Understanding Spevigo Prescribing Information: What You Need to Know

Understanding Spevigo Prescribing Information: What You Need to Know

As a healthcare professional, it is crucial to stay informed about the latest medications and their prescribing information. Spevigo (generic name: risdiplam) is a new oral therapy recently approved by the FDA for the treatment of spinal muscular atrophy (SMA) in adults and children aged 2 months and older. In this blog article, we will explore the prescribing information for Spevigo, what it is used for, how it works, and other essential considerations.


SMA is a rare genetic disorder that affects the muscles used for movement, resulting in muscle weakness and wasting. There are different types of SMA, depending on the severity of the symptoms, and it is the leading genetic cause of infant mortality. Until recently, there were no FDA-approved oral treatments for SMA. However, Spevigo is changing the game and providing new hope for patients and their families.

What is Spevigo?

Spevigo is a small molecule therapy that works by increasing the production of a protein called survival motor neuron (SMN) from the SMN2 gene. SMA is caused by a deficiency of functional SMN protein, and Spevigo aims to restore its levels in the body. The medication is administered orally and comes in the form of a liquid that can be mixed with food or drink. The dosage of Spevigo varies depending on the patient’s weight and age, and it should be taken once a day at the same time every day.

Who can take Spevigo?

Spevigo is approved for the treatment of SMA in patients aged 2 months and older. It is essential to note that not all types of SMA are suitable for treatment with Spevigo. The medication is indicated for the treatment of SMA types 1, 2, and 3. Patients with type 4 SMA are not recommended for treatment with Spevigo due to the relatively mild nature of their symptoms.

What are the potential side effects of Spevigo?

Like any medication, Spevigo may cause side effects. The most common side effects reported during clinical trials were fever, diarrhea, rash, and upper respiratory tract infection. These side effects were generally mild to moderate in severity and were manageable with dose adjustments or supportive care. Less common but more severe side effects may include liver damage, low platelet counts, and blood clotting disorders. Patients taking Spevigo should be monitored closely for these potential side effects.

Other considerations

It is essential to note that there are possible drug interactions with Spevigo. Patients who are taking medications that are metabolized by a certain liver enzyme, CYP3A, should exercise caution when taking Spevigo. Other medications that affect blood clotting function may also interact with Spevigo. It is crucial to discuss all medications and supplements with your healthcare provider before starting Spevigo.


Spevigo is a new and exciting treatment option for patients with SMA. Its approval by the FDA marks a significant milestone in the treatment of this rare genetic disorder. As healthcare professionals, it is our duty to stay informed about the latest medications and their prescribing information to help our patients make informed decisions about their healthcare. By understanding the prescribing information for Spevigo, we can provide our patients with the best possible care and support.

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