FANTAMAX TTS MATRIX 50μG/H [SIN13621P]

Product Info

FANTAMAX TTS MATRIX 50μG/H

[SIN13621P]

4.1 Therapeutic indications
Management of chronic pain and intractable pain requiring opioid analgesia that requires continuous opioid administration for an extended period of time in opioid-tolerant children age 2 years and older and in adults.

4.2 Posology and method of administration
FANTAMAX TTS MATRIX doses should be individualized based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches are designed to deliver approximately 12, 25 and 50 mcg/hour fentanyl to the systemic circulation, which represent about 0.3, 0.6 and 1.2 mg per day (see Qualitative and Quantitative Composition – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), respectively.

Initial Dosage Selection
The appropriate initiating dose of FANTAMAX TTS MATRIX should be based on the patient’s current opioid use. It is recommended that FANTAMAX TTS MATRIX be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.

Dosage-Adults
Opioid-tolerant patients
To convert opioid-tolerant patients from oral or parenteral opioids to FENTANYL PATCH, refer to Equianalgesic potency conversion below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/hour depending on response and supplementary analgesic requirements.

Equianalgesic Potency Conversion

1. Calculate the previous 24-hour analgesic requirement.

2. Convert this amount to the equianalgesic oral morphine dose using Table 1. All intramuscular (IM) and oral doses in this chart are considered equivalent to 10 mg of IM morphine in analgesic effect.

3. To derive the FANTAMAX TTS MATRIX dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use the dosage-conversion Table 2 as follows:

Table 2 is for adult patients who have a need for rotation of, or conversion from, another opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).

Initial evaluation of the maximum analgesic effect of FANTAMAX TTS MATRIX cannot be made before the patch is worn for 24 hours. This delay is due to the gradual increase in serum fentanyl concentration in the 24 hours following initial patch application.

Previous analgesic therapy should therefore be gradually phased out after the initial dose application until analgesic efficacy with FANTAMAX TTS MATRIX is attained.

Dose Titration and Maintenance Therapy
General

• Replace the patch every 72 hours.

• If the patch needs to be replaced (e.g. the patch falls off) before 72 hours, apply a patch of the same strength to a different skin site. This may result in increased serum concentrations (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) therefore monitor the patient closely.

• More than one FANTAMAX TTS MATRIX patch may be used for doses greater than 100 mcg/hour.

• At any point during treatment, a patient may require periodic supplemental doses of a short-acting analgesic for “breakthrough” pain. Some patients may require additional or alternative methods of opioid administration when the FANTAMAX TTS MATRIX dose exceeds 300 mcg/hour.

First Patch Application
If analgesia is insufficient, during the first application:

• Replace the FANTAMAX TTS MATRIX patch with a patch of the same dose after 48 hours, OR

• Increase the dose when a new patch is applied after 72 hours (see Dose Titration below).

Dose Titration

• Titrate the dose individually based on average daily use of supplemental analgesics, until a balance between analgesic efficacy and tolerability is attained.

• A 12 mcg/hour strength is available for dose titration. Dosage titration is normally in 12 mcg/h or 25 mcg/hour increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ≈ FANTAMAX TTS MATRIX 12/25 mcg/hour) and pain status of the patient should be taken into account.

• After an increase in dose, it may take up to 6 days for the patient to reach equilibrium on the new dose level. Therefore after a dose increase, patients should wear the higher dose patch through two 72-hour applications before increasing the dose further.

Maintenance Therapy

• The principles described under General above are applicable during maintenance therapy.

Dosage-Pediatrics
FANTAMAX TTS MATRIX should be administered only to opioid-tolerant pediatric patients (ages 2 to 16 years) who are already receiving at least 45 mg oral morphine equivalents per day. To convert pediatric patients from oral or parenteral opioids to FANTAMAX TTS MATRIX, refer to Equianalgesic potency conversion (Table 1) and Recommended FANTAMAX TTS MATRIX dosage based upon daily oral morphine dose (Table 3).

Discontinuation of FANTAMAX TTS MATRIX
If discontinuation of FANTAMAX TTS MATRIX is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly. This is because while fentanyl concentrations fall gradually after FANTAMAX TTS MATRIX is removed, it takes 20 hours or more for the fentanyl serum concentrations to decrease 50%. In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms. There have been reports that rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms and uncontrolled pain.

Opioid withdrawal symptoms (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) are possible in some patients after conversion or dose adjustment. Table 1 and Table 2 should not be used to convert from FANTAMAX TTS MATRIX to other therapies to avoid overestimating the new analgesic dose and potentially causing overdose.

Method of administration
For transdermal use.

Using and changing the patches

• Make a note of the day, date and time the patch is applied, as a reminder of when it needs to be changed

• There is enough medicine in each patch to last 3 days (72 hours).

• Change the patch every third day.

• Always remove the old patch before applying a new one.

• Always change the patch at the same time of day every 3 days (72 hours).

• If more than one patch is used, change all the patches at the same time.

Where to apply the patch

• Do not apply the patch on the same place twice in a row.

• Fentanyl patch should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.

Children

• Always apply the patch to the child’s upper back to make it difficult for the child to reach it or take it off.

• Every so often, check that the patch remains stuck to the skin.

• It is important that the child does not remove the patch and put it in their mouth as this could be life threatening or even fatal.

• Watch the child very closely for 48 hours after:

  • The first patch has been put on

  • A higher dose patch has been put on

It may take some time for the patch to have its maximum effect. Therefore, the child might need to use other painkillers as well until the patches become effective.

Putting a patch on

• Hair at the application site (a non-hairy area is preferable) should be clipped (not shaved) prior to application.

• If the site of FANTAMAX TTS MATRIX application requires cleansing prior to application of the patch, this should be done with clear water. Soaps, oils, lotions, or any other agent that might irritate the skin or alter its characteristics should not be used.

• The skin should be completely dry before the patch is applied. Patches should be inspected prior to use.

• FANTAMAX TTS MATRIX should be applied immediately upon removal from the sealed package.

• Inspect the patch for any damage. Patches that are cut, divided, or damaged in any way should not be used.

• Avoid touching the adhesive side of the patch.

• Apply the patch to the skin by applying light pressure with the palm of the hand for about 30 seconds.

• Make certain that the edges of the patch are adhering properly.

• Then wash hands with clean water.

Disposing of the patch

• As soon as the patch is taken off, fold it firmly in half so that the sticky side sticks to itself.

• Put it back in its original pouch and dispose of the pouch as instructed by the pharmacist.

• Unused patches should be returned to the (hospital) pharmacy.

• Keep used patches out of sight and reach of children – even used patches contain some medicine which may harm children and may even be fatal.

4.3 Contraindications
FANTAMAX TTS MATRIX is contraindicated in patients with known hypersensitivity to fentanyl or to the adhesives present in the patch. Because serious or life-threatening hypoventilation could occur and because there is no opportunity for dose titration during short-term use, FANTAMAX TTS MATRIX is contraindicated:

• in the management of acute pain or in patients who require opioid analgesia for a short period of time

• in the management of post-operative pain, including use after out-patient or day surgeries (e.g. tonsillectomies)

• in the management of mild pain

• in the management of intermittent pain (e.g. use on a as needed basis (prn))

• in situations of significant respiratory depression, especially in unmonitored settings where there is a lack of resuscitative equipment

• in patients who have acute or severe bronchial asthma

FANTAMAX TTS MATRIX is contraindicated in patients who have or are suspected of having paralytic ileus.