Amondys 45 Side Effects Center

Last updated on RxList: 7/22/2021
Amondys 45 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is 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.

What Are Side Effects of Amondys 45?

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

Dosage for Amondys 45

The dose of Amondys 45 is 30 milligrams per kilogram of body weight once weekly administered as an intravenous (IV) infusion over 35 to 60 minutes via an in-line 0.2-micron filter.

Amondys 45 In Children

Amondys 45 is indicated for the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping, including pediatric patients.

What Drugs, Substances, or Supplements Interact with Amondys 45?

Amondys 45 may interact with other medicines.

Tell your doctor all medications and supplements you use.

Amondys 45 During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Amondys 45; it is unknown how it would affect a fetus. It is unknown if Amondys 45 passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Amondys 45 (casimersen) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amondys 45 Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, blistering or peeling; fever; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pink, brown, or red urine;
  • foamy urine; or
  • swelling in your face, hands, feet, or stomach.

Common side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Amondys 45 (Casimersen Injection)

Amondys 45 Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the AMONDYS 45 clinical development program, 76 patients received at least one intravenous dose of AMONDYS 45 (30 mg/kg). All patients were male and had genetically confirmed Duchenne muscular dystrophy. Age at study entry was 7 to 20 years (mean 9.9 years). Most (88%) patients were White, and 9% were Asian.

AMONDYS 45 was studied in a double-blind, placebo-controlled study (Study 1).

Patients in ongoing Study 1 received AMONDYS 45 (n=57) 30 mg/kg or placebo (n=31) intravenously once weekly for up to 96 weeks, after which all patients received or will receive AMONDYS 45 30 mg/kg for up to 48 weeks.

Adverse reactions observed in ≥20% of patients treated with AMONDYS 45 and 5% more frequently than in the placebo group in Study 1 are shown in Table 1.

Table 1: Adverse Reactions Occurring in at Least 20% of Patients Treated with AMONDYS 45 and at a Rate at Least 5% More Frequently than in the Placebo Group in Study 1

Adverse ReactionAMONDYS 45 30 mg/kg Once Weekly
(n = 57) %
Placebo
(n = 31) %
Upper Respiratory Tract Infections*6555
Cough3326
Pyrexia3323
Headache3219
Arthralgia2110
Oropharyngeal Pain217
*Includes upper respiratory infection, pharyngitis, nasopharyngitis, and rhinitis.

Other adverse reactions that occurred in at least 10% of patients treated with AMONDYS 45, and that were reported at a rate at least 5% more frequently in the AMONDYS 45 group than in the placebo group, were: ear pain, nausea, ear infection, post-traumatic pain, and dizziness and light-headedness.

Read the entire FDA prescribing information for Amondys 45 (Casimersen Injection)

© Amondys 45 Patient Information is supplied by Cerner Multum, Inc. and Amondys 45 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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