Lanadelumab

Lanadelumab is a prescription medication used to prevent attacks of hereditary angioedema.

• Lanadelumab is available under the following different brand names: Takhzyro, lanadelumab-flyo

Common side effects of Lanadelumab include:

• headache,
• stuffy nose,
• sneezing,
• sore throat,
• rash, and
• pain, redness, or bruising where the injection was given

Serious side effects of Lanadelumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat, and
• lightheadedness

Rare side effects of Lanadelumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 150 mg/mL (single-dose prefilled syringe)
• 300 mg/2 mL (150 mg/mL, single-dose prefilled syringe)
• 300 mg/2 mL (150 mg/mL, single-dose vial)

Hereditary Angioedema

Adult dosage

• 300 mg SC every 2 weeks
• Dosing interval of 300 mg SC every 4 weeks is also effective and may be considered if the patient is well controlled (attack free) for more than 6 months

Pediatric dosage

• Aged below 2 years: Safety and efficacy not established
• 2 to less than 6 years: 150 mg SC every 4 weeks
• 6 to less than 12 years: 150 mg SC every 2 weeks; consider a dosing interval of 150 mg every 4 weeks if well-controlled (eg, attack free) for more than 6 months
• Aged above 12 years: 300 mg SC every 2 weeks; consider a dosing interval of 300 mg SC every 4 weeks if well-controlled for more than 6 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lanadelumab has no noted severe interactions with any other drugs.
• Lanadelumab has no noted serious interactions with any other drugs.
• Lanadelumab has no noted serious interactions with any other drugs.
• Lanadelumab has no noted serious interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lanadelumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lanadelumab?”

Cautions

• Hypersensitivity reactions reported; if a severe hypersensitivity reaction occurs, discontinue lanadelumab and institute appropriate treatment
• Interaction with aPPT assay
• Can increase activated partial thromboplastin time (aPTT) owing to an interaction with the aPTT assay
• Reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system
• Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay

Pregnancy and Lactation

• There are no available data regarding use in pregnant women
• Lactation
  • There are no data on the presence of lanadelumab in human milk, its effects on the breastfed infant, or its effects on milk production
  • Detected in the milk of lactating cynomolgus monkeys at ~0.2% of the maternal plasma concentration
  • Consider the development and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition