Evrysdi available from Europe at insulinhub
Non-english packaging - English label and English insert included. Plan in advance - allow us 7 days to ship your medicine
Manufacturer for Europe:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Information about Evrysdi (Risdiplam)
Evrysdi (generic name: risdiplam) is an FDA-approved oral medication used in the treatment of spinal muscular atrophy (SMA), a rare and debilitating genetic disorder that causes progressive muscle weakness and atrophy. Evrysdi, developed by Roche in collaboration with Plexxikon, works by boosting the production of survival motor neuron (SMN) protein in the body, which is deficient in individuals with SMA. By enhancing SMN protein levels, Evrysdi helps improve motor function and prevent the progression of the disease.
Product Highlights
- Evrysdi is approved for the treatment of spinal muscular atrophy (SMA), which includes:
- SMA in Infants and Children:
Evrysdi is approved for use in infants aged 2 months or older, as well as children and adults who have SMA Type 1, Type 2, or Type 3. - Adults with SMA:
It is also indicated for adult patients with SMA, especially those with Type 2 or Type 3, who may still benefit from maintaining motor function and preventing disease progression.
Key Ingredient
Key Benefits
- Risdiplam helps increase SMN protein levels, improving motor function in patients with SMA. In clinical studies, patients have demonstrated better motor milestones and motor performance.
- Unlike some other SMA treatments that require injections or infusions, Evrysdi is taken orally, either as a liquid or tablet, which can be more convenient for patients.
- Clinical trials have shown that Evrysdi can provide sustained improvements in motor function over time, even in patients with advanced stages of SMA.
- Evrysdi can be used in infants, children, and adults, making it a versatile treatment option for different age groups with SMA.
Direction of Use
- Dosage for Infants and Children (under 2 years):
The recommended dose for children under 2 years of age is 0.2 mg/kg once daily, administered as an oral solution. - Dosage for Older Children and Adults:
For patients aged 2 years and older, the recommended dose is 5 mg (one tablet) once daily for those weighing 20 kg or more, or 0.25 mg/kg (oral solution) once daily for those weighing less than 20 kg. - The oral solution can be mixed with water, and it should be taken at the same time each day to help maintain consistent levels of the drug in the body.
Safety Concerns
- Common side effects of Evrysdi may include fever, diarrhea, rash, and respiratory infections. While these side effects are typically mild and temporary, they should still be monitored.
- Liver enzyme elevations have been reported in some patients taking Evrysdi, so liver function should be monitored regularly during treatment.
- Evrysdi may increase the risk of respiratory infections, especially in those who have existing lung or respiratory issues, so patients should be closely monitored for signs of infection.
- In infants and young children, any signs of abnormal growth or development should be assessed, although such effects are rare.
Avoid Evrysdi (Risdiplam) If
- If a patient has a known allergy to risdiplam or any of its components, they should not use Evrysdi.
- Patients with severe liver impairment should avoid Evrysdi, as liver function needs to be monitored regularly. Dose adjustments may be required for patients with moderate liver impairment.
- Evrysdi is classified as a Category D drug for pregnancy. This means there is evidence of risk to the fetus, so Evrysdi should be avoided during pregnancy unless the benefits outweigh the risks. Women of childbearing potential should use effective contraception while on treatment.
- It is unclear whether risdiplam is excreted in breast milk, so breastfeeding mothers should exercise caution.It’s recommended to discuss potential risks with a healthcare provider.
