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Takhzyro (Lanadelumab-flyo)

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Takhzyro

Takhzyro (Lanadelumab-flyo)

Hereditary angioedema is one of the rarest medical conditions in the world. According to research, one out of every 50,000 to 150,000 people all around the world have this rare condition. It affects both men and women equally, and its symptoms usually begin in early childhood.

 

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Shortened as HAE, hereditary angioedema is a genetic condition that causes painful and severe swelling of certain body parts (hands, arms, feet, legs, and face) due to the accumulation of fluids outside of the blood vessels. The swelling can also occur in the gastrointestinal tract causing painful cramps, nausea, or vomiting. HAE can also occur in the airway, causing obstruction which can lead to suffocation which is very serious and could be fatal. Symptoms of hereditary angioedema may occur repeatedly and can get worse over time. Hereditary angioedema can be triggered, or its symptoms can be worsened by viral infections, injuries, surgeries, dental procedures, severe pain, or stress. If left untreated, these swellings could occur every 1 to 2 weeks, lasting between 3 and 4 days for each episode.

As there is currently no cure, you can only prevent these symptoms or treat them when they occur. One of the drugs used for the prevention of hereditary angioedema attacks is Takhzyro. 

 

What Is Takhzyro?

Takhzyro (lanadelumab-flyo) is a prescription drug used to prevent swelling attacks of hereditary angioedema. It belongs to a family of drugs called monoclonal antibodies. These are similar to antibodies that our bodies make to protect us when an unwanted substance enters our bodies. In the case of Takhzyro, the antibody is a recombinant, full-human monoclonal antibody, which means that it is a human antibody that has been produced/replicated in the lab using Chinese Hamster Ovary Cells (CHO). It is then purified and sterilized to make it safe for human administration.

Takhzyro was approved by the Food and Drug Administration (FDA) in 2018 and can be administered to adults and children from age 12 and up. It comes in a liquid form that is injected under the skin. The active agent in the drug is lanadelumab. The suffix “flyo” is added to the name to distinguish it from other types of drugs that have been made and that will be made in the future. 

Takhzyro is a biologic medication made from parts of living organisms, and there are currently no biosimilars for it. Takhzyro is only available as a brand-name medication.  

 

Approval and Effectiveness

The FDA approved Takhzyro in 2018 as a drug for preventing hereditary angioedema attacks. In the clinical trials that preceded this approval, researchers discovered that the participants that took the 300 mg dose of Takhzyro every 4 weeks experienced 73% reduction in HAE attacks than those that did not. And participants who took the recommended initial dose of 300 mg once every 2 weeks experienced 87% fewer attacks than those who did not take the drug. 

 

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How Does Takhzyro Work?

Hereditary angioedemaHereditary angioedema is a genetic disorder. People suffering from this disorder do not produce enough C1 inhibitor protein (fully known as complement component C1 esterase inhibitor), and this condition is known as hereditary angioedema type I. Hereditary angioedema type II is a less common form of the disorder and may occur because of having abnormal C1 esterase proteins that do not function properly.

The main function of the C1 inhibitor protein is to reduce the activity of another protein, kallikrein, which is responsible for increasing blood pressure. 

Besides increasing blood pressure, kallikrein also produces bradykinin, a peptide. This peptide is one of the body’s inflammatory mediators, which causes vasodilation (widening of blood vessels that happens near the skin surface) and leads to increased blood flow, causing swelling as well as the other symptoms that people with hereditary angioedema suffer. Therefore, with insufficient C1 inhibitor proteins, the kallikrein works unabated and produces excess bradykinin. When the quantity of the peptide increases in the body, certain body parts start to swell. 

As a drug for preventing HAE attacks, Takhzyro works by assuming the function of the C1 inhibitor protein. It reduces the activity of the kallikrein protein, which reduces the production of the peptide responsible for the excessive swelling that comes with HAE. By blocking these proteins, the frequency and duration of swelling are reduced. 

 

Considerations Before Using Takhzyro

You must provide certain information to your doctor before using Takhzyro. Some of the information you need to provide include:

  • Any other medical conditions you have apart from hereditary angioedema
  • Your overall health condition
  • Other medications you are currently taking 
  • Your medical history

With this information, the doctor can determine if Takhzyro is the ideal drug for you. After providing the necessary information to the doctor, you need to consider the drug’s interaction with other substances you use or ingest. Substances such as food, drugs, drinks, and even vaccines that enter the body can potentially affect how medications work in the body. 

Food Interactions

Takhzyro is not known to be affected by any food. However, as a precaution, you should still talk to your doctor about the types of food that you consume.  

Other Medications

There is no evidence that drugs, supplements, vitamins, and herbs affect the way Takhzyro works in the body. Nevertheless, you should still talk to the doctor about the drugs you are currently taking to prevent any unexpected drug interactions. 

Lab Tests

Takhzyro can affect the results of certain lab tests. There is enough evidence to show that the drug can alter and affect the result of an activated partial thromboplastin time blood test, also known as the PTT test. This test measures the time it takes for your blood to clot. With Takhzyro in your system, the results of the test may show a higher number than they normally would. 

However, clinical trials show that the drug does not affect the result of the INR, another test used to measure the time taken for blood to clot. Therefore, it is important to tell your doctor about being on Takhzyro before undergoing any lab tests.

