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Rx Item-Givlaari (givosiran) Injection by Alnylam Pharma

RX71336-1001-1 Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.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

Rx Item-Givlaari (givosiran) Injection by Alnylam Pharma

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NDC No. 71336-1001-1 71336-1001-01 7133610011 71336100101 UPC/GTIN No. 3-71336-10011-6 371336-100116 371336100116 MPN No. 101 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 Scope Of their Practice Can Order Rx Item. Other Name: Givosiran or: Acute Hepatic Porphyria
Givlaari (givosiran) is an aminolevulinate synthase

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These highlights do not include all the information needed to use GIVLAARI� safely and effectively. See full prescribing information for GIVLAARI.

GIVLAARI (givosiran) injection, for subcutaneous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE

GIVLAARI is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP). (1)
DOSAGE AND ADMINISTRATION

The recommended dose of GIVLAARI is 2.5 mg/kg once monthly by subcutaneous injection. (2.1)
DOSAGE FORMS AND STRENGTHS

Injection: 189 mg/mL in a single-dose vial. (3)
CONTRAINDICATIONS

Severe hypersensitivity to givosiran. (4)
WARNINGS AND PRECAUTIONS

Anaphylactic Reaction: Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI. Monitor for signs and symptoms. If anaphylaxis occurs, discontinue GIVLAARI and administer appropriate medical treatment. (5.1)
Hepatic Toxicity: Measure liver function at baseline and periodically during treatment with GIVLAARI. Interrupt or discontinue treatment with GIVLAARI for severe or clinically significant transaminase elevations. (2.1, 5.2)
Renal Toxicity: Monitor renal function during treatment with GIVLAARI as clinically indicated. (5.3)
Injection Site Reactions: May occur, including recall reactions. Monitor for reactions and manage clinically as needed. (5.4)

ADVERSE REACTIONS

The most common adverse reactions (?20% of patients) included nausea and injection site reactions. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Alnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Sensitive CYP1A2 and CYP2D6 Substrates: Avoid concomitant use with CYP1A2 and CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities. (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2019

RX71336-1001-1
Rx Item-Givlaari (givosiran) Injection b
RX71336-1001-1

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-Givlaari (givosiran) Injection b
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

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
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