• Takhzyro is a brand (trade) name for lanadelumab-flyo which may be used to prevent attacks of hereditary angioedema (HAE). HAE is a rare genetic condition that occurs in adults and children with low levels of certain proteins (C1-INH and C4) in their bodies. These low levels trigger excessive activation of the complement pathway and another protein called kallikrein.
• Takhzyro works by binding to kallikrein and inhibiting its activity. Kallikrein regulates the production of bradykinin, a chemical that leads to inflammation, swelling, and HAE attacks.
• Takhzyro belongs to the class of medicines known as miscellaneous coagulation modifiers. It may also be called a human plasma kallikrein inhibitor or a human monoclonal antibody.

• May be used to prevent attacks of hereditary angioedema (HAE) in adults, adolescents, and children aged 2 years and older.
• Was the first monoclonal antibody approved in the U.S. to prevent HAE types I and II.
• Was the first prophylactic treatment to be approved for children aged 2 years through 6 years.
• Administered by subcutaneous injection. The recommended starting dose in adults and adolescents aged 12 years and older is 300mg every 2 weeks which may be increased to every 4 weeks once the patient is well-controlled (attack-free for more than 6 months). For children aged 6 to 12 years is 150mg every 2 weeks (which may be increased to every 4 weeks if the patient is well-controlled) and for those aged 2 to 6 years, it is 150mg every 4 weeks.
• People can be easily taught how to self-administer Takhzyro. In clinical studies, the majority of patients self-administered it over 10 to 60 seconds.
• Takhzyro is a ready-to-use injectable solution in a single-dose, pre-filled syringe.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Injection site reactions (bruising, swelling, pain, redness), headache, upper respiratory tract infection, rash, muscle aches, dizziness, or diarrhea, are the most common side effects reported.
• Allergic reactions have been reported. Advise people to report any signs of an allergic reaction such as hives, rash, fast heartbeat, difficulty breathing (wheezing), chest tightness, feeling light-headed or faint, swelling of your face, lips, tongue, or throat, and to seek emergency help if needed.
• Increased liver enzymes, such as AST and ALT have also been reported.
• Does not treat attacks of HAE. Another medication, Kalbitor (ecallantide) does this.
• There is also the potential for immunogenicity and antibody formation. In one trial 12% of patients treated with Takhzyro developed anti-drug antibodies, but these did not appear to adversely affect the response, safety, or pharmacokinetic parameters.
• There is no data regarding the use of Takhzyro in pregnant women, although research has shown that monoclonal antibodies, such as Takhzyro are transported across the placenta during the third trimester of pregnancy so the possible effects on a fetus are likely to be greater during this time. Animal studies have not revealed any evidence of harm. There is no data about using Takhzyro in women who are breastfeeding. Consider Takhzyro use if the benefits outweigh the risks.
• The safety of Takhzyro in children under the age of 2 has not been established.
• No generic is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Store Takhzyro in the refrigerator in its original packaging at 36°F to 46°F (2°C to 8°C). Do not freeze.
• When it is time for a dose, take one Takhzyro syringe out of its box in the refrigerator and leave it to warm up to room temperature for 15 minutes. Do not try to warm it up in any way (such as by putting it in hot water or with the microwave) and do not shake it. Check the expiry date on the syringe and do not use it if it has expired or if the liquid in the vial appears discolored or contains visible particles. It should look clear to slightly opalescent, colorless, or slightly yellow. The syringe should not be broken, cracked, or damaged in any way, but small bubbles within the liquid are normal.
• Prepare for your injection by taking an alcohol swab, a cotton wall ball, and an adhesive bandage. Choose a site on your body where you will inject Takhzyro, such as your stomach area (but not within 2 inches of your belly button) or your upper thighs. If a caregiver is giving you your medicine you may also choose your upper arms as a place to have it administered. Do not choose an area that is bruised, broken, or scarred. Each new injection should be given in a slightly different area to the one two weeks previously because this helps to reduce scar tissue formation. Wipe the area with an alcohol wipe and allow it to dry. Do not blow on it or touch it.
• Hold the middle of the Takhzyro syringe with one hand and pull the needle cap off with the other hand. Throw it away. Pinch up the area of the skin where you want to inject Takhzyro and keep holding it pinched as you insert the needle into the skin. This makes sure Takhzyro is injected subcutaneously into the fatty layer under the skin. Insert the needle into the skin with a dart-like motion at a 45 to 90-degree angle then slowly push down on the plunger until it stops. Gently remove the needle and then let go of the skin. Wipe any blood that appears with a cotton wool ball and then place an adhesive bandage over the injection area. Throw the used Takhzyro syringe in an FDA-approved sharps container.
• Make sure you administer Takhzyro within 2 hours of drawing it up (if left unrefrigerated) or within 8 hours if kept in the refrigerator. Discard any unused portions of the drug remaining in the vial and syringe. Dispose of your used syringe and needle in an FDA-approved sharps container.
• Takhzyro is usually administered every two weeks to adults and children over the age of 6 (in children aged 2 to 6 years it is administered every 4 weeks). For people who are stable on this dose for at least 6 months, the dosing interval may be extended to every 4 weeks, but discuss this with your doctor first. Keep to your regular dosing schedule and do not miss any doses. If you do miss a dose, administer it as soon as you remember, but do not double up on doses.
• Takhzyro has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking this drug during pregnancy or while breastfeeding especially if you are considering trying to become pregnant.
• Seek emergency medical help or call 911 if you have signs of an allergic reaction to Takhzyro. Signs of an allergic reaction may include hives, rash, fast heartbeat, difficulty breathing (wheezing), chest tightness, feeling light-headed or faint, and swelling of your face, lips, tongue, or throat.

• Research has shown that the administration of Takhzyro significantly reduces HAE attacks. A study that compared three different dosages of Takhzyro found after 182 days there was a 76% reduction in attack frequency in those administered 150mg Takhzyro every 4 weeks; a 73% reduction in attack frequency in those administered 300mg Takhzyro every 4 weeks; and an 87% reduction in attack frequency in those administered 300mg Takhzyro every 2 weeks. Of the attacks that happened, fewer required acute treatment.
• In an extension of a trial, approximately 80% of patients who had received 300mg Takhzyro every 2 weeks remained attack-free at week 4 post-dose.

There are currently no documented interactions with Takhzyro, according to the product information.

Takhzyro is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Takhzyro can increase activated partial thromboplastin time (aPTT) due to an interaction of Takhzyro with the aPTT assay. There have been no reports of abnormal adverse bleeding events associated with increases in aPTT.

You should refer to the prescribing information for Takhzyro for any updates or newly noted interactions.