ETEPLIRSEN - INJECTION

ETEPLIRSEN - INJECTION

PHONETIC PRONUNCIATION: (e-TEP-lir-sen)

COMMON BRAND NAME(S): Exondys 51

GENERIC NAME(S): eteplirsen

Uses

USES: Eteplirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This disorder is caused by a lack of a certain muscle protein (dystrophin). This medication can increase the amount of dystrophin in your body.


How to use ETEPLIRSEN - INJECTION

HOW TO USE: This medication is given by injection into a vein by a health care professional as directed by your doctor. It is usually given once every week over 35 to 60 minutes. The dosage is based on your weight. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

SIDE EFFECTS: Pain at injection site, dizziness, vomiting, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, flushing, cough, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using eteplirsen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for ETEPLIRSEN - INJECTION

Eteplirsen is an injectable medication used for the treatment of Duchenne muscular dystrophy (DMD) in patients with a specific genetic mutation.

Eteplirsen works by skipping a particular section of genetic material called exon 51. This helps in the production of a functional form of the dystrophin protein, which is essential for muscle function.

The recommended dosage of Eteplirsen is based on the patient's weight. Generally, a dose of 30 mg/kg is administered once a week as an intravenous infusion over a period of approximately 35 to 60 minutes.

The common side effects of Eteplirsen include injection site reactions, vomiting, and infections of the upper respiratory tract. It is important to discuss any potential side effects with your healthcare provider.

The effects of Eteplirsen on muscle function vary among individuals. Some patients may experience improvements in muscle strength and function within a few weeks or months, while for others, it may take longer to witness significant benefits.

Eteplirsen is not a cure for Duchenne muscular dystrophy. It is a medication that helps slow down the progression of the disease and improve muscle function in patients with specific genetic mutations.

Some precautions and warnings associated with Eteplirsen include the risk of kidney problems, hypersensitivity reactions, and prolongation of the QT interval (a heart rhythm disorder). It is important to discuss your medical history and any current medications with your healthcare provider before starting Eteplirsen.

Yes, Eteplirsen can be used in children with Duchenne muscular dystrophy who have a specific genetic mutation and meet the eligibility criteria determined by their healthcare provider.

While specific drug interactions with Eteplirsen are not well-established, it is always important to inform your healthcare provider about any medications, supplements, or herbal products you are taking before starting Eteplirsen to avoid any potential interactions.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.