Casimersen

Casimersen is a prescription medication used for the treatment of Duchenne Muscular Dystrophy.

• Casimersen is available under the following different brand names: Amondys 45

Common side effects of Casimersen include:

• headache;
• fever;
• joint pain;
• cough; or
• cold symptoms such as stuffy nose, sneezing, and sore throat.

Serious side effects of Casimersen include:

• hives, itching, rash, blistering, or peeling
• fever
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• pink, brown, or red urine;
• foamy urine; or
• swelling in the face, hands, feet, or stomach.

Rare side effects of Casimersen 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 and pediatric dosage

Injection, solution

• 50 mg/mL (2-mL single-dose vial)
• Duchenne Muscular Dystrophy

Adult and pediatric dosage

• 30 mg/kg IV once weekly

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

• Casimersen has no noted severe interactions with any other drugs.
• Casimersen has no noted serious interactions with any other drugs.
• Casimersen has no noted moderate interactions with any other drugs.
• Casimersen 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 Casimersen?”

Long-Term Effects

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

Cautions

Nephrotoxicity

• Based on animal data, may cause nephrotoxicity
• Although not observed in clinical studies with casimersen, nephrotoxicity (eg, potentially fatal glomerulonephritis) observed in some antisense oligonucleotides
• Monitor serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio, and consider GFR
• If persistent increased serum cystatin C or proteinuria is detected, refer the patient to a pediatric nephrologist for further evaluation

Pregnancy and Lactation

• No data are available to assess use during pregnancy

Lactation

• There are no human or animal data to assess effects on milk production, drug presence in milk, or effects on breastfed infants