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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Lanadelumab: Pediatric drug information")
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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
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]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Takhzyro: Lanadelumab-flyo 300 mg/2 mL (2 mL) [contains polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Takhzyro: 300 mg/2 mL (2 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Takhzyro: 300 mg/2 mL (2 mL) [contains polysorbate 80]
SUBQ: For SUBQ injection into the abdomen, thigh, or upper arm. 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.
Allow vial or prefilled syringe 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.
Note: In addition to administration by health care providers, the vial or prefilled syringe may be used for self-administration or administration by a caregiver after training.
SUBQ: Administer subcutaneously into the upper arm (health care provider or caregiver administration only), abdomen, or thigh. Rotate injection sites; injection site should be ≥2 inches (5 cm) away from any scars or navel; each new injection site should be at least 1 inch from the site last used. Do not inject in an area that is bruised, swollen, or painful.
Allow vial or prefilled syringe to reach room temperature prior to injection (~15 minutes).
Vial: Gently invert the vial 3 to 5 times to mix; do not shake. Use an 18-gauge transfer needle to withdraw dose and a 27-gauge, 1/2-inch needle or other needle suitable for SUBQ injection to administer dose; in trials, most patients administered their dose over 10 to 60 seconds. Once dose has been removed from vial, it must be administered within 2 hours if at room temperature, or within 8 hours if refrigerated.
Prefilled syringe: Do not remove needle cap while allowing product to reach room temperature; do not heat prefilled pen in microwave, hot water, or direct sunlight. Do not shake. Do not try to remove air bubbles. After administration, do not rub injection site.
Hereditary angioedema, prophylaxis: Prevention of attacks of hereditary angioedema (HAE) in patients ≥12 years of age.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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%)
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to lanadelumab or any component of the formulation.
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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
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]).
It is not known if lanadelumab is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Current guidelines recommend other agents for management of HAE during lactation (WAO/EEACI [Maurer 2018]).
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
Half-life elimination: 14.2 to 15 days
Time to peak: 4.11 to 5.17 days
Solution (Takhzyro Subcutaneous)
300 mg/2 mL (per mL): $14,469.89
Solution Prefilled Syringe (Takhzyro Subcutaneous)
300 mg/2 mL (per mL): $14,469.89
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