the doorstep [1%):60 msecs from pre-dose) and had QTc intervals greater than 500 msecs acutely after dosing. Doses of 6 mg or less thus are associated with minimal increases in QTc. Decreases in blood pressure Dose-dependent mean decrements in systolic blood pressure ranged from 5 mmHg after 2 mg to 16 mmHg after 10 mg. Dose-dependent mean decrements in diastolic blood pressure ranged from 3 mmHg after 2 mg to 8 mmHg after 10 mg. These changes were observed at 20 minutes, and were maximal between 20 and 40 minutes after dosing. Lesser, but still noteworthy blood pressure decrements persisted up to at least 90 minutes after dosing. Pharmacokinetics Absorption Apomorphine hydrochloride is a lipophilic compound that is rapidly absorbed (time to peak concentration ranges from 10 minutes to 60 minutes) following subcutaneous administration into the abdominal wall. After subcutaneous administration, apomorphine appears to have bioavailability equal to that of an intravenous administration. Apomorphine exhibits linear pharmacokinetics over a dose range of 2 mg to 8 mg following a single subcutaneous injection of Apokyn into the abdominal wall in patients with idiopathic Parkinson's disease. Distribution The plasma-to-whole blood apomorphine concentration ratio is equal to one. Mean (range) apparent volume of distribution was 218 L (123 L to 404 L). Maximum concentrations in cerebrospinal fluid (CSF) are less than 10% of maximum plasma concentrations and occur 10 minutes to 20 minutes later. Metabolism and Elimination The mean apparent clearance (range) is 223 L/hr (125 L/hr to 401 L/hr) and the mean terminal elimination half-life is about 40 minutes (range about 30 minutes to 60 minutes). The route of metabolism in humans is not known. Potential routes of metabolism in humans include sulfation, N-demethylation, glucuronidation and oxidation. In vitro, apomorphine undergoes rapid autooxidation. Special Populations The clearance of apomorphine does not appear to be influenced by age, gender, weight, duration of Parkinson's disease, levodopa dose or duration of therapy. Renal Impairment In a study comparing renally-impaired subjects (moderately impaired as determined by estimated creatinine clearance) to healthy matched volunteers, the AUC 0 - and Cmax values were increased by approximately 16% and 50%, respectively, following a single subcutaneous administration of Apokyn into the abdominal wall. The mean time to peak concentrations and the mean terminal half-life of apomorphine were unaffected by the renal status of the individual. Studies in subjects with severe renal impairment have not been conducted. The starting dose for patients with mild or moderate renal impairment should be reduced [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ] . Hepatic Impairment In a study comparing subjects with hepatic impairment (moderately impaired as determined by the Child-Pugh classification method) to healthy matched volunteers, the AUC 0 - and C max values were increased by approximately 10% and 25%, respectively, following a single subcutaneous administration of Apokyn into the abdominal wall. Studies in subjects with severe hepatic impairment have not been conducted [see Dosage and Administration (2.5) and Use in Specific Populations (8.7) ] . Drug-Drug Interactions Carbidopa/levodopa: Levodopa pharmacokinetics were unchanged when subcutaneous Apokyn and levodopa were co-administrated in patients. However, motor response differences were significant. The threshold levodopa concentration necessary for an improved motor response was reduced significantly, leading to an increased duration of effect without a change in the maximal response to levodopa therapy. Other Drugs Eliminated Via Hepatic Metabolism Based upon an in vitro study, cytochrome P450 enzymes play a minor role in the metabolism of apomorphine. In vitro studies have also demonstrated that drug interactions are unlikely due to apomorphine acting as a substrate, an inhibitor, or an inducer of cytochrome P450 enzymes. COMT Interactions A pharmacokinetic interaction of Apokyn with catechol-O-methyl transferase (COMT) inhibitors or drugs metabolized by this route is unlikely since apomorphine appears not to be metabolized by COMT. