Medicinal Products

PECFENT 100 μg / spray 100 micrograms / spray

Generic drug of the therapeutic class: Analgesics
Active ingredients: Fentanyl
laboratory: Archimedes Dev Ltd

Nasal spray solution
Box of 1 Spray Bottle of 8 Sprays
All forms

Indication

PecFent is indicated for the treatment of paroxysmal pain episodes (ADP) in adults already receiving opioid ophthalmic 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 on opioid background therapy are those taking at least 60 mg / day of oral morphine, at least 25 micrograms / hour of transdermal fentanyl, at least 30 mg / day of oxycodone, at least 8 mg / day of oral hydromorphone or an equianalgesic dose of another opioid for at least one week.

Dosage PECFENT 100 μg / spray 100micrograms / spray Solution for nasal spray Box of 1 spray bottle of 8 sprays

Treatment should be initiated and monitored by a physician experienced in the management of opioid therapy in cancer patients. Physicians should consider the potential risk of misuse of fentanyl.

Dosage

The dosage of PecFent should be increased until an "effective" dose (titration phase) provides sufficient analgesia with a minimum of adverse (or intolerable) effects on two consecutive treatments of episodes of breakthrough pain. . The effectiveness of a given dose should be evaluated over the 30-minute period following administration.

Patients should be closely monitored until the effective dose is achieved.

A dose of PecFent may include the administration of 1 spray (100 microgram or 400 microgram doses) or 2 sprays (200 microgram or 800 microgram doses) of the same dosage (either the 100 microgram or the 400 microgram dose). micrograms).

Patients should not take more than 4 doses per day. Patients should wait at least 4 hours after a dose before treating another paroxysmal pain attack with PecFent.

Initial dose

• The initial dose of PecFent to treat episodes of breakthrough pain is always 100 micrograms (one spray), including in patients previously treated with other fentanyl products for this indication.

• Patients should wait at least 4 hours before treating another paroxysmal pain attack with PecFent.

Titration method

• For the purpose of the initial titration, the patient should be prescribed a vial (8 sprays) of PecFent 100 micrograms / spray.

• In cases where the prescribed 100 microgram initial dose provides insufficient analgesia, the patient may be asked to perform two 100 microgram sprays (one in each nostril) at the next breakthrough pain episode. If this dose is not effective, the patient may be prescribed a vial of PecFent 400 micrograms / spray, recommending a 400 mg spray at the next pain episode. If analgesia remains insufficient, the dose may be increased to two sprays of 400 micrograms (one in each nostril).

• Patients should be followed closely upon initiation of treatment and the dose increased until the effective dose is reached in two consecutive episodes of breakthrough pain.

Titration in patients switching immediate-release fentanyl products The pharmacokinetics of immediate-release fentanyl products may differ significantly, possibly leading to differences in fentanyl absorption (speed and quantity) clinically important. Therefore, when relaying between two drugs containing fentanyl and indicated in the treatment of paroxysmal pain, including nasal formulations, it is crucial to repeat the titration with the new product and not to replace the product with the same dose (same number of micrograms).

Maintenance treatment

Once the effective dose is established during the titration phase, patients should continue to take this dose without exceeding the maximum dosage of 4 doses per day.

Readjustment of the dose

As a general rule, the maintenance dose of PecFent should only be increased if the dose used does not provide satisfactory pain relief for several consecutive bouts.

It may be necessary to adjust the dosage of opioid background therapy if patients routinely present more than four breakthrough pain bouts per 24 hours.

In case of intolerable or persistent side effects, the dose should be reduced or treatment with PecFent replaced with another analgesic.

Stop treatment

PecFent should be discontinued immediately if the patient no longer has breakthrough pain. The treatment of chronic chronic pain should be maintained as prescribed. If discontinuation of all opioid therapy is necessary, the patient should be closely monitored by the physician, as a gradual decrease in opioid therapy is necessary to avoid the risk of symptoms of abrupt withdrawal.

Pediatric population

The efficacy and safety of PecFent has not been established in children under 18 years of age. No data available.

Use in the elderly (over 65 years old)

In PecFent's clinical trial program, 104 (26.1%) patients were over the age of 60, 67 (16.8%) were older than 65, and 15 (3.8%) were over 75 years of age. years. There was no evidence that elderly patients had an effective dose that was lower or that there were more side effects. Nevertheless, given the importance of renal and hepatic function in the metabolism and clearance of fentanyl, additional caution is warranted when using PecFent in the elderly. No data on the pharmacokinetics of PecFent in elderly patients is available.

Hepatic or renal insufficiency

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

Administration mode

PecFent is intended for nasal administration.

PecFent can deliver doses of 100, 200, 400 or 800 micrograms as follows:

Dose required (micrograms)

Dosage of the product (micrograms)

Amount

100

100

A spray in a single nostril

200

100

A spray in each nostril

400

400

A spray in a single nostril

800

400

A spray in each nostril

The bottle should only be removed from the child-resistant outer packaging at the time of use and the protective cap removed. Before first use, the spray bottle should be primed by holding it upright and pressing and releasing the finger rest fins on either side of the nosepiece several times until a green bar appears the dose counter window (normally visible after four sprays).

If the product has not been used for more than 5 days or if it has been more than 14 days since it was first used, the PecFent vial must be discarded.

To administer PecFent, insert the nosepiece into the nostril, about 1 cm away from the nostril entrance and toward the root of the nose. A spray is then administered by pressing and releasing the finger rest fins on either side of the nosepiece. A "click" will be heard and the number displayed by the dose counter will increase by one.

Patients should be cautioned that they may not feel the administration of the spray and should therefore rely on the audible click and modification of the meter display to confirm the actual delivery of a spray. . A definitive blockage of the pump occurs after delivery of the eighth spray.

The mist of droplets produced by the PecFent sprayer forms a gel on the surface of the nasal mucosa. Patients are advised not to blow their nose immediately after PecFent administration.

The protective cap must be put back in place after each use and the bottle placed in the outer packaging with child safety for safe and proper storage.

Against indications

Hypersensitivity to the active substance or to any of the excipients.
Use in patients who have never received opioid treatment.
Severe respiratory depression or severe obstructive bronchopneumopathy.

Adverse effects Pecfent 100 μG / Spray

The side effects expected with PecFent are the typical effects of opioids. Most often they will stop or diminish with continued treatment once the titration has been successfully completed. However, the most serious adverse effects are respiratory depression (which may lead to apnea or respiratory arrest), circulatory depression, hypotension and shock; the eventual occurrence of these effects should be monitored in all patients.

Since clinical studies with PecFent were designed to evaluate the efficacy and safety of the product in the treatment of breakthrough pain, all patients also received other opioids (morphine extended-release or transdermal fentanyl) background of their chronic pain. Therefore, it is not possible to isolate with certainty the effects of PecFent. alone

Adverse events considered at least possibly related to treatment reported in Phase II and III clinical studies are summarized in the table below. Adverse reactions are classified by frequency of occurrence according to the following definitions: very common (> 1/10), common (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1/100) ), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000).

Within each frequency category, adverse effects are presented in descending order of severity.

Frequent

Rare

Infections and infestations:

Pneumonia

nasopharyngitis

Pharyngitis

rhinitis

Hematological and lymphatic system disorders:

neutropenia

Immune system disorders

hypersensitivity

Metabolism and nutrition disorders

dehydration

hyperglycemia

Loss of appetite

Increased appetite

Psychiatric disorders

disorientation

Addiction

Delirium

Hallucination

Confusional syndrome

Depression

Attention Deficit / Hyperactivity Disorder

Anxiety

Euphoric mood

Nervousness

Nervous system disorders

dysgeusia

dizziness

Drowsiness

headaches

Loss of consciousness Decreased level of consciousness

convulsions

ageusia

anosmia

Memory problems

parosmia

Speech disorders

Sedation

Lethargy

tremors

Affections of the ear and labyrinth

Dizziness

Heart conditions

Cyanosis

Vascular disorders

Cardiovascular insufficiency Lymphoedema Hypotension Flushing

Respiratory, thoracic and mediastinal disorders

Epistaxis

rhinorrhea

nasal discomfort

Obstruction of the upper airways

Laryngopharyngeal pain

Rhinalgie

Affection of the nasal mucosa

Cough

Dyspnea

Sneeze

Congestion of upper respiratory tract

Nasal congestion

Intranasal hypoaesthesia

Irritation of the throat

Posterior pharyngeal discharge Nasal dryness

Gastrointestinal disorders

vomiting

nausea

Constipation

Intestinal perforation

Peritonitis

Oral hypoaesthesia

Oral paraesthesia

Diarrhea

Tops the heart

Abdominal pain

Affection of language

Oral ulcer

Dyspepsia

Oral dryness

Skin and subcutaneous tissue disorders

itching

Hyperhidrosis

Urticaria

Musculoskeletal and Connective Tissue Disorders

arthralgia

Muscular Fasciculations

Renal and urinary disorders

Anuria

Dysuria

proteinuria

Abusive hesitation

Disorders of reproductive organs and breast

Vaginal haemorrhages

General disorders and administration site conditions

Chest pain of extra-cardiac origin

Asthenia

Chills

Edema of the face

Peripheral edema

Walking disorder

pyrexia

Tired

Discomfort

Thirst

exams

thrombocytopenia

Weight gain

Injury, poisoning and procedural complications

Fall

Deliberate misuse of the drug

Medication error

ANSM alert of 25/09/13:

In case of nasal administration: feeling of nasal discomfort, rhinorrhea (runny nose), epistaxis (nosebleed), perforation of the nasal septum.

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