United States -
English -
NLM (National Library of Medicine)
tyvaso- treprostinil inhalant
united therapeutics corporation - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil 1.74 mg in 2.9 ml - tyvaso is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to improve exercise ability. studies establishing effectiveness predominately included patients with nyha functional class iii symptoms and etiologies of idiopathic or heritable pah (56%) or pah associated with connective tissue diseases (33%). the effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. while there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). the controlled clinical experience was limited to 12 weeks in duration [see clinical studies (14)] . tyvaso is indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (ph-ild; who group 3) to improve exercise ability. the study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (iip) (45%) inclusive of idiopathic pulmonary fibrosis (ipf), combined pulmonary fibrosis and emphysema (cpfe) (25%), and who group 3 connective tissue disease (22%) [see clinical studies (14)] . none. risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmental effects were seen for treprostinil at ≥9 and ≥145 times the human exposure when based on cmax and auc, respectively, following a single treprostinil dose of 54 mcg. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and embryo-fetal risk pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. data animal reproduction studies have been conducted with treprostinil via continuous subcutaneous administration and with treprostinil diolamine administered orally. in studies with orally administered treprostinil diolamine, no adverse effect doses for fetal viability/growth, fetal development (teratogenicity), and postnatal development were determined in rats. in pregnant rats, no evidence of harm to the fetus was observed following oral administration of treprostinil diolamine at the highest dose tested (20 mg/kg/day), which represents about 154 and 1479 times the human exposure, when based on cmax and auc, respectively, following a single tyvaso dose of 54 mcg. in pregnant rabbits, external fetal and soft tissue malformations and fetal skeletal malformation occurred. the dose at which no adverse effects were seen (0.5 mg/kg/day) represents about 9 and 145 times the human exposure, when based on cmax and auc, respectively, following a single tyvaso dose of 54 mcg. no treprostinil treatment-related effects on labor and delivery were seen in animal studies. animal reproduction studies are not always predictive of human response. risk summary there are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness in pediatric patients have not been established. clinical studies of tyvaso did not include patients younger than 18 years to determine whether they respond differently from older patients. across clinical studies used to establish the effectiveness of tyvaso in patients with pah and ph-ild, 268 (47.8%) patients aged 65 years and over were enrolled. the treatment effects and safety profile observed in geriatric patients were similar to younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy. plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects with mild-to-moderate hepatic insufficiency. uptitrate slowly when treating patients with hepatic insufficiency because of the risk of an increase in systemic exposure which may lead to an increase in dose-dependent adverse effects. treprostinil has not been studied in patients with severe hepatic insufficiency [see clinical pharmacology (12.3)] . no dose adjustments are required in patients with renal impairment. treprostinil is not cleared by dialysis [see clinical pharmacology (12.3)] . tyvaso ® inhalation system instructions for use tyvaso ® (treprostinil) inhalation solution table of contents general instructions the tyvaso inhalation system should be handled with care. follow these important instructions to ensure proper use: - always unplug the device after each use. - do not immerse the device in water or other liquids. - do not place the device in a microwave or regular oven. - do not place the device or use the device in the presence of strong electric or magnetic fields (eg, microwave oven, magnetic imaging equipment). - do not leave the device alone with a small child. - do not use the device near flammable liquids and materials or heated surfaces. - read the instructions carefully and completely to prevent damage to your tyvaso inhalation system and help you get the best results. - this device should only be used on the order of your doctor or licensed healthcare practitioner. - ensure the breath counter is correctly programmed prior to beginning a treatment (see page 14). - do not peel or remove the labels from device. - do not drop the device. introduction your doctor has prescribed tyvaso® (treprostinil) inhalation solution. please see the accompanying patient package insert for important safety information on tyvaso. tyvaso is breathed in (inhaled) using the tyvaso inhalation system, which consists of the inhalation device and its accessories. these instructions for use (ifu) for the tyvaso inhalation system provide important safety information. it is important that you read these instructions and the tyvaso patient package insert (ppi) before setting up and using the tyvaso inhalation system. if you have any questions, talk to your doctor or specialty pharmacy provider. before beginning treatment with tyvaso, you will receive either a patient starter kit containing a 28-day supply of tyvaso or an institutional starter kit containing a 4-day supply of medication. both kits include two (2) complete inhalation devices (all accessories and supplies included). when you refill your prescription for tyvaso each month, you will receive a refill kit that contains a 28-day supply of tyvaso and new accessories. you will receive a replacement device every two (2) years. preparing for treatment with tyvaso preparing the use environment for treatment follow these important instructions before setting up your treatment: - use the device in a quiet, distraction-free area. - try to use the device at times when your treatment will not be interrupted. if you encounter any distractions during treatment, you can pause your treatment (see page 19). - use the device in a comfortable space where you can stand or sit in an upright position that allows you to take deep breaths. - use the device in an area that provides enough space for the tyvaso inhalation system and its accessories. - gather all necessary supplies before starting to prepare for treatment (see pages 6 and 7). - the tyvaso inhalation system is recommended for use indoors. be sure to use and store the inhalation device in environments that match the specified temperature and humidity ranges (see specifications on page 36). markings, indicators, and symbols device markings gathering supplies gather the following supplies before starting treatment. use only the parts and accessories that are provided with your starter kit or in the monthly refill kit. note: supplies are not shown to scale. setting up your tyvaso inhalation system filling the inhalation device chamber and medicine cup before using the tyvaso inhalation system, you should: - wash your hands - make sure the device is not connected to a power source - make sure the device is resting on a stable, flat surface during assembly only use distilled water in the device. distilled water is highly purified water that can be purchased at most grocery stores and pharmacies. it is necessary for the device to function properly. if you use another type of water (such as bottled or tap water), the device may not function properly. 