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime carcinogenicity studies of apomorphine were conducted in male (0.1, 0.3, or 0.8 mg/kg/day) and female (0.3, 0.8, or 2 mg/kg/day) rats. Apomorphine was administered by subcutaneous injection for 22 months or 23 months, respectively. In males, there was an increase in Leydig cell tumors at the highest dose tested, which is less than the MRHD (20 mg) on a mg/m 2 basis. This finding is of questionable significance because the endocrine mechanisms believed to be involved in the production of Leydig cell tumors in rats are not relevant to humans. No drug-related tumors were observed in females; the highest dose tested is similar to the MRHD on a mg/m 2 basis. In a 26-week carcinogenicity study in P53-knockout transgenic mice, there was no evidence of carcinogenic potential when apomorphine was administered by subcutaneous injection at doses up to 20 mg/kg/day (male) or 40 mg/kg/day (female). Mutagenesis Apomorphine was mutagenic in the in vitro bacterial reverse mutation (Ames) and the in vitro mouse lymphoma tk assays. Apomorphine was clastogenic in the in vitro chromosomal aberration assay in human lymphocytes and in the in vitro mouse lymphoma tk assay. Apomorphine was negative in the in vivo micronucleus assay in mice. Impairment of Fertility Apomorphine was administered subcutaneously at doses up to 3 mg/kg/day (approximately 1.5 times the MRHD on a mg/m 2 basis) to male and female rats prior to and throughout the mating period and continuing in females through gestation day 6. There was no evidence of adverse effects on fertility or on early fetal viability. A significant decrease in testis weight was observed in a 39-week study in cynomolgus monkey at all subcutaneous dose tested (0.3, 1, or 1.5 mg/kg/day); the lowest dose tested is less than the MRHD on a mg/m 2 basis. In a published fertility study, apomorphine was administered to male rats at subcutaneous doses of 0.2, 0.8, or 2 mg/kg prior to and throughout the mating period. Fertility was reduced at the highest dose tested. Clinical Studies The effectiveness of Apokyn in the acute symptomatic treatment of the recurring episodes of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes), in patients with advanced Parkinson's disease was established in three randomized, controlled trials of Apokyn given subcutaneously (Studies 1, 2, and 3). At baseline in these trials, the mean duration of Parkinson's disease was approximately 11 years. Whereas all patients were using concomitant L-dopa at baseline, 86% of patients were using a concomitant oral dopaminergic agonist, 31% were using a concomitant catechol-ortho-methyl transferase (COMT) inhibitor, and 10% were using a concomitant monoamine B oxidase inhibitor. Study 1 was conducted in patients who did not have prior exposure to Apokyn (i.e., Apokyn naïve) and Studies 2 and 3 were conducted in patients with at least 3 months of Apokyn use immediately prior to study enrollment. Almost all patients without prior exposure to Apokyn began taking an antiemetic (trimethobenzamide) three days prior to starting Apokyn and 50% of patients were able to discontinue the concomitant antiemetic, on average 2 months after initiating Apokyn. The change from baseline in Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS) served as the primary outcome assessment measure in each study. Part III of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. Study 1 Study 1 was a randomized, double-blind, placebo-controlled, parallel-group trial in 29 patients with advanced Parkinson's disease who had at least 2 hours of "off" time per day despite an optimized oral regimen for Parkinson's disease including levodopa and an oral dopaminergic agonist. Patients with atypical Parkinson's disease, psychosis, dementia, hypotension, or those taking dopamine antagonists were excluded from participation. In an office setting, hypomobility was allowed to occur by withholding the patients' Parkinson's disease medications overnight. The following morning, patients (in a hypomobile state) were started on study treatment in a 2:1 ratio (2 mg of Apokyn or placebo given subcutaneously). At least 2 hours after the first dose, patients were given additional doses of study medication until they achieved a "therapeutic response" (defined as a response similar to the patient's response to their usual dose of levodopa) or until 10 mg of Apokyn or placebo equivalent was given. At each injection re-dosing, the study drug dose was increased in 2 mg increments up to 4 mg, 6 mg, 8 mg, 10 mg of Apokyn) or placebo equivalent. Of the 20 patients randomized to Apokyn, 18 achieved a "therapeutic response" at about 20 minutes. The mean Apokyn dose was 5.4 mg (3 patients on 2 mg, 7 patients on 4 mg, 5 patients on 6 mg, 3 patients on 8 mg, and 2 patients on 10 mg). In contrast, of the 9 placebo-treated patients, none reached a "therapeutic response." The mean change-from-baseline for UPDRS Part III score for Apokyn group (highest dose) was statistically significant compared to that for the placebo group (Table 2). Table 2: Mean Change from Baseline in UPDRS Motor Score for Intent-to-Treat Population in Study 1 Treatment Baseline UPDRS Motor Score Mean Change from Baseline Difference from placebo Placebo 36.3 - 0.1 NA Apokyn 39.7 - 23.9 - 23.8 Study 2 Study 2 used a randomized, placebo-controlled crossover design of 17 patients with Parkinson's disease who had been using Apokyn for at least 3 months. Patients received their usual morning doses of Parkinson's disease medications and were followed until hypomobility occurred, at which time they received either a single dose of subcutaneous Apokyn (at their usual dose) and placebo on different days in random order. UPDRS Part III scores were evaluated over time. The mean dose of Apokyn was 4 mg (2 patients on 2 mg, 9 patients on 3 mg, 2 patients on 4 mg, and 1 patient each on 4.5 mg, 5 mg, 8 mg, and 10 mg). The mean change-from-baseline UPDRS Part III score for the Apokyn group was statistically significant compared to that for the placebo group (Table 3). Table 3: Mean Change from Baseline in UPDRS Motor Score for Intent-to-Treat Population in Study 2 Treatment Baseline UPDRS Motor Score Mean Change from Baseline Difference from placebo Placebo 40.1 - 3.0 NA Apokyn 41.3 - 20.0 - 17.0 Study 3 Study 3 used a randomized withdrawal design in 4 parallel groups from 62 patients (Apokyn-35; Placebo-27) with Parkinson's disease who had been using Apokyn for at least 3 months. Patients were randomized to one of the following 4 treatments dosed once by subcutaneous administration: Apokyn at the usual dose (mean dose 4.6 mg), placebo at a volume matching the usual Apokyn dose, Apokyn at the usual dose + 2 mg (0.2 mL) (mean dose 5.8 mg), or placebo at a volume matching the usual Apokyn dose + 0.2 mL. Patients received their usual morning doses of Parkinson's disease medications and were followed until hypomobility occurred, at which time they received the randomized treatment. Apokyn doses ranged between 2 mg 10 mg. The mean change-from-baseline for the Apokyn group for UPDRS Part III scores at 20 minutes post dosing was statistically significant compared to that for the placebo group (Table 4). Figure 2 describes the mean change from baseline in UPDRS Motor Scores over time for pooled Apokyn and placebo administration. Table 4: Mean Change from Baseline in UPDRS Motor Score for Intent-to-Treat Population in Study 4 Treatment Baseline UPDRS Motor Score Mean Change from Baseline Difference from placebo Placebo (Pooled) 40.6 - 7.4 NA Apokyn (Pooled) 42.0 - 24.2 - 16.8 Figure 2: Mean Change from Baseline in UPDRS Motor Scores of Pooled Apokyn Groups and Placebo Group in Study 3 In Study 3, the mean changes-from-baseline for UPDRS Part III scores at 20 minutes post dosing for the Apokyn and higher dose Apokyn groups were 24 and 25, respectively. This result suggests that patients chronically treated at a dose of 4 mg might derive little additional benefit from a dose increment of 2 mg. There was also an increased incidence of adverse reactions in patients randomized to higher Apokyn dose. How Supplied/Storage and Handling Apokyn is supplied as a 10 mg/mL clear, colorless, sterile, solution in 3 mL (30 mg) glass cartridges. NDC 27505-004-05 Cartons of five 3 mL cartridges Apokyn Pen The pen injector is provided in a package with six needles and a carrying case. Store at 25 C (77 F). Excursions permitted to 15 C to 30 C (59 F to 86 F) [See USP Controlled Room Temperature] Patient Counseling Information See FDA-approved patient labeling ( Patient Information and Instructions for Use ) Administration with the Apokyn Pen Instruct patients and caregivers to read the "Apokyn Pen Instructions for Use" and Patient Information. Instruct patients to use Apokyn only as prescribed [See Dosage and Administration (2) ] . Instruct patients and caregivers that the Apokyn Pen is dosed in milliliters, not milligrams. Inform patients and caregivers that it is possible to dial in their usual dose of Apokyn 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. 