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
Apokyn Patient, Information, Instructions - Apomorphine
Apokyn Patient, Information, Instructions - Apomorphine
PATIENT INFORMATION
APOKYN is intended only for subcutaneous injection and must
not be given intravenously. Patients and caregivers should be urged to read
the attached Patient Package Insert and Directions for Use of the ampule and
dosing pen. Patients should be instructed to use APOKYN only as prescribed.
Patients and/or caregivers who are advised to administer APOKYN in medically
unsupervised situations should receive instruction on the proper use of the
product from the physician or other suitably qualified health care professional
and then observed during the initial dosing.
In particular, patients and caregivers must receive detailed
instruction in the use of the dosing pen, with particular attention paid to
two issues: 1) Patients need to be aware that the drug is dosed in milliliters,
not milligrams. Patients should be particularly cautioned that a dose of 1 mg
is represented on the dosing pen as 0.1 mL, and not as 1.0 (the latter representing
a dose of 10 mg). It is critical that patients and caregivers be made to understand
this distinction to prevent potentially life-threatening overdose if a dose
of 1 mg is prescribed. 2) Patients and caregivers must be informed that it is
possible to dial in their usual dose of apomorphine even though the cartridge
may contain less than that amount of drug. In this case, they will receive only
a partial dose with the injection, and the amount left to inject will appear
in the dosing window. To complete the correct dose, patients/caregivers will
need to "re-arm" the device and dial in the correct amount of the
remaining dose. If at all possible, this situation should be avoided, and patients
and caregivers should be alerted to the fact that there may be insufficient
drug left in the cartridge to deliver a complete dose (for example, patients
and caregivers should be urged to keep records of how many doses they have delivered
for each cartridge, so that they can replace any cartridge that has an inadequate
amount of drug remaining).
Patients should be instructed to rotate the injection site
and to observe proper aseptic technique.
Patients should be informed that hallucinations can occur.
Patients should be advised that they may develop postural (orthostatic)
hypotension with or without symptoms such as dizziness, nausea, syncope, and
sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently
during initial therapy or with an increase in dose at any time (cases have been
seen after months of treatment). Accordingly, patients should be cautioned against
rising rapidly after sitting or lying down, especially if they have been sitting
or lying for prolonged periods, and especially at the initiation of treatment
with APOKYN. Alcohol, antihyper-tensive medications, and vasodilating medications
may potentiate the hypotensive effect of apomorphine (see WARNINGS:
Symptomatic Hypoten-sion; PRECAUTIONS: Drug
Interactions).
Patients should be alerted to the potential sedating effects
of APOKYN, including somnolence and the possibility of falling asleep while
engaged in activities of daily living. Since somnolence is a frequent adverse
event with potentially serious consequences, patients should neither drive a
car nor engage in other potentially dangerous activities until they have gained
sufficient experience with APOKYN to gauge whether or not it affects their mental
and/or motor performance adversely. Patients should be advised that if increased
somnolence or episodes of falling asleep during activities of daily living (e.g.,
watching television, passenger in a car, etc.) are experienced at any time during
treatment, they should not drive or participate in potentially dangerous activities
until they have contacted their physician. Because of possible additive effects,
caution should be advised when patients are taking other sedating medications
or alcohol in combination with APOKYN.
Because apomorphine has not been evaluated for effects on reproduction
and embryo-fetal development, patients should be advised to notify their physicians
if they become pregnant or intend to become pregnant (see PRECAUTIONS:
Pregnancy).
Because of the possibility that apomorphine may be excreted
in breast milk, patients should be advised to notify their physicians if they
intend to breast-feed.
Rare cases of abuse (use of apomorphine significantly in excess
of prescribed frequency) have been reported. Apomorphine abuse may be associated
with inappropriate sexual behavior.
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