1 fill the white chamber inside the device with approximately 45 ml of distilled water (about 1.5 ounces), using the water level cup provided. fill the cup until water level is between the two arrow markings. there is a silver sensor on the inside wall of the chamber. the water level should be above the silver sensor and below the blue ring in the device chamber. do not overfill the chamber, or the medicine cup will not fit correctly. check the water level after filling the chamber. 2 obtain one (1) medicine cup and inspect it for any damage, holes, cracks, or dents. do not use the medicine cup if it is damaged. insert the empty medicine cup into the chamber of the device, making sure that the cup's bottom tip is in the distilled water. the cup will sit on the blue ring. 3 carefully cut open the top of the foil pouch, making sure not to cut the ampules. each pouch contains four (4) ampules. remove one (1) ampule of tyvaso. keep unused ampules in the foil pouch because the tyvaso medicine is sensitive to light. one (1) ampule contains enough medicine for one (1) day of treatment no matter how many breaths your doctor has prescribed. 4 gently hold the ampule in the upright (topup) position and twist off its top. 5 point the ampule straight down toward the medicine cup's center to avoid spills. gently squeeze the medicine out of the ampule into the medicine cup. squeeze until it is empty. check to see that all of the medicine is in the medicine cup. assembling the inhalation device the tyvaso inhalation system is designed so the parts only fit together properly one way. when the device is assembled correctly, the parts should fit together easily. do not force the parts together. 1 visually check to make sure the blue plastic baffle plate and black ring are correctly placed in the dome assembly. they should appear as they do in the images below. in the unlikely event that the baffle plate is loose or disconnected, use a new dome assembly. if you need to order a new dome assembly, contact your specialty pharmacy provider. 2 align the raised circle on the side of the dome assembly with the circle on the side of the device. push down and screw the dome assembly onto the device clockwise (right) until you hear a click, indicating the dome assembly is fully connected to the medicine cup. when the dome assembly is properly aligned, the filter shell port will point to the back of the device. 3 insert the inhalation piece into the upper opening of the dome assembly and rotate toward the front of the device. gently push down the inhalation piece to make sure it is securely inserted in the dome assembly. 4 insert the mouthpiece into the inhalation piece. 5 each day you will need to use a new filter membrane in each filter shell. to install a new filter membrane: - open the filter shell by unscrewing the two (2) halves. - place a new filter membrane in one (1) of the filter shell halves. - close the filter shell by screwing the two (2) halves together until you can twist no further. note: new filter shells come with fresh filter membranes already installed. 6 insert one (1) of the filter shells into the filter shell port on the side of the dome assembly and insert the other filter shell into the port on the bottom of the inhalation piece. the two (2) filter shells are identical and can be used in either opening. make sure to insert the filter shells straight into their ports, rather than at an angle. if necessary, rotate the inhalation piece so you can insert the filter shell without the device getting in the way. 7 when the device is fully assembled, it should appear as it does in the photo below. for convenience, rotate the inhalation piece so you can best see the indicator lights and display screen, which provide important prompts during your treatment. turning on the inhalation device 1 connect your device to one (1) of the power source options by plugging one end of the power cord into the back of the inhalation device and the other end into the power source. if using the ac wall plug, make sure to plug the output cable into the device before plugging adapter into the power source. if using the rechargeable battery, make sure it is not also plugged into the ac wall plug. 2 to turn on the device, press and hold the on/off button for approximately three (3) seconds. when you hear a short beep and the yellow status light is illuminated, release the on/off button. remember to press the center of the on/off button when powering the device on or off. when the power is on, the display screen will show the last number of breaths programmed and a yellow light will appear next to the screen. make sure the number matches the prescribed number of breaths for that treatment session. if it does not match, see the next page for instructions on setting the number of breaths in a treatment session. setting the number of breaths in a treatment session you will inhale tyvaso during four (4) treatment sessions each day. during each treatment session, you will take a series of breaths through the mouthpiece of the tyvaso inhalation system. your doctor will prescribe the number of breaths you should inhale in each treatment session. you should record the number of breaths in your treatment tracker. 1 make sure the device is powered off. to power off the device, press and hold the on/off button for three (3) seconds. when you hear a short beep and the display screen turns off, release the on/ off button. to set the number of breaths, press and hold both the start/stop and on/off buttons at the same time until the display flashes and the device emits three (3) short beeps. the flashing display indicates the inhalation device is in breath programming mode. you cannot begin a treatment while the display is flashing. 2 to increase the number of breaths press the + (on/off) button. to decrease the number of breaths press the – (start/stop) button. remember to press in the center of the buttons. 3 once you have entered your prescribed number of breaths, remove your hands from the device and wait approximately 15 seconds. after approximately 15 seconds, the display will stop flashing and the device will emit three (3) short beeps, indicating that it has saved the new number of breaths. the new number of breaths will appear on the display. make sure the number of breaths on the display matches the number of breaths in your prescription. if the numbers do not match, repeat steps 1-3. inhaling your medicine, tyvaso® (treprostinil) inhalation solution you will inhale tyvaso during four (4) treatment sessions each day. during each treatment session, you will take a series of breaths through the mouthpiece of the tyvaso inhalation system. inhalation tips technique: when breathing each tyvaso treatment, be sure to keep the device level, directing the flow of medicine into the throat and not toward the roof of the mouth. seal your lips around the mouthpiece to ensure that you can inhale the full amount of tyvaso after it is produced by the device. inhalation: each breath should last approximately three (3) seconds, breathing "normal full breaths." do not hold your breath. exhale normally and prepare for the next breath. 