Version May 2024
Hereditary angioedema, prophylaxis: SUBQ: Initial: 300 mg every 2 weeks; increasing dosing interval to 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.
Refer to adult dosing.
(For additional information see "Lanadelumab: Pediatric drug information")
Hereditary angioedema (HAE), prophylaxis:
Children ≥2 to <6 years: SUBQ: 150 mg every 4 weeks.
Children ≥6 to <12 years: SUBQ: Initial: 150 mg every 2 weeks; may consider administering every 4 weeks in patients who are well controlled (eg, attack free) for >6 months.
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
>10%:
Immunologic: Antibody development (12%)
Local: Injection-site reaction (45% to 56%)
Nervous system: Headache (33%)
Neuromuscular & skeletal: Myalgia (11%)
Respiratory: Upper respiratory tract infection (44%)
1% to 10%:
Dermatologic: Skin rash (10%)
Gastrointestinal: Diarrhea (4%)
Hepatic: Increased serum alanine aminotransferase (2%), increased serum aspartate aminotransferase (2%)
Hypersensitivity: Hypersensitivity reaction (1%)
Nervous system: Dizziness (4% to 10%)
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.
Takhzyro 150 mg/mL prefilled syringe: FDA approved February 2023; anticipated availability currently unknown. Takhzyro 150 mg/mL prefilled syringes are indicated for use in pediatric patients 2 to <12 years of age.
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 150 mg/mL (1 mL); Lanadelumab-flyo 300 mg/2 mL (2 mL) [contains polysorbate 80]
No
Solution (Takhzyro Subcutaneous)
300 mg/2 mL (per mL): $15,351.10
Solution Prefilled Syringe (Takhzyro Subcutaneous)
150 mg/mL (per mL): $15,351.11
300 mg/2 mL (per mL): $15,351.10
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Takhzyro: Lanadelumab-flyo 300 mg/2 mL (2 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Takhzyro: Lanadelumab-flyo 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; self-administration is not recommended in children <12 years of age.
SUBQ: SUBQ administration only; administer SUBQ 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 irritated, red, bruised, or infected. After administration, do not rub injection site.
Vial: Allow vial to reach room temperature (15 minutes). Gently invert the vial 3 to 5 times to mix; do not shake; no reconstitution or dilution is necessary. 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: Allow prefilled syringe to reach room temperature prior to injection (15 minutes). Do not remove needle cap until ready to inject; do not heat prefilled pen in microwave or in hot water. Do not shake. Do not try to remove air bubbles.
Hereditary angioedema, prophylaxis: Prevention of attacks of hereditary angioedema in adults and pediatric patients ≥2 years of age.
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
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Adverse events were not observed in animal reproduction studies. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
If prevention of attacks of hereditary angioedema (HAE) is needed during pregnancy, agents other than lanadelumab are recommended. Patients with HAE should be monitored closely during pregnancy and for at least 72 hours after delivery (WAO/EAACI [Maurer 2022]).
It is not known if lanadelumab is present in breast milk.
Lanadelumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
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. Lactation may increase the frequency of hereditary angioedema (HAE) attacks; patients with HAE should be monitored closely. Current guidelines recommend agents other than lanadelumab for management of HAE during lactation (WAO/EAACI [Maurer 2022]).
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
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