Rx Item-TAKHZYRO lanadelumab-flyo SUBCUT VIAL 300 MG/2ML INJ BY THERACOM/SHIRE

for: Hereditary Angioedema

Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) for the prevention of angioedema attacks in patients with hereditary angioedema. How Supplied

TAKHZYRO (lanadelumab-flyo) injection is a ready-to-use, clear to slightly opalescent, colorless to slightly yellow solution supplied in a carton containing one single-dose glass vial with chlorobutyl rubber stopper, aluminum crimp seal and polypropylene flip-off cap.
NDC 47783-644-01: 300 mg/2 mL (150 mg/mL) vial.

Storage and handling

Store vials refrigerated at 36�F to 46�F (2�C to 8�C).
Do not freeze. Do not shake.
Keep the vial in the original carton in order to protect the vial from light. These highlights do not include all the information needed to use TAKHZYRO� safely and effectively. See full prescribing information for TAKHZYRO�.

TAKHZYRO� (lanadelumab-flyo) injection, for subcutaneous use.
Initial U.S. Approval: 2018.
INDICATIONS AND USAGE

TAKHZYRO is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION

For subcutaneous use only

Administer 300 mg every 2 weeks. Dosing every 4 weeks may be considered in some patients (2.1)
Patients may self-administer. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose vial. (3)
CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. (5.1)
ADVERSE REACTIONS

The most common adverse reactions are injection site reactions, upper respiratory infections, headache, rash, myalgia, dizziness, and diarrhea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp. (a wholly-owned, indirect subsidiary of Shire plc) at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

No dedicated drug interaction studies have been conducted. (7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2018

Rx Item-TAKHZYRO lanadelumab-flyo SUBCUT
RX47783-0644-01

Rx Item-TAKHZYRO lanadelumab-flyo SUBCUT
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop