Drug delivery device with feedback element and method for providing a user of a drug delivery device feedback regarding a dose dispensing process

A drug delivery device for delivering a dose of a medicament in a dose dispensing process, the drug delivery device comprising:

• a device body having a distal end and a proximal end, the device body comprising a drug window, wherein the device body is adapted to receive a medicament container, the medicament container comprising a plunger stopper sealing the medicament container proximally, the plunger stopper being moveably retained in a container body of the medicament container, wherein an interior of the medicament container is visible in the drug window;
• a plunger rod releasably retained in the device body and adapted to be moved in a distal direction relative to the device body by energy provided by an energy member,
• a plunger release mechanism configured to release the plunger rod in order to initiate movement of the plunger rod in the distal direction relative to the device body,
• a trigger member being configured to activate the plunger release mechanism to release the plunger rod;
• the drug delivery device being configured to have:
• a first state in which the plunger rod and the plunger stopper are not visible through the drug window;
• and
• a second state in which the plunger stopper is not visible through the drug window and the plunger rod is visible through the drug window,
• wherein the drug delivery device is configured to initiate a transition from the first state into the second state upon activation of the plunger release mechanism,
• wherein the plunger rod is provided with at least one feedback element, and
• wherein the feedback element is configured to be visible through the drug window in the second state.

A method of delivering a medicament from a drug delivery device, the method comprising:

• using the drug delivery device, the drug delivery device comprising:
• a device body having a distal end and a proximal end, the device body comprising a drug window, wherein the device body is adapted to receive a medicament container, the medicament container comprising a plunger stopper sealing the medicament container proximally, the plunger stopper being moveably retained in a container body of the medicament container, wherein an interior of the medicament container is visible in the drug window;
• a plunger rod releasably retained in the device body and adapted to be moved in a distal direction relative to the device body by energy provided by an energy member,
• a plunger release mechanism configured to release the plunger rod in order to initiate movement of the plunger rod in the distal direction relative to the device body,
• a trigger member being configured to activate the plunger release mechanism to release the plunger rod;
• the drug delivery device being configured to have:
• a first state in which the plunger rod and the plunger stopper are not visible through the drug window;
• and
• a second state in which the plunger stopper is not visible through the drug window and the plunger rod is visible through the drug window,
• wherein the drug delivery device is configured to initiate a transition from the first state into the second state upon activation of the plunger release mechanism,
• wherein the plunger rod is provided with at least one feedback element, and
• wherein the feedback element is configured to be visible through the drug window in the second state.

A method of prophylactic treatment of a patient with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors, the method comprising:

• subcutaneously delivering, using a drug delivery device, about 50 mg of fitusiran to the patient in need thereof once every two months, wherein the about 50 mg of fitusiran is delivered in about 0.5 mL of phosphate buffered saline (PBS) at a concentration of about 100 mg fitusiran/mL,
• wherein the drug delivery device comprises
• a device body having a distal end and a proximal end, the device body comprising a drug window, wherein the device body is adapted to receive a medicament container, the medicament container comprising a plunger stopper sealing the medicament container proximally, the plunger stopper being moveably retained in a container body of the medicament container, wherein an interior of the medicament container is visible in the drug window;
• a plunger rod releasably retained in the device body and adapted to be moved in a distal direction relative to the device body by energy provided by an energy member,
• a plunger release mechanism configured to release the plunger rod in order to initiate movement of the plunger rod in the distal direction relative to the device body,
• a trigger member being configured to activate the plunger release mechanism to release the plunger rod;
• the drug delivery device being configured to have:
• a first state in which the plunger rod and the plunger stopper are not visible through the drug window;
• and
• a second state in which the plunger stopper is not visible through the drug window and the plunger rod is visible through the drug window,
• wherein the drug delivery device is configured to initiate a transition from the first state into the second state upon activation of the plunger release mechanism,
• wherein the plunger rod is provided with at least one feedback element, and
• wherein the feedback element is configured to be visible through the drug window in the second state.

A method of reducing frequency of bleeding episodes in a patient with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors, the method comprising:

• subcutaneously delivering, using a drug delivery device, about 50 mg of fitusiran to the patient in need thereof once every two months, wherein the about 50 mg of fitusiran is delivered in about 0.5 mL of phosphate buffered saline (PBS) at a concentration of about 100 mg fitusiran/mL,
• wherein the drug delivery device comprises
• a device body having a distal end and a proximal end, the device body comprising a drug window, wherein the device body is adapted to receive a medicament container, the medicament container comprising a plunger stopper sealing the medicament container proximally, the plunger stopper being moveably retained in a container body of the medicament container, wherein an interior of the medicament container is visible in the drug window;
• a plunger rod releasably retained in the device body and adapted to be moved in a distal direction relative to the device body by energy provided by an energy member,
• a plunger release mechanism configured to release the plunger rod in order to initiate movement of the plunger rod in the distal direction relative to the device body,
• a trigger member being configured to activate the plunger release mechanism to release the plunger rod;
• the drug delivery device being configured to have:
• a first state in which the plunger rod and the plunger stopper are not visible through the drug window;
• and
• a second state in which the plunger stopper is not visible through the drug window and the plunger rod is visible through the drug window,
• wherein the drug delivery device is configured to initiate a transition from the first state into the second state upon activation of the plunger release mechanism,
• wherein the plunger rod is provided with at least one feedback element, and
• wherein the feedback element is configured to be visible through the drug window in the second state.

A method of prophylactic treatment of a patient with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors, the method comprising:

• subcutaneously delivering, using a drug delivery device, about 50 mg of fitusiran to the patient in need thereof once every two months, wherein the about 50 mg of fitusiran is delivered in about 0.5 mL of phosphate buffered saline (PBS) at a concentration of about 100 mg fitusiran/mL,
• providing a user of the drug delivery device with a first feedback to indicate a beginning of the drug delivery process;
• providing the user with a second feedback to indicate progress of the drug delivery process;
• providing the user with a third feedback to indicate an end of the drug delivery process.

A method of reducing frequency of bleeding episodes in a patient with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors, the method comprising:

• subcutaneously delivering, using a drug delivery device, about 50 mg of fitusiran to the patient in need thereof once every two months, wherein the about 50 mg of fitusiran is delivered in about 0.5 mL of phosphate buffered saline (PBS) at a concentration of about 100 mg fitusiran/mL,
• providing a user of the drug delivery device with a first feedback to indicate a beginning of the drug delivery process;
• providing the user with a second feedback to indicate progress of the drug delivery process;
• providing the user with a third feedback to indicate an end of the drug delivery process.