Patent Description:
The current subject matter described herein relates generally to drug infusion from a vial to a patient. More particularly, the current subject matter relates to an apparatus and a method that provides for direct drug infusion from a vial to a patient.

Infusion of a drug, such as one or more pharmaceuticals, biopharmaceuticals, and/or biologics, may involve an intravenous administration of the drug into the patient. One or more health care providers may be responsible for the intravenous administration, which may include, for example, dose preparation procedures and patient preparation procedures to provide for the drug to be intravenously administered to the patient.

The invention is defined by the subject-matter of claim <NUM>.

Aspects of the current subject matter relate to direct drug infusion from a vial to a patient, thereby simplifying the health care provider's workflow and reducing the infusion time for the patient.

This innovation simplifies the health care provider's workflow by allowing direct intravenous (IV) infusion of an undiluted liquid drug solution from its primary container. It does not require dilution into IV bags prior to administration and has a shorter infusion time. Therefore, it provides a more convenient and faster IV administration option for healthcare systems. Because it reduces the infusion time substantially, it is also expected to improve patient experience.

According to aspects disclosed herein, an apparatus is provided. The apparatus includes a label. The label includes a back surface area, and a front surface area opposite the back surface area. A portion of the back surface area of the label and an opposing portion of the front surface area of the label include a movable hanger. The movable hanger is configured to move from a first position to a second position. In the first position, the movable hanger is at least substantially aligned with a remainder portion of the back surface area and an opposing remainder portion of the front surface area. In the second position, the movable hanger is at least partially separated from the remainder portion of the back surface area and the opposing remainder portion of the front surface area.

In some variations, one or more of the features disclosed herein including the following features can optionally be included in any feasible combination. According to the invention, the remainder portion of the back surface area of the label may be configured to adhere to an outer sidewall of a vial. In some variations, the label may include a flexible material. In some variations, the back surface area may include the portion of the back surface area and the remainder portion of the back surface area, and the front surface area may include the opposing portion of the front surface area and the opposing remainder portion of the front surface area. In some variations, the label may further include a perforation that extends through the back surface area and the front surface area, and the perforation may define at least a portion of a perimeter of the movable hanger. In some variations, the perforation may be configured to cause the movable hanger to at least partially separate from the remainder portion of the back surface area and the opposing remainder portion of the front surface area. In some variations, the movable hanger may be configured to move from the first position to the second position along the perforation. In some variations, the movable hanger in the second position may include a loop configuration, and the loop configuration may include two fixed ends. In some variations, the movable hanger in the second position may be configured to support a vial from an infusion stand, when the label is adhered to the vial. In some variations, the movable hanger in the second position may be positioned such that the vial hangs substantially downward away from the infusion stand. In some variations, the label may include text on the front surface area, and the text may be upside down, right side up, or a combination thereof when the vial hangs substantially downward. In some variations, the movable hanger in the second position may be configured to support a weight of the vial up to about <NUM>. In some variations, a length of the label may be between about <NUM> and about <NUM>. In some variations, a height of the label may be between about <NUM> and about <NUM>. In some variations, a width of the movable hanger may be between about <NUM> and about <NUM>.

In another, interrelated aspect, not forming part of the invention, a method is provided. The method includes infusing, via an infusion pump, an infusion line with a first quantity of saline; removing a vial cap from a vial containing a drug, where the vial includes a stopper at a top portion thereof, and further where the vial cap is configured to cover the stopper; piercing the stopper with an infusion line spike at a proximal end of the infusion line; opening, from a label adhered to the vial, a movable hanger into a loop configuration, where the movable hanger is formed from a portion of the label and is configured to move from a closed configuration into the loop configuration; and hanging the vial, via the movable hanger, from an infusion stand.

In some variations, one or more of the features disclosed herein including the following features can optionally be included in any feasible combination. In some variations, the method may further include opening an air venting cap on the infusion line spike; and setting, on the infusion pump, an infusion rate and an infusion volume for the drug to be administered to a patient, such that the drug may travel from the vial, via the infusion line spike, through the infusion line to a needle inserted into the patient, where the needle may be positioned at a distal end of the infusion line, and further where the infusion pump may interface with the infusion line to pump the drug at the infusion rate. In some variations, the method may further include infusing, via the infusion pump and upon completion of administration of the drug to the patient, a second drug through the infusion line for administration to the patient, where the second drug may be of a same type or a different type as the drug. In some variations, the method may further include infusing, via the infusion pump, the infusion line with a second quantity of saline. In some variations, less than <NUM>% of an initial volume of the drug may remain in the infusion line following the infusion of the second quantity of saline for an infusion time of up to about <NUM> minutes at an infusion rate of about <NUM>/min, where the infusion time may include a drug administration time and a second saline flush time. In some variations, less than <NUM>% of an initial volume of the drug may remain in the infusion line following the infusion of the second quantity of saline for an infusion time of up to about <NUM> minutes at an infusion rate of about <NUM>/min, where the infusion time may include a drug administration time and a second saline flush time. In some variations, the drug may not be diluted prior to administration. In some variations, an initial amount of the drug in the vial may be less than about <NUM>. In some variations, the movable hanger may be formed from a portion of a back surface area and an opposing portion of a front surface area of the label. In some variations, the label may include a perforation that extends through the back surface area and the front surface area of the label, and the perforation may further define at least a portion of a perimeter of the movable hanger. In some variations, the perforation may be configured to cause the movable hanger to open into the loop configuration from the closed configuration.

In another, interrelated aspect, an apparatus is provided. The apparatus includes means for infusing an infusion line with a first quantity of saline; means for infusing the infusion line with a drug from a vial for administration of the drug to a patient; and means for infusing the infusion line with a second quantity of saline upon completion of the administration of the drug to the patient. The vial is suspended from an infusion stand via a movable hanger formed from a portion of a label adhered to the vial, where the movable hanger is configured to move from a closed configuration into a loop configuration.

In another, interrelated aspect, a method of administering a drug to a patient in need thereof is provided. The method includes infusing into the patient via an infusion line a first quantity of saline; infusing into the patient via the infusion line an infusion volume of the drug from a vial for a first period of time, where an initial amount of drug in the vial is less than or equal to about <NUM> and is not diluted prior to infusion into the patient; and infusing into the patient via the infusion line a second quantity of saline for a second period of time. Less than about <NUM>% of the initial amount of the drug remains in the infusion line after infusion of the second quantity of saline.

In some variations, one or more of the features disclosed herein including the following features can optionally be included in any feasible combination. In some variations, the drug may be administered at a fixed dose. In some variations, the initial amount of drug in the vial may be less than or equal to about <NUM>. In some variations, the total of the first period of time and the second period of time may be less than or equal to about <NUM> minutes. In some variations, the total of the first period of time and the second period of time may be less than or equal to about <NUM> minutes. In some variations, the total of the first period of time and the second period of time may be less than or equal to about <NUM> minutes. In some variations, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some variations, the infusion volume of the drug may be between about <NUM> and about <NUM> and the second quantity of saline may be between about <NUM> and about <NUM>. In some variations, the drug and second quantity of saline may be infused into the patient at an infusion rate between about <NUM>/min and about <NUM>/min.

"Patient" or "subject in need thereof" refers to a living organism suffering from or prone to a disease or condition that can be treated by administration of a pharmaceutical composition as provided herein. Non-limiting examples include humans, other mammals, bovines, rats, mice, dogs, cats, monkeys, goat, sheep, cows, deer, and other non-mammalian animals. In some embodiments, a patient is human.

Dosages may be varied depending upon the requirements of the patient and the compound being employed. The dose administered to a patient, in the context of the present disclosure, should be sufficient to effect a beneficial therapeutic response in the patient over time. The size of the dose also will be determined by the existence, nature, and extent of any adverse side-effects. Determination of the proper dosage for a particular situation is within the skill of the practitioner. Dosage amounts and intervals can be adjusted individually to provide levels of the administered compound effective for the particular clinical indication being treated. This will provide a therapeutic regimen that is commensurate with the severity of the individual's disease state.

An "anticancer agent" as used herein refers to a molecule (e.g. compound, peptide, protein, nucleic acid) used to treat cancer through destruction or inhibition of cancer cells or tissues. Anticancer agents may be selective for certain cancers or certain tissues. In embodiments, anticancer agents herein may include epigenetic inhibitors and multi-kinase inhibitors.

As used herein, the term "administering" generally means intravenous administration, unless otherwise indicated. Other modes of administration include, without limitation: administration as a suppository, topical contact, oral, parenteral, intraperitoneal, intramuscular, intralesional, intrathecal, intranasal, subcutaneous administration, implantation of a slow-release device, e.g., a mini-osmotic pump, transmucosal (e.g., buccal, sublingual, palatal, gingival, nasal, vaginal, rectal, or transdermal). Parenteral administration includes, e.g., intravenous, intramuscular, intra-arteriole, intradermal, subcutaneous, intraperitoneal, intraventricular, and intracranial. Other modes of delivery include, but are not limited to, the use of liposomal formulations, transdermal patches, etc..

It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims.

The current subject matter is directed to direct drug infusion from a vial to a patient. Consistent with implementations of the current subject matter, a movable hanger label is provided to adhere to and support the vial to facilitate direct infusion of a drug, such as one or more pharmaceuticals, biopharmaceuticals, and/or biologics, from the vial to the patient.

For a conventional drug infusion procedure, one or more health care providers may be responsible for the intravenous administration, which may include, for example, dose preparation procedures and patient preparation procedures to provide for the drug to be intravenously directed to the patient. For example, the dose preparation procedures may involve one or more health care providers preparing a diluted drug in an intravenous bag, which expends valuable resources of time (e.g., the time of the health care providers to prepare the diluted drug) and materials (e.g., the intravenous bag). Moreover, the dose preparation procedures need to be conducted in a sterile environment, further expending resources including sterile equipment (e.g., health care provider gloves and masks) and hospital or clinical space. Additionally, such dose preparation procedures inherently are at risk for error due to the reliance on human interaction in the preparation of the diluted drug.

With respect to patient considerations, conventional drug infusion procedures typically involve a significant amount of time to administer the drug to the patient. As the drug is diluted with, for example, saline, an increased amount of fluids are being delivered to the patient, thereby resulting in an increased amount of time for the drug administration.

The movable hanger label consistent with implementations of the current subject matter simplifies the conventional drug infusion procedure by providing for the drug to be directly infused to the patient from the vial. This decreases the time, material, and space resources that are involved in conventional dose preparation procedures. Additionally, use of the movable hanger label for the direct drug infusion of the drug to the patient reduces the amount of time for the drug administration, thereby increasing the overall patient experience.

<FIG> illustrate features of a movable hanger label <NUM> configured to adhere to and support a vial consistent with implementations of the current subject matter. <FIG> is a perspective view of the movable hanger label <NUM> in a flat orientation, and <FIG> is a front view of the movable hanger label <NUM> in the flat orientation. <FIG> is a perspective view of the movable hanger label <NUM> in a curved orientation (e.g., a configuration in which the movable hanger label <NUM> is applied to a vial), and <FIG> is a perspective view of the movable hanger label <NUM> in a curved orientation with a movable hanger portion <NUM> in an open or loop configuration.

As shown in <FIG>, the movable hanger label <NUM> has a back surface area <NUM> and a front surface area <NUM> that is opposite the back surface area <NUM>. The back surface area <NUM> and the front surface area <NUM> are generally planar surfaces. The movable hanger portion <NUM> is formed from a portion of the back surface area <NUM> and an opposing portion of the front surface area <NUM> of the movable hanger label <NUM>, and is configured to move from a first position (e.g., a closed position or a closed configuration) to a second position (e.g., an open position or an open configuration or a loop position or a loop configuration). In the first position (e.g., the closed position), the movable hanger portion <NUM> is aligned with a remaining area of the movable hanger label <NUM>. In the second position (e.g., the open position or the loop position), the movable hanger portion <NUM> of the movable hanger label <NUM> is at least partially separated from the remaining area of the movable hanger label <NUM>. That is, consistent with implementations of the current subject matter, the movable hanger portion <NUM> is a portion of the movable hanger label <NUM> that may be moved relative to the movable hanger label <NUM> to form a loop or hanger <NUM> (as shown in <FIG>).

Consistent with implementations of the current subject matter, the movable hanger label <NUM> is perforated such that the movable hanger portion <NUM> is formed from a portion of the back surface area <NUM> and an opposing portion of the front surface area <NUM> of the movable hanger label <NUM>. Perforations <NUM> allow for the movable hanger portion <NUM> to be at least partially separated from the remaining portion of the movable hanger label <NUM> so that the movable hanger portion <NUM> may move (along the perforations <NUM>) relative to the movable hanger label <NUM>, as shown in <FIG>. The perforations <NUM> define at least a portion of a perimeter of the movable hanger portion <NUM>, as shown in <FIG>. The movable hanger portion <NUM> may be peeled away from the remaining portion of the movable hanger label <NUM> by grasping a first and/or second extended tab or corner or an end region of the movable hanger portion <NUM>, and peeling the movable hanger portion <NUM> along the perforations <NUM>.

The movable hanger portion <NUM> is fixed to the movable hanger label <NUM> at fixed ends <NUM> of the movable hanger label <NUM>. The perforations <NUM> adjacent or near the fixed ends <NUM> may be in a curved form or the like to provide for or facilitate movement (e.g., rotational movement) of the movable hanger portion <NUM>. The curved form of the end regions of the perforations <NUM> may also prevent the movable hanger label <NUM> from tearing at the end regions. For example, the movable hanger portion <NUM> may rotate from the closed position to the open position or the loop position by about <NUM>°, and the curved form of the end regions of the perforations <NUM> provides for the rotation with no or minimal tearing of the movable hanger label <NUM> apart from the perforations <NUM>.

The movable hanger label <NUM> consistent with implementations of the current subject matter is made of a flexible material such that the movable hanger label <NUM> is able to conform to the shape of a surface on which the movable hanger label <NUM> is being applied. For example, the movable hanger label <NUM> may be made of a flexible plastic or reinforced paper product. The movable hanger label <NUM> may adhere to a vial having a curved outer sidewall, and the movable hanger label <NUM> may substantially conform to the curvature of the outer sidewall of the vial. The movable hanger label <NUM> may conform to a variety of surface shapes and is not limited to being adhered to and used with a cylindrical vial but may also be used with, for example, a cubic vial.

The back surface area <NUM> of the movable hanger label <NUM> may include a bonding material or substance that sticks or adheres to a variety of materials, such as glass, plastic, metal, and the like. Consistent with implementations of the current subject matter, the portion of the back surface area <NUM> that forms the movable hanger portion <NUM> does not contain the bonding material or substance, allowing the movable hanger portion <NUM> to separate from the remainder of the movable hanger label <NUM> to move between the first position (e.g., the closed position) to the second position (e.g., the open or loop position) when the movable hanger label <NUM> is adhered to a vial.

With reference to <FIG>, aspects of the movable hanger label <NUM> when adhered to a vial <NUM> consistent with implementations of the current subject matter are illustrated. On the left-hand side of <FIG>, the movable hanger label <NUM> is shown adhered to the vial <NUM> with the movable hanger portion <NUM> in the closed configuration (or position). On the right-hand side of <FIG>, the movable hanger portion <NUM> is moved from the closed configuration (or position) to the open configuration (or position), in which a type of hanger is formed as a result of the separation and movement (e.g., rotational movement) of the movable hanger portion <NUM> away from the remainder of the movable hanger label <NUM>. As shown, the movable hanger portion <NUM> may take the form of a loop such that when the vial <NUM> is turned topside down, the loop (positioned at the bottom of the vial <NUM>) is topside up, allowing the vial <NUM> to be attached or secured to an apparatus with the topside of the vial <NUM> accessible. Such configuration, as shown in <FIG>, provides for the drug contained in the vial <NUM> to be able to be directly accessed from the vial <NUM> while the vial is attached or secured (e.g., hanging from) an apparatus. For example, with the movable hanger portion <NUM> in the open configuration, the vial <NUM> may be secured to an infusion stand or the like by the movable hanger portion <NUM> being looped or otherwise secured to an arm or extension of the infusion stand or the like. In this configuration with the vial <NUM> supported by the movable hanger portion <NUM> of the movable hanger label <NUM> and with the vial <NUM> oriented substantially downward, text and/or markings on the movable hanger label <NUM> may be upside down, right side up, or a combination thereof. For example, consistent with implementations of the current subject matter, text and/or markings on the movable hanger label <NUM> may be upside down when the vial <NUM> is situated in an upright position, allowing for the text and/or markings to be right side up when the vial <NUM> is hanging and supported by the movable hanger portion <NUM>.

With further reference to <FIG>, a process <NUM> of preparing the vial <NUM> with the movable hanger label <NUM> for drug administration to a patient of a drug contained in the vial <NUM> is shown.

At <NUM>, a vial cap is removed from the vial <NUM> containing the drug. As shown, the movable hanger label <NUM> is adhered to the vial <NUM>. In some examples, the vial <NUM> may include a stopper at a top portion thereof, and the vial cap may be configured to cover the stopper.

At <NUM>, the vial stopper is pierced with an infusion line spike, which interfaces with an infusion line (not shown in <FIG>). In some examples, the infusion line spike pierces a center or near center portion of the vial stopper. In some examples, a lengthwise orientation of the infusion line spike is <NUM>° with respect to a top surface of the vial stopper. In some examples, the lengthwise orientation of the infusion line spike is about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, or about <NUM>° with respect to the top surface of the vial stopper.

At <NUM>, the infusion line spike is inserted through the vial stopper into the vial <NUM> at a point at which at least an end region of the infusion line spike is visible through the vial <NUM>. For example, the infusion line spike is inserted through the vial stopper into the vial <NUM> until the infusion line spike is visible at a neck portion of the vial <NUM>.

At <NUM>, the process begins of moving the movable hanger portion <NUM> of the movable hanger label <NUM> from the first position (e.g., the closed position or the closed configuration) to the second position (e.g., the open position or the open configuration or the loop position or the loop configuration). In some examples, a first and/or second extended tab or corner or an end region of the movable hanger portion <NUM> may be lifted off or peeled away from the vial <NUM> and the remaining portion of the movable hanger label <NUM>.

At <NUM>, the process continues of moving the movable hanger portion <NUM> of the movable hanger label <NUM> from the first position to the second position. Consistent with implementations of the current subject matter, the movable hanger portion <NUM> is tom and/or peeled away from the movable hanger label <NUM> along the perforations <NUM>, described above with reference to <FIG>.

At <NUM>, when the movable hanger portion <NUM> is completely or near completely in the second position such that a loop is formed and able to be grasped, the vial <NUM> is inverted while holding in place in the vial the infusion line spike. At <NUM>, the vial <NUM> is attached to an apparatus, such as an infusion stand, an infusion pole, or the like, by way of the movable hanger portion <NUM>. In particular, with the movable hanger portion <NUM> in the open configuration, the vial <NUM> may be secured to an infusion stand, an infusion pole, or the like by the movable hanger portion <NUM> being looped or otherwise secured to an arm or extension of the infusion stand, the infusion pole, or the like. In this configuration, the vial <NUM> is supported by the movable hanger portion <NUM> of the movable hanger label <NUM> with the vial <NUM> oriented substantially downward.

Consistent with implementations of the current subject matter, the movable hanger portion <NUM> may support a weight of the vial <NUM> up to about <NUM>. The movable hanger portion <NUM> may support a weight of the vial <NUM> up to about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. The movable hanger portion <NUM> may support a weight of the vial <NUM> up to about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. The movable hanger portion <NUM> may support a weight of the vial <NUM> up to about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. The movable hanger portion <NUM> may support a weight of the vial <NUM> between about <NUM> and about <NUM>. The weight of the vial may be any value or subrange within the recited ranges, including endpoints.

According to the invention, the movable hanger portion <NUM> is reinforced with extra, supportive material to resist breaking and to provide increased support for the vial <NUM>. In some implementations, the movable hanger portion <NUM> may be made of a material that is stronger than the remainder of the movable hanger label <NUM>.

The movable hanger label <NUM> and the movable hanger portion <NUM> may be of a variety of sizes and shapes, and are not limited to particular sizes and shapes. For example, an overall length of the movable hanger label <NUM> may be between about <NUM> and <NUM>, and an overall height of the movable hanger label <NUM> may be between about <NUM> and <NUM>. A width of a support portion (e.g., the portion from which the vial <NUM> is suspended when mounted or attached to an apparatus) of the movable hanger portion <NUM> may be between about <NUM> and about <NUM>; for example, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. A thickness of the hanger label may be between about <NUM> and about <NUM>; for example about <NUM> to about <NUM>. Any indicated parameter may be any value or subrange within the recited ranges, including endpoints.

The movable hanger label <NUM> and the movable hanger portion <NUM> are not limited to the sizes, shapes, and ratios shown in the example illustrations of <FIG>. Rather, the movable hanger label <NUM> and the movable hanger portion <NUM> consistent with implementations of the current subject matter may take the form of various sizes, shapes, and ratios. For example, the movable hanger label <NUM> and the movable hanger portion <NUM> may be sized and shaped to accommodate a variety of vials or containers.

As described herein, the movable hanger label <NUM> may be used to facilitate direct infusion of a drug contained in a vial to a patient. The drug contained in the vial is not, consistent with implementations of the current subject matter, diluted prior to administration. A process for administering the drug contained in the vial to the patient may include infusion of the drug to the patient with use of an infusion line and an infusion pump, followed by a saline flush also using the infusion line and the infusion pump. An infusion line spike may be positioned at a proximal end of the infusion line.

<FIG> is a diagram illustrating aspects of an example infusion line spike <NUM> for direct drug infusion that may be employed consistent with implementations of the current subject matter. As shown in <FIG>, the infusion line spike <NUM> includes a drug port <NUM>, an air venting cap <NUM>, and a main body <NUM> in fluid communication with the drug port <NUM>. The main body <NUM> interfaces with an infusion line <NUM> such that there is fluidic communication from the drug port <NUM>, through the main body <NUM>, to the infusion line <NUM>. The infusion line spike <NUM> is configured to introduce the drug contained in the vial <NUM> into the infusion line <NUM>, as illustrated in <FIG>. Other mechanisms may be used in place of the infusion line spike configuration. The infusion line <NUM> interfaces with the infusion pump (not shown), which operates to pump the fluid or material contained in the infusion line <NUM> at a prescribed rate. At a distal end of the infusion line <NUM> is a needle (not shown) that is inserted into the patient for delivering the drug from the infusion line <NUM> to the patient.

Consistent with implementations of the current subject matter, the process for drug administration utilizing the movable hanger label <NUM> may include infusing the infusion line with a first quantity of saline. For example, the first quantity of saline may be provided in a saline bag or container (containing, for example, <NUM>% NaCl), and the infusion line spike (or other mechanism) may interface with the saline bag or container to introduce (via the pump operation) the first quantity of saline into the infusion line. This may be done so that air is removed from the infusion line prior to the drug infusion into the patient (and prior to the needle insertion in the patient).

The process may continue by removing a vial cap from the vial containing the drug. In some examples, the vial may include a stopper at a top portion thereof, and the vial cap may be configured to cover the stopper. The stopper may be rubber or another resilient and compressible material to allow for the infusion line spike to pierce the stopper such that the infusion line spike is inserted into the vial, thereby allowing the drug contained in the vial to be directed to the infusion line.

The movable hanger label <NUM> adhered to the vial may then be opened such that the movable hanger portion <NUM> is moved from the first position (e.g., the closed configuration) to the second position (e.g., the open or loop configuration). As described herein, by moving the movable hanger portion <NUM> to the open or loop configuration, the vial is able to be attached to an apparatus to facilitate direct infusion of the drug from the vial. For example, the vial may hang via the movable hanger portion <NUM> from an infusion stand or the like.

Once the vial is properly positioned, the air venting cap on the infusion line spike may be opened, and the infusion pump may be set with an infusion rate and an infusion volume for the drug to be administered to the patient. When the infusion pump begins operating at the prescribed infusion rate, the drug travels from the vial, via the infusion line spike, through the infusion line to the needle inserted into the patient at the distal end of the infusion line.

In an aspect, a method of intravenously administering a drug to a patient is provided. The method may utilize a vial with a movable hanger label as described herein, or any other vial or container that may be suitable for this purpose.

The method includes administering the drug to the patient by intravenous administration, without diluting the drug prior to administration. In embodiments, the method also includes intravenously administering saline to the patient after the drug. This saline infusion can "flush" the infusion line and reduce the amount of drug left in the line after administration. For drugs administered in small volumes (e.g., less than or equal to about <NUM>, or less than or equal to about <NUM>), this step can allow administration of the full dose of drug to the patient. The method also can decrease the total time (drug administration plus saline flush) of administration to the patient compared to standard methods of administration.

The method may include infusing the infusion line with a first quantity of saline (or other appropriate liquid). For example, a first quantity of saline may be provided in a saline bag or container (containing, for example, <NUM>% NaCl), and introduced (via the pump operation) into the infusion line. This may be done so that air is removed from the infusion line prior to the drug infusion into the patient (and prior to the needle insertion in the patient).

The drug may be administered using an infusion pump. Upon completion of the infusion volume of the drug being administered to the patient, a second drug may be administered to the patient following the same or similar procedure. The second drug may be of the same type or a different type as the drug that was first administered. Upon completion of the infusion volume of the drug being administered or following the administration of the second drug, the infusion line may be flushed with a second quantity of saline. For example, once the dose of the drug has been dispensed, the infusion line may be moved to a saline bag or container containing saline, for example <NUM>% NaCl, for flushing the infusion line.

Consistent with implementations of the current subject matter, less than <NUM>% of an initial volume of the drug may remain in the infusion line following the infusion of the second quantity of saline for an infusion time of up to about <NUM> minutes at an infusion rate of about <NUM>/min. The infusion time may include the drug administration time and the second saline flush time.

Consistent with implementations of the current subject matter, less than <NUM>% of an initial volume of the drug may remain in the infusion line following the infusion of the second quantity of saline for an infusion time of up to about <NUM> minutes at an infusion rate of about <NUM>/min. Again, the infusion time may include the drug administration time and the second saline flush time. An initial amount of the drug in the vial may be less than about <NUM>.

A process for administering a drug to a patient, consistent with additional implementations of the current subject matter, may include infusing into the patient via an infusion line a first quantity of saline, followed by infusing into the patient via the infusion line an infusion volume of the drug from a vial for a first period of time. The drug may be administered at a fixed dose (e.g., the same dose regardless of the patient age and/or weight).

An initial amount of drug in the vial may be less than or equal to about <NUM>. In embodiments, the drug is not diluted prior to infusion into the patient. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. In some embodiments, the initial amount of drug in the vial is between about <NUM> and about <NUM>. The amount may be any value or subrange within the recited ranges, including endpoints.

In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>. In some instances, the initial amount of drug in the vial is less than or equal to about <NUM>. In some embodiments, the initial amount of drug in the vial is less than or equal to about <NUM>.

The patient may then be infused via the infusion line with a second quantity of saline for a second period of time. Consistent with implementations of the current subject matter, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, less than about <NUM>%, <NUM>%, <NUM>%, or <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In other instances, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, less than about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline.

In some embodiments, between about <NUM>% and about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, between about <NUM>% and about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, between about <NUM>% and about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, between about <NUM>% and about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. In some embodiments, between about <NUM>% and about <NUM>% of the initial amount of the drug may remain in the infusion line after infusion of the second quantity of saline. The amount may be any value or subrange within the recited ranges, including endpoints.

The total of the first period of time (the time for the infusion of the drug) and the second period of time (the time for the saline flush) may be less than or equal to about <NUM> minutes, less than or equal to about <NUM> minutes, or less than or equal to about <NUM> minutes.

In embodiments, the total may be between about <NUM> and about <NUM>. In embodiments, the total may be between about <NUM> and about <NUM>. In embodiments, the total may be between about <NUM> and about <NUM>. In embodiments, the total may be between about <NUM> and about <NUM>. In embodiments, the total may be between about <NUM> and about <NUM>. In embodiments, the total may be between about <NUM> and about <NUM>. In embodiments, the total may be between about <NUM> and about <NUM>. The amount of time may be any value or subrange within the recited ranges, including endpoints.

The infusion volume of the drug may be between about <NUM> and about <NUM>, and the second quantity of saline may be between about <NUM> and about <NUM>.

In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. In embodiments, the second quantity of saline may be between about <NUM> and about <NUM>. The amount may be any value or subrange within the recited ranges, including endpoints.

The drug and/or second quantity of saline may be infused into the patient at an infusion rate between about <NUM>/min and about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate between about <NUM>/min and about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate between about <NUM>/min and about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate between about <NUM>/min and about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate between about <NUM>/min and about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The drug and/or second quantity of saline may be infused into the patient at an infusion rate of about <NUM>/min. The amount may be any value or subrange within the recited ranges, including endpoints.

Simplifying dose preparation by allowing direct infusion of Tecentriq®, the cancer immunotherapy agent atezolizumab, and enabling rapid infusion (e.g., <NUM> minutes for IV infusion) can improve the experience of the healthcare professional and the patient experience.

The RRTI approach for IV infusion allows for administering medicine directly from the primary package (e.g., vial) which can simplify the healthcare professional's workflow. Infusing medicine rapidly (e.g., <NUM> infusion time) can further improve patient experience. Therefore, Tecentriq® is a good candidate for RRTI as it is a liquid formulation (no reconstitution needed) and is provided as a flat dose.

The following protocol is an example method for rapid infusion of a liquid drug, e.g., atezolizumab, from a vial. First, prime the infusion line with normal saline (e.g., <NUM>% NaCl) before insertion. Remove the vial cap and pierce the center of the rubber stopper with the infusion spike. <FIG> illustrates an infusion line spike alone (top) and after insertion into the vial (bottom). Ensure that the drug port section is resting in the neck region of the vial, near the stopper, as shown in the bottom of <FIG>. Open the hanger label and hang the vial, inverted, on an IV stand. Open the air venting cap on the infusion line, and set infusion rate and volume to be infused (VTBI) per Table <NUM> and begin infusion. For example, for the <NUM> dose, set VTBI to <NUM> and begin infusion. Once the infusion is complete, open another <NUM> cc vial and repeat the protocol. Set VTBI to <NUM> and begin infusion. Once the desired dose has been dispensed, move the infusion line to a container with <NUM>% NaCl to flush the line, and set infusion rate and VTBI per Table <NUM>.

Atezolizumab is available at three different doses (<NUM>, <NUM>, and <NUM>), depending on the indication and protocol to be used. Currently, atezolizumab is diluted into a <NUM> infusion bag containing <NUM>% Sodium Chloride Injection, USP prior to administration. The first infusion of atezolizumab is to be administered intravenously over <NUM> minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over <NUM> minutes. TECENTRIQ® (atezolizumab) Prescribing Information, www. com/download/pdf/tecentriq_prescribing.

A rapid and ready-to-infuse method for infusion of atezolizumab as described herein was tested. A total of six infusion scenarios were assessed. Two infusion times were assessed: <NUM> minutes for the initial dose, and <NUM> minutes for subsequent doses. Three doses were assessed: <NUM>, <NUM>, and <NUM>. To simplify the process for end users, it is proposed that the same infusion rate is used for all three tested doses under the same infusion time. In this assessment, a rate of <NUM>/min was tested for the <NUM> minute initial dose infusion, and a rate of <NUM>/min was tested for the <NUM> minute subsequent dose infusion. Table <NUM> provides the VTBI for the three doses and two infusion times.

<FIG> are graphs <NUM> and <NUM>, respectively, of the atezolizumab concentration as a function of time for two scenarios. Scenario <NUM>, shown in <FIG>, is an <NUM> dose of atezolizumab infused over <NUM> minutes. Scenario <NUM>, shown in <FIG>, is an <NUM> dose of atezolizumab infused over <NUM> minutes. The atezolizumab concentration was measured from the end of the infusion line, which is the concentration that the patients are expected to experience.

<FIG> are graphs <NUM> and <NUM>, respectively, of the atezolizumab concentration as a function of time for two scenarios. Scenario <NUM>, shown in <FIG>, is a <NUM> dose of atezolizumab infused over <NUM> minutes. Scenario <NUM>, shown in <FIG>, is a <NUM> dose of atezolizumab infused over <NUM> minutes. The atezolizumab concentration was measured from the end of the infusion line, which is the concentration that the patients are expected to experience.

Table <NUM> below gives a summary of the six scenarios of simulated infusion and saline flush assessed. The maximum concentration (Cmax) of atezolizumab during infusion and saline flush was between <NUM>/mL and <NUM>/mL. The remaining atezolizumab in the infusion line after infusion (i.e., underdose) was <NUM>% to <NUM>%. The underdose due to remaining atezolizumab in the infusion line also applies to current IV bag set-ups, and is not a RRTI-specific risk.

Load testing of the hanger label was performed based on or similar to DIN ISO <NUM> (Self-adhesive hanging devices for infusion bottles and injection vials - Requirements and test methods; available on the ISO website, e.g. www. org/standard/<NUM>. html, and is incorporated herein by reference in its entirety). Permanent load test <NUM> was performed based on/similar to DIN ISO <NUM> with adapted weight of <NUM>. Short-term load test <NUM> based on/similar to DIN ISO <NUM> with adapted weight of <NUM>. The hanger label meets or exceeds the requirements based on these tests.

Although the disclosure, including the figures, described herein may describe and/or exemplify different variations separately, it should be understood that all or some, or components of them, may be combined.

Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the claims.

References to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

Spatially relative terms, such as, for example, "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures.

The phrase "about" "or "approximately" may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), etc. In embodiments, "about" refers to +/- <NUM>% or less of the stated value (or range of values). Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise.

The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. Combinations of the above embodiments, and other embodiments not specifically described herein, are possible.

In the descriptions above and in the claims, phrases such as, for example, "at least one of" or "one or more of" may occur followed by a conjunctive list of elements or features.

Claim 1:
An apparatus, comprising:
a label (<NUM>) comprising:
a back surface area (<NUM>); and
a front surface area (<NUM>) opposite the back surface area;
wherein a portion of the back surface area of the label and an opposing portion of the front surface area of the label comprise a movable hanger (<NUM>), the movable hanger configured to move from a first position to a second position;
wherein in the first position, the movable hanger is at least substantially aligned with a remainder portion of the back surface area and an opposing remainder portion of the front surface area, and wherein in the second position, the movable hanger is at least partially separated from the remainder portion of the back surface area and the opposing remainder portion of the front surface area;
wherein the remainder portion of the back surface area of the label is configured to adhere to an outer sidewall of a vial (<NUM>); and
wherein the movable hanger is reinforced with extra, supportive material to resist breaking and to provide increased support for the vial.