Exondys 51

Last updated on RxList: 7/20/2020
Exondys 51 Side Effects Center

What Is Exondys 51?

Exondys 51 (eteplirsen) injection 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 51 skipping.

What Are Side Effects of Exondys 51?

Common side effects of Exondys 51 include:

Dosage for Exondys 51

The dose of Exondys 51 is 30 milligrams per kilogram of body weight once weekly.

What Drugs, Substances, or Supplements Interact with Exondys 51?

Exondys 51 may interact with other drugs. Tell your doctor all medications and supplements you use.

Exondys 51 During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Exondys 51; it is unknown if it would affect a fetus. It is unknown if Exondys 51 passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Exondys 51 (eteplirsen) injection 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.

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Exondys 51 Consumer Information

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Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • pain, bruising, itching, skin rash, or other irritation where the medicine was injected;
  • vomiting;
  • joint pain;
  • problems with balance; 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 Exondys 51 (Eteplirsen Injection)

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Exondys 51 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 EXONDYS 51 clinical development program, 107 patients received at least one intravenous dose of EXONDYS 51, ranging between 0.5 mg/kg (0.017 times the recommended dosage) and 50 mg/kg (1.7 times the recommended dosage). All patients were male and had genetically confirmed Duchenne muscular dystrophy. Age at study entry was 4 to 19 years. Most (89%) patients were Caucasian.

EXONDYS 51 was studied in a double-blind, placebo-controlled study for 24 weeks (Study 1), followed by an open label extension (Study 2). In Study 1, 12 patients were randomized to receive weekly intravenous infusions of EXONDYS 51 (n=8) or placebo (n=4) for 24 weeks. All 12 patients continued in Study 2 and received open-label EXONDYS 51 weekly for up to 208 weeks.

In Study 1, 4 patients received placebo, 4 patients received EXONDYS 51 30 mg/kg, and 4 patients received EXONDYS 51 50 mg/kg (1.7 times the recommended dosage). In Study 2, 6 patients received EXONDYS 51 30 mg/kg/week and 6 patients received EXONDYS 51 50 mg/kg/week [see Clinical Studies].

Adverse reactions that occurred in 2 or more patients who received EXONDYS 51 and were more frequent than in the placebo group in Study 1 are presented in Table 1 (the 30 and 50 mg/kg groups are pooled). Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended [see DOSAGE AND ADMINISTRATION].

The most common adverse reactions were balance disorder and vomiting.

Table 1: Adverse Reactions in DMD Patients Treated with 30 or 50 mg/kg/week1 EXONDYS 51 with Incidence at Least 25% More than Placebo (Study 1)

Adverse ReactionsEXONDYS 51
(N=8)%
Placebo
(N=4)%
Balance disorder380
Vomiting380
Contact dermatitis250
1 50 mg/kg/week = 1.7 times the recommended dosage

In the 88 patients who received ≥30 mg/kg/week of EXONDYS 51 for up to 208 weeks in clinical studies, the following events were reported in ≥10% of patients and occurred more frequently than on the same dose in Study 1: vomiting, contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection.

Hypersensitivity reactions have occurred in patients treated with EXONDYS 51 [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Exondys 51 (Eteplirsen Injection)

© Exondys 51 Patient Information is supplied by Cerner Multum, Inc. and Exondys 51 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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