A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Actiq Indications, Dosage, Storage, Stability - Fentanyl Citrate
Actiq Indications, Dosage, Storage, Stability - Fentanyl Citrate
INDICATIONS
(See BOXED WARNING and CONTRAINDICATIONS
)
Actiq is indicated only for the management of breakthrough
cancer pain in patients with malignancies who are already receiving
and who are tolerant to opioid therapy for their underlying persistent
cancer pain. Patients considered opioid tolerant are those who
are taking at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour,
or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening hypoventilation could occur at any dose in patients
not taking chronic opiates, Actiq is contraindicated in
the management of acute or postoperative pain. This product must
not be used in opioid non-tolerant patients.
Actiq is intended to be used only in the care of cancer
patients and only by oncologists and pain specialists who are knowledgeable
of and skilled in the use of Schedule II opioids to treat cancer pain.
Actiq should be individually titrated to a dose that provides
adequate analgesia and minimizes side effects. 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 (see DOSAGE AND ADMINISTRATION
- below).
Patients and their caregivers must be instructed that Actiq
contains a medicine in an amount that can be fatal to a child. Patients
and their caregivers must be instructed to keep all units out of the reach
of children and to discard opened units properly in a secured container.
DOSAGE AND ADMINISTRATION
Actiq is contraindicated in non-opioid tolerant individuals.
Actiq should be individually titrated to a dose that provides
adequate analgesia and minimizes side effects.(see Dose
Titration).
As with all opioids, the safety of patients using such products is dependent
on health care professionals prescribing them in strict conformity with
their approved labeling with respect to patient selection, dosing, and
proper conditions for use.
Physicians and dispensing pharmacists must specifically question patients
and caregivers about the presence of children in the home on a full time
or visiting basis and counsel accordingly regarding the dangers to children
of inadvertent exposure to Actiq.
Administration of Actiq
The foil package should be opened with scissors immediately prior to
product use. The patient should place the Actiq unit in his or
her mouth between the cheek and lower gum, occasionally moving the drug
matrix from one side to the other using the handle. The Actiq unit
should be sucked, not chewed. A unit dose of Actiq, if chewed and
swallowed, might result in lower peak concentrations and lower bioavailability
than when consumed as directed.
The Actiq unit should be consumed over a 15-minute period.
Longer or shorter consumption times may produce less efficacy than reported
in Actiq clinical trials. If signs of excessive opioid effects
appear before the unit is consumed, the drug matrix should be removed
from the patient's mouth immediately and future doses should be decreased.
Patients and caregivers must be instructed that Actiq
contains medicine in an amount that could be fatal to a child. While
all units should be disposed of immediately after use, partially used
units represent a special risk and must be disposed of as soon as they
are consumed and/or no longer needed. Patients and caregivers should be
advised to dispose of any units remaining from a prescription as soon
as they are no longer needed (see DISPOSAL OF ACTIQ
and PATIENT INFORMATION).
Dose Titration
Starting Dose: The initial dose of Actiq to treat episodes
of breakthrough cancer pain should be 200 mcg. Patients should be
prescribed an initial titration supply of six 200 mcg Actiq units,
thus limiting the number of units in the home during titration. Patients
should use up all units before increasing to a higher dose.
From this initial dose, patients should be closely followed and the dosage
level changed until the patient reaches a dose that provides adequate
analgesia using a single Actiq dosage unit per breakthrough cancer
pain episode.
Patients should record their use of Actiq over several episodes
of breakthrough cancer pain and review their experience with their physicians
to determine if a dosage adjustment is warranted.
Redosing Within a Single Episode: Until the appropriate dose is
reached, patients may find it necessary to use an additional Actiq
unit during a single episode. Redosing may start 15 minutes after the
previous unit has been completed (30 minutes after the start of the previous
unit). While patients are in the titration phase and consuming units which
individually may be subtherapeutic, no more than two units should be taken
for each individual breakthrough cancer pain episode.
Increasing the Dose: If treatment of several consecutive breakthrough
cancer pain episodes requires more than one Actiq per episode,
an increase in dose to the next higher available strength should be considered.
