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Lanadelumab

Brand name: Takhzyro
Dosage forms: subcutaneous injection. Prefilled single-dose syringes (150 mg/mL or 300 mg/2mL) and single-dose vials (300 mg/2mL)
Drug class: hereditary agioedema agents

What is Lanadelumab?

Lanadelumab is a monoclonal antibody that reduces the activity of an uncontrolled enzyme in people who have hereditary oedema, a rare genetic immune disorder. Lanadelumab prevents attacks of hereditary oedema in patients older than 2 years.Lanadelumab reduces the amount of bradykinin in people with hereditary edema. This helps prevent swelling and other symptoms associated with angioedema. Hereditary angioedema, an immune condition, causes rapid swelling of the skin under the skin, especially in the arms, legs, face, and throat. Hereditary angioedema attacks can be deadly if the swelling in the throat blocks the airway.The FDA has approved Lanadelumab Flyo (Brand Name: Takhzyro), an injection, for patients 2 years and older in order to prevent attacks of hereditary edema. FDA approval was based on data from the HELP Study as well as the HELP-OLE Study and Phase 3 SPRING Study.

Side effects of Lanadelumab

Lanadelumab's mechanism of action is to attach and block an enzyme called "kallikrein". Kallikrein causes inflammation and angiodema symptoms by increasing the levels of bradykinin. Lanadelumab reduces bradykinin levels by blocking kallikrein. This helps prevent swelling and the symptoms associated with angioedema.

Before you take this drug

If you have an allergy to lanadelumab or one of its inactive ingredients, then it is best not to use this medication. The ingredients section is at the bottom of the page. It contains a complete list of Takhzyro's ingredients.

Lanadelumab should not be used by children under 2 years of age.

This medication can interfere with certain medical tests. Inform any doctor that treats you about your use of lanadelumab.

Pregnancy

  • If you're pregnant or plan to become pregnant, There is no way to know if Lanadelumab will harm your unborn child.
  • Inform your doctor of any pregnancy or plans to become pregnant.

Breastfeeding

  • If you plan to or are currently breastfeeding, It is unknown if lanadelumab can pass into breastmilk.
  • Consult your doctor about the best way for you to feed your child while taking this medication.

How to take Lanadelumab?

Be sure to follow all directions outlined on your prescription label and read any medication guides or instruction sheets provided with the medication.Read all the instructions and directions included on the prescription label.Before you inject yourself for the first time, your healthcare provider will show you how to prepare your dose and inject it. Do not inject this medication unless your healthcare provider has trained you.

  • Allow the medicine to reach room temperature for 15 minutes prior to injecting.
  • Do not shake.
  • Use the single-dose vial or bottle only when you're ready to administer the injection within 2 hours.
  • Lanadelumab can be injected under the skin (subcutaneously) by a healthcare provider, carer, or you.
  • Click here for detailed instructions and diagrams on how you can use the prefilled glass vial or single-dose syringe.
  • This medicine comes in single-dose vials that are only for one-time use. After one use, throw it out, even if the medicine is still inside.
  • Only use a needle or syringe once, and then store them in a "sharps container" that is puncture-proof. Be sure to follow local or state laws on how to properly dispose of the container. Keep the container out of reach of pets and children.

Details on dosage

The usual dose for adults and paediatric patients aged 12 and older with hereditary angioedema is:

  • Initial dose: 300mg subcutaneously every 2 weeks.
  • Maintenance dose: A 4-week interval can be considered when the patient has been well controlled (e.g., free of attacks) for over 6 months.

The usual dose for children aged 6 to 12 years for hereditary oedema is:

  • Initial dose: 150mg subcutaneously every 2 weeks.
  • Maintenance dose: A 4-week interval can be considered when the patient has been well controlled (e.g., free of attacks) for over 6 months.

Children aged 2-6 years should typically take:

  • Dose: 150mg administered subcutaneously once every four weeks.
  • Children aged 2–12 years are not advised to self-inject.

What happens if I miss the dose?

If you miss a dosage, call your doctor to get instructions.

What happens if I overdose?

Contact 1-800-222-1222 immediately in case of poisoning and seek immediate medical care.

Side effects of Lanadelumab

The most common side effects of lanadelumab are:

  • Injection site reactions (pain and swelling)
  • Upper respiratory infections
  • Rash
  • Dizziness
  • Diarrhoea
  • Muscle aches.

Lanadelumab can cause severe side effects, including allergic reactions. Lanadelumab can cause allergic reactions. If you experience any of these symptoms, call your healthcare provider immediately or seek emergency medical attention.

  • Wheezing
  • Having difficulty breathing
  • Chest tightness
  • Fast heartbeat
  • Faintness
  • Rash
  • Hives

There may be other side effects. For medical advice on side effects, call your doctor. Contacting the FDA in regards to side effects can be done via their toll free number: 1-800-FDA-1088.

Interaction with other drug

Other drugs, such as vitamins and herbal products, may also affect lanadelumab. Inform your doctor of all the medicines you are taking and those that you stop or start using.

 

DRUG STATUS

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Prescription only

Pregnancy & Lactation

CSA Schedule*
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