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Anti-plasma kallikrein monoclonal antibody Pregnancy: There are no or limited data from use in pregnant women; animal studies do not indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity. As a precautionary measure, it is preferable to avoid use during pregnancy. It is unknown whether lanadelumab is excreted in human milk; a risk to the breast-fed child cannot be excluded during the first few days after birth, after which lanadelumab could be used during breast-feeding if clinically needed (§4.6).

Lanadelumab

Brand names: Takhzyro

Lanadelumab is a monoclonal antibody used for routine prevention (prophylaxis) of recurrent attacks of hereditary angioedema in adults and adolescents.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 300 mg
Route: Subcutaneous injection (abdomen, thighs or upper outer arms; rotate injection sites)
Frequency: Every 2 weeks (recommended starting dose); in patients who are stably attack free on treatment a dose reduction to 300 mg every 4 weeks may be considered, especially in patients with low weight
eMC §4.2 (TAKHZYRO 150 mg solution for injection in pre-filled syringe) — routine prevention of recurrent attacks of hereditary angioedema. Same regimen applies to adults and adolescents 12 to less than 18 years of age. In patients with a body weight less than 40 kg, a starting dose of 150 mg every 2 weeks may also be considered, with a reduction to 150 mg every 4 weeks in patients who are stably attack free. NOT intended for treatment of acute HAE attacks — in a breakthrough attack, individualised treatment with an approved rescue medication should be initiated. Consideration should be given to discontinuing treatment in patients with HAE with normal C1 esterase inhibitor (nC1-INH) who have shown insufficient reduction in attacks after 3 months. Missed doses: administer as soon as possible, then adjust the schedule to ensure at least 10 days between doses on a 2-weekly regimen, at least 17 days on a 3-weekly regimen, and at least 24 days on a 4-weekly regimen. Should be initiated under the supervision of a physician experienced in the management of HAE; may be self-administered or given by a caregiver only after training in subcutaneous injection technique. PAEDIATRIC DOSING FOR CHILDREN 2 TO LESS THAN 12 YEARS IS BY WEIGHT BAND, NOT PER KG (§4.2): 10 to less than 20 kg — 150 mg every 4 weeks, with a possible increase to 150 mg every 3 weeks if attacks are insufficiently controlled; 20 to less than 40 kg — 150 mg every 2 weeks, with a possible reduction to 150 mg every 4 weeks if stably attack free; 40 kg or more — 300 mg every 2 weeks, with a possible reduction to 300 mg every 4 weeks if stably attack free. Patients weighing 20 to less than 40 kg who are stably attack free may continue the same dose on reaching 12 years of age. Safety and efficacy in children under 2 years have not been established; in this age group the injection should only be given by a trained caregiver. Verify paediatric use against a children's formulary.

Dose adjustments

Renal

No dose adjustment is required in patients with renal impairment; no studies have been conducted in severe renal impairment, but renal impairment is not expected to affect exposure or the safety profile (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Injection site reactions (very common, 52.4%) — pain, erythema, bruising, discomfort, haematoma, pruritus, swelling, induration
  • Hypersensitivity (common) — pruritus, discomfort and tingling of the tongue
  • Dizziness (common)
  • Maculo-papular rash (common); myalgia (common)
  • Alanine aminotransferase and aspartate aminotransferase increased (common)

Interactions

  • No dedicated drug-drug interaction studies have been conducted; based on the characteristics of lanadelumab no pharmacokinetic interactions with co-administered medicinal products are expected (§4.5)
  • C1 esterase inhibitor rescue medication — concomitant use results in an additive effect on the lanadelumab-cHMWK response (§4.5)
  • Laboratory interference: lanadelumab can increase activated partial thromboplastin time (aPTT) through interaction with the aPTT assay; increases were not associated with abnormal bleeding and INR was unaffected (§4.4)

Clinical monograph

How it works

It inhibits plasma kallikrein, reducing the generation of bradykinin and thereby preventing the bradykinin-driven swelling that characterises hereditary angioedema attacks.

Prescribing in practice

  • It is a preventive therapy and does not treat acute attacks, so patients must retain access to, and a plan for, on-demand acute treatment for breakthrough attacks.
  • Administered by subcutaneous injection on a regular schedule and may be self-administered or carer-administered after training; injection-site reactions are common.
  • Hypersensitivity reactions have been reported; consult the SPC for the prescribing detail.

Monitoring

Monitor attack frequency and severity to assess response, alongside injection-site and hypersensitivity reactions.

Counselling the patient

  • This injection is to prevent attacks and will not treat one that is already happening.
  • Keep your emergency (on-demand) treatment available and know when to use it.
  • Injection-site redness or pain is common and usually short-lived.

Evidence & guidelines

Lanadelumab is licensed for hereditary angioedema prophylaxis based on the HELP trial, which showed a substantial reduction in attack frequency, and is recommended by NICE for preventing recurrent attacks in eligible patients.

Reference: NICE TA606; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.