Medicinal Products

EFFENTORA 200 micrograms

Generic drug of the therapeutic class: Analgesics
Active ingredients: Fentanyl
laboratory: Cephalon Europe

Gingival tablet
Case of 28
All forms

Indication

Effentora is indicated for the treatment of breakthrough pain in adult patients with cancer who are already receiving morphine treatment for chronic pain of cancer.

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

Patients on morphine DMARD are those taking at least 60 mg of 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 per oral route or an equianalgesic dose of another opioid for a period of at least one week.

Dosage EFFENTORA 200 micrograms Gingival tablet Case of 28

Treatment should be initiated and followed by a physician experienced in the management of opioid treatment in cancer patients. Physicians should consider the potential risk of misuse with fentanyl. Patients treated for breakthrough pain should be instructed not to simultaneously use two different formulations of fentanyl and to eleminate any other fentanyl product prescribed for ADP when switching to Effentora. The number of tablets made available to the patient at all times should be kept to a minimum to avoid errors and potential overdose.

Titration of the dose

The "effective" dosage of Effentora should be determined individually for each patient (titration), ie the dose producing the appropriate analgesic effect with a minimum of adverse effects. In clinical studies, it was not possible to predict the effective dose of Effentora for the treatment of breakthrough pain based on the daily dose of morphine DMARD. Patients should be closely monitored until an effective dose is achieved.

Titration in patients receiving fentanyl for the first time

The initial dose of Effentora should be 100 micrograms, with dosage increased, if necessary, according to the range of dosages available (100, 200, 400, 600, and 800 micrograms).

Titration in patients switching from another drug containing fentanyl to Effentora

Due to the fact that these products have different absorption profiles, the substitution should not be in a ratio of 1: 1. In patients switching from another oral form of fentanyl citrate to Effentora, Effentora dose titration should be performed independently as the bioavailability between the products differs significantly. Nevertheless, in these patients, an initial dose greater than 100 micrograms may be considered.

Titration method

During titration, if satisfactory analgesia is not achieved within 30 minutes after administration of a single tablet, a second Effentora tablet of the same strength may be used.

If the treatment of breakthrough pain requires more than one tablet, consideration should be given to the next higher dose for treatment of the following breakthrough pain.

Several tablets may be used during the titration phase of the dose: up to four 100 microgram tablets or up to four 200 microgram tablets may be used to treat a single breakthrough pain attack as follows:

• If the initial dose of a 100 microgram tablet is not effective, the patient should be advised to treat the next breakthrough pain with two 100 microgram tablets. It is recommended to place one tablet on each side of the mouth. If this dose is considered the effective dose, treatment of subsequent paroxysmal pain attacks should be continued with a single 200 microgram Effentora tablet.

• If the use of a single 200 microgram Effentora tablet (or two 100 microgram tablets) is not considered effective, the patient should be instructed to take two 200 microgram tablets (or four tablets). 100 micrograms) to treat the following paroxysmal pain attack. It is recommended to place two tablets on each side of the mouth. If this dose is considered the effective dose, treatment of subsequent paroxysmal pain attacks should be continued with a single 400 microgram Effentora tablet.

• 200 microgram tablets should be used for a dose increase to 600 micrograms or 800 micrograms.

Doses above 800 micrograms have not been evaluated in clinical studies.

No more than two tablets should be used to treat the same paroxysmal pain episode, except in the dosage adjustment described above, using up to four tablets. During titration, patients must wait at least 4 hours before treating another breakthrough pain attack with Effentora.

Maintenance treatment

Once the effective dose is determined during the titration phase, patients should continue to use a single tablet of this dose. Breakthrough pain may vary in intensity and the required dose of Effentora may increase over time due to the progression of underlying cancer disease. In these cases, a second tablet of the same dose may be used. If a second Effentora tablet has been needed several times in a row, the usual maintenance dose should be readjusted (see below).

During maintenance therapy, patients must wait at least 4 hours before treating another breakthrough pain episode.

Readjustment of the dose

The maintenance dose of Effentora should be increased if the treatment of several consecutive breakthrough pain requires more than one tablet per access. For the readjustment dose the same principles as those described for the titration apply (see above). If patients experience more than four paroxysmal breakthroughs per 24 hours, it may be necessary to readjust the opioid morphine treatment.

Stop treatment

Treatment with Effentora should be stopped immediately when no longer necessary.

Use in children and adolescents

Effentora should not be used in children and adolescents under the age of 18 due to the lack of data on safety and efficacy.

Use in the elderly (over 65 years old)

In clinical studies, the effective dose tended to be lower in patients older than 65 years of age than in younger patients. Great caution should be exercised when titrating the dose of Effentora in elderly patients.

Hepatic or renal insufficiency

Effentora should be used with caution in patients with moderate to severe renal or hepatic impairment (see Warnings and Precautions ).

Patients with xerostomia

Patients with xerostomia are advised to drink water before taking Effentora to moisten the oral cavity. It is advisable to change the treatment in case this recommendation is not sufficient to obtain an appropriate effervescence of the tablet.

Administration mode

In the presence of moisture, the Effentora tablet uses an effervescent reaction to deliver the active substance. It is therefore recommended that patients do not open the blister before being ready to place the tablet in the oral cavity.

Opening the blister pack

Patients should be advised not to try to push the tablet through the cover sheet as this may damage the gum tablet. The appropriate method for opening the blister pack is:

Detach one of the cells from the blister by cutting according to the perforations. Fold the cell along the line printed on the cover sheet. Remove the cover sheet to reveal the tablet.