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). Instruct patients to rotate the injection site and to observe proper aseptic technique. Advise patients that Apokyn is intended only for subcutaneous injection and must not be given intravenously because of the risk of serious complications such as thrombus formation and pulmonary embolism due to crystallization [see Warnings and Precautions (5.1) ]. Avoidance of Concomitant Antiemetic Drugs of 5HT 3 Antagonist Class Advise patients that they should not use concomitant drugs of the 5HT 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron with Apokyn. Use of Apokyn with concomitant antiemetic drugs of the 5HT 3 antagonist class is contraindicated because there have been reports of profound hypotension and loss of consciousness when Apokyn was administered with ondansetron [see Contraindications (4) ]. Hypersensitivity / Allergic Reactions Advise patients that hypersensitivity/allergic reaction characterized by urticaria, rash, pruritus, and/or various manifestations of angioedema may occur because of Apokyn or any of its excipients including a sulfite (i.e., sodium metabisulfite). Inform patients with a sulfite sensitivity that they may experience various allergic-type reactions, including anaphylactic symptoms and life-threatening asthmatic attacks. Advise patients who experience any hypersensitivity/allergic reaction to Apokyn that they should avoid taking Apokyn again [see Contraindications (4) ]. Nausea and Vomiting Advise patients that they may experience severe nausea and/or vomiting and that they should begin taking trimethobenzamide 300 mg orally 3 times per day for 3 days prior to starting Apokyn injections. Advise patients that Apokyn taken with trimethobenzamide may increase the risks for somnolence, dizziness, and falls. Inform patients that their healthcare provider will tell them when trimethobenzamide can be discontinued [see Warnings and Precautions (5.2) ]. Falling Asleep Suddenly and Sedation / Sleepiness Alert patients to the potential sedating effects of Apokyn, including somnolence and falling asleep while engaged in activities of daily living. Instruct patients not to drive a car or 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. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) occur, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects of alcohol use, advise patients to limit their alcohol intake [see Warnings and Precautions (5.3) ]. Syncope Advise patients that Apokyn may cause syncope [see Warnings and Precautions (5.4) ]. Hypotension / Orthostatic Hypotension Advise patients 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). Instruct patients to rise slowly after sitting or lying down after taking Apokyn. Instruct patients to limit their alcohol intake because it may potentiate the hypotensive effect of Apokyn [see Warnings and Precautions (5.5) ]. Falls Alert patients that they may have increased risk for falling when using Apokyn [see Warnings and Precautions (5.6) ] . Hallucinations and/or Psychotic-Like Behavior Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur. Tell patients if they have a major psychotic disorder, ordinarily they should not use Apokyn because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of Apokyn [see Warnings and Precautions (5.7) ] . Dyskinesia Inform patients that Apokyn may cause and/or exacerbate pre-existing dyskinesias [see Warnings and Precautions (5.8) ]. Impulse Control / Compulsive Behaviors Patients and their caregivers should be alerted to the possibility that they may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge eating and/or other intense urges and the inability to control these