Biogen has provided the following update on resources they have made available for the SMA community:
Biogen recently announced that the U.S. Food and Drug Administration has approved SPINRAZA™ (nusinersen) for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. At Biogen, we understand that there are many challenges that families living with SMA must address on a daily basis. We are committed to providing information, resources, and support to help appropriate patients and their families navigate the SPINRAZA treatment process.
To that end, we have developed the enclosed resources for families seeking information about SPINRAZA and the services Biogen may provide. We created these materials specifically for the SMA community and with the understanding that many families will have pressing questions about the approval of SPINRAZA.
Within the packet you will find the following materials:
- SPINRAZA Q&A
- SPINRAZA Approval Community Statement
- SMA360°™* Brochure
- Brochure: A caregiver’s guide to understanding health insurance options for SMA
- SPINRAZA Now Available Leave Behind
- SPINRAZA Treatment Logistics Graphic
*SMA360° support provides certain services that address non-medical barriers to access. These include: logistical assistance, product education, insurance benefits investigations, and financial assistance. A complete list of the SMA360° offerings can be found at www.SPINRAZA.com/support.
If you have any further questions about Biogen’s support services, please contact an SMA Support Coordinator at 1-844-4SPINRAZA (1-844-477-4672), 8:30 AM – 8:00 PM EST.
INDICATION
SPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.
IMPORTANT SAFETY INFORMATION
Increased risk of bleeding complications has been observed after administration of similar medicines. Your healthcare provider should perform blood tests at baseline and before each dose of SPINRAZA to monitor for early signs of these risks. Seek medical attention if unexpected bleeding occurs.
Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing at baseline and before each dose of SPINRAZA to monitor for early signs of this risk.
The most common side effects of SPINRAZA include upper and lower respiratory tract infections, complete or partial collapse of a lung or lobe of a lung, constipation, headache, back pain, and post-lumbar puncture syndrome.
These are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This information is not intended to replace discussions with your healthcare provider.
Please see full Prescribing Information for additional important safety information.
Regards,
The Team at Biogen