TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

TAKHZYRO mechanism of action

Refine the approach

TAKHZYRO provides targeted inhibition of plasma kallikrein, a critical regulator of bradykinin
production, to help prevent HAE attacks.1

Untreated
patient

How plasma kallikrein, HMWK, cHMWK, bradykinin work in an untreated HAE patient

HAE attack

When C1-INH is deficient or
dysfunctional, plasma kallikrein activity
is increased. This leads directly to
excessive bradykinin production and,
ultimately, HAE attacks1

HMWK=high molecular weight kininogen.
cHMWK=cleaved high molecular weight kininogen.

Patient treated with
TAKHZYRO

How plasma kallikrein, HMWK, bradykinin, and TAKHZYRO® (lanadelumab-flyo) work in a patient treated with TAKHZYRO How plasma kallikrein, HMWK, bradykinin, and TAKHZYRO® (lanadelumab-flyo) work in a patient treated with TAKHZYRO

Prevention of attacks

Unlike other preventive HAE
treatments that address C1-INH,
TAKHZYRO directly inhibits plasma
kallikrein to control excess
bradykinin production1

HMWK=high molecular weight kininogen.
cHMWK=cleaved high molecular weight kininogen.

The first and only monoclonal
antibody (mAb) for HAE

TAKHZYRO is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain). It is manufactured using a process that is free of human plasma.1

Watch TAKHZYRO in action

Use this video to help explain to your patients how TAKHZYRO works in the body.

View Transcript

NARRATOR: As you know, people with HAE don't have enough working C1 inhibitor protein. This causes another protein, kallikrein, to become overactive. This increase in kallikrein activity results in the release of too much bradykinin, the substance that causes HAE attacks. Today, there's TAKHZYRO®, a plasma-free treatment that decreases kallikrein activity.

NARRATOR: It's a first-of-its-kind subcutaneous injection taken once every two weeks to help prevent HAE attacks in people 12 years of age and older. TAKHZYRO is a type of treatment known as a therapeutic antibody. These medications, which are actually proteins, have been used to treat a variety of conditions and work by targeting specific substances in the body.

NARRATOR: In the case of TAKHZYRO, the target is kallikrein. Think of kallikrein as a faucet that controls the flow of bradykinin. In HAE, the faucet is turned all the way up, causing attacks. The key ingredient in TAKHZYRO, lanadelumab, decreases kallikrein activity to turn down the faucet. This slows the release of bradykinin, bringing levels closer to normal to prevent HAE attacks.

NARRATOR: TAKHZYRO (lanadelumab) 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. 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.

NARRATOR: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness and bruising), upper respiratory infection, and headache. 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.

NARRATOR: Talk to your healthcare provider about TAKHZYRO, the only preventive HAE treatment you take as a subcutaneous injection just once every two weeks.

INDICATION

TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-FDA-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATION

TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-FDA-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Dyax Corp 2018.