Qfitlia 50 mg/.5mL
fitusiran · INJECTION, SOLUTION · Genzyme Corporation
Qfitlia is a injection, solution containing fitusiran at 50 mg/.5mL, taken subcutaneous. Manufactured by Genzyme Corporation.
Key Facts
- Brand Name
- Qfitlia
- Generic Name
- fitusiran
- NDC Code (Product)
58468-0348- Manufacturer
- Genzyme Corporation
- Strength
- 50 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA219019
- Drug Class
- Antithrombin-directed RNA Interaction [EPC]; Small Interfering RNA [EPC]
- Marketing Start
- 03/28/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous use only. Starting dose: 50 mg once every 2 months ( 2.1 ). Monitor AT activity using an FDA-cleared test. Maintain AT activity between 15–35% by adjusting the dose and/or frequency of administration ( 2.2 ). See Full Prescribing Information for important preparation and administration instructions ( 2.4 ). 2.1 Recommended Dosage For subcutaneous use only. Use of QFITLIA is recommended under the supervision of a healthcare professional experienced in the treatment of hemophilia or bleeding disorders. Measure AT activity prior to initiation of QFITLIA. Do not initiate QFITLIA dosing if AT activity is <60%. Monitor AT activity using an FDA-cleared test. Information on FDA-cleared tests for AT activity is available at http://www.fda.gov/CompanionDiagnostics. After QFITLIA is initiated, patients may continue their prior clotting factor concentrates (CFC) or bypassing agent (BPA) prophylaxis for the first 7 days of treatment. Discontinue CFC or BPA prophylaxis no later than 7 days after the initial dose of QFITLIA. The starting dose of QFITLIA is 50 mg once subcutaneously every two months. Adjust the dose and/or dosing interval, if needed, to…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Hypercoagulability with Concomitant Use of CFC or BPA QFITLIA prophylaxis leads to increased thrombin generation with additive increase in peak thrombin when used concomitantly with CFC or BPA [see Boxed Warning , Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Thrombotic Events [see Boxed Warning and Warnings and Precautions (5.1) ] Acute and Recurrent Gallbladder Disease [see Boxed Warning and Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Common adverse reactions (incidence >10%) are viral infection, nasopharyngitis, and bacterial infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation 1-800-745-4447 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. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to QFITLIA as fixed doses and AT-DR (N=335). The safety of the QFITLIA AT-DR was assessed in 286 adult and pediatric male patients with hemophilia A or B with or without inhibitors [see Clinical Studies (14) ] . Among patients who re…
Frequently Asked Questions
What is Qfitlia used for?
Qfitlia contains fitusiran. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Qfitlia a controlled substance?
Qfitlia is not classified as a controlled substance by the DEA.
What is the generic name for Qfitlia?
The generic name for Qfitlia is fitusiran. There are no other listed brand versions of fitusiran.
What is the NDC code for Qfitlia 50 mg/.5mL?
The NDC (National Drug Code) for Qfitlia 50 mg/.5mL is 58468-0348, listed by Genzyme Corporation.
Other Qfitlia Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)