Medicinal Products

ACTIQ 1,200 micrograms

Generic drug of the therapeutic class: Analgesics
Active ingredients: Fentanyl
laboratory: Teva Pharma BV

Tablet with oral applicator
Box of 3
All forms

Indication

ACTIQ is indicated for the treatment of paroxysmal pain in patients already receiving morphine treatment for chronic pain of cancerous origin.

A paroxysmal pain attack is a transient exacerbation of chronic pain that is also controlled by a background treatment.

Patients receiving morphine DMARD are those taking at least 60 mg oral morphine per day, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone per day, at least 8 mg of hydromorphone orally per day or an equianalgesic dose of another opioid for a period of at least one week.

Dosage ACTIQ 1200 micrograms Tablet with oral applicator Box of 3

Reserved for adults.

In order to minimize the risk of opioid-related adverse events and to determine the most "effective" dose for a patient, it is essential that patients be closely monitored by health professionals during the titration period.

ACTIQ is not interchangeable on the basis of dose equivalence with other fast-acting fentanyl prescribed for cancerous breakthrough pain, since the pharmacokinetic profiles and / or dose schedules of these products are significantly different. Patients treated for cancerous breakthrough pain should be instructed not to use multiple fast-acting fentanyl simultaneously, and to discard any other fentanyl-containing products previously prescribed for breakthrough pain attacks (ADP) when switching to ACTIQ. The number of different ACTIQ assays made available to the patient at any time should be kept to a minimum to avoid errors and potential overdose.

Any unit of ACTIQ not used and whose patient no longer has utility must be duly eliminated.

Patients should be reminded that ACTIQ must be kept out of the reach of children.

Administration mode

ACTIQ is intended for transmucosal oral administration, therefore, the tablet should be placed against the inner side of the cheek. With the aid of the applicator, the tablet must then be moved against the lining of the cheeks in order to optimize the degree of exposure of the mucosa to the active product. The ACTIQ tablet should be allowed to melt in contact with the mucous membrane, without sucking, chewing or chewing, as the absorption of fentanyl through the oral mucosa is faster than systemic absorption by the gastrointestinal tract.

Patients with dry mouth can moisten their oral mucosa by drinking a little water before taking the medicine.

The unit of ACTIQ must be consumed in 15 minutes. If excessive opioid effects occur before the ACTIQ tablet is completely dissolved, it should be immediately removed from the mouth and consideration should be given to reducing subsequent doses.

In the adult

Dosage adjustment and maintenance treatment

The optimal dosage of ACTIQ for each patient should be determined, that is, the dose producing the desired analgesic effect with a minimum of adverse effects. In clinical studies, no relationship has been established between the effective dose of ACTIQ in breakthrough pain and the dose of morphine treatment.

a) Titration

Before determining the dosage of ACTIQ in a patient, it is necessary to ensure that his chronic pain is controlled by a background morphine treatment and that he has no more than 4 paroxysmal breakthroughs per day.

The initial dose of ACTIQ should be 200 micrograms, with dosage increase, if necessary, according to the range of available assays (200, 400, 600, 800, 1200 and 1600 micrograms). Patients should be carefully monitored until a dose providing effective analgesia and acceptable adverse effects is obtained, with only one unit of ACTIQ per paroxysmal pain. This dose is defined as the effective dose.

During titration, if satisfactory analgesia is not obtained within 30 minutes after administration of a first Actiq unit (ie, 15 minutes after the end of ACTIQ), a second ACTIQ unit of the same assay may be used. Under no circumstances should more than two units of ACTIQ be used to treat the same paroxysmal pain. With a dosage of 1600 micrograms, it will likely be necessary to administer a second dose only in a minority of patients.

If the treatment of several consecutive breakthrough pain requires more than one unit of ACTIQ per access, consider switching to the next higher dosage.

PRACTICAL SCHEME OF TITRATION

Start with a unit dosed at 200 μg

¯

1. Leave 1 unit of ACTIQ to melt in the mouth until completely dissolved (15 minutes)

2. Wait another 15 minutes

3. If necessary, take a second unit to melt in 15 minutes

¯

Satisfactory relief with 1 unit?

(Test the same dose of ACTIQ during several breakthrough pain bouts)

¯

YES

¯

NO

Effective dose determined

use the dosage of ACTIQ

immediately superior

(Available assays: 200, 400, 600, 800, 1200, 1600 μg)

b) Maintenance treatment

Once the effective dose is established (ie, paroxysmal pain is effectively treated by a single unit, on average), patients should use this dose and limit their consumption to no more than four units of ACTIQ per day.

Patients should be supervised by a health professional to ensure that the maximum consumption of four units of ACTIQ per day is not exceeded.

Readjustment of the dose

The maintenance dose of ACTIQ should be increased if the treatment of several consecutive breakthrough pain requires more than one tablet per access. For dose adjustment, the same principles as those described for titration apply (see above).