1 hold the device upright as shown below. make sure you can see the display screen and lights clearly and that your hands do not cover the display screen or lights while holding device. if the inhalation piece or mouthpiece block your view of the display screen or lights, move the inhalation piece so you can best see them. 2 perform steps a-g to complete one (1) treatment session. follow the instructions exactly to make sure you receive the correct medication dose. 3 to pause the treatment between breaths, press the start/stop button. the display screen will show "pa." to resume treatment, press start/ stop again. "pa" will disappear and the display screen will show the number of breaths remaining. if the device is disconnected from its power source for any reason (for example, a power failure), reconnect the device to a power source. follow the instructions on page 13 to turn on the device. the display will show how many breaths are left in that treatment session. press the start/stop button to continue your treatment session. storing the tyvaso inhalation system between treatment sessions if you have more treatment sessions left in the day, perform the following steps. if you have completed your last treatment session of the day, skip to cleaning and maintenance of the tyvaso inhalation system (see page 24). be sure to pack all parts, including a backup power supply, in the carry case whenever transporting your device. 1 disconnect the device from its power source. 2 remove both filter shells. do not remove the filter membranes from filter shells until after the last treatment session of the day. 3 remove the mouthpiece. 4 remove the inhalation piece. 5 leave the dome assembly and medicine cup (with the medicine still in it) connected to the device. 6 insert a plug into each of the open holes on the dome assembly to prevent the medicine from spilling out. 7 the inhalation device with the plugged dome assembly and all the accessories can be stored in the carrying case between treatment sessions. cleaning and maintenance of the tyvaso inhalation system end of day cleaning of the accessories 1 disconnect the device from the power source. 2 remove both filter shells. 3 open the filter shells by twisting in opposite directions. remove and discard the used filter membranes. 4 remove the mouthpiece. 5 remove the inhalation piece. 6 remove the dome assembly by turning it counter-clockwise (to the left). the medicine cup should stay attached to the dome assembly. 7 remove the medicine cup by gently squeezing on the sides where it is attached to the dome assembly. empty the medicine cup into a sink or waste basket, then discard the medicine cup. be careful not to spill the medicine when removing or discarding the medicine cup. 8 empty the distilled water from the chamber and let the inhalation device air dry upside down. you can wipe the chamber with a soft cloth or paper towel to collect water. 9 clean the accessories (pictured below) by hand in mild, soapy, warm water, then rinse them thoroughly with water. allow accessories to air dry. 10 once all the items are dry, the filter shells, inhalation piece, mouthpiece, dome assembly, and inhalation device can be stored in the carrying case until the next day's treatment sessions. weekly cleaning - once a week, use a clean cloth to wipe the interior of the inhalation device chamber, be sure to wipe the disc in the bottom of the device. you may wipe the exterior of the device with a damp cloth if the lights or buttons become difficult to see. proper cleaning will help to avoid corrosion and leaks and keep your device working properly. monthly refill kit - once a month, you will receive a refill kit that will come with a new set of accessories from your specialty pharmacy provider. inspect the shipment to be sure all parts are included (see page 7). once the new kit has arrived, discard the used dome assembly, inhalation piece, mouthpiece, and two (2) filter shells. do not recycle the used accessories. device replacement - the inhalation device should be replaced every two (2) years from your first day of use. replacement inhalation devices will be supplied by your specialty pharmacy provider. charging your tyvaso inhalation system rechargeable battery the rechargeable battery is supplied with its own instructions for use. refer to these instructions for more information. - your tyvaso inhalation system is supplied with a portable, rechargeable battery. do not use other batteries. - your battery can only be charged by using one (1) of the ac wall plugs that comes with your inhalation device. - to check the battery's voltage level, press and hold the blue button on the front of the battery. you can only check the battery's voltage level when the battery is not plugged into a power source. the light below the button will turn on and indicate the battery's voltage level. a red light indicates the battery needs to be charged. a green light indicates the battery is ready to operate the device. - to charge the battery, connect the ac wall plug to the battery pack and plug the ac wall plug into an outlet. a yellow light on the front of the battery will turn on, indicating that the battery is charging. - your battery may take up to 40 hours to fully charge. it is not possible to use the tyvaso inhalation system with the battery while it is recharging. a fully charged battery will typically last up to 200 inhalations. a battery charged for one (1) night (about 10 hours) will typically last up to one (1) day of therapy (about 40 inhalations). - you should connect the charged battery to the tyvaso inhalation system only for your treatment. when using the battery pack to power the device, make sure the battery is not plugged into a power source. - after your treatment session is complete, remove the power plug of the battery from the device. - charge the battery whenever you are not using it to power the inhalation device. - always have your ac wall plug or 12v dc adapter available for backup, in case the battery is not charged. troubleshooting the tyvaso inhalation system - low battery - unplug the battery from the device. charge the battery by attaching it to the ac wall plug and outlet. - use an alternative power source, such as the ac wall plug or 12v dc adapter, for treatment. - defective adapter (ac wall plug or 12v dc adapter) - ensure that the plug is properly connected to an outlet. - ac wall plug is still plugged into battery and battery is connected to device. - turn off device (see page 14). - disconnect ac wall plug from battery. - check battery status, following instructions on page 28. - if device is properly powered and still does not function, contact your specialty pharmacy provider for a replacement. - device chamber is empty or distilled water level in the device chamber is too low. - unplug the device from its power source. remove the dome assembly carefully, making sure not to spill its medicine. empty the device chamber then refill it with distilled water (see page 8) and reconnect the dome assembly (see page 10). - the distilled water you are using is too purified - empty device chamber. add one (1) teaspoon of tap water to the water fill cup. fill cup with distilled water up to level between the two arrow markings on cup (see page 8). pour cup's contents into device chamber. - the sensor has a thin layer of build-up - clean sensor and interior surfaces of water chamber with a clean cloth. - if device is properly powered and still does not function, contact your specialty pharmacy provider for a replacement. - no tyvaso® (treprostinil) inhalation solution in the medicine cup - unplug the device from its power source. fill medicine cup with one (1) ampule of tyvaso. - damaged medicine cup - unplug the device from its power source. replace the medicine cup. - distilled water level in the device chamber is too high - unplug the device from its power source. empty the device chamber then refill it with 45 ml of distilled water. - multiple medicine cups