Plozasiran

Plozasiran is a prescription medicine indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

• Plozasiran is available under the following different brand names: Redemplo

Common side effects of Plozasiran include:

• hyperglycemia 
• headache 
• nausea
• injection site reaction (pain, redness, or swelling)

Serious side effects of Plozasiran include:

• not available

Rare side effects of Plozasiran 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, coordination loss, 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

Injection, Solution for subcutaneous

• 25 mg/0.5 mL single-dose prefilled syringe

Familial Chylomicronemia Syndrome

Adult dosage

• 25 mg subcutaneous every 3 months 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• None

Pregnancy and Lactation

Pregnancy

• Data are insufficient regarding use during pregnancy to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Clinical considerations

• Triglyceride levels increase in the third trimester of pregnancy
• In patients with underlying defects in lipid metabolism (eg, FCS), severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy
• Patients with FCS are at risk for pancreatitis during pregnancy because of defects in lipid metabolism and increased triglyceride levels

Lactation

• There is no information regarding the presence of plozasiran in human or animal milk, its effects on breastfed infants, or milk production
• Oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered that if plozasiran is present in breastmilk, it is unlikely to lead to clinically relevant levels in breastfed infants