What is Leqvio?
Leqvio (generic name: inclisiran) is a prescription medication used to lower low-density lipoprotein cholesterol (LDL-C) in adults with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). It is typically used alongside diet and statin therapy to help further reduce cholesterol levels.
Efficacy And Statistics Of Leqvio (inclisiran)
1. LDL Reduction (Efficacy Data from ORION Trials)
Primary Endpoint (LDL-C % reduction at Day 510):
- ORION-9 (HeFH patients): 48%
- ORION-10 (ASCVD patients): 52%
- ORION-11 (ASCVD & high-risk patients): 50%
Time to Maximum LDL Reduction:
- Peak LDL reduction occurs at ~150 days after first dose.
- Consistent ~50% LDL reduction maintained over 18 months.
Other Lipid Effects (ORION-10 & ORION-11 Data):
| Lipid Parameter | % Change vs. Placebo |
|---|---|
| LDL-C | ↓ 50-52% |
| Non-HDL-C | ↓ 45% |
| Total Cholesterol | ↓ 30% |
| ApoB (Atherogenic) | ↓ 40% |
| Triglycerides | ↓ 10-15% |
2. Pharmacokinetics (PK Data)
Absorption & Distribution:
- Peak plasma concentration (Tmax): ~6 hours post-injection.
- Bioavailability: 100% (subcutaneous injection).
- Volume of distribution (Vd): ~500 L.
Metabolism & Elimination:
- Half-life (t½): ~9 hours (plasma) but effects last ~6 months due to hepatic RNA interference mechanism.
- Primarily cleared by the liver.
- Excreted mostly as metabolized RNA fragments, with <1% excreted unchanged.
3. Long-Term Safety Data (Pooled ORION Trial Analysis)
| Adverse Event (AE) | Leqvio (%) | Placebo (%) |
|---|---|---|
| Injection-Site Reaction | 8.2% | 0.9% |
| Serious Adverse Events | 22.4% | 22.3% |
| Liver Enzyme Elevation (ALT/AST) | 1.3% | 1.5% |
| Myalgia (Muscle Pain) | 3.1% | 3.2% |
| Neurocognitive Events | <1% | <1% |
- No significant impact on liver or kidney function.
- No increase in diabetes, neurocognitive issues or immune-related events.
4. Comparison With Other LDL-Lowering Drugs
| Drug | LDL Reduction | Dosing Frequency | Administration |
|---|---|---|---|
| Leqvio | ~50% | Every 6 months | Subcutaneous (SC) Injection |
| Repatha (evolocumab) | ~58% | Every 2-4 weeks | SC Injection |
| Praluent (alirocumab) | ~50-60% | Every 2-4 weeks | SC Injection |
| Statins (e.g., Atorvastatin 80 mg) | ~55% | Daily | Oral |
| Ezetimibe | ~18-25% | Daily | Oral |
What Are The Side Effects Of Leqvio (inclisiran)?
1. Common Side Effects (From ORION Trials Data)
| Side Effect | Leqvio (%) | Placebo (%) | Notes |
|---|---|---|---|
| Injection-Site Reactions | 8.2% | 0.9% | Mild redness, pain, or swelling. |
| Joint Pain (Arthralgia) | 3.3% | 2.9% | Similar to placebo. |
| Urinary Tract Infection (UTI) | 3.5% | 3.1% | Slightly increased risk. |
| Diarrhea | 3.0% | 2.8% | Mild and self-limiting. |
| Bronchitis (Respiratory Infection) | 3.2% | 2.8% | No serious lung effects. |
| Fatigue | 2.5% | 2.2% | Mild tiredness in some patients. |
| Nasopharyngitis (Common Cold) | 2.4% | 2.1% | Slight increase in colds. |
- Key Finding: Most common side effects were mild and occurred at a slightly higher rate than placebo.
2. Serious but Rare Side Effects
| Side Effect | Leqvio (%) | Placebo (%) | Notes |
|---|---|---|---|
| Severe Injection-Site Reaction | 0.1% | 0.05% | Rare cases of significant swelling. |
| Liver Enzyme Elevation (ALT/AST) | 1.3% | 1.5% | No significant liver toxicity. |
| Muscle Pain (Myalgia) | 3.1% | 3.2% | Similar to placebo and much lower than statins. |
| Neurocognitive Issues | <1% | <1% | No significant effect on memory or cognition. |
| Kidney Function Impairment | No cases | No cases | No impact on kidney function. |
| Hypersensitivity (Allergy-like Reactions) | Rare (<1%) | Rare (<1%) | Isolated reports of rash or swelling. |
- Key Finding: No significant safety concerns for liver, kidneys or neurocognitive function.
3. Safety Comparison: Leqvio vs. Other LDL-Lowering Drugs
| Side Effect | Leqvio (Inclisiran) | Statins (e.g., Atorvastatin 80 mg) | PCSK9 Inhibitors (e.g., Repatha, Praluent) |
|---|---|---|---|
| LDL Reduction | ~50% | ~55% | ~50-60% |
| Injection-Site Reactions | 8% | N/A (oral) | 20% |
| Muscle Pain (Myalgia) | 3.1% | 5-10% | 2-4% |
| Liver Enzyme Elevation | 1.3% | 1-3% | <1% |
| Neurocognitive Effects | Rare (<1%) | Up to 3% | 1-2% |
| Diabetes Risk Increase | No | Yes (~10-15%) | No |
| Dosing Frequency | Every 6 months | Daily | Every 2-4 weeks |
- Key Takeaways:
✔ Fewer muscle-related side effects than statins.
✔ Lower injection-site reaction rate than PCSK9 inhibitors.
✔ No increased risk of diabetes (statins increase diabetes risk by ~10-15%).
✔ Only 2 injections per year compared to daily pills (statins) or biweekly injections (PCSK9 inhibitors).
What Are The Costs Of Leqvio (inclisiran)?
United States:
- List Price: Approximately $3,373.41 per dose. leqvio.com
- With Commercial Insurance: Patients may pay as little as $0 per treatment, with 75% paying less than $10 and 54% paying nothing in 2022. leqvio.com
- Medicare Part B: Patients with traditional Medicare and supplemental insurance may pay as little as $0. leqvio.com
- Without Insurance: The cost is around $3,611 for a 284 mg/1.5 mL dose. Drugs.com+
International Prices:
- Europe: Approximately €3,262 per dose. everyone.org
- United Kingdom: Around £2,740 per dose. everyone.org
- Australia: Approximately AUD 5,611 per dose.
- Canada: Around CAD 5,056 per dose.
- New Zealand: Approximately NZD 6,133 per dose.
- Nigeria: Around NGN 5,424,641 per dose.
- Singapore: Approximately SGD 4,730 per dose.
Financial Assistance Programs:
Patient Assistance: Novartis offers programs to help patients with limited or no prescription coverage.
Co-pay Programs: Eligible commercially insured patients may pay $0 per treatment, with a maximum savings of $1,800.
What Are The Dosages Of Leqvio (inclisiran)?
Leqvio (Inclisiran) Dosage Information
Standard Dosage Schedule:
- First Dose: 284 mg subcutaneous (SC) injection.
- Second Dose: 284 mg at 3 months after the first dose.
- Maintenance Doses: 284 mg every 6 months thereafter.
Administration Details:
- Given as a single subcutaneous injection into the abdomen, upper arm or thigh.
- Doctor must administer the injection (not for self-injection).
- No dose adjustments are needed for elderly patients or mild-to-moderate kidney/liver impairment.
Where Do You Inject Inclisiran?
Where to Inject Inclisiran (Leqvio)
Inclisiran (Leqvio) is administered via a subcutaneous injection, which means it is injected just under the skin. Recommended injection sites are:
- Abdomen (stomach area)
- Upper arm
- Thigh
Injection Tips:
- Rotate injection sites to avoid irritation or discomfort.
- Do not inject into areas that are red, irritated or have scars.
- Stay hydrated and avoid any extreme skin conditions in the area of injection.
- Ensure the injection is administered by a healthcare professional for proper technique, as it’s not intended for self-injection.
How the Injection Is Done:
- A single-dose 284 mg injection is given at the recommended intervals (first dose, 3-month booster, then every 6 months).
- You will likely be asked to sit or lie down in a comfortable position during the injection.
Tips for Comfortable Leqvio (Inclisiran) Injection
Since Leqvio is administered via subcutaneous injection (under the skin), here are some tips to help make the process more comfortable:
1. Relax Before the Injection
- Take deep breaths and try to relax your muscles. Tension can make the injection feel more uncomfortable.
- Ask your healthcare provider to explain the process beforehand if you’re feeling anxious. Understanding what to expect can help reduce stress.
2. Rotate the Injection Sites
- Avoid injecting in the same spot repeatedly. Rotating between the abdomen, upper arm and thigh helps prevent irritation, redness or discomfort.
- Avoid scar tissue or broken skin when choosing an injection site.
- Leave at least 2.5 cm (1 inch) between injection sites to allow the skin to heal.
3. Use a Clean and Comfortable Environment
- Choose a calm, well-lit environment for the injection. Being in a comfortable place can help reduce stress.
- Wash your hands thoroughly before administering the injection to reduce the risk of infection.
4. Numb the Area for Comfort (Optional)
- If you are particularly sensitive to injections, you can ask your doctor about numbing creams or cold packs.
- Apply a cold pack to the injection site for a few minutes before the injection to numb the skin slightly. This can help reduce the pain of the needle going in.
5. Relax During the Injection
- Try to stay still while the injection is being administered. Flinching or moving too quickly can make the injection feel more painful.
- Deep breathing during the injection can also help you relax and minimize discomfort.
6. Post-Injection Care
- After the injection, you may feel some mild redness or swelling at the site. This is normal and should go away after a few minutes to hours.
- Avoid rubbing the injection site to prevent irritation.
- If there’s excessive pain, swelling or redness, or you notice bleeding, notify your doctor.
7. Stay on Schedule
Remember, Leqvio requires an initial dose, a booster at 3 months and then maintenance every 6 months. Keeping track of your schedule and following through on these injections helps maintain the benefits.
Advices For Leqvio (inclisiran) Users
1. Follow the Correct Dosing Schedule
✔ First Dose → Initial 284 mg injection.
✔ Second Dose → Given 3 months after the first dose.
✔ Maintenance Doses → Every 6 months thereafter.
📌 Tip: Keep track of your injection dates and schedule follow-up appointments on time.
2. Be Aware of Possible Side Effects
🔹 Common Side Effects (usually mild and temporary):
- Injection-site reactions (8.2% of users experience redness, swelling or pain).
- Joint pain (3.3%), urinary tract infections (3.5%), and mild fatigue.
🔹 Rare but Serious Reactions (seek medical help if they occur):
- Severe allergic reactions (rash, swelling, breathing difficulties).
- Liver enzyme elevation (though rare, monitor liver health if needed).
📌 Tip: Report any unusual symptoms to your doctor, especially severe pain, swelling or allergic reactions.
3. Continue Lifestyle & Medication Plan
🔹 Leqvio is NOT a replacement for statins or a healthy lifestyle.
- Maintain a heart-healthy diet (low in saturated fats, high in fiber).
- Exercise regularly and manage weight.
- Keep taking prescribed statins and other cholesterol-lowering drugs unless told otherwise.
📌 Tip: Leqvio works best when combined with diet, exercise, and statins.
4. Insurance & Cost Assistance
- Cost without insurance: ~$3,373 per dose in the U.S.
- With commercial insurance: Many patients pay $0 or low co-pays.
- Medicare/Medicaid patients may qualify for financial assistance.
📌 Tip: Check with your insurance provider or use Novartis’ patient assistance programs to lower costs.
5. Who Should NOT Use Leqvio?
❌ Not recommended for:
- People with a severe allergy to inclisiran or its ingredients.
- Pregnant or breastfeeding women (safety not well studied).
- Children (not approved for those under 18).
📌 Tip: If you’re pregnant or planning pregnancy, discuss alternative cholesterol management with your doctor.
6. Stay in Touch With Your Doctor
- Regular LDL testing: Your doctor will monitor LDL levels before and after Leqvio use.
- Watch for statin interactions: If you’re on high-dose statins, discuss any muscle pain or unusual symptoms.
📌 Tip: Schedule routine cholesterol checks to track progress and adjust treatment if necessary.
