Lanadelumab is a monoclonal antibody that was designed for the treatment of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. These swelling episodes can occur in various parts of the body, including the hands, feet, face, gastrointestinal tract, and even the airway, which can be life-threatening.

Lanadelumab works by inhibiting the activity of a protein called plasma kallikrein, which is believed to play a role in the episodes of swelling seen in patients with HAE.

Lanadelumab is a human monoclonal antibody that inhibits the excessive release of bradykinin in patients with hereditary angioedema. Lenadelumab-fly 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 recommended for individuals 12 years of age and older as a preventative measure to avoid hereditary angioedema (HAE) episodes.

Lanadelumab (Takhzyro) Dose in adullts:

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

• Starting dose: 300 mg given as a shot under the skin every 2 weeks.
• If things go well for 6 months: The shot can be given once every 4 weeks instead.

Lanadelumab (Takhzyro) Dose in Chiildrens:

Dosage of Lanadelumab (Takhzyro) for the prevention of Hereditary Angioedema (HAE):

For kids 12 years and older with Hereditary Angioedema (HAE):

• Starting dose: They get a 300 mg shot under the skin every 2 weeks.
• If they don't have any swelling attacks for more than 6 months, the doctor might change it to a shot once every 4 weeks.

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

• No bad effects were seen in animal tests when they were given lanadelumab while pregnant.
• Lanadelumab is a special kind of protein (humanized monoclonal antibody).
• This type of protein can sometimes move to the baby in the womb. How much gets to the baby can depend on the specific kind of protein and how far along the pregnancy is. The least amount gets to the baby early in the pregnancy.
• Even though lanadelumab seems safe in animals, there are other recommended treatments for pregnant women with Hereditary Angioedema (HAE).
• Women with HAE should be watched closely during pregnancy and for a few days after giving birth.

Lanadelumab use during breastfeeding:

• We don't know if lanadelumab gets into breast milk.
• The company that makes the medicine says if you're thinking of breastfeeding while taking it, think about:
  • Any possible risks to the baby.
  • The good that breastfeeding does for the baby.
  • The benefits of the medicine for the mom.
• Current advice suggests using different treatments for HAE if you're breastfeeding.

Dose in Renal disease:

• The company that makes the medicine hasn't given any special dose instructions for people with kidney problems.
• This is because they haven't studied its effects in such cases.

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 aspartate aminotransferase
  • Increased serum alanine aminotransferase
• Miscellaneous:
  • Hypersensitivity

Contraindications to Lanadelumab (Takhzyro):

The company that makes the medicine hasn't listed any reasons or conditions for which you shouldn't take it.

Warnings and precautions

Hypersensitivity reactions

• Allergic reactions have happened with this medicine.
• If there's a strong allergic reaction, stop taking it and get the right medical treatment.

Monitor:

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

How to administer Lanadelumab (Takhzyro)?

• You can inject it under the skin in the stomach area, thigh, or upper arm.
• Let the bottle get to room temperature before using. This takes about 15 minutes.
• Don't shake the bottle. Instead, flip it upside-down gently 3 to 5 times to mix it.
• Use a big needle (18-gauge) to get the medicine out of the bottle. Then use a smaller needle (27-gauge, ½-inch long) to give the shot.
• Change where you inject each time. Make sure it's at least 2 inches away from any scars or the belly button.
• Don't inject where the skin is bruised, swollen, or hurts.

Mechanism of action of Lanadelumab (Takhzyro):

• This medicine is a special human-made protein that sticks to and stops another protein called plasma kallikrein.
• By doing this, it controls the production of too much bradykinin in people with hereditary angioedema.
• Bradykinin is a molecule that can cause swelling, which is a problem in this condition.

Distribution:

• The volume where the medicine spreads in the body is between 14.1 to 16.6 liters.

Half-life:

• It takes between 14.2 to 15 days for the amount of the medicine in the body to reduce by half.

Time to peak:

• It takes between 4.11 to 5.17 days for the medicine to reach its highest level in the body after taking it.

International Brands of Lanadelumab:

• Takhzyro

Lenadelumab-flyo (Takhzyro) cost in the US:

300 mg/2 mL: $13,639.26

Lanadelumab Brand Names in Pakistan:

Not Availabel.