attached to the dome assembly - unplug the device from its power source. remove and dispose of all medicine cups in the device. insert a single, new medicine cup into device chamber and fill with one (1) ampule of tyvaso. - filter membrane is clogged - unplug the device from its power source. replace filter membrane (see page 11). - no medicine cup in the chamber of the device - insert an empty medicine cup into the chamber of the device and fill it with one (1) ampule of tyvaso. - multiple medicine cups attached to the dome assembly - unplug the device from its power source. remove and dispose of all medicine cups in the device. insert a single, new medicine cup into device chamber and fill with one (1) ampule of tyvaso. - dome assembly is not securely in place - unplug the device from its power source. align the circle on the side of the dome assembly with the circle on the side of the device. push down and screw the dome assembly onto the device clockwise (right) until you hear a click, indicating the dome assembly is fully connected to the medicine cup. - device is disconnected from its power source - reconnect the device to a power source and press the on/off button to turn on the device. the display will show how many breaths are left in that treatment session. press the start/stop button to continue your treatment session. - power source is temporarily disrupted (for example, electricity interruption due to a storm) - reconnect the device to a power source and turn on the device (see page 13). the display will show how many breaths are left in that treatment session. press the start/ stop button to continue your treatment session. specifications inhalation device packaging dimensions (approximate length × width × height) tyvaso mass and particle specifications for 9 breaths accessories glossary accessories: parts of the tyvaso inhalation system. see pages 6 and 7. ampule: a sealed, lightweight clear plastic vial containing a 1-day supply of tyvaso® (treprostinil) inhalation solution. control light for inhalation: a green led on the top surface of the inhalation device that signals when you should inhale. baffle plate: a blue plastic piece that is inside the dome assembly. the baffle plate helps turn tyvaso into particles that are the correct size to inhale. black ring: a round seal that fits on the bottom of the dome assembly. the seal helps ensure that tyvaso does not mix with the distilled water in the device chamber. display screen: a small area on the inhalation device that displays number and letter prompts to guide you through your treatment sessions. distilled water: water that is highly purified so that it contains only essential elements. dome assembly: the plastic accessory that contains the baffle plate and connects the mouthpiece, inhalation piece, and filter shells to the base of the inhalation device. filter membrane: the white pad that goes into the filter shells. filter shells: plastic accessories that hold the filter membranes. inhalation piece: the plastic accessory that connects the mouthpiece with the dome assembly. inhalation device: the base of the tyvaso inhalation system to which the accessories connect. the inhalation device contains the display screen and lights. inhale: how you will breathe in tyvaso with the tyvaso inhalation system. medicine cup: the disposable plastic cone-shaped cup into which tyvaso is poured. the medicine cup fits inside the inhalation device chamber. mouthpiece: the plastic part that you will breathe through (using your mouth) to inhale tyvaso. on/off button: a manually activated control on the front of the device that switches between fully on and fully off power states. plugs: plastic accessories that are inserted into the openings of the dome assembly between treatment sessions. plugs help keep tyvaso from spilling if the inhalation device tips over. prompts: the audio and visual signals that help guide you through the treatment sessions. sensor: the silver object on the inside wall of the device chamber. the sensor must be covered with distilled water for the tyvaso inhalation system to function properly. status light: a multicolored led on the front of the inhalation device that indicates the device's operational status. start/stop treatment button: a manually activated control on the front of the device that begins or pauses treatment. specialty pharmacy provider: a pharmacy that carries only specialized medicines and medical devices. your specialty pharmacy provider is a good source of information about tyvaso and the tyvaso inhalation system. treatment session: one (1) of four (4) daily sessions during which you will take tyvaso with a specific number of inhalations. tyvaso: the prescription medicine that you will use with the tyvaso inhalation system. water chamber: the white hollow portion in the center of the inhalation device into which distilled water and the medicine cup are placed. warranty information your tyvaso inhalation system is granted a full replacement or repair warranty good for two (2) years from your date of receipt of the tyvaso inhalation system starter kit or five (5) years from the date of manufacture, whichever comes first. this warranty applies to the tyvaso inhalation system device only. accessory components are not covered under warranty. circumstances that may void your warranty include: - modification or disassembly of the tyvaso inhalation system device by anyone other than a factory-authorized technician - failure to comply with the written instructions for use manual when operating the tyvaso inhalation system - unapproved use of the tyvaso inhalation system for all inquiries relating to service or warranty for your tyvaso inhalation system, contact your specialty pharmacy provider. you should have the following information available: - device serial number (located on bottom of tyvaso inhalation system) - date tyvaso inhalation system was acquired - nature of the problem and any steps taken to fix it graphics in ifu are for representation only. images may not be shown to scale tyvaso ® inhalation system instructions for use tyvaso inhalation solution is for prescription use only. tyvaso is a registered trademark of united therapeutics corporation. literature issued 2016-07-30 for further questions and information, or to report an adverse reaction, please call 1-877-unither (1-877-864-8437). emergency contact information clinician: ___________________________________ nurse educator: ______________________________ specialty pharmacist: __________________________ united therapeutics: ___________________________ distributed by: united therapeutics corporation research triangle park, north carolina 27709 tyvaso ® (treprostinil) inhalation solution © 2016, united therapeutics corporation. all rights reserved. rtp-1-00052 rev. e tyvaso ® inhalation system instructions for use manual tyvaso ® (treprostinil) inhalation solution contents overview of your tyvaso inhalation system section overview this section introduces you to your tyvaso inhalation system and provides important safety information about using your system. important: do not start treatment with tyvaso until you have been trained to use the tyvaso inhalation system. make sure you understand all of the directions. always ask your doctor or specialty pharmacy provider if you have any questions or are unsure of anything you are taught. your doctor has prescribed tyvaso® (treprostinil) inhalation solution. please see the accompanying patient information for important safety information on tyvaso. tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (pah; who group 1) and pulmonary hypertension