Amondys 45

Amondys 45 (casimersen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.

Side effects of Amondys 45 include:

• upper respiratory tract infection,
• cough,
• fever,
• headache,
• joint pain,
• mouth and throat pain,
• ear pain,
• ear infection,
• nausea,
• post-traumatic pain,
• dizziness, and
• lightheadedness

Monitoring to Assess Safety

Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio (UPCR) should be measured before starting Amondys 45. Consider measurement of glomerular filtration rate prior to initiation of Amondys 45. Monitoring for kidney toxicity during treatment is recommended. Obtain the urine sample prior to infusion of Amondys 45 or at least 48 hours after infusion.

Dosing Information

The recommended dosage of Amondys 45 is 30 milligrams per kilogram administered once weekly as a 35 to 60-minute intravenous infusion via an in-line 0.2 micron filter.

If a dose of Amondys 45 is missed, it may be administered as soon as possible after the scheduled dose.

• There are no human or animal data available to assess the use of Amondys 45 during pregnancy.
• There are no human or animal data to assess the effect of Amondys 45 on milk production, the presence of casimersen in milk, or the effects of Amondys 45 on the breastfed infant.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Amondys 45 and any potential adverse effects on the breastfed infant from Amondys 45 or from the underlying maternal condition.