Sybrava 284 mg/1.5 mL Solution for Injection

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). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. …

• 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
• LEQVIO should be administered by a healthcare professional
• Inject LEQVIO subcutaneously into the abdomen, upper arm, or thigh
• 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
• Important Administration Instructions LEQVIO should be administered by a healthcare professional
• Inject LEQVIO subcutaneously into the abdomen, upper arm, or thigh
• Do not inject in areas of active skin disease or injury, such as sunburns, skin rashes, inflammation, or skin infections
• Inspect LEQVIO visually before use
• It should appear clear and colorless to pale yellow
• Do not use if particulate matter or discoloration is seen. …

Injection: 284 mg/1.5 mL (189 mg/mL) of inclisiran as a clear and colorless to pale yellow solution in a single-dose prefilled syringe. Injection: 284 mg/1.5 mL (189 mg/mL) in a single-dose prefilled syringe. ( 3 )

• The safety and effectiveness of LEQVIO as an adjunct to diet and other LDL-C-lowering therapies
• For the treatment of HeFH have been established
• In pediatric patients aged 12 years and older. Use of LEQVIO for this indication is based on data from a 12-month, randomized, placebo-controlled, double-blind study in 141
• Pediatric patients with HeFH
• This indication is also supported by evidence from an adequate and well-controlled study
• In adults with HeFH. …

Of the 1,833 patients treated with LEQVIO in clinical trials, 981 (54%) patients were 65 years of age and older, while 239 (13%) patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.

• Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus
• Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if LEQVIO should be discontinued [see Use in Specific Populations ]
• Advise women who are exposed to LEQVIO during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes
• Encourage these patients to report their pregnancy to Novartis at 1-888-669-6682 or usdrugsafety.operations@novartis.com [see Use in Specific Populations ] . …

• 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 ]
• Prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO

Hypersensitivity Reactions: Have been reported in patients treated with LEQVIO. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to seek medical attention promptly. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients treated with LEQVIO [see Adverse Reactions (6.2)] . Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to seek medical attention promptly. LEQVIO is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO.

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. …

8.1 Pregnancy Risk Summary Discontinue LEQVIO when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Inclisiran increases LDL-C uptake and lowers LDL-C levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, LEQVIO may cause fetal harm when administered to pregnant patients based on the mechanism of action …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.