associated with interstitial lung disease (ph-ild; who group 3), which are diseases causing high blood pressure in the arteries of your lungs. tyvaso can improve exercise ability. the effects decrease over 4 hours; treatment timing can be adjusted for planned activities. tyvaso is breathed in (inhaled) using the tyvaso inhalation system, which consists of the inhalation device and its accessories. this instructions for use manual for the tyvaso inhalation system provides important safety information. it is important that you read these instructions and the tyvaso patient information before setting up and using the tyvaso inhalation system. if you have any questions, talk to your doctor or specialty pharmacy provider. before beginning treatment with tyvaso, you will receive either a patient starter kit containing a 28-day supply of tyvaso or an institutional starter kit containing a 4-day supply of medication. both kits include 2 complete inhalation devices (all accessories and supplies included). when you refill your prescription for tyvaso each month, you will receive a refill kit that contains a 28-day supply of tyvaso and new accessories. you will receive replacement devices every 2 years from your date of receipt of the tyvaso inhalation system. caution: federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner. important: - keep this instructions for use manual in a safe place where you can easily get to it for reference. for example, store the booklet in the tyvaso inhalation system carrying case, along with your other supplies. - tyvaso inhalation system is intended solely for the delivery of tyvaso (treprostinil) inhalation solution. tyvaso is for administration only with the tyvaso inhalation system. the tyvaso inhalation system should be handled carefully. take the following precautions and follow all instructions in this document to avoid injury and ensure proper use: delivering treatments: - read the instructions carefully and completely to prevent damage to your tyvaso inhalation system and help you get the best results. - this device should only be used on the order of your doctor or licensed healthcare practitioner. - conduct only the number of treatment sessions and inhalations you have been prescribed. - ensure the breath counter is correctly programmed prior to beginning a treatment (see page 22). - turn off the device when not in use. - do not use the device with an anesthetic breathing system or ventilator breathing system. - use only the supplies provided in the starter kit and monthly refill kit for correct device function. handling the device: - do not peel or remove the labels from the device. - do not drop the device. - the device does not include internal, replaceable parts. do not attempt to open the device, modify the device, or remove device labeling. your environment: - do not leave the device alone with a small child. - do not immerse the device in water or other liquids, or place in dishwasher. - do not place any system components in a microwave, conventional oven, or dishwasher. - do not use the device near flammable liquids and materials or heated surfaces. - do not place the device or use the device in the presence of strong electric or magnetic fields (e.g., microwave oven, magnetic imaging equipment). - wireless communications equipment (e.g., cell phone) can affect operation of the device and should be kept at least a distance of 3.3 meters (about 11 feet) away while using the device. - if the device performance is affected by exposure to any conditions listed here, see the troubleshooting section, or contact your healthcare provider or specialty pharmacy provider. inhalation device inhalation indicator lights lights on top of device flash green when you should inhale. on/off, start/pause (blue) button press and hold to power device on or off. once device is on, press and immediately release (do not hold down) to start or pause treatment. device display provides instructions and device information. run / program switch slide up to run mode when you are ready to deliver your dose. slide down to program mode to program the number of breaths for your dose. volume / breaths toggle button when set to run mode, push + to increase beeping volume, or push - to decrease beeping volume. when set to program mode, push + to increase the number of breaths, or push - to decrease the number of breaths required for each dose. power status light lights green when power is connected and battery is charging. power port port for plugging into a power source using the ac wall plug. programming your tyvaso inhalation system before use section overview this section provides instructions for charging your device, setting your dose, and adjusting the device's audio volume before you use the device for a treatment. important: do not start treatment with tyvaso until you have been trained to use the tyvaso inhalation system. make sure you understand all of the directions. always ask your doctor or specialty pharmacy provider if you have any questions or are unsure of anything you are taught. 1. plug in device important: a new device might not be fully charged when you receive it. always charge the device before you first use it. you can also charge the device overnight, when not in use and in between uses. plug the ac wall plug's white connector into the port on the back of the inhalation device. then, plug the ac wall plug into the wall outlet. the power status light above the port will light green when properly plugged in. 2. check the battery's status make sure the run / program switch is set to run. press and hold the blue button to power on the device. the battery icon at the bottom of the screen indicates battery status. when you are done checking the battery status, press and hold the on/off button until the display screen shuts off (note: letting the button go before the screen shuts off will start a treatment session). your doctor will prescribe the number of breaths you should take in each treatment session. you should program this number into the inhalation device before you use the device. 1. switch to program slide the run / program switch on the side of the device down to program mode. in program mode you enter the prescribed number of breaths for each dose. you cannot begin a treatment in program mode. 2. power on press and hold the on/off button until the display screen turns on. the program breaths screen appears. the number of breaths currently set for each treatment session will flash. 3. set breaths use the volume / breaths toggle button to enter your prescribed number of breaths onto the program screen. 4. switch to run slide the run / program switch up to run mode. make sure your new breath count appears on screen. 5. power off press and hold the on/off button until the display screen shuts off (note: letting the button go before the screen shuts off will start a treatment session). note: you will not need to program the breath count again, unless your prescribed number of breaths changes. you can use the volume / breaths toggle button to adjust the volume of the audible signals (beeps) that the device provides as feedback during treatment sessions. 1. switch to run slide the run / program switch up to run mode, if it is not in this position already. 2. power on press and hold the on/off button until the display screen turns on, if it is not already turned on. the programmed number of breaths will appear with the words "breaths left" and the battery icon at the bottom. 3. adjust volume with the run / program switch in the run position, press the volume / breaths toggle button to access the adjust volume screen. push + on the volume / breaths toggle button to increase beeping volume, or push - to decrease beeping volume. 