Patients should be warned that the tablet should not be crushed or cut.

The tablet should not be stored after the cover has been removed because the integrity of the tablet can not be guaranteed in this case and there is a risk of accidental exposure to the product.

Tablets administration

Patients should remove one tablet from the blister and place it immediately in the oral cavity (near a molar between the cheek and the gum).

The Effentora tablet should not be sucked, chewed or swallowed, as the plasma concentrations would be lower than those obtained when used according to the instructions.

Effentora should be placed in the oral cavity and remain there for a period of time sufficient to allow disintegration of the tablet, which usually takes 14 to 25 minutes. The tablet can also be placed under the tongue (see section Pharmacokinetic properties ).

After 30 minutes, if any pieces of Effentora tablets remain, it is possible to swallow them with a glass of water.

The total disintegration time of the tablet after transmucosal oral administration does not appear to influence the early systemic exposure to fentanyl.

When a tablet is in the oral cavity, patients should not drink or eat. If irritation of the oral mucosa occurs, it is recommended to change the location of the tablet.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Patients not treated with morphine DMARD because of an increased risk of respiratory depression.

Severe respiratory depression or severe obstruction of the airways.

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

Adverse effects Effentora

The side effects expected with Effentora are the typical side effects of opioids. Most often, these effects will stop or diminish with continued treatment and the appropriate dose for the patient. However, the most serious adverse effects are respiratory depression (which may lead to apnea or respiratory arrest), circulatory depression, hypotension and shock; the possible occurrence of these effects should be closely monitored in all patients.

Since clinical studies with Effentora were designed to evaluate the efficacy and safety of the product in the treatment of breakthrough pain, the patients included at the same time received 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 of Effentora alone.

The following side effects have been reported during Effentora clinical trials and postmarketing 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, rare (≥1 / 10, 000 to <1/1000), unknown (can not be estimated from the available data), within each frequency group, side effects are shown by a descending order of gravity):

Very common

Frequent

Rare

Rare

Unknown

investigations

Weightloss

Dimunition of

number of

platelets

Increase

of the

frequency

cardiac

Decrease

hematocrit

Decrease

rate

hemoglobin e

Heart conditions

tachycardia

, bradycardia

Blood and lymphatic system disorders

Neutropenia anemia

Thrombocyto-penia

Affections of

system

nervous

state

dizzying Headaches

dysgeusia

Drowsiness

Lethargy

tremor

Sedation

Hypoaesthesia

Migraine

Decreased level of consciousness Disorder of attention Disorder of balance Dysarthria

Cognitive disorders Motor dysfunction

Loss of consciousness

Eye disorders

Vision Disorder Eye Hyperemia Blurred vision Decreased visual acuity

Abnormal eye sensations Photopsia

Affections of the ear and labyrinth

Dizziness Tinnitus Hearing discomfort

Chest and mediastinal respiratory disorders

Dyspnea Pharyngolaryn pain

Respiratory Depression Sleep Apnea Syndrome

Respiratory stop

Gastrointestinal disorders

Nausea Vomiting

Constipation Stomatitis Oral dryness Diarrhea Abdominal pain Gastroesophageal reflux Gastric discomfort

ileus

Ulceration

mouth

Hypoaesthesia

oral

Oral discomfort

Discoloration

of the

mucous

mouth

Disorder

Bubbles at

level of

mucous

mouth

Drought

labial

Very common

Frequent

Rare

Rare

Unknown

Dyspepsia

Pain

dental

soft tissues of the oral cavity Glossodynia Bubbles at the level of the tongue Gingival pain Ulceration of the tongue Disorder of the tongue Esophagitis Chapped lips Dental disorder

Renal and urinary disorders

Urinary retention

Skin and subcutaneous tissue disorders

itching

Hyperhydrosis Rash

Cold sweats facial edema Generalized pruritus Alopecia

Onychorrhexis

Musculoskeletal and systemic disorders

Myalgia Back Pain

Muscle contractions Muscle weakness

Endocrine disorders

hypogonadism

Metabolism and nutrition disorders

Anorexia

Infections and infestations

Oral candidiasis

Pharyngitis

Oral pustule

injury,

poisoning

and

complications

related to

proceedings

Fall

Vascular disorders

Hypertension Hypertention

Flushing Boost

Very common

Frequent

Rare

Rare

Unknown

General disorders and administration site conditions

Reactions to

site

of administrati

including

bleeding,

pain,

ulcer,

irritation,

paresthesia,

anesthesia,

erythema,

edema,

swelling and

vesicles

Edema

peripheral

Tired

Asthenia

Syndrome of

weaning

Chills

Malaise Sensation of weakness Chest discomfort Sensation of not being in a normal state Sensation of nervousness Thirst

Feeling cold Chills Feeling hot

Hepatobiliary disorders

Dilation of the bile ducts

Psychiatric disorders

Depression

Anxiety

Syndrome

confusional

Insomnia

Mood

euphoric

Nervousness

Hallucination

Hallucination

visual

change

of State

mental

Addiction

(substance addiction)

disorientation

Repeated opioid administration, such as fentanyl, may result in tolerance, physical and / or psychological dependence.

Studies with Effentora have shown symptoms of opioid withdrawal such as nausea, vomiting, diarrhea, anxiety, and chills.

In case of overdose, loss of consciousness and respiratory arrest have been observed.

ANSM alert of 25/09/13:

In the case of oral administration: pain and irritation of the oral mucosa, ulcer, deterioration of the dental state (caries, partial or total loss of teeth).

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