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Risdiplam is available as 60 mg of Risdiplam as a powder for constitution to provide 0.75 mg/mL solution.

Risdiplam is an RNA splicing modifier that is used to treat spinal muscular atrophy (SMA) in adults and children.

Risdiplam is a survival of motor neuron 2 (SMN2)-directed RNA splicing modifier. It helps your body make more SMN protein that works properly. This is thought to help improve motor skills in people with SMA.

The dose is based on your age and body weight. Take Risdiplam after a meal at the same time every day.

• Younger than 2 months of age: The typical dose is 0.15 mg/kg by mouth once daily
• Age 2 months to under 2 years: The typical dose is 0.2 mg/kg by mouth once daily
• Age 2 years and older who weigh less than 20 kg (44 lbs): The typical dose is 0.25 mg/kg by mouth once daily
• Age 2 years and older who weigh 20 kg (44 lbs) or more: The typical dose is 5 mg by mouth once daily

Risdiplam is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Risdiplam:

• Fever
• Diarrhea
• Rash

Serious side effects are rare with Risdiplam.

The following medications may interact with Risdiplam:

• Avoid coadministration with drugs that are substrates of multidrug and toxin extrusion (MATE) transporters

Various FDA-approved generic manufacturers

Risdiplam may harm your unborn baby.
If you are a woman who can become pregnant:
Before you start your treatment with Risdiplam, your healthcare provider may test you for pregnancy. Because Risdiplam may harm your unborn baby, you and your healthcare provider will decide if taking Risdiplam is right for you during this time. Talk to your healthcare provider about birth control methods that may be right for you. Use birth control while on treatment and for at least 1 month after stopping Risdiplam. Pregnancy Registry. There is a pregnancy registry for women who take Risdiplam during pregnancy. The purpose of this registry is to collect information about the health of the pregnant woman and her baby. If you are pregnant or become pregnant while receiving Risdiplam, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Risdiplam Pregnancy Registry. Your healthcare provider can enroll you in this registry or you can enroll by calling 1-833-760-1098 or visiting Risdiplam pregnancy registry

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