urges while taking Apokyn [see Warnings and Precautions (5.9) ] . Coronary Events Inform patients that Apokyn may cause coronary events including angina and myocardial infarction and these outcomes could possibly be related to significant hypotension/orthostatic hypotension [see Warnings and Precautions (5.10) ]. QTc Prolongation and Potential for Proarrhythymic Effects Alert patients that Apokyn may cause QTc prolongation and might produce proarrhythmic effects that could cause torsades de pointes and sudden death. Palpitations and syncope may signal the occurrence of an episode of torsades de pointes [see Warnings and Precautions (5.11) ]. Withdrawal-Emergent Hyperpyrexia and Confusion Advise patients to contact their healthcare provider if they wish to discontinue Apokyn or decrease the dose of Apokyn [see Warnings and Precautions (5.12) ]. Melanoma Advise patients with Parkinson's disease that they have a higher risk of developing melanoma. Advise patients to have a qualified healthcare provider examine that patient's skin periodically for melanomas on a regular basis when using Apokyn [see Warnings and Precautions (5.13) ]. Priapism Advise patients that Apokyn may cause prolonged painful erections and that if this occurs that they should seek medical attention immediately [see Warnings and Precautions (5.15) ]. Injection Site Reactions Inform patients that injections of Apokyn may result in injection site reactions including bruising, granuloma, and pruritus [see Adverse Reactions (6.1) ]. Distributed by: US WorldMeds, LLC 4441 Springdale Rd Louisville, KY 40241 US WorldMeds, LLC is the exclusive licensee and distributor of Apokyn in the United States and Its territories. 2017. Apokyn is a registered trademark of BRITUSWIP. Apokyn Pen Instructions for Use Designed to be used only with 3 mL Apokyn (apomorphine hydrochloride injection) Cartridges For more information, call your specialty pharmacy provider or 1-877-7Apokyn (727-6596). Apokyn (apomorphine hydrochloride injection) Apokyn Pen Apokyn (apomorphine hydrochloride injection) is for under the skin (subcutaneous) injection only. Do not inject Apokyn into a vein. Do not use the Apokyn Pen unless you and your care partner have been taught the right way to use it and both of you understand all of the instructions. The Apokyn Pen is for use only with 3 mL Apokyn (apomorphine hydrochloride injection) Cartridges. The Apokyn Pen is only for use by 1 patient and should not be shared. Gray Pen Cap Gray Pen Body Pen Needle Unit Cartridge a. Clip Teal Cartridge Holder b. Black Rod c. White Dose Window d. White Dose Knob e. Teal Injection Button f. Outer Needle Shield g. Pink Inner Needle Shield h. Pen Needle i. Pink Paper Tab j. Rubber Septum k. Metal Cap l. Cartridge Plunger Read First: Important Safety Information The Apokyn Pen is a medicine delivery device. It is very important that you or your care partner read this Instructions for Use and follow the instructions for using the Apokyn Pen correctly to receive the correct Apokyn dose. Always perform a flow check (prime) before every injection and after loading a new cartridge. The liquid in the Apokyn Cartridge can cause irritation if it gets on your skin or in your eyes. Flush your eyes with cold water and wash the liquid off your skin right away if this happens. The BD pen needle unit is sterile. Avoid contaminating the needle after opening. Do not place it on a surface or touch other items with the needle. Do not dial the dose or try to correct a dialing error with the pen needle in the skin. You could receive the wrong dose. Be careful when removing the needle. Accidental needle sticks can transmit serious infections. Never store or carry the Apokyn Pen with a pen needle attached. Storing or carrying the Apokyn Pen with a pen needle attached may let: Air enter the cartridge Medicine leak out This can affect your Apokyn dose. The Apokyn Pen should only be used with pen needles (29G x 1/2"). These needles are available through your specialty pharmacy provider or your local pharmacy. Magnification: 50 You must use a new, sterile BD pen needle with each injection. How to Use the Apokyn Pen Preparing the Apokyn Pen for Cartridge Loading Step 1. Remove the gray pen cap by pulling it straight off. Step 