4. power off after adjusting the beeping volume up or down, the screen will display your new setting for a couple of seconds then return to the screen displaying the breaths left. press and hold the on/off button until the display screen shuts off (note: letting the button go before the screen shuts off will start a treatment session). preparing and using your tyvaso inhalation system for daily treatments section overview this section provides instructions for preparing and using your tyvaso inhalation system for daily treatments. important: before using the tyvaso inhalation system, you should: - wash your hands. - make sure the device is resting on a stable, flat surface during assembly. follow these important instructions before setting up your treatment: - use the device in a quiet, distraction-free area. - try to use the device at times when your treatment will not be interrupted. if needed, you can pause your treatment (see page 44). - use the device in a comfortable space where you can stand or sit in an upright position. - use the device in an area where you can access a power source if you need to use the ac wall plug. - the tyvaso inhalation system is recommended for use indoors. - use the device in an area that provides enough space for the tyvaso inhalation system and its accessories. - gather all necessary supplies on a stable, flat surface for assembly (see page 29 for list of supplies). - store the inhalation device at 15°c to 30°c (59°f to 86°f). use at 15°c to 25°c (59°f to 77°f). - use the device in a well-lit area where you can clearly read these instructions, labels on the device, and the device screen. gather the following supplies before starting treatment. use only the supplies provided in the starter kit and monthly refill kit for correct device function. prior to use, inspect each part and do not use parts if they appear damaged or dirty. important: - wash your hands - unplug device when filling to avoid damage to cords or connectors. - only use distilled water in the device. distilled water is highly purified water that is required for the device to function properly. if you use another type of water (such as bottled or tap water), the device might not function properly. you can purchase distilled water at most grocery stores and pharmacies. 1. fill water chamber fill the water level cup with distilled water up to the arrow markers on the water cup. use fresh distilled water each day (i.e., do not use water left in the water chamber from the previous day). pour the distilled water into the water chamber. make sure the water level is above the upper, silver sensor and below the blue ring in the water chamber (about 45 ml of distilled water). do not overfill the water chamber, or else the medicine cup might not fit correctly. 2. place medicine cup obtain 1 new medicine cup and inspect it. do not use a medicine cup that is damaged (e.g., cracked or contains holes or dents), dirty, or was used before. place the empty medicine cup into the water chamber of the device, making sure that the cup's bottom tip is in the distilled water. caution: make sure you place only 1 medicine cup. placing multiple cups will prevent the flow of medicine. 3. gather one ampule carefully cut open the top of the foil pouch, making sure not to cut the ampules. each pouch contains 4 ampules. remove 1 ampule of tyvaso. keep unused ampules in the foil pouch because the tyvaso medicine is sensitive to light. write the date you first opened the pouch on the foil pouch. one ampule contains enough medicine for 1 day of treatment no matter how many breaths your doctor has prescribed. caution: ampules must be used within 7 days of opening foil pouch. open only 1 pouch at a time. throw away (discard) any unused ampules after 7 days. 4. open ampule gently hold the ampule in the upright (top up) position and twist off its top. caution: if any medicine from the ampule spills on your hands, wash your hands right away. medicine contact with the skin can cause irritation. 5. squeeze ampule point the ampule straight down toward the medicine cup's center to avoid spills. gently squeeze the medicine out of the ampule into the medicine cup. squeeze until it is empty. check to see that all of the medicine is in the medicine cup. important: do not force parts together. the tyvaso inhalation system is designed so the parts only fit together properly one way. when the device is assembled correctly, the parts should fit together easily. 1. check dome assembly visually check to make sure the black ring is securely placed in the dome assembly. the black ring should look like it does in the pictures below. if the black ring is loose or missing, do not use the dome assembly. throw it away and get a new one. if you need to order a new dome assembly, contact your specialty pharmacy provider. 2. attach dome assembly align the raised circle on the side of the dome assembly with the raised circle on the side of the device. push down and screw the dome assembly onto the device clockwise (right) until the filter shell port is tight and pointed to the back of the device. you will hear clicks (or a slight crunching sound) as the dome assembly presses down on the medicine cup. important: the dome assembly "clicks" only the first time it connects to the medicine cup. if you then realign the dome assembly you will not hear another click. 3. install new filter membrane each day you will need to use a new filter membrane in each filter shell. note: new filter shells come with fresh filter membranes already installed. 4. attach filter shells insert 1 filter shell into the filter shell port on the side of the dome assembly and insert the second filter shell into the port on the bottom of the inhalation piece. the filter shells are the same and can be used in either port. you can turn the filter shells around to fit into the ports, as needed. make sure to insert filter shells straight into ports, not at an angle. 5. insert inhalation piece insert the inhalation piece with attached filter shell into the upper opening of the dome assembly and turn it toward the front of the device. gently push down the inhalation piece to make sure it is securely inserted in the dome assembly. 6. insert mouthpiece carefully insert the mouthpiece into the inhalation piece. 7. check assembled device when the device is fully assembled, it should look like it does below. slightly turn the inhalation piece so you can see the display screen, which provides important prompts during your treatment. important: do not use device if you see liquid leaking from bottom of the device. 1. power on device press and hold the on/off button until the screen turns on and the device beeps once. the screen will display the splash screen, then the time since your last treatment, then the current breaths programmed for each dose. important: make sure the number on screen above "breaths left" matches the prescribed number of breaths for that treatment session. if it does not match, see page 22 for instructions on setting the number of breaths for a treatment session. 