Inclisiran

Inclisiran is a prescription medication used to treat the symptoms of Hypercholesterolemia (high blood cholesterol). 

• Inclisiran is available under the following different brand names: Leqvio

Common side effects of Inclisiran include:

• injection site reaction (redness, itching, rash, swelling, warmth, pain, or drainage at the injection site),
• pain in arms, hands, legs, or feet, and
• diarrhea

Serious side effects of Inclisiran include:

• Hives, 
• Difficulty breathing, 
• Swelling of the face, lips, tongue, or throat, 
• Increased urge to urinate, 
• Pain with urination,
• Blood in the urine 
• Cough with or without mucus, 
• Chest pressure, 
• Fatigue, 
• Mild headache, 
• Body aches, and 
• Sore throat

Rare side effects of Inclisiran include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable subcutaneous solution

• 284 mg/1.5 mL (prefilled syringe)

Hypercholesterolemia

Adult dosage

• 284 mg subcutaneous into 1 dose initially
• Repeat in 3 months and then every 6 months thereafter

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Inclisiran has no noted severe interactions with any other drugs.
• Inclisiran has no noted serious interactions with any other drugs.
• Inclisiran has no noted moderate interactions with any other drugs.
• Inclisiran has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Inclisiran?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Inclisiran?”

Cautions

• None

Pregnancy and Lactation

• No data are available on use in pregnant females for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Discontinue therapy when pregnancy is recognized
• Based on the mechanism of action, therapy may cause fetal harm when administered to pregnant females
• Lactation
  • There is no information on drug presence in human milk, effects on breastfed infants, or effects on milk production
  • Inclisiran was present in the milk of lactating rats in all dosing groups
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk
  • Oligonucleotide-based products usually have poor bioavailability; consider it unlikely that low levels of inclusion present in milk will adversely impact an infant’s development during lactation