2. Unscrew the teal cartridge holder from the gray pen body by turning it clockwise. Loading a Cartridge Step 3. Only use Apokyn that is clear and colorless. Do not use an Apokyn Cartridge that contains medicine that is cloudy, green, or contains particles. Call your specialty pharmacy provider for replacement cartridges. Insert the Apokyn Cartridge, metal cap first, into the teal cartridge holder. Step 4. Lower the gray pen body onto the teal cartridge holder so that the black rod presses against the cartridge plunger. Screw the teal cartridge holder onto the gray pen body. Tighten the pieces by turning the teal cartridge holder clockwise until no gap remains and 1 of the white arrows line up with the white marker on the gray pen body. Step 5. If you already have a cartridge in the pen and have used the pen, you should check the cartridge through the window in the teal cartridge holder to make sure there is enough Apokyn solution in the cartridge to provide your next dose. If the gray cartridge plunger has reached the red line on the cartridge, remove the cartridge and insert a new cartridge into the pen before attaching the pen needle and preparing the dose. Attaching the Pen Needle Step 6. Remove the pink paper tab from the back of a new pen needle. Use a new needle for each injection. Never reuse needles. Step 7. Holding the Apokyn Pen by the teal cartridge holder, push the pen needle unit onto the pen. Screw the threaded hub of the pen needle onto the teal cartridge holder counter-clockwise. When the needle unit is attached, remove the outer shield that protects the needle with a gentle pull. Save the outer shield. You will use it to remove the needle from the pen after the injection is finished. Do not remove the inner needle shield at this time. The needle is sterile and must stay clean. After opening, do not place the needle on a surface or let it touch anything. Preparing (Priming) the Apokyn Pen for Use IMPORTANT Prior to each injection, it is important that the Apokyn Pen be properly primed. For a new Apokyn Cartridge (1 that has not been used before), repeat the priming procedure described on the next page (Steps 8-9) 3 or 4 times to make sure all the air has been removed from the needle and cartridge. For an Apokyn Cartridge you have used before (1 that has been previously primed), repeat the priming procedure described on the next page (Steps 8-9) 1 time to make sure all the air has been removed from the needle and cartridge. Step 8. You must prepare (prime) the Apokyn Pen for use before injecting the medicine. To prime the Apokyn Pen, set the dose by turning the dose knob to 0.1 mL. This is important so you can get rid of any air bubbles in the cartridge. Step 9. Remove the inner needle shield. Remember, do not let the needle touch any- thing. With the needle pointing up, firmly push the injection button in as far as it will go and hold for at least 5 seconds. A small stream of medicine must come out of the end of the needle. If it does not, reset the dose by repeating Step 8. Repeat these steps (Steps 8-9) until a small stream of medicine comes out the end of the needle. When medicine comes out of the end of the needle, the Apokyn Pen is primed for injection and ready to use. Apokyn medicine can cause staining to fabric and other surfaces it touches. Be careful where you prime the Apokyn Pen. Setting the Dose Step 10. To set the dose, turn the white dose knob until the correct dose (number of mLs) is shown in the window. The dose will appear as a red number between two black lines that will line up next to the letters "mL" on the pen body. Make sure the correct number (dose) appears in the window. Step 11. Dose Correction. If you turn the dose knob past your dose, do not dial backwards. If you dial backwards, Apokyn will be pushed through the needle and you will lose medicine. Continue to turn the dial until it is fully turned. Press the injection button fully. This will reset the dial to zero without pushing medicine out of the needle. Repeat Step 10 to redial your dose. Giving the Injection Step 12. Apokyn is only for injection under the skin (subcutaneous injection). Choose an injection site on your stomach area, upper arm or upper leg. Change the site with each injection. Do not