Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential of abuse of fentanyl.
Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. Patients must be carefully monitored during the titration process.
Titration to a higher dose necessitates contact with the health care professional.
The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).
Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.
Patients should wait 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy. On exceptional occasions where a new episode occurs earlier, patients can use Instanyl to treat it but they must wait at least 2 hours before doing so. Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.
Before patients are titrated with Instanyl, it is expected that their background persistent pain is controlled by use of chronic opioid therapy and that they are experiencing no more than four episodes of breakthrough pain per day.
Method of titration
The initial strength should be one dose of 50 micrograms in one nostril, titrating upwards as necessary through the range of available strengths (50, 100, and 200 micrograms). If adequate analgesia is not obtained redosing of the same strength may be administered at the earliest after 10 minutes. Each titration step (dose strength) should be evaluated in several episodes.
Once the dose has been established according to the steps described above, the patient should be maintained on this strength of Instanyl. If the patient has insufficient pain relief, redosing with same strength can be done at the earliest after 10 minutes.
Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.
Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.
If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics.
Discontinuation of therapy
Instanyl 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 as gradual downward opioid titration is necessary in order to avoid the possibility of abrupt withdrawal effects.
Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above >65 years of age. Elderly patients may have a reduced clearance, a prolonged half-life and higher sensitivity to fentanyl than younger patients. Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.
In clinical trials elderly patients tend to titrate to a lower effective strength than patients less than 65 years of age. Particular caution should be exercised when titrating Instanyl in elderly patients.
Instanyl should be administered with caution to patients with moderate to severe hepatic impairment (see section 4.4).
Instanyl should be administered with caution to patients with moderate to severe renal impairment (see section 4.4).
The safety and efficacy of Instanyl in children aged below 18 years have not yet been established.
No data are available.
Method of administration
Instanyl is intended for nasal use.
It is recommended that the patient sit or stand in upright position when administrating Instanyl.
Cleaning of the nasal spray tip is required after each use.
Precautions to be taken before handling or administering the medicinal product
Before using Instanyl for the first time, the nasal spray must be primed until a fine mist appears; 3 to 4 actuations of the nasal spray are usually required.
If the product has not been used for a period of more than seven days, the nasal spray must be primed again by actuating once before the next dose is taken.
During the priming process product will be expelled. Therefore, the patient must be instructed that the priming should be conducted in a well ventilated area, pointing away from the patient and other people, and away from surfaces and objects that could come into contact with other people, particularly children.