 

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Pregnancy

No evidence shows that Takhzyro affects pregnancy or prevents you from getting pregnant. According to a study carried out on animals, Takhzyro does not affect pregnancy, nor does it prevent pregnancy. However, it is still important to mention if you are pregnant or planning to get pregnant before the doctor prescribes the drug. 

Birth Control Pills

There is no evidence that Takhzyro affects the ability of birth control pills to work effectively. It is still advisable to let the doctor know if you are on any birth control method before you start using the drug. 

Breastfeeding

There are no substantial clinical studies on the effect of Takhzyro on breastfeeding mothers. Therefore, it cannot be affirmed that it is safe to breastfeed while using Takhzyro. 

However, in a study involving animals, there were traces of Takhzyro found in the breast milk of breastfeeding animals on which Takhzyro was administered. Because of this, if you are breastfeeding, you should talk to your doctor before using this medication. 

 

How To Take Takhzyro

As with other subcutaneous medications, you should take Takhzyro according to the doctor’s prescription. The first dose will usually be administered by the doctor, who will train you or your caregiver to inject the medication for subsequent use. This training may occur in your house or at the hospital. 

Administering TakhzyroDuring this training, you will learn how to subcutaneously administer the drug into your abdomen or thigh, as these are the injection points for self-injection. If another person is administering the injection, you can have the injection on your upper arm or thighs. 

There is a whole regimen that comes with the usage of the medication. You should take Takhzyro out of the refrigerator 15 minutes before using it. You can then follow step-by-step directions to prepare for the administration of the drug. Once you take it out of the refrigerator, you must use Takhzyro within 2 hours. 

The drug should be taken once every 2 weeks initially. Taking Takhzyro every 4 weeks can be considered in patients who are well-controlled (attack free) for more than 6 months. To achieve consistency, you should take the medication on the same day of the week whenever you take the drug. For instance, if you take the first dose on a Monday, you should take the next dose on a Monday 2 or 4 weeks later as prescribed by your doctor. 

When you take Takhzyro, it takes about 4 to 5 days for it to reach its peak concentration level (time to peak). This concentration level is necessary before the drug can start to effectively block the activities of the kallikrein protein. 

Takhzyro has a half-life of about 14 days, which allows it to be taken every 2 weeks. Because of this, it may take up to 6 doses (about 10 weeks) for it to reach a steady state, which is when the quantity of drug eliminated per unit of time is equal to the quantity of the drug that reaches the systemic circulation in the same unit of time. This is when the medication is expected to be steadily exhibiting its therapeutic effect.

 

Dosage and What To Do in the Case of an Overdose

The usual dosage for adults and children above 12 years of age with HAE is a 300 mg injection every 2 weeks. This dosage may be reduced to 300 mg every 4 weeks if the patient has not had an angioedema attack for more than 6 months. However, the decision to reduce the dosage must come only from the doctor. 

If you miss a dose, you should call your doctor immediately. The doctor will tell you if you are to take the missed dose immediately or wait until the next scheduled dose. 

In case of an overdose, you should call your doctor right away. If the symptoms get severe, the next line of action is to call 911 or find your way to an emergency room as soon as possible.

 

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Side Effects

There have been reports of possible side effects that come with the use of Takhzyro. These side effects are divided into either mild or severe side effects. 

Some of the mild side effects include:

  • Pain, redness, or swelling where the shot was given
  • Bruising where the shot was given
  • Signs of a common cold
  • Rash
  • Diarrhea
  • Headache
  • Muscle pain
  • Upper respiratory infections
  • Dizziness
  • Injection site reactions

These side effects are mild because they are expected to go away after a few days or weeks. However, if these side effects do not subside or grow severe, or if they are bothering you too much, you should talk to your doctor or pharmacist. 

Although uncommon, some people may have very bad and sometimes deadly side effects when taking medication. You should tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: 

  • For both children and adults, signs of an allergic reaction, including: 
    • Rash
    • Hives
    • Mouth tingling
    • Itching
    • Flushing of the skin 
    • Skin rash
    • Trouble breathing, swallowing, or talking
    • Swelling under your skin and other body parts
    • Swelling of the mouth, face, lips, tongue, or throat.
  • Fast heartbeat
  • Very bad dizziness or passing out

In addition to the side effects mentioned above, there may be injection site reactions, which can include bleeding under the skin, bruising, pain, redness,  swelling, hardening of the skin, and a warm and tingling sensation. 

These are not all the possible side effects of Takhzyro; talk to your doctor or pharmacist for more information.

 

Where To Get Takhzyro

You can only get this drug from a specialty pharmacy, which is a pharmacy that has the authority and licenses to sell specialized medications. 

Specialty drugs can sometimes be expensive. If you have an existing insurance plan, the insurance company would have to speak to your doctor and get prior authorization before covering the payment for the drug. Thus, it is advisable to talk to your insurance company first to find out if they will cover all or a percentage of the medication cost.

If you cannot afford the medication, a copay-assistance program is an option you may want to consider.

 

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Copay and Financial Assistance

Financial assistance is available to people who need help purchasing Takhzyro. 

Takeda, the company that manufactures Takhzyro, offers a copay assistance program. However, you need a commercial insurance plan to qualify. 

You can also enlist the help of Ameripharma, which can save you from the rigorous process of sourcing financial assistance by yourself. We can help you locate all available funding sources and match you with the ones that meet your needs. Contact us today to find out how we can help.

 

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