inject Apokyn into skin that is red or sore. Clean the site with an alcohol swab and allow to air dry. Pinch about an inch of skin and fat tissue of your injection site between your thumb and forefinger. With the other hand, insert the needle all the way into the pinched skin. Step 13. Fully push the teal injection button on the Apokyn Pen. A clicking sound will be heard while the dose is injected. Push the injection button firmly for 5 seconds. Remove the needle from your skin. If medicine keeps dripping from the needle, keep the needle in the skin longer the next time you inject Apokyn. IMPORTANT If you set your dose and cannot depress the teal injection button, the cartridge is empty. Remove the pen needle and cartridge and prepare the pen as described in Steps 2-9 with a new cartridge. Set the dose and give the injection. If you set your dose and the injection button stops before you receive a complete dose, note the number in the window, remove the pen needle and cartridge, and prepare the pen as described in Steps 2-9 with a new cartridge. Set the dose to the number that last appeared in the window and administer the injection. This completes the dose. Before attempting to replace a cartridge, be sure that a needle unit is not attached to the Apokyn Pen. Removing the Pen Needle Step 14. Carefully replace the outer needle shield. Be careful to avoid a needle-stick. Place the outer needle shield in the notch located on the far left side of your carrying case. The opening of the needle shield should be pointing up. Carefully insert the needle (attached to the pen) into the opening of the shield. Without holding onto the shield, push down firmly. Step 15. Hold the pen by the teal cartridge holder and unscrew the pen needle from the cartridge holder. Recap the pen. Never recap the pen with a needle attached. Safely dispose of used pen needles in a "sharps" container. Your specialty pharmacy provider will provide you with a "sharps" container. Do not throw used needles in a trash can. Storage Information Store Apokyn cartridges at room temperature, 68 F to 77 F (20 C to 25 C) Excursions permitted to 59 to 86 F (15 to 30 C) [See USP Controlled Room Temperature] Proper Disposal Put your used needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Care and Storage The Apokyn Pen can now be stored in its carrying case. Never store or carry the Apokyn Pen with a pen needle attached. You must store and care for your pen the right way: Avoid exposure to dust, moisture, and cold or hot temperatures. Never wash the pen in water or use strong disinfectants. Only a clean, damp cloth should be used for cleaning. Do not try to repair the pen if it is damaged or if you cannot solve a problem shown in the following "Troubleshooting" section. Do not use pen for more than 1 year after the first use or after the expiration date on the carton. For more information, call your specialty pharmacy provider or 1-877-7Apokyn (727-6596). Troubleshooting PROBLEM POSSIBLE CAUSE HOW TO FIX THE PROBLEM For more information, call your specialty pharmacy provider or 1-877-7Apokyn (727-6596). No medicine comes out of the pen (the dosage dial moves freely, but no click is heard). The pen is in dose correction mode. Push the injection button all the way in so the dial returns to zero. The dosage dial does not return to zero during an injection. The cartridge is empty. Replace the cartridge as described in Steps 3-5. The pen needle is clogged. Replace the pen needle as described in Steps 14 & 6-7. The dosage dial does not turn easily. Dust or dirt is on the pen. Turn the dial past the highest setting on the pen. Wipe all exposed pen surfaces with a clean, damp cloth. Pen does not close. Cartridge is inserted incorrectly. Remove cartridge and reload it. See Steps 3 - 4. Injection button will not depress. Cartridge is empty. Replace cartridge. See Steps 3-5. Injection button stops before a complete dose is delivered. Not enough medication in cartridge to complete the dose. Replace cartridge. See Steps 3-5. Pen does not work. Mechanical failure. Replace pen. Call your specialty pharmacy provider or 1-877-7Apokyn (727-6596). Dose numbers and/or white markers wea prospective customers
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