Inclisiran
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
| Target | Action | Gene / 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
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
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
If inclisiran is required by the mother, it is not a reason to discontinue breastfeeding.
Registered Products (1)
| Brand | Form / strength | Pack | Agent | Citizen (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 | — |