LEQVIO 284 mg/1.5mL
inclisiran · INJECTION, SOLUTION · Novartis Pharmaceuticals Corporation
Leqvio (inclisiran) is a prescription injection used to lower LDL cholesterol levels in patients who need additional help managing their cholesterol despite taking other cholesterol-lowering medications. It is given as a shot under the skin and works by reducing the production of cholesterol in the liver.
Key Facts
- Brand Name
- LEQVIO
- Generic Name
- inclisiran
- NDC Code (Product)
0078-1000- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 284 mg/1.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA214012
- Marketing Start
- 12/22/2021
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 LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). LEQVIO is a small interfering RNA (siRNA) directed to proprotein convertase subtilisin kexin type 9 (PCSK9) mRNA indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. ( 1 ) adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). ( 1 ) pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of LEQVIO for adults and pediatric patients aged 12 years and older is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months. ( 2.1 ) LEQVIO should be administered by a healthcare professional. ( 2.2 ) Inject LEQVIO subcutaneously into the abdomen, upper arm, or thigh. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of LEQVIO for adults and pediatric patients aged 12 years and older is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months. If a planned dose is missed by less than 3 months, administer LEQVIO and maintain dosing according to the patient’s original schedule. If a planned dose is missed by more than 3 months, restart with a new dosing schedule - administer LEQVIO initially, again at 3 months, and then every 6 months. Assess LDL-C when clinically indicated. The LDL-lowering effect of LEQVIO may be measured as early as 30 days after initiation and anytime thereafter without regard to timing of the dose. 2.2 Important Administration Instructions LEQVIO should be administered by a healthcare professional. Inj…
Contraindications
4 CONTRAINDICATIONS LEQVIO is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO. Serious hypersensitivity reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2)] . Prior serious hypersensitivity to inclisiran or any of the excipients in LEQVIO.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Common adverse reactions in clinical trials (≥ 3%): injection site reaction, arthralgia, and bronchitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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. Adverse Reactions in Adults with Hypercholesterolemia The data in Table 1 are derived from 3 placebo-controlled trials that included 1,833 adults with hypercholesterolemia treated with LEQVIO, including 1,682 exposed for 18 months (median treatment duration of 77 weeks) [see Clinical Studies (14)] . The mean age of the population was 64 years, 32% of the population were female, 92% were White, 6% were Black or African American, 1% were Asian, and < 1% were other races; 6…
Frequently Asked Questions
What is LEQVIO used for?
Leqvio (inclisiran) is a prescription injection used to lower LDL cholesterol levels in patients who need additional help managing their cholesterol despite taking other cholesterol-lowering medications. It is given as a shot under the skin and works by reducing the production of cholesterol in the liver.
Is LEQVIO a controlled substance?
LEQVIO is not classified as a controlled substance by the DEA.
What is the generic name for LEQVIO?
The generic name for LEQVIO is inclisiran. There are no other listed brand versions of inclisiran.
What is the NDC code for LEQVIO 284 mg/1.5mL?
The NDC (National Drug Code) for LEQVIO 284 mg/1.5mL is 0078-1000, listed by Novartis Pharmaceuticals Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)