Eplontersen

Eplontersen is a prescription medication used for the treatment of hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN).

• Eplontersen is available under the following different brand names: Wainua.

Common side effects of Eplontersen include:

• decreased in serum vitamin A 
• vomiting

Serious side effects of Eplontersen include:

• low vitamin A level

Rare side effects of Eplontersen 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

Injectable, solution for SC

• 45 mg/0.8 mL

Hereditary transthyretin amyloidosis

Adult dosage

• 45 mg SC once monthly

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, healthcare provider, or pharmacist first.

• Eplontersen has no noted severe interactions with any other drugs
• Eplontersen has no noted serious interactions with any other drugs
• Eplontersen has no noted moderate interactions with any other drugs
• Eplontersen 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 the products you use. 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, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Reduced serum vitamin A levels and supplementation
• Treatment leads to decreased serum vitamin A levels
• Supplement vitamin A at the recommended daily allowance
• Do not give higher doses to try to achieve normal serum vitamin A levels during treatment, as serum vitamin A levels do not reflect the total vitamin A in the body
• Refer patients to an ophthalmologist if ocular symptoms develop suggestive of vitamin A deficiency (eg, night blindness, dry eyes)
• Instruct patient to inform healthcare provider if taking vitamin A or beta-carotene supplements

Pregnancy and Lactation

• Data are unavailable regarding use in pregnant women regarding the drug-associated risk of adverse developmental outcomes
• Vitamin A
  • Eplontersen treatment leads to a decrease in serum vitamin A levels and vitamin A supplementation is advised for patients taking eplontersen
  • Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects
  • The effect of vitamin A supplementation on the fetus in the setting of a reduction in maternal serum TTR caused by eplontersen administration is unknown
• Lactation
  • Data are not available regarding the presence of eplontersen in human milk, its effects on breastfed infants, or its effects on milk production