Lanadelumab-flyo
Generic Name: lanadelumab-flyo
Brand Names:
Takhzyro
11 DESCRIPTION Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa.
Overview
11 DESCRIPTION Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa.
Uses
1 INDICATIONS AND USAGE TAKHZYRO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older. TAKHZYRO is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION For subcutaneous use only. Recommended Dosage: Adult and pediatric patients 12 years of age and older: administer 300 mg every 2 weeks by the patient or caregiver. Dosing interval every 4 weeks may be considered in some patients. ( 2.1 ) Pediatric patients 6 to less than 12 years of age: administer 150 mg every 2 weeks by a healthcare provider or caregiver. Dosing interval every 4 weeks may be considered in some patients. ( 2.2 ) Pediatric patients 2 to less than 6 years of age: administer 150 mg every 4 weeks by a healthcare provider or caregiver. ( 2.2 ) See Full Prescribing Information for Administration Instructions.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions (≥10%) are injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. 4 CONTRAINDICATIONS None. None. ( 4 )
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.
Storage
Storage and Handling Store the prefilled syringes and vials refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Keep the prefilled syringe and vial in the original carton to protect from light.
Frequently Asked Questions
What is Lanadelumab-flyo used for?▼
1 INDICATIONS AND USAGE TAKHZYRO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older. TAKHZYRO is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. ( 1 )
What are the side effects of Lanadelumab-flyo?▼
6 ADVERSE REACTIONS The most common adverse reactions (≥10%) are injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Lanadelumab-flyo during 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.
What are the important warnings for Lanadelumab-flyo?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. 4 CONTRAINDICATIONS None. None. ( 4 )
Related Medications
Clomipramine Hcl
clomipramine hcl
Dosage form: POWDER. Active ingredients: CLOMIPRAMINE HYDROCHLORIDE (1 g/g). Category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING.
Kochia Scoparia
kochia scoparia
Dosage form: SOLUTION. Route: INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS. Active ingredients: BASSIA SCOPARIA POLLEN (.05 g/mL). Category: BLA.
Argentum Nitricum, Atropinum Sulphuricum, Aurum Muriaticum Natronatum, Bos Taurus Ovary, Bos Taurus Pancreas, Bos Taurus Pituitarum Posterium, Bos Taurus Uterus, Cimicifuga Racemosa, Estrone, Helonias Dioica, Progesterone, Pulsatilla Vulgaris, Sabina, Sepia, Sequoiadendron Giganteum Whole, Sus Scrofa Pineal Gland, Sus Scrofa Spleen, Thiosinaminum, Thyroidinum, Viburnum Opulus
argentum nitricum, atropinum sulphuricum, aurum muriaticum natronatum, bos taurus ovary, bos taurus pancreas, bos taurus pituitarum posterium, bos taurus uterus, cimicifuga racemosa, estrone, helonias dioica, progesterone, pulsatilla vulgaris, sabina, sepia, sequoiadendron giganteum whole, sus scrofa pineal gland, sus scrofa spleen, thiosinaminum, thyroidinum, viburnum opulus
Progesterone [EPC]
Uses: For temporary relief of minor: • menstrual irregularity* • headache* • fatigue* • menstrual cramps* • backache during menstruation* • irritability* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.