Takhzyro

Takhzyro (lanadelumab-flyo) is a prescription medicine used to prevent hereditary angioedema (HAE) attacks in patients aged 2 years and older. It is a long-acting injection given under the skin to help reduce how often and how severe HAE attacks are. It does not treat an attack that has already started.

Takhzyro is given as a subcutaneous injection every 2 to 4 weeks.

Takhzyro is a monoclonal antibody and is part of the drug class of plasma kallikrein inhibitors.

Takhzyro works by blocking plasma kallikrein, which lowers the production of bradykinin to help prevent HAE attacks.

In people with HAE, an enzyme in the blood called plasma kallikrein is too active. This causes too much bradykinin, which is a substance that widens blood vessels and makes them leaky. Fluid then leaks into nearby tissues, causing the swelling and pain of an HAE attack.

Patients using Takhzyro 300 mg every 2 weeks had 87% fewer hereditary angioedema attacks on average than those who received a placebo in a 26-week clinical study called Trial 1 (NCT02586805). The study included 125 people aged 12 and older with Type I or Type II HAE, which are the two main forms of the condition. Before the study began, everyone had at least 1 attack every 4 weeks.

Use this Takhzyro injection exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Takhzyro is injected under the skin every 2 to 4 weeks according to your doctor's instructions. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use this injection if you do not understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

If you are using a single-dose vial (bottle), prepare your injection only when you are ready to give it within the next 2 hours.

Do not shake.

Take the medicine out of the refrigerator and let it reach room temperature for 15 minutes before injecting your dose.

Each single-use vial (bottle) and prefilled syringe of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this injection.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medications you are taking.

You should not use Takhzyro injection if you are allergic to the active ingredient lanadelumab.

This medicine is not approved for use by anyone younger than 2 years old.

This medicine can affect the results of certain medical tests. Inform any doctor who treats you that you are using Takhzyro injection.

Pregnancy

It is not known if this medicine will harm an unborn baby. Inform your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

Common Side Effects

Common Takhzyro side effects may include:

• Headache (33%),
• Rash (4%),
• Dizziness (4%),
• Diarrhea (4%),
• Muscle pain (11%),
• Cold symptoms such as stuffy nose, sneezing, sore throat (44%),
• Injection site reaction including rash, or pain, redness, or bruising (56%).

These common side effects occurred in Trial 1 when Takhzyro 300mg was given every 2 weeks.

Serious Side Effects

Get emergency medical help if you have signs of an allergic reaction to this medicine, such as

• Hives,
• Rapid heart rate,
• Difficulty breathing,
• Lightheadedness,
• Swelling of the face, lips, tongue, or throat.

This is not a complete list of side effects, and others may occur. You can call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Takhzyro dose for adult and pediatric patients 12 years and older:

Initial dose: 300 mg subcutaneously once every 2 weeks.

Maintenance dose: a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Usual Takhzyro dose for pediatric patients 6 years to less than 12 years old:

Initial dose: 150 mg subcutaneously once every 2 weeks.

Maintenance dose: a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Usual Takhzyro dose for pediatric patients 2 years to less than 6 years old dose:

Dose: 150 mg administered subcutaneously every 4 weeks.

Self-injection is not recommended in children 2 years to less than 12 years.

Takhzyro is available as:

• 150 mg/1 mL in a single-dose prefilled syringe
• 300 mg/2 mL in a single-dose prefilled syringe
• 300 mg/2 mL solution in a single-dose vial

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with lanadelumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

HCPs and patients often use the Takhzyro Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Takhzyro Prescribing Information (PI) or FDA label.

• Store the prefilled syringes and vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Keep the prefilled syringe and vial in the original box to protect them from light.

Takhzyro manufacturer Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA 02421.

Active Ingredient: lanadelumab-flyo

Inactive Ingredients: citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and sodium phosphate, dibasic, dihytrate.