If patients have more than 4 paroxysmal breakthroughs per day, it may be necessary to re-evaluate the dosage of the background morphine treatment. If this is increased, it may be necessary to readjust the dose of ACTIQ used to treat breakthrough pain.

Any readjustment of the dosage of analgesic treatment must imperatively be monitored by a health professional.

Stop treatment

In patients continuing their opioid analgesic background treatment, ACTIQ treatment can usually be stopped immediately when no longer necessary.

On the other hand, in the event of suspension of all morphine treatment, the progressive morphine discontinuation protocol must take into account the dosage of ACTIQ to avoid the appearance of symptoms of abrupt withdrawal.

Use in the elderly

Elderly patients were more sensitive to the effects of intravenous fentanyl. Therefore, titration requires special precautions in these patients. Fentanyl is eliminated more slowly in the elderly and its terminal elimination half-life is longer, which can lead to accumulation of the active ingredient and increase the risk of adverse effects.

No specific clinical studies have been conducted with ACTIQ in the elderly. However, in clinical studies, doses of ACTIQ for effective relief of paroxysmal pain were lower in patients older than 65 years.

Use in patients with hepatic or renal impairment

Special care should be taken during the titration phase in patients with renal or hepatic impairment (see Warnings and Precautions ).

Pediatric population

In children 16 years of age and older: follow the adult dosage

In children aged 2 to 16 years: clinical experience with the use of ACTIQ in pediatric patients who are already receiving morphine treatment is limited (see sections on Pharmacodynamic properties and Pharmacokinetic properties ). Safety and efficacy in patients younger than 16 years of age have not been established; therefore, use in this patient population is not recommended.

Against indications

Hypersensitivity to fentanyl or any of the excipients of ACTIQ.

· Patients not receiving morphine DMARD (see Therapeutic indications section) because of an increased risk of respiratory depression.

· Treatment of acute pain other than paroxysmal pain (eg postoperative pain, headache, migraine).

· Concomitant or discontinued for less than 2 weeks with monoamine oxidase inhibitors (MAOIs).

· Severe respiratory depression or severe obstruction of the airways.

Adverse effects Actiq

The typical side effects of opioids can be observed when taking ACTIQ. Most often, they disappear or diminish in intensity with the continuation of treatment and obtaining the appropriate dosage.

However, the most serious adverse effects are respiratory depression (which may lead to apnea or respiratory arrest), circulatory depression, hypotension and shock, and patients should be carefully monitored for these adverse effects.

Administration site reactions such as bleeding gums, local irritations, pain and ulcers have been reported since the marketing of ACTIQ.

Since clinical studies conducted with ACTIQ were designed to evaluate the efficacy and safety of the product in the treatment of breakthrough pain, the included patients received at the same time other opioids (morphine extended-release or fentanyl transdermal) to treat their chronic pain. Therefore, it is not possible to isolate with certainty the adverse effects due to ACTIQ alone.

The following adverse reactions have been reported in clinical trials with ACTIQ and post-marketing experience. Adverse reactions are listed below according to the MedDRA classification by organ class and frequency (frequencies are defined as follows: very common ≥ 1/10, common ≥ 1/100 to <1/10, uncommon ≥ 1 / 1000 to <1/100, frequency not known (can not be estimated from the available data):

Immune system disorders

Not known:

anaphylactic reaction, edema of the tongue, edema of the lip.

Metabolism and nutrition disorders

Frequent

anorexia.

Psychiatric disorders

Frequent

confusion, anxiety, hallucinations, depression, emotional lability

Uncommon:

nightmares, depersonalization, disturbances of thought, euphoria.

Nervous system disorders

Very frequent:

drowsiness, dizziness, headache.

Frequent

loss of consciousness, convulsions, vertigo, myoclonus, sedation, paresthesia (including hyperesthesia / perioral paresthesia), abnormal gait / incoordination, dysgeusia.

Uncommon:

coma, slurred speech.

Eye disorders

Frequent

visual disturbances (blurred vision, double vision).

Vascular disorders

Uncommon:

vasodilatation.

Respiratory, thoracic and mediastinal disorders

Very frequent:

dyspnea.

Not known:

pharyngeal edema.

Gastrointestinal disorders

Very frequent:

nausea, vomiting, constipation, abdominal pain.

Frequent

dry mouth, dyspepsia, stomatitis, lingual affections (eg burning sensation, ulcers), flatulence, increased abdominal volume.

Uncommon:

ileus, oral ulcer, dental caries, bleeding gums.

Not known:

tooth loss, gingival retraction, gingivitis.

Skin and subcutaneous tissue disorders

Frequent

pruritus, sweating, erythema.

Uncommon:

urticaria.

Renal and urinary disorders

Frequent

urinary retention.

General disorders and administration site conditions

Very frequent:

asthenia.

Frequent

administration site reactions including irritation, pain and ulcer, malaise.

investigations

Frequent

weightloss.

Injury, poisoning and procedural complications

Frequent

accidental injuries (eg falls).

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