Lanadelumab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Plasma Kallikrein Inhibitor
Dosing in kidney impairment
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Preparation and administration
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Preparation and Administration Instructions TAKHZYRO is administered subcutaneously only. TAKHZYRO is intended for administration by a healthcare provider, patient or caregiver. The patient or caregiver should be trained in subcutaneous injection technique by a healthcare professional. Adult and pediatric patients 12 years of age and older: TAKHZYRO may be administered by the patient or caregiver.
Pediatric patients 2 years to less than 12 years of age: TAKHZYRO should be administered by a healthcare provider or caregiver. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use TAKHZYRO if the solution appears discolored or contains visible particles.
TAKHZYRO is a clear to slightly opalescent, colorless to slightly yellow solution. Administration Instructions for Single-Dose Prefilled Syringes Instruct patients and/or caregivers on proper use of the TAKHZYRO prefilled syringe and assess that they are well trained in subcutaneous injection technique prior to administration by patient and/or caregiver.
Avoid vigorous agitation of the prefilled syringe. Take the TAKHZYRO prefilled syringe out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature. Using aseptic technique, inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm. Discard any unused portion of drug remaining in the prefilled syringe.
For detailed instructions on the preparation and administration of TAKHZYRO see Instructions for Use for either single-dose 1 mL prefilled syringe or single-dose 2 mL prefilled syringe.
Drug interactions
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- Lanadelumab
Label text (3 paragraphs)
No dedicated drug interaction studies have been conducted [see Clinical Pharmacology (12.3) ]. No dedicated drug interaction studies have been conducted. ( 7 )
7.1 Drug-Laboratory Test Interactions Coagulation tests TAKHZYRO can increase activated partial thromboplastin time (aPTT) due to an interaction of TAKHZYRO with the aPTT assay. The 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 TAKHZYRO can increase aPTT in this assay. In Trial 1, prolongation of aPTT (>1× ULN) was observed at one or more time points in 3, 9, and 11 patients treated with TAKHZYRO 150 mg every 4 weeks (q4wks), 300 mg every 4 weeks (q4wks), and 300 mg every 2 weeks (q2wks), respectively, compared to 5 placebo-treated patients.
Only one patient in the 300 mg every 2 weeks (q2wks) treatment group experienced transient aPTT prolongation ≥1.5x ULN which was confounded by ongoing heparin therapy. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in INR values between treatment groups.
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Lanadelumab is a human IgG1 monoclonal antibody to kallikrein which blocks the activation of bradykinin, a potent vasodilator responsible for the attacks of swelling, inflammation and pain in hereditary angioedema (HAE). Lanadelumab has been linked to a low rate of serum enzyme elevations during therapy, but has not been implicated in instances of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on TAKHZYRO use in pregnant women to inform any drug associated risks. Monoclonal antibodies such as lanadelumab-flyo 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 pre- and postnatal development (ePPND) 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.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In the ePPND study, pregnant cynomolgus monkeys were administered lanadelumab-flyo once weekly at subcutaneous doses resulting in up to 33 times the exposure at the MRHD (on an AUC basis with maternal subcutaneous doses up to 50 mg/kg/week) from gestation day 20, at the beginning of organogenesis, through to parturition.
There were no lanadelumab-flyo-related effects on maintenance of pregnancy or parturition. Maternal lanadelumab-flyo treatment had no effects on embryo-fetal development, survival, growth, or postnatal development of offspring through 3 months of age. Lanadelumab-flyo crossed the placenta in monkeys. Offspring were exposed to lanadelumab-flyo at approximately 50% of the maternal plasma concentration out to postnatal day 21 (PND 21). Lanadelumab-flyo concentrations were approximately equivalent in maternal and offspring plasma at PND 90.
Breastfeeding (LactMed)
Minimal information available on the clinical use of lanadelumab during breastfeeding indicated no infant harm. Because lanadelumab is a large protein molecule with a molecular weight of about 146,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. If lanadelumab is required by the mother, it is not a reason to discontinue breastfeeding. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
- C1-esterase inhibitor
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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