Lanadelumab

What is lanadelumab used for?

Lanadelumab is a prescription medicine that is used to prevent swelling attacks in people with hereditary angioedema (HAE).

Description

Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa.

TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use.

Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0.

Mechanism of Action

Lanadelumab-flyo is a fully human monoclonal antibody (IgG1/κ-light chain) that binds plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

Before taking lanadelumab, tell your doctor:

• If you are allergic to lanadelumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take lanadelumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take lanadelumab?

• Tell all of your health care providers that you take lanadelumab. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine will not treat HAE attacks. This medicine is only used to prevent these health problems. Talk with the doctor to if you have questions about how to treat HAE attacks.
• Talk with the doctor before you travel. You will need to bring enough of lanadelumab for use during travel.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take lanadelumab.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using lanadelumab while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is lanadelumab best taken?

Use lanadelumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Before giving the shot, let it come to room temperature. Do not heat lanadelumab.
• Do not shake.
• Move the site where you give the shot with each shot.
• Do not give into skin within 2 inches of the belly button.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Do not use if the solution is leaking or has particles.
• Throw away any part of the opened vial not used after the shot is given.
• Throw syringe away after use. Do not use the same syringe more than one time.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of lanadelumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. 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:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where the shot was given.
• A fast heartbeat.
• Very bad dizziness or passing out.

What are some other side effects of lanadelumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Signs of a common cold.
• Headache.
• Muscle pain.
• Dizziness.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out lanadelumab?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• After you prepare the dose in a syringe, use within 2 hours if stored at room temperature. If needed, the prepared syringe may be stored in a refrigerator for up to 8 hours.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 2 ML VIAL CARTON

• Rx Only
  NDC 47783-644-01
• TAKHZYRO®
  (lanadelumab-flyo)
  injection
• 300 mg/2 mL (150 mg/mL)
• Single-dose Vial, for Subcutaneous use only.
• 2 mL
  1 single-dose vial.
• Takeda

SRC: NLM .