lanadelumab (Rx)

Brand and Other Names:Takhzyro, lanadelumab-flyo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

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

Hereditary Angioedema

Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE)

300 mg SC q2Weeks

Dosing interval of 300 mg SC q4Weeks is also effective and may be considered if patient is well controlled (attack free) for >6 months

Also see Administration

Dosage Forms & Strengths

injectable solution

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

Hereditary Angioedema

Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and adolescents aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years:300 mg SC q2Weeks

Dosing interval of 300 mg SC q4Weeks is also effective and may be considered if patient is well controlled (attack free) for >6 months

Also see Administration

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Adverse Effects

>10%

300 mg q2Week dosing

  • Injection site reaction (56%)
  • Upper respiratory tract infection (44%)
  • Headache (33%)
  • Myalgia (11%)

300 mg q4Week dosing

  • Injection site reaction (45%)
  • Upper respiratory tract infection (31%)
  • Headache (21%)

1-10%

Increased AST or ALT (2%)

Hypersensitivity (1%)

300 mg q2Week dosing

  • Rash (4%)
  • Dizziness (4%)
  • Diarrhea (4%)

300 mg q4Week dosing

  • Rash (10%)
  • Dizziness (10%)
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Warnings

Contraindications

None

Cautions

Hypersensitivity reactions reported; if 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
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Pregnancy

Pregnancy

There are no available data regarding use in pregnant women

Animal studies

  • Monoclonal antibodies are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy
  • An enhanced prenatal and postnatal development study conducted in pregnant monkeys at doses resulting in exposures of up to 33 times the exposure achieved (on an AUC basis) at the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus

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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Human monoclonal antibody (IgG1 kappa-light chain) that targets plasma kallikrein and inhibits proteolytic activity to control excess bradykinin generated with HAE

Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE

In patients with HAE caused by C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks

Absorption

Every 2 week dosing

  • Peak plasma time: 4.11 days
  • Peak plasma concentration, steady-state: 34.4 mcg/mL
  • Minimum concentration, steady-state: 25.4 mcg/mL
  • AUC, steady-state: 408 mcg·day/mL

Every 4 week dosing

  • Peak plasma time: 5.17 days
  • Peak plasma concentration, steady-state: 23.3 mcg/mL
  • Minimum concentration, steady-state: 8.77 mcg/mL
  • AUC, steady-state: 441 mcg·day/mL

Distribution

Vd: 16.6 L (q2wk dosing); 14.9 L (q4wk dosing)

Elimination

Every 2 week dosing

  • Half-life: 15 days
  • Clearance: 0.809 L/day

Every 4 week dosing

  • Half-life: 14.2 days
  • Clearance: 0.742 L/day
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Administration

SC Preparation

Remove vial or prepared syringe from refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature; avoid vigorous agitation of the vial

Using aseptic technique, withdraw dose from vial using an 18-gauge needle; change needle on syringe to a 27-gauge, 0.5-inch needle or other needle suitable for SC injection

Administer within 2 hr of preparing the dosing syringe if left at room temperature

Discard any unused portions of drug remaining in the vial and syringe

SC Administration

For SC administration only

Intended for self-administration or administration by a caregiver following training by a healthcare professional

Clean injection site with alcohol wipe and allow to dry completely

Inject complete dose SC into the abdomen, thigh, or upper arm (caregiver only)

Inject in area at least 2 inches (5 cm) away from the navel or any scars; do not inject in area that is bruised, swollen, or painful

Rotate injection sites

Storage

Unopened vials

  • Refrigerate at 2-8°C (36-46°F)
  • Do not freeze
  • Do not shake
  • Store in original carton to protect from light

Prepared syringe

  • Refrigerate at 2-8°C (36-46°F)
  • Must be used within 8 hr of preparation
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.