Lanadelumab is a human monoclonal antibody that inhibits the excessive release of bradykinin in patients with hereditary angioedema. Lenadelumab-flyo is available by the brand name of Takhzyro as a 300 mg/2ml injection for SubQ use. It has got FDA approval in August 2018.

Lanadelumab (Takhzyro) Indications:

• Prophylaxis of Hereditary angioedema:

  • It is indicated in the prophylactic treatment for the prevention of attacks of hereditary angioedema (HAE) in patients 12 years of age or older.

Lanadelumab (Takhzyro) Dose in adullts:

Lanadelumab (Takhzyro) Dose in the prophylaxis of hereditary angioedema:

• 300 mg SubQ initially every 2 weeks.
• The dosing interval may be prolonged to every 4 weeks in patients whose disease is well controlled and are attack-free for 6 months or more.

Lanadelumab (Takhzyro) Dose in Chiildrens:

Lanadelumab (Takhzyro) Dose in the prophylaxis of Hereditary angioedema (HAE):

• Children older than 12 years of age and Adolescents:

  • 300 mg SubQ initially every 2 weeks.
  • In children whose disease is well controlled and are attack-free for 6 months or more, the drug can be administered every 4 weeks.

Lanadelumab (Takhzyro) Pregnancy Risk Category: N (not assigned)

• Negative fetal events have not been observed in animal reproduction studies.
• Lenadelumab, a monoclonal human antibody of the IgG type, can cross the placental boundary.
• The likelihood of placental transfer becoming more common with increasing fetal age is higher.
• Women suffering from hereditary angioedema must be monitored closely during pregnancy and 72 hours after giving birth.
• For the prevention of HAE, it is a good idea to use other preferred drugs during pregnancy.

Lanadelumab use during breastfeeding:

• It is unknown if the drug will be excreted into breastmilk.
• Manufacturer suggests weighing the risks and benefits of treatment for the mother.
• Alternative agents should be preferred for breastfeeding mothers.

Dose in Renal disease:

The manufacturer has not provided any adjustment in the dose in patients with kidney disease. It has not been studied in patients with renal disease.

Dose in Liver disease:

The manufacturer has not provided any adjustment in the dose in patients with liver disease.

Common Side Effects of Lanadelumab (Takhzyro):

• Central nervous system:

  • Headache

• Immunologic:

  • Antibody development

• Local:

  • Injection site reaction

• Neuromuscular & skeletal:

  • Myalgia

• Respiratory:

  • Upper respiratory tract infection

Less Common Side Effects of Lanadelumab (Takhzyro):

• Central nervous system:

  • Dizziness

• Dermatologic:

  • Skin rash

• Gastrointestinal:

  • Diarrhea

• Hepatic:

  • Increased serum transaminases
  • Increased serum alanine aminotransferase
  • Increased serum aspartate aminotransferase

• Hypersensitivity:

  • Hypersensitivity

Contraindications to Lanadelumab (Takhzyro):

There are no contraindications for its use, according to the manufacturer.

Warnings and precautions

• Hypersensitivity reactions
  • After the injection, severe allergic reactions were reported.
  • Stop all therapy immediately if severe reactions occur.

Monitor:

Observe for the clinical features of allergic reactions. Monitor Liver function tests

How to administer Lanadelumab (Takhzyro)?

• It is intended for SubQ use only.
• Avoid administering via other routes. It is administered as a subQ injection into the abdomen, anterior thigh, or the upper arms.
• Prior to administering the drug, allow it (for 15 minutes or so) to reach the room temperature.
• Gently invert the vial 3 - 5 times to mix the contents of the vial. Do not shake the vial vigorously.
• Administer the drug using an 18-gauge transfer needle to withdraw dose and a 27-gauge, ½-inch needle or another needle suitable for SubQ injection.
• Avoid injecting into an inflamed, bruised, or scarred area.
• Rotate the injection site and inject at least 5 cms away from the navel or any scarred area.
• Once the dose has been removed from the vial, Takhzyro (lanadelumab-flyo) should be administered within 2 hours if kept at room temperature and within 8 hours if refrigerated

Mechanism of action of Lanadelumab (Takhzyro):

• Takhzyro, a monoclonal antibody belonging to the IgG1/k light chain type, controls excessive bradykinin release in patients with hereditary angiopathy.
• It does this by binding to the plasma kallikrein and inhibiting its proteolytic activities.

Elimination of Half-life The average duration of the drug is between 14.2 and 15 days It is now peak serum concentration It takes 4.11 to 5.17 Days

International Brands of Lanadelumab:

• Takhzyro

Lenadelumab-flyo (Takhzyro) cost in the US:

300 mg/2 mL: $13,639.26

Lanadelumab Brand Names in Pakistan:

No Brands Available in Pakistan.