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Lanadelumab

Medically reviewed by Drugs.com. Last updated on May 12, 2020.

Pronunciation

(LAN a DEL ue mab)

Index Terms

  • Lanadelumab-flyo
  • Takhzyro

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Takhzyro: lanadelumab-flyo 300 mg/2 mL (2 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Takhzyro

Pharmacologic Category

  • Kallikrein Inhibitor
  • Monoclonal Antibody

Pharmacology

Human monoclonal antibody (IgG1/κ-light chain) that binds plasma kallikrein and inhibits its proteolytic activity, controlling excess bradykinin generation in patients with hereditary angioedema.

Distribution

Vd: 14.1 to 16.6 L

Time to Peak

4.11 to 5.17 days

Half-Life Elimination

14.2 to 15 days

Use: Labeled Indications

Hereditary angioedema, prophylaxis: Prevention of attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Hereditary angioedema, prophylaxis: SubQ: Initial: 300 mg every 2 weeks; dosing every 4 weeks may be considered in patients well-controlled (eg, attack free) for >6 months

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Hereditary angioedema (HAE), prophylaxis: Children ≥12 years and Adolescents: SubQ: Initial: 300 mg every 2 weeks; may consider administering every 4 weeks in patients who are well controlled (eg, attack free) for >6 months

Administration

SubQ: For SubQ injection into the abdomen, thigh, or upper arm. Allow vial to reach room temperature before injection (15 minutes). Before preparing dose, gently invert vial 3 to 5 times to mix; do not shake. Use an 18-gauge transfer needle to withdraw dose and a 27-gauge, ½-inch needle or other needle suitable for SubQ injection to administer dose. Rotate injection sites; injection site should be ≥2 inches (5 cm) away from any scars or navel. Do not inject in an area that is bruised, swollen, or painful.

Storage

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Keep the vial in the original carton to protect from light. Administer within 2 hours of preparing the dose; may also store prepared dose at 36ºF to 46ºF (2°C to 8°C) and must use within 8 hours. Discard any unused portion.

Drug Interactions

There are no known significant interactions.

Test Interactions

May increase activated partial thromboplastin time (aPTT) due to an interaction with the aPTT assay.

Adverse Reactions

>10%:

Central nervous system: Headache (33%)

Immunologic: Antibody development (12%)

Local: Injection site reaction (45% to 56%)

Neuromuscular & skeletal: Myalgia (11%)

Respiratory: Upper respiratory tract infection (44%)

1% to 10%:

Central nervous system: Dizziness (4% to 10%)

Dermatologic: Skin rash (10%)

Gastrointestinal: Diarrhea (4%)

Hepatic: Increased serum transaminases (4%), increased serum alanine aminotransferase (2%), increased serum aspartate aminotransferase (2%)

Hypersensitivity: Hypersensitivity (1%)

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Have occurred. In case of a severe hypersensitivity reaction, discontinue therapy and institute appropriate treatment.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Lanadelumab is a humanized monoclonal antibody (IgG1). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Other agents are currently recommended for prophylaxis of hereditary angioedema (HAE) during pregnancy. Women with HAE should be monitored closely during pregnancy and for at least 72 hours after delivery (WAO/EEACI [Maurer 2018]).

Patient Education

What is this drug used for?

• It is used to prevent swelling attacks in people with hereditary angioedema (HAE).

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:

• Common cold symptoms

• Headache

• Muscle pain

• Diarrhea

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:

• Severe injection site irritation

• Fast heartbeat

• Severe dizziness

• Passing out

• 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.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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