ACTIQ 800 micrograms Compressed with oral applicator Box of 3

ACTIQ 800 micrograms Compressed with oral applicator Box of 3
Therapeutic class:   Analgesics
Active ingredients:   Fentanyl
Statute:   Drug subjected to medical regulation
Rate of refunding S:   65%
Laboratory:   Cephalon France

Indications

- ACTIQ is indicated for the treatment of the paroxystic painful accesses among patients already receiving a morphine basic treatment for chronic pains of cancerous origin.
- A paroxystic painful access is a momentary exacerbation of a chronic pain in addition controlled by a basic treatment.

Posology

Reserved with the adult.
- In order to the minimum reduce the risks of undesirable effects related to morphine and to determine the “effective” amount adapted more to a patient, it is essential that the patients are narrowly supervised by health professionals during the period of titration.
- Any unit of ACTIQ not used and whose patient does not have any more the utility must be duly eliminated.
- It should be reminded the patients that ACTIQ must imperatively be preserved out of the range of the children.
MODE Of ADMINISTRATION:
- ACTIQ is intended for the administration by transmuqueuse oral way, consequently, the tablet must be placed against the inner face of the cheek. For the applicator, it is then necessary to move the tablet against the mucous membrane of the cheeks in order to optimize the degree of exposure of the mucous membrane to the active product. It is necessary to let melt the tablet of ACTIQ in contact with the mucous membrane, without sucking it, to chew it or crunch it, because the absorption of the fentanyl by the oral mucous membrane is faster than systemic absorption by gastro-intestinal way.
- The patients suffering from oral dryness can humidify their oral mucous membrane by drinking a little water before the catch of the drug.
- The unit of ACTIQ must be consumed in 15 minutes. So excessive morphine effects appear before the tablet of ACTIQ is entirely dissolves, this one will have to be immediately withdrawn of the mouth and it will have to be planned to reduce the later amounts.
POSOLOGICAL ADAPTATION AND TREATMENT Of MAINTENANCE:
It is advisable to determine the optimal posology of ACTIQ for each patient, i.e. the amount producing the required antalgic effect with a minimum of undesirable effects. At the time of the clinical studies, it was not established of relation between the effective amount of ACTIQ in the paroxystic painful accesses and the amount of the basic morphine treatment.
a) Titration:
- Before determining the posology of ACTIQ at a patient, it is necessary to make sure that its chronic pains are controlled by a basic morphine treatment and that it does not present more than 4 paroxystic painful accesses per day.
- The initial amount of ACTIQ must be 200 micrograms, with increase in posology, if necessary, in accordance with the range of proportionings available (200, 400,600,800,1200 and 1600 micrograms). The patients must be supervised with attention until obtaining the amount getting an effective analgesia and acceptable undesirable effects, with only one unit of ACTIQ per paroxystic painful access. This amount is defined as being the effective amount.
- During titration, if a satisfactory analgesia is not obtained in the 15 minutes following the end of the dissolution of a unit of ACTIQ, one second unit of ACTIQ of the same proportioning could be used. To in no case one will not have to use more than two units of ACTIQ to treat the same paroxystic painful access. With the proportioning of 1600 micrograms, it will be probably necessary to administrate one second amount only at one minority of patients.
- If the treatment of several consecutive paroxystic painful accesses requires more than one unit of ACTIQ by access, it is advisable to plan to pass to immediately higher proportioning.
DIAGRAM PRACTICES TITRATION:
- To start with a proportioned unit with 200 µg.
1. To let melt in mouth 1 unit of ACTIQ until complete dissolution (15 minutes).
2. To wait 15 more minutes additional.
3. If necessary, to take a second unit to be let melt in 15 minutes.
- Satisfactory Relief with 1 unit? :
(To test the same amount of ACTIQ at the time of several paroxystic painful accesses)
YES: Given effective amount.
NOT: to use the proportioning of immediately higher ACTIQ (proportionings available: 200,400,600,800,1200,1600 µg).
b) Treatment of maintenance:
- Once the established effective amount (i.e. a paroxystic painful access is effectively treated by only one unit, on average), the patients must use this amount and limit their consumption to a maximum of four units of ACTIQ per day.
- The patients must be supervised by an health professional in order to take care that the maximum consumption of four units of ACTIQ per day is not exceeded.
c) Readjustment of the amount:
- If the patients present more than 4 paroxystic painful accesses per day during more than 4 days consecutive, it can be necessary to revalue the posology of the basic morphine treatment. If this one is increased, it can be necessary to readjust the amount of ACTIQ used to treat the paroxystic painful accesses.
- Any readjustment of the posology of the analgesic treatment must imperatively be supervised by an health professional.
d) Stop of the treatment:
- Among patients continuing their basic morphine analgesic treatment, the treatment by ACTIQ can generally be immediately stopped when it does not prove necessary any more.
- On the other hand, in the event of suspension of the totality of the morphine treatment, the protocol of progressive stop of morphine must take account of the posology of ACTIQ to avoid the appearance of symptoms of a brutal weaning.
USE IN the CHILD:
Suitable posology and the job security of ACTIQ were not established at the child and the teenager.
USE AT THE OLD SUBJECT:
- The old subjects proved more sensitive to the effects of the fentanyl managed by intravenous way. Consequently, titration imposes special precautions among these patients. The fentanyl is eliminated more slowly at the old subject and its final half-life of elimination is longer, which can involve an accumulation of the active ingredient and raise the risks of undesirable effects.
- No specific clinical study was undertaken with ACTIQ at the old subject. Nevertheless, during the clinical studies, the amounts of ACTIQ allowing an effective relief of the paroxystic painful accesses were lower among old patients of more than 65 years.
USE IN PARTICULAR POPULATIONS OF PATIENTS:
It is advisable to be particularly careful during the phase of titration among patients presenting an impaired renal function or hepatic.

Against indications

- Over-sensitiveness with the fentanyl or the one of the excipients of ACTIQ.
- Severe respiratory Depression or severe obstruction of the air routes.
- Administration concomitant or stopped since less than 2 weeks, inhibiters of mono-amine-oxydase (IMAO).
- Because of the presence of glucose and saccharose, this drug is contra-indicated in the event of intolerance with the fructose, of syndrome of malabsorption of glucose and galactose or of invert sugar-isomaltase deficit.
- Use in the child: suitable posology and the job security of ACTIQ were not established at the child and the teenager.
- It is recommended not to use ACTIQ during the childbirth, because the fentanyl crosses the placental barrier and can involve a respiratory depression at the fetus.
- Breast feeding: the fentanyl is excreted in the mother’s milk, consequently, the women should not nurse in period of treatment with ACTIQ, because of the possibility of sedation and/or respiratory depression in the infant. Breast feeding should not be begun again before at least 24 hours after the last administration of fentanyl.

Undesirable effects

- The typical side effects of morphine can be observed at the time of the catch of ACTIQ. Generally, they disappear or decrease by intensity with the continuation of the treatment and obtaining adequate posology.
- However, the most serious undesirable effects are the respiratory depression (being able to lead to the apnea or respiratory stop), the circulatory depression, hypotension and the shock and the patients must be attentively followed in order to detect these undesirable effects.
- Reactions on the level of the site of administration such as bleedings of the gums and local irritations were reported since the marketing of ACTIQ.
- The clinical studies undertaken with ACTIQ having had for goal to evaluate the effectiveness and the tolerance of the product in the treatment of the paroxystic painful accesses, the patients included received the other morphine ones at the same time (morphine with prolonged release or fentanyl by transdermic way) to treat their chronic pains. Consequently, it is not possible to isolate with certainty the undesirable effects due to the only treatment by ACTIQ.
- At the time of the clinical studies, the undesirable effects of which the imputability with the product was considered to be at least possible were the following (very frequent > 10% of the patients; frequent > 1 to 10%; rare > 0,1 to 1%):
- Disorders of the metabolism and the nutrition:
Not very frequent: anorexia.
- Psychiatric Affections:
. Frequent: confusion, anxiety, hallucinations, disorders of the thought.
. Not very frequent: nightmares, depersonalization, depression, emotional lability, euphoria.
- Affections of the nervous system:
. Very frequent: somnolence, giddinesses.
. Frequent: cephalgias, myoclonie, dysgueusy.
. Not very frequent: paraesthesias (including hyperesthésies/paraesthesias péribuccales), abnormal step/incoordination.
- Ocular Affections:
Not very frequent: eye trouble (fuzzy vision, double vision).
- Vascular affections:
Frequent: vasodilatation.
- Respiratory affections, thoracic and médiastinales:
Not very frequent: dyspnea.
- Gastro-intestinal Affections:
. Very frequent: nauseas, constipation.
. Frequent: vomiting, oral dryness, abdominal pains, dyspepsia, oral ulceration/stomatitis, lingual affections (for example: feeling of burn, ulcers).
. Not very frequent: flatulence, increase in the volume of the abdomen.
- Affections of the skin and subcutaneous fabric:
. Frequent: prurit, sweats.
. Not very frequent: erythema.
- Affections of the kidney and the urinary tracts:
Not very frequent: urinary retention.
- General Disorders and anomalies with the site of administration:
. Frequent: asthenia.
. Not very frequent: faintness.
- Lesions, intoxications and complications related to the procedures:
Frequent: accidental wounds (for example: falls).