation, headache, somnolence/fatigue and dizziness.
    For full details see prescribing information.


    Drug interactions

    Selective Serotonin Reuptake Inhibitor (SSRI), Serotonin Norepinephrine Re-uptake Inhibitor (SNRI), Monoamine Oxidase Inhibitor (MAOI).
    Monoamine oxidase (MAO) inhibitors.
    CYP3A4 inhibitors. Alcohol. Grapefruit juice. CYP3A4 inducers.
    Central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines.
    Partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine).
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Fenta SL should not be used in 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 or in the new-born infant. If Fenta SL is administered, an antidote for the child should be readily available.
    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 breastfeeding should not be restarted until at least 5 days after the last administration of fentanyl.


    Overdose

    The symptoms of fentanyl overdosage are expected to be similar in nature to those of intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with the most serious significant effects being altered mental status, loss of consciousness, coma, cardiorespiratory arrest, respiratory depression, respiratory distress and respiratory failure, which have resulted in death.
    Immediate management of opioid overdose includes removal of the Fenta SL if still in the mouth, ensuring a patent airway, physical and verbal stimulation of the patient, assessment of the level of consciousness, ventilatory and circulatory status, and assisted ventilation (ventilatory support) if necessary.
    For treatment of overdosage (accidental ingestion) in the opioid naïve person, intravenous access should be obtained, and naloxone or other opioid antagonists should be employed as clinically indicated. The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist’s action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
    Consult the Summary of Product Characteristics of the individual opioid antagonist for details about such use.
    For treatment of overdose in opioid-maintained patients, intravenous access should be obtained. The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
    If severe or persistent hypotension occurs, hypovolaemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
    Muscle rigidity interfering with respiration has been reported with fentanyl and other opioids. In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.


    Important notes

    Storage: Store below 25ºC.


    Manufacturer
    Ethypharm, France
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