2. plug in device, if needed if the device's internal battery is too low to deliver a full treatment, the screen will display an instruction to plug in the power to charge the device battery. if the battery is fully depleted, the screen will not turn on. you can charge the battery at any time, before the screen displays "charge battery." you can conduct a treatment session with the power plugged in. first, plug the ac wall plug's white connector into the port on the back of the inhalation device. then, plug the ac wall plug into the wall outlet. the power status light above the port will light green when properly plugged in. 1. before starting, confirm treatment you will breathe in (inhale) tyvaso during 4 treatment sessions each day (evenly spaced during your waking hours). during each treatment session, you will take a series of breaths through the mouthpiece of the tyvaso inhalation system. before inhaling your medicine, ensure the run/program switch is in the 'run' position, and make sure the number displayed on screen matches your prescribed number of breaths for that treatment session. during the treatment the device counts down each breath after a set time interval. once you complete all breaths, record the breath number in your treatment tracker. important: if the number of breaths displayed does not match the number of breaths in your prescription, see page 22 "setting your prescribed dose" and repeat steps 1-4. 2. hold the device upright hold the device upright and stand or sit in an upright position as shown below. avoid covering the bottom of the device so that the audio speaker is not blocked. make sure you can see the display screen and lights clearly and that your hands do not cover the display screen or lights while holding device. if needed, you can move the inhalation piece and mouthpiece slightly to either side to see the screen and lights better. see next page to start treatment. inhalation tips: technique: when breathing each tyvaso treatment, be sure to keep the device level, directing the flow of medicine into the throat and not toward the roof of the mouth. seal your lips around the mouthpiece to ensure that you can inhale the full amount of tyvaso after it is produced by the device. inhalation: each breath should last approximately 3 seconds, breathing "normal full breaths." do not hold your breath. remove your lips from the mouthpiece, breathe out (exhale) normally and prepare for the next breath. 3. press blue button to start treatment if you need to pause treatment, you can press and immediately release (do not hold down) the blue button. press the button again and immediately release to resume treatment. (note: if you do not resume treatment after pausing, power off device.) 4. wait look at the display screen for cues. wait until you hear 2 short beeps. when you hear 1 long beep, exhale to prepare to inhale. 5. inhale when you hear 1 short beep and the indicator lights flash green, place your lips securely around the mouthpiece and inhale for 3 seconds. when lights stop flashing, remove lips from mouthpiece and exhale normally. 6. repeat for each breath left the screen will decrease the number of breaths left by 1. repeat steps 4 and 5 for the number of prescribed breaths. 7. finish session after displaying the last breath sequence, the green done screen appears, you will hear a beep, and your treatment is done. if the device is left in the "✓ done" mode for more than 60 seconds, it will turn off automatically. 8. record breaths, turn off device record the number of breaths you inhaled on the treatment tracker. press and hold blue button until screen turns off. caution: if medicine does not appear to be flowing properly, the system might be set up incorrectly. see "troubleshooting", starting on page 64 for details. cleaning and storing your tyvaso inhalation system section overview this section provides instructions for storing your tyvaso inhalation system after each treatment and daily and weekly cleaning. there is also information about your monthly refill kits, replacing your device, and recharging the device's battery. important: for further support, you can: - fill out and refer to your emergency contact information on the back of this instructions for use manual. - call 1-877-unither (1-877-864-8437) for questions and information, or to report an adverse reaction. if you have more treatment sessions left in the day, perform the steps in this section. if you have completed your last treatment session of the day, skip to "end of day cleaning" on page 52. be sure to pack all parts, including the ac wall plug, in the carrying case whenever transporting your device. 1. disconnect ac wall plug (if it is currently connected) 2. remove mouthpiece 3. remove inhalation piece important: when removing accessories between treatment sessions, hold the device by its base to avoid spilling the medicine. 4. remove both filter shells note: do not remove the filter membranes from filter shells until after the last treatment session of the day. 5. leave dome assembly leave dome assembly and medicine cup (with the medicine still in it) attached to the device. 6. place plugs in dome assembly insert a plug into each of the 2 open holes on the dome assembly to prevent the medicine from spilling out. important: if the plugs are not in place, the medicine may spill. if you spill any medicine, discard remaining medicine and start your next treatment with a new ampule. 7. store in carrying case you can store the inhalation device with the plugged dome assembly and disassembled accessories in the carrying case between treatment sessions. keep the carrying case upright while inserting the device and components so that water and medicine does not spill out of the device. important: store the inhalation device in an upright position until the next treatment session. see "specifications" on page 76 for additional storage and transport information. if you have completed your last treatment session of the day, perform the steps in this section. if you have more treatment sessions left in the day, refer back to "storing between sessions during the day" on page 48. 1. disconnect ac wall plug (if it is currently connected) 2. remove mouthpiece 3. remove inhalation piece with attached filter shell 4. remove both filter shells 5. discard filter membranes open filter shells by twisting in opposite directions. remove and discard used filter membranes in the trash. 6. remove dome assembly remove the dome assembly by turning it counter-clockwise (to the left). the medicine cup should stay attached to the dome assembly. 7. remove medicine cup remove the medicine cup by gently squeezing on the sides where it is attached to the dome assembly. be careful not to spill any leftover medicine. caution: if any medicine from the medicine cup spills on your hands, wash your hands immediately. medicine contact with the skin can cause irritation. 8. empty medicine cup empty any leftover medicine in the medicine cup into a waste basket, and discard the medicine cup. important: discard remaining tyvaso® (treprostinil) inhalation solution in an appropriate waste receptacle. discard plastic medicine cup in the trash. do not reuse or recycle medicine cup. 9. empty and clean device empty distilled water from water chamber and let inhalation device air dry upside down. you can wipe the water chamber with a soft cloth or paper towel to remove any remaining water. important: do not place the inhalation device in water or in a dishwasher. 10. clean accessories clean accessories (pictured below) by hand in mild, soapy, warm water, then rinse them thoroughly with water. allow accessories to air dry. important: do not place the inhalation device or its accessories in a microwave, conventional oven, or dishwasher. 11. store components once all the items are dry, you can store the filter shells, inhalation piece, mouthpiece, dome assembly, ac wall plug, and inhalation device in the carrying case until the next day's treatment sessions. you can also recharge the device for the next day of use (see page 57). 1. checking the battery's status you can recharge your battery at any time. press and hold the blue button to power on the device to check battery status. make sure the run / program switch is set to run. - the battery icon at the bottom of the screen indicates battery status: - "charge battery" appears on screen if there is not enough charge to conduct a treatment session. important: always charge the device before you first use it. you should also charge the device when not in use and in between uses. 2. charging the battery plug the ac wall plug's white connector into the port on the back of the inhalation device. then, plug the ac wall plug into the wall outlet. the power status light above the port will light green when properly plugged in. the device battery might take up to 8 hours to fully charge. if the device is powered on, the battery charging icon appears next to the battery icon at the bottom of the screen. clean the device once a week to help avoid corrosion and leaks and to keep your device working properly. once a week, use a clean, dry cloth to wipe the interior of the water chamber. make sure to wipe the 2 silver sensors and the white disc in the bottom of the water chamber. you may wipe the exterior of the device with a damp cloth if the lights or buttons become difficult to see. once a month, you will receive a refill kit that will come with a new set of accessories from your specialty pharmacy provider. - inspect the shipment to be sure all parts are included. - once the new kit has arrived, discard the used dome assembly, inhalation piece, mouthpiece, filter shells, and plugs. - do not recycle the used accessories. the inhalation devices should be replaced every 2 years from your first day of use. replacement inhalation devices will be supplied by your specialty pharmacy provider. when you receive a new inhalation device your specialty pharmacy provider will provide instructions for returning the old device. help / more information about your tyvaso inhalation system section overview this section provides additional information about your device. use this section to troubleshoot difficulties you have with the device, or to learn more about the device's specifications and warranty. important: for further support, you can: - fill out and refer to your emergency contact information on the back of this instructions for use manual. - call 1-877-unither (1-877-864-8437) for questions and information, or to report an adverse reaction. the tyvaso inhalation system has been tested and found to comply with the electromagnetic compatibility (emc) limits for medical devices according to iec 60601-1-2: (2007). compliance is intended to provide reasonable protection against harmful interference in a typical user environment. table 1, table 2 and table 3 document the intended emc use environment and established compliance levels for the tyvaso inhalation system. to ensure the intended performance, use the system in the environments described in these tables. the tyvaso inhalation system is intended for use in the electromagnetic environment specified in this section. accessories: parts of the tyvaso inhalation system. see page 29. ampule: a sealed, lightweight clear plastic vial containing a 1-day supply of tyvaso® (treprostinil) inhalation solution. black ring: a round seal that fits on the bottom of the dome assembly. the seal helps ensure that tyvaso does not mix with the distilled water in the device water chamber. display screen: a small area on the inhalation device that provides instructions and device information. distilled water: water that is highly purified so that it contains only essential elements. dome assembly: the plastic accessory that contains the baffle plate and connects the mouthpiece, inhalation piece, and filter shells to the base of the inhalation device. filter membrane: the white pad that goes into the filter shells. filter shells: plastic accessories that hold the filter membranes. inhalation indicator lights: two green lights on the top surface of the inhalation device that signals when you should inhale. inhalation piece: the plastic accessory that connects the mouthpiece with the dome assembly. inhalation device: the base of the tyvaso inhalation system to which the accessories connect. the inhalation device contains the display screen and lights. inhale: how you will breathe in tyvaso with the tyvaso inhalation system. medicine cup: the disposable plastic cone-shaped cup into which tyvaso is poured. the medicine cup fits inside the water chamber. mouthpiece: the plastic part that you will breathe through (using your mouth) to inhale tyvaso. on/off, start/pause (blue) button: a manually activated control on the front of the device that switches between fully on and fully off power states. once the device power is on, the button begins or pauses treatment. plugs: plastic accessories that are inserted into the openings of the dome assembly between treatment sessions. plugs help keep tyvaso from spilling if the inhalation device tips over. power status light: led on the back of the device that lights green when power is connected and battery is charging. power port: port on back of device for plugging into a power source using the ac wall plug. prompts: the audio and visual signals that help guide you through the treatment sessions. run / program switch: a manually activated control on the side of the device that switches between the modes for delivering treatment (run) and programming breaths (program). sensors: the silver objects on the inside wall of the water chamber. the sensors must be covered with distilled water for the tyvaso inhalation system to function properly. specialty pharmacy provider: a pharmacy that carries only specialized medicines and medical devices. your specialty pharmacy provider is a good source of information about tyvaso and the tyvaso inhalation system. treatment session: 1 of 4 daily sessions during which you will take tyvaso with a specific number of inhalations. tyvaso: the prescription medicine that you will use with the tyvaso inhalation system. volume / breaths toggle button: a manually activated control on the side of the device that increases or decreases audio volume (when in run mode) and programmed breaths (when in program mode). water chamber: the white hollow portion in the center of the inhalation device into which distilled water and the medicine cup are placed. your tyvaso inhalation system is granted a replacement or repair warranty good for 2 years from your date of receipt of the tyvaso inhalation system or 5 years from the date of manufacture, whichever comes first. this warranty applies to the tyvaso inhalation system device only. accessory components are not covered under warranty. for all inquiries relating to service or warranty for your tyvaso inhalation system, contact your specialty pharmacy provider. tyvaso ® inhalation system tyvaso ® (treprostinil) inhalation solution tyvaso inhalation solution is for prescription use only. for further questions and information, or to report a problem with your device or an adverse event with your tyvaso inhalation system, please call 1-877-unither (1-877-864-8437). distributed by: united therapeutics corporation research triangle park, north carolina 27709 © 2022, united therapeutics corporation. all rights reserved. 102040 tyvaso is a registered trademark of united therapeutics corporation. this instructions for use has been approved by the u.s. food and drug administration. revised: august 2022
United States -
English -
NLM (National Library of Medicine)
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