New Release: Alpha testing version has been released.

Inclisiran

J01 - Antibacterials for systemic use Oligonucleotide

JFDA label: Leqvio 284 mg / 1.5 ml solution for injection in Pre-filled Syringe

Mechanism of Action

Rnai Inhibitor of PCSK9 mRNA — PCSK9 mRNA RNAi inhibitor

TargetActionGene / class
PCSK9 mRNA efficacy RNAI INHIBITOR

Indications

Off-label

  • Acute Coronary Syndrome
  • Atherosclerosis
  • Cardiovascular Diseases
  • Coronary Disease
  • Hypercholesterolemia
  • Hyperlipoproteinemia Type II

Contraindications

Source: openFDA

  • 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. Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Musculoskeletal and connective tissue disorders (1)

Common Arthralgia

Infections and infestations (1)

Common And Bronchitis 6 To Report Suspected Adverse Reactions

General disorders and administration site conditions (1)

Common Injection Site Reaction

Dosing

Source: openFDA

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. 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. For more detailed instruction on administration of the prefilled syringe, see Instructions for Use.

Warnings & Precautions

Source: openFDA

Warnings & Precautions

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 )

Hypersensitivity Reactions Hypersensitivity reactions, including anaph

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.

Pregnancy & Lactation

Lactation

Compatible Hale L1

If inclisiran is required by the mother, it is not a reason to discontinue breastfeeding.

Registered Products (1)

BrandForm / strengthPackAgentCitizen (JOD)
Leqvio 284 mg / 1.5 ml solution for injection in Pre-filled Syringe Injection 284 mg/1.5 ml 1 SYR/1 BOX The Jordan Drugstore Co