At each new dose of Actiq during titration, it is recommended that
six units of the titration dose be prescribed. Each new dose of Actiq
used in the titration period should be evaluated over several episodes
of breakthrough cancer pain (generally 1-2 days) to determine whether
it provides adequate efficacy with acceptable side effects. The incidence
of side effects is likely to be greater during this initial titration
period compared to later, after the effective dose is determined.
Daily Limit: Once a successful dose has been found (i.e., an average
episode is treated with a single unit), patients should limit consumption
to four or fewer units per day. If consumption increases above four units/day,
the dose of the long-acting opioid used for persistent cancer pain should
be re-evaluated.
Dosage Adjustment
Experience in a long-term study of Actiq used in the treatment
of breakthrough cancer pain suggests that dosage adjustment of both Actiq
and the maintenance (around-the-clock) opioid analgesic may be required
in some patients to continue to provide adequate relief of breakthrough
cancer pain.
Generally, the Actiq dose should be increased when patients require
more than one dosage unit per breakthrough cancer pain episode for several
consecutive episodes. When titrating to an appropriate dose, small quantities
(six units) should be prescribed at each titration step. Physicians should
consider increasing the around-the-clock opioid dose used for persistent
cancer pain in patients experiencing more than four breakthrough cancer
pain episodes daily.
Discontinuation of Actiq
For patients requiring discontinuation of opioids, 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.
SAFETY AND HANDLING
Actiq is supplied in individually sealed child-resistant foil
pouches. The amount of fentanyl contained in Actiq can be fatal
to a child. Patients and their caregivers must be instructed to keep Actiq
out of the reach of children (see BOXED
WARNING, WARNINGS, PRECAUTIONS
and PATIENT INFORMATION).
Store at 25°C (77°F) with excursions permitted between 15° and 30°C (59°
to 86°F) until ready to use. (See USP Controlled Room Temperature.)
Actiq should be protected from freezing and moisture. Do not store
above 25°C. Do not use if the foil pouch has been opened.
DISPOSAL OF ACTIQ
Patients must be advised to dispose of any units remaining from a prescription
as soon as they are no longer needed. While all units should be disposed
of immediately after use, partially consumed units represent a special
risk because they are no longer protected by the child resistant pouch,
yet may contain enough medicine to be fatal to a child (see PATIENT
INFORMATION).
A temporary storage bottle is provided as part of the Actiq Welcome
Kit (see PATIENT INFORMATION).
This container is to be used by patients or their caregivers in the event
that a partially consumed unit cannot be disposed of promptly. Instructions
for usage of this container are included in the patient leaflet.
Patients and members of their household must be advised to dispose of
any units remaining from a prescription as soon as they are no longer
needed. Instructions are included in PATIENT
INFORMATION and in the patient leaflet. If additional assistance
is required, referral to the Actiq 800# (1-800-896-5855) should
be made.
HOW SUPPLIED
Actiq is supplied in six dosage strengths. Each unit is individually
wrapped in a child-resistant, protective foil pouch. These foil pouches
are packed 24 per shelf carton for use when patients have been titrated
to the appropriate dose.
Patients should be prescribed an initial titration supply of six 200
mcg Actiq units. At each new dose of Actiq during titration,
it is recommended that only six units of the next higher dose be prescribed.
Each dosage unit has a white to off-white color. The dosage strength
of each unit is marked on the handle, the foil pouch and the carton. See
foil pouch and carton for product information.
Dosage Strength
(fentanyl base) |
Carton/ Foil Pouch Color |
NDC Number |
| 200 mcg |
Gray |
NDC 0074-2460-24 |
| 400 mcg |
Blue |
NDC 0074-2461-24 |
| 600 mcg |
Orange |
NDC 0074-2462-24 |
| 800 mcg |
Purple |
NDC 0074-2463-24 |
| 1200 mcg |
Green |
NDC 0074-2464-24 |
| 1600 mcg |
Burgundy |
NDC 0074-2465-24 |
Note: Colors are a secondary aid in product identification. Please
be sure to confirm the printed dosage before dispensing.
Rx only.
DEA order form required. A Schedule CII narcotic.
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