Register for January 9, 2018 Webinar

 

Science & Innovation Theater Webinar 

 

Clinical Overview of a Treatment for SMA
Sponsored by Biogen


Tuesday, January 9, 2018, at 2:00 PM ET, 1:00 PM CT, 11 AM PT

This content is intended for health care professional and payer audiences. 

Please join us for an in-depth clinical overview of a treatment for SMA by a clinical specialist.

The presentation will highlight the clinical profile of SPINRAZA® (nusinersen), including efficacy and safety data. In addition, the presentation will discuss other relevant information regarding SPINRAZA, including an overview of the clinical study designs, efficacy results, adverse events, dosing and administration, and mechanism of action.

This webinar is sponsored, developed and presented by the sponsor. The content of the Science & Innovation Theater Webinar and opinions expressed by the presenters are those of the sponsor or presenters and not of the Academy of Managed Care Pharmacy. 

INDICATION 

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

IMPORTANT SAFETY INFORMATION 

Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications. Perform a platelet count and coagulation laboratory testing at baseline and prior to each administration of SPINRAZA and as clinically needed.

In a clinical study, 11% of SPINRAZA-treated patients with normal or above normal platelet levels at baseline developed a platelet level below the lower limit of normal compared to zero sham-procedure control patients. No patient had a platelet count <50,000 cells per mcL and no patient developed a sustained low platelet count despite continued drug exposure.

Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides.

SPINRAZA is present in and excreted by the kidney. In a clinical study (mean treatment exposure 7 months), 33% of SPINRAZA-treated patients had elevated urine protein, compared to 20% of sham-control patients. In a group of later-onset SMA patients (mean treatment exposure 34 months), 69% had elevated urine protein.

No elevations in serum creatinine or cystatin C were observed in studies with SPINRAZA. Conduct quantitative spot urine protein testing (preferably using a first morning urine specimen) at baseline and prior to each dose of SPINRAZA. For urinary protein concentration >0.2 g/L, consider repeat testing and further evaluation.

Severe hyponatremia was reported in an infant treated with SPINRAZA requiring salt supplementation for 14 months.

Cases of rash were reported in patients treated with SPINRAZA.

SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment.

The most common adverse reactions that occurred in the controlled study in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were upper respiratory infection (39% vs 34%), lower respiratory infection (43% vs 29%), and constipation (30% vs 22%). Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (14%) than in control patients (5%). Because patients in the controlled study were infants, adverse reactions that are verbally reported could not be assessed in this study. In the open-label studies, the most common adverse events in later onset patients were headache (50%), back pain (41%) and post lumbar puncture syndrome (41%).

Please see full Prescribing Information for additional Important Safety Information. 

Sponsored by:  

 New Biogen Logo   

** IMPORTANT: AMCP webinars are limited to the first 500 that join the webinar. However, AMCP will provide a link to the recording and slides to all registrants within a week from the webinar date. The recording and slides of sponsored webinars will be provided if permitted by the sponsor.