Takhzyro Injection

Lanadelumab

300mg/2ml

SHIRE PHARMACEUTICALS IRELAND LIMITED

Pack size	1 Glass Vial (2ml) + 1 Syringe + 2 Needle
Dispensing mode	POM
Source	IRELAND
Agent	Modern Pharmaceutical Co.
Retail Price	78607.50 AED

Indications

Takhzyro Injection is used for: Hereditary Angioedema

Adult Dose

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

Child Dose

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

Renal Dose

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

Contra Indications

Hypersensitivity

Precautions

Hypersensitivity reactions reported; if severe hypersensitivity reaction occurs, discontinue lanadelumab and institute appropriate treatment

Pregnancy-Lactation

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

Interactions

Adverse Effects

Side effects of Lanadelumab : >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%)

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

Note

Takhzyro 300mg/2ml Injection manufactured by SHIRE PHARMACEUTICALS IRELAND LIMITED. Its generic name is Lanadelumab. Takhzyro is availble in United Arab Emirates. Farmaco UAE drug index information on Takhzyro Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.