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
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
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.
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.
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. Uprima abuse may be associated with inappropriate sexual behavior.