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Takhzyro: 7 things you should know

Medically reviewed by Carmen Fookes, BPharm. Last updated on March 31, 2021.

1. How it works

  • 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 people 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.

2. Upsides

  • May be used to prevent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
  • Was the first monoclonal antibody approved in the U.S. to prevent HAE types I and II.
  • Administered usually once every two weeks by subcutaneous injection. The recommended starting dose is 300mg every 2 weeks.
  • A dosing interval of 300mg every 4 weeks may be considered in people who have not had an HAE attack for more than 6 months.
  • People can be easily taught how to self-administer it. In clinical studies, the majority of patients self-administered Takhzyro over 10 to 60 seconds.
  • Provided as a ready-to-use solution that does not need additional dilution.

3. Downsides

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, difficult 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 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 12 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

4. Bottom Line

  • Takhzyro works by binding to a protein called kallikrein and inhibiting its activity and may be used to prevent hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. People can be taught how to self-administer it and it is well tolerated with no reported drug interactions. Trials have reported an 80% to 87% reduction in HAE attacks in those administered 300mg Takhzyro every 2 weeks.

5. Tips

  • Store Takhzyro in the refrigerator in its original carton at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • When it is time for a dose, take one Takhzyro vial out of the refrigerator 15 minutes before injecting, to allow it to warm up to room temperature. Check the expiry date on the vial 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.
  • Remove the vial from the packaging. Do not shake Takhzyro, instead gently turn the vial upside down (invert) 3 to 5 times to mix the medicine. Remove the plastic cap and wipe the top of the vial with an alcohol swab and allow it to dry. Attach a needle to the dosing syringe then withdraw the prescribed dose of Takhzyro from the vial using an 18-gauge needle. Change the needle on the syringe to a 27-gauge, ½-inch needle or another needle suitable for subcutaneous injection. Inject Takhzyro subcutaneously into the abdomen, thigh, or upper arm.
  • 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. In 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 in pregnancy or during 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, difficult breathing (wheezing), chest tightness, feeling light-headed or faint, swelling of your face, lips, tongue, or throat.

6. Response and Effectiveness

  • 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.

7. Interactions

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.

References

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Takhzyro only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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