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Starting SPINRAZA/How to start

Help your patients begin treatment and access support for SPINRAZA

Below are the steps needed to initiate treatment. Please keep in mind these are generalized steps; because each patient has unique needs, additional steps may be required.

STEP 1

Discuss the benefits and risks of SPINRAZA with appropriate patients. Download the brochures below to help start the conversation.

Pediatric
Brochure

Information
for Adults

STEP 2

Download and complete the healthcare provider section of the Start Form to prescribe SPINRAZA and enroll your patient in support services.

Download the Start Form (English)

Download the Start Form (Spanish)

STEP 3

Make a photocopy of your patient’s insurance and pharmacy benefit card.

STEP 4

Give your patient the Instructions and Consent Information pages of the Start Form to take home.

 

STEP 5

Send the completed Start Form and copies of the insurance/pharmacy benefit cards to Biogen by fax or email.

Fax: 1-888-538-9781

Email as an attachment: StartForm@biogen.com
Please note this email address is an unattended inbox and is for Start Forms only.

Once Biogen receives the SPINRAZA Start Form, a SPINRAZA Family Access Manager (FAM) or Lead Case Manager (LCM) will contact the patient or parent/guardian to help them navigate the process.

Biogen takes the confidentiality of personal information seriously.

The benefits for patients of granting consent include:

  • Expediting enrollment into SMA360°™* patient
    support services from Biogen, which includes
    help in areas such as treatment logistics,
    insurance, and financial assistance
  • Giving Biