Dear SMA Community,
Based on our commitment to the SMA community to provide transparent, timely updates related to our medicines, we are writing to share information regarding recent reports of leaking bottles of Evrysdi, and provide information on steps we are initiating as a result. Below we have provided additional details and next steps should you receive a bottle of Evrysdi that shows evidence of leakage.
First, it is important to understand that the bottle leakage is not anticipated to impact the safety or efficacy of the administered drug for people currently taking Evrysdi. Patients can continue to take Evrysdi as clinically indicated until they receive replacement. Caregivers and those involved in preparing and administering Evrysdi, as well as those who might otherwise handle the bottle, may be at risk of drug exposure from getting Evrysdi on the skin, though no associated adverse events have been reported. As with all medications, it is important to store Evrysdi out of sight and reach of children and to follow the instructions in the Evrysdi Instructions for Use (IFU) leaflet when handling Evrysdi.
The safety of patients and their caregivers is our highest priority. The actions that we have outlined in this letter are being taken in collaboration with the U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA). Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents, as required by the Poison Prevention Packaging Act (PPPA). The CPSC alert issued today is available here.
Requested Actions
Please follow the steps below to ensure safe handling and to request replacement for a leaking bottle at no additional cost:
- Upon receipt of a shipment carefully inspect each bottle for leaking.
- If you notice leakage on any bottle, dry off the bottle with a dry paper towel then rinse the closed bottle with water.
- Store the bottle out of sight and out of reach of children.
- Call Genentech Product Complaints at 1-800-334-0290 to coordinate your free replacement and further instructions.
Genentech is taking immediate measures to minimize the leakage, which may occur due to the fit between the Evrysdi bottleneck and the inserted Press in Bottle Adapter (PIBA) and exposure to certain conditions (e.g., when the bottle is not shipped in an upright position). In addition, we are in the process of informing all patients receiving Evrysdi through written correspondence about the potential leakage, and providing guidance on how to inspect the shipment and seek replacement for a bottle that may have leaked. In an effort to ensure that all who support SMA patients are aware of this information, we are likewise providing healthcare professionals with similar updates and direction. Please take the time to read our “Dear Patient” and “Dear Healthcare Provider” letters on our website.
Please know that you have our commitment that we will continue to keep the SMA community informed of additional updates related to this situation should they arise.
What is Evrysdi?
Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. It is not known if Evrysdi is safe and effective in children under 2 months of age.
Important Safety Information
- Before taking Evrysdi, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- are pregnant or plan to become pregnant. If you are pregnant, or are planning to become pregnant, ask your healthcare provider for advice before taking this medicine. Evrysdi may harm your unborn baby.
- are a woman who can become pregnant:
- Before you start your treatment with Evrysdi, your healthcare provider may test you for pregnancy. Because Evrysdi may harm your unborn baby, your healthcare provider will decide if taking Evrysdi 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 Evrysdi
- are an adult male planning to have children: Evrysdi may affect a man’s ability to have children (fertility). If this is of concern to you, make sure to ask a healthcare provider for adviceare breastfeeding or plan to breastfeed. It is not known if Evrysdi passes into breast milk and may harm your baby. If you plan to breastfeed, discuss with your healthcare provider about the best way to feed your baby while on treatment with Evrysdi
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine
- You should receive Evrysdi from the pharmacy as a liquid that can be given by mouth or through a feeding tube. The liquid solution is prepared by your pharmacist. If the medicine in the bottle is a powder, do not use it. Contact your pharmacist for a replacement.
- Avoid getting Evrysdi on your skin or in your eyes. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water
- The most common side effects of Evrysdi include:
- For later-onset SMA:
- fever
- diarrhea
- rash
- For infantile-onset SMA:
- fever
- diarrhea
- rash
- runny nose, sneezing, sore throat, and cough (upper respiratory infection)
- lung infection
- constipation
- vomiting
- For later-onset SMA:
These are not all of the possible side effects of Evrysdi. For more information on the risk and benefits profile of Evrysdi, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see full Prescribing Information for additional Important Safety Information.
Additional Note from Cure SMA:
The impact of this issue, as we currently understand it to be, is relatively minimal as the number of reported bottles is <1% of all bottles distributed to date. Further, while inconvenient for those impacted, the bottle leakage is not anticipated to impact the safety or efficacy of the administered drug. Therefore, patients can continue to safely take Evrysdi as clinically appropriate until they receive a replacement bottle.