NARRATOR: What is TAKHZYRO®? TAKHZYRO (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 12 years of age. Important safety information. TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, and/or hives. Please see full Prescribing Information, including information for patients, located at www.takhzyro.com.
SARAH: Hi, my name is Sarah. Together with your doctor, you have determined that TAKHZYRO is an appropriate treatment for you to help prevent HAE attacks.
SARAH: TAKHZYRO is administered as a single subcutaneous injection every two weeks. TAKHZYRO is a ready-to-use solution that does not require reconstitution and is supplied in a single-use glass vial. Today, in this instructions-for-use video, I will be walking you through the administration process for TAKHZYRO. After being trained by a nurse or your healthcare provider, you'll be able to self-administer TAKHZYRO from the comfort of your home. Your caregivers can also be trained on the administration process.
SARAH: In addition, you should always follow specific instructions given by your healthcare provider and contact him or her if you have any questions. It may be helpful to use reminders for your injection dates to help you stay consistent with your treatment. I like to set a reminder notification in my phone, but you can use any tool that's helpful for you, such as a calendar, journal, or planner. When you are ready to administer TAKHZYRO, you will need the vial containing TAKHZYRO ready-to-use solution.
SARAH: TAKHZYRO should be stored in the refrigerator between 36 and 46 degrees Fahrenheit, or 2 and 8 degrees Celsius, until used. Never freeze the vial. Store TAKHZYRO in the original carton to protect the vial from light. Always keep TAKHZYRO and all medicines out of the reach of children. You will also need the following supplies which do not come with the medication: one 18G transfer needle, one 27G, 1/2-inch injection needle, one empty 3 mL syringe.
SARAH: You'll also need alcohol wipes to clean the top of the vial and to clean the injection site, a sharps disposal container to discard all materials after each injection, and TAKHZYRO Instructions For Use. Administering TAKHZYRO can be summarized in six steps. Prepare for your injection. Attach transfer needle to the syringe. Transfer TAKHZYRO into the syringe and switch to the injection needle. Select and prepare an injection site. Inject TAKHZYRO, and throw away the needles and syringe.
SARAH: Gather all supplies, and place them on a clean, well-lighted, flat work surface. To prepare the vial, take it out of the refrigerator 15 minutes before use, and allow it to reach room temperature. Check the expiration date on the box and vial label. Do not use if the expiration date has passed. Check the supplies for damage, and do not use if they appear damaged.
SARAH: Make sure your work area is clean, and wash your hands with soap and water. Do not touch any surface or body part, especially your face, after washing your hands before your TAKHZYRO injection. Remove the vial from the packaging. Do not use the vial if the plastic cap covering is missing. Gently turn the vial upside down three to five times to mix the medicine.
SARAH: Do not shake the vial to avoid foaming. Be sure to look at the medicine in the vial. Do not use if it contains visible particles or has changed color. Normally, the medicine is colorless to slightly yellow. Next, place the vial on a flat surface. Remove the plastic cap from the vial, and clean the rubber stopper with an alcohol wipe and allow it to dry. Do not remove the rubber stopper.
SARAH: To transfer TAKHZYRO from the vial to the syringe, first screw the 18G transfer needle to the 3 mL syringe, keeping the needle cap on. Pull back the plunger to fill the syringe with air equal to the amount of medicine in the vial. This should be equivalent to 2 mL. Hold the syringe by the barrel with one hand, and the transfer needle cap with the other hand.
SARAH: Pull off the needle cap straight away from the syringe and away from your body. Do not pull on the plunger or touch the needle tip. Keep the vial on a flat surface and insert the transfer needle into the center of the rubber stopper. Push the plunger down to inject air into the vial, and hold the plunger down. Then, turn the needle and vial upside down slowly and pull back on the plunger to withdraw the full dose in the vial.
SARAH: To be sure the full dose is withdrawn, it's critical to keep the tip of the needle in the medicine to avoid drawing air into the syringe as you pull the plunger back. Next, remove large air bubbles by gently tapping the syringe barrel until bubbles rise to the top, then slowly push the plunger to allow air to go back into the vial until the medicine reaches the top of the syringe. Repeat these steps until large air bubbles are removed. Check again to make sure you have the right amount of medicine in the syringe.
SARAH: If you don't have enough, pull back on the plunger again while keeping the needle in the medicine to get your full dose. Return the vial to an upright position. Without removing the needle from the vial, unscrew the syringe by holding the needle hub and turning the syringe counterclockwise. Return the syringe to an upright position. You'll need to inject your dose of TAKHZYRO within two hours of drawing it into the syringe.
SARAH: Remember to throw away the 18G transfer needle and the vial in a sharps disposal container. Attach the 27G, 1/2-inch injection needle by screwing it to the syringe. Do not remove the needle cap from the needle when attaching the syringe. TAKHZYRO can be self-administered in your abdomen or thigh. If given by a caregiver, TAKHZYRO may also be injected in the upper arm.
SARAH: Clean the injection site with a new alcohol wipe, and let it dry completely. You can inject your abdomen, thigh, or upper arm. You should use a different injection site each time you inject to keep your skin healthy. When choosing a site, keep in mind that the spot should be at least 2 inches away from any scar or your belly button. Do not choose an area that is bruised, swollen, or painful.
SARAH: When ready, hold the syringe by the barrel with one hand and the injection needle cap with the other hand. Remove the needle cap by pulling it straight away from the syringe and away from your body. Do not pull on the plunger or touch the needle tip or allow it to touch any other surface. Gently pinch about one inch of skin at the cleaned injection site and insert the needle subcutaneously, or under the skin. Be sure to inject under the skin, which is not too shallow (skin layer) or too deep (muscle).
SARAH: Slowly push the plunger to inject all the medicine until none of it remains in the syringe. Release the skin fold and gently remove the needle. Do not recap the needle. Discard the injection needle and syringe in a sharps disposal container. Follow your community guidelines on the right way to dispose of your sharps disposal container.
SARAH: As a reminder, by taking TAKHZYRO every two weeks as prescribed, you'll continue to help prevent HAE attacks. You can set notification reminders to help remember. If you ever have any questions regarding administration, you can call OnePath® to put you in contact with an injection training nurse, or you can always talk to your healthcare provider. Also, OnePath will arrange at any time for a specially trained nurse to take you or a loved one through the TAKHZYRO injection process step-by-step to make sure you are comfortable with administration.
SARAH: If you have any questions, feel free to call your OnePath Patient Support Manager at 1-866-888-0660.
NARRATOR: What is TAKHZYRO? TAKHZYRO (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 12 years of age.
NARRATOR: Important safety information. TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, and/or hives. The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, and headache.
NARRATOR: These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088. TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed. Please see full Prescribing Information, including information for patients, located at www.takhzyro.com.