ACTIQ
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Package(a):
COMPRESSED TABLET ON A HANDLE (lozenge): 30 x 200 mcg.
Dosage(a):
Initial dose: 200 mcg. Patients should be prescribed an initial titration supply of 6 x 200 mcg units, thus limiting the number of units in the home during titration. Individually titrate to a tolerable dose that provides adquate analgesia using single dosage unit per breakthrough cancer pain episode. Patients should use up all units before increasing to a higher dose. After that, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Until the appropriate dose is reached, patients may find it necessary to use an additional unit during a single episode. Redosing may start 15 minutes after the previous unit has been complete, however no more than two units should be taken for each individual breakthrough cancer pain episode.
If treatment of several consecutive breakthrough cancer pain episodes requires more than one unti per episode, consider an increase in dose to the next higher available strength. At each new dose during titration, it is recommended that six units be prescribed. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.
The unit should be sucked, not chewed and should be consumed over a 15-minuter period.
Discontinuation: A gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Prescribing Restrictions:
Package(b):
COMPRESSED TABLET ON A HANDLE (lozenge): 30 x 400 mcg.
Dosage(b):
Initial dose: 200 mcg. Patients should be prescribed an initial titration supply of 6 x 200 mcg units, thus limiting the number of units in the home during titration. Individually titrate to a tolerable dose that provides adquate analgesia using single dosage unit per breakthrough cancer pain episode. Patients should use up all units before increasing to a higher dose. After that, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Until the appropriate dose is reached, patients may find it necessary to use an additional unit during a single episode. Redosing may start 15 minutes after the previous unit has been complete, however no more than two units should be taken for each individual breakthrough cancer pain episode.
If treatment of several consecutive breakthrough cancer pain episodes requires more than one unti per episode, consider an increase in dose to the next higher available strength. At each new dose during titration, it is recommended that six units be prescribed. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.
The unit should be sucked, not chewed and should be consumed over a 15-minuter period.
Discontinuation: A gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Prescribing Restrictions:
Package(c):
COMPRESSED TABLET ON A HANDLE (lozenge): 30 x 600 mcg.
Dosage(c):
Initial dose: 200 mcg. Patients should be prescribed an initial titration supply of 6 x 200 mcg units, thus limiting the number of units in the home during titration. Individually titrate to a tolerable dose that provides adquate analgesia using single dosage unit per breakthrough cancer pain episode. Patients should use up all units before increasing to a higher dose. After that, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Until the appropriate dose is reached, patients may find it necessary to use an additional unit during a single episode. Redosing may start 15 minutes after the previous unit has been complete, however no more than two units should be taken for each individual breakthrough cancer pain episode.
If treatment of several consecutive breakthrough cancer pain episodes requires more than one unti per episode, consider an increase in dose to the next higher available strength. At each new dose during titration, it is recommended that six units be prescribed. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.
The unit should be sucked, not chewed and should be consumed over a 15-minuter period.
Discontinuation: A gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Prescribing Restrictions:
Package(d):
COMPRESSED TABLET ON A HANDLE (lozenge): 30 x 800 mcg.
Dosage(d):
Initial dose: 200 mcg. Patients should be prescribed an initial titration supply of 6 x 200 mcg units, thus limiting the number of units in the home during titration. Individually titrate to a tolerable dose that provides adquate analgesia using single dosage unit per breakthrough cancer pain episode. Patients should use up all units before increasing to a higher dose. After that, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Until the appropriate dose is reached, patients may find it necessary to use an additional unit during a single episode. Redosing may start 15 minutes after the previous unit has been complete, however no more than two units should be taken for each individual breakthrough cancer pain episode.
If treatment of several consecutive breakthrough cancer pain episodes requires more than one unti per episode, consider an increase in dose to the next higher available strength. At each new dose during titration, it is recommended that six units be prescribed. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.
The unit should be sucked, not chewed and should be consumed over a 15-minuter period.
Discontinuation: A gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Prescribing Restrictions:
Package(e):
COMPRESSED TABLET ON A HANDLE (lozenge): 30 x 1,200 mcg.
Dosage(e):
Initial dose: 200 mcg. Patients should be prescribed an initial titration supply of 6 x 200 mcg units, thus limiting the number of units in the home during titration. Individually titrate to a tolerable dose that provides adquate analgesia using single dosage unit per breakthrough cancer pain episode. Patients should use up all units before increasing to a higher dose. After that, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Until the appropriate dose is reached, patients may find it necessary to use an additional unit during a single episode. Redosing may start 15 minutes after the previous unit has been complete, however no more than two units should be taken for each individual breakthrough cancer pain episode.
If treatment of several consecutive breakthrough cancer pain episodes requires more than one unti per episode, consider an increase in dose to the next higher available strength. At each new dose during titration, it is recommended that six units be prescribed. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.
The unit should be sucked, not chewed and should be consumed over a 15-minuter period.
Discontinuation: A gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Prescribing Restrictions:
Package(f):
COMPRESSED TABLET ON A HANDLE (lozenge): 30 x 1,600 mcg.
Dosage(f):
Initial dose: 200 mcg. Patients should be prescribed an initial titration supply of 6 x 200 mcg units, thus limiting the number of units in the home during titration. Individually titrate to a tolerable dose that provides adquate analgesia using single dosage unit per breakthrough cancer pain episode. Patients should use up all units before increasing to a higher dose. After that, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Until the appropriate dose is reached, patients may find it necessary to use an additional unit during a single episode. Redosing may start 15 minutes after the previous unit has been complete, however no more than two units should be taken for each individual breakthrough cancer pain episode.
If treatment of several consecutive breakthrough cancer pain episodes requires more than one unti per episode, consider an increase in dose to the next higher available strength. At each new dose during titration, it is recommended that six units be prescribed. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.
The unit should be sucked, not chewed and should be consumed over a 15-minuter period.
Discontinuation: A gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Prescribing Restrictions:
Indications:
Only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Contra-Indications:
Management of acute or postoperative pain. Opioid non-tolerant patients. Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer. Known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported. See prescribing information for full details.
Special Precautions:
There is a risk of clinically significant hypoventilation. Therefore, titrate with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to hypoventilation. Patients and their caregivers must be instructed that ACTIQ contains a medicine in an amount which can be fatal to a child. Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Should be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Not recommended for use in patients who have received MAOI's within 14 days. See prescribing information for full details. Safety and efficacy in pediatric patients below the age of 16 have not been established. Caution should be exercised when individually titrating ACTIQ in elderly patients. Use with caution in patients suffering with renal/hepatic impairment.
Pregnancy and lactation: Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Should not be used in nursing mothers.
Side Effects:
Asthenia, nausea, vomiting, dizziness, somnolence. See prescribing information for full details.
Drug Interactions:
Not recommended for use in patients who have received MAOI's within 14 days. The concomitant with other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages may produce increased depressant effects (e.g., hypoventilation, hypotension, and profound sedation). Concomitant use with potent inhibitors of cytochrome P450 3A4 isoform (e.g., erythromycin, ketoconazole, and certain protease inhibitors) may increase fentanyl levels.
