Risdiplam

Generic name: Risdiplam
Brand names: Evrysdi
Dosage form: oral powder for reconstitution (0.75 mg/mL)
Drug class: Miscellaneous uncategorized agents

Usage of Risdiplam

Risdiplam is used to treat a genetic condition called spinal muscular atrophy (weakness and wasting of the muscles needed for movement of the body).

Risdiplam is for use in adults and children at least 2 months old.

Risdiplam may also be used for purposes not listed in this medication guide.

Risdiplam side effects

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

Risdiplam may cause serious side effects. Call your doctor at once if you have:

  • pain or burning when you urinate; or
  • signs of a lung infection--fever, cough with mucus, chest pain, feeling short of breath.

    • Common side effects of risdiplam may include:

  • fever, lung infection;
  • nausea, vomiting;
  • diarrhea, constipation;
  • rash; 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.

    Before taking Risdiplam

    Risdiplam is not approved for use in a child younger than 2 months old.

    Tell your doctor if you have ever had liver problems.

    You may need to have a negative pregnancy test before starting this treatment. Tell your doctor if you plan to become pregnant.

    Risdiplam may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using risdiplam and for at least 1 month after your last dose. Tell your doctor right away if you become pregnant.

    Risdiplam may affect fertility (ability to have children), in men. Talk to your doctor if you have concerns about this risk.

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    How to use Risdiplam

    Usual Adult Dose for Spinal Muscular Atrophy:

    5 mg orally once a dayComments:-See Other Comments/Administration Advice for important information on dose preparation and administration.Use: For the treatment of spinal muscular atrophy.

    Usual Pediatric Dose for Spinal Muscular Atrophy:

    2 months to less than 2 years: 0.2 mg/kg orally once a day2 years and older weight less than 20 kg: 0.25 mg/kg orally once a day2 years and older weight 20 kg or more: 5 mg orally once a dayComments:-See Other Comments/Administration Advice for important information on dose preparation and administration.Use: For the treatment of spinal muscular atrophy in patients 2 months of age and older.

    Warnings

    Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

    What other drugs will affect Risdiplam

    Other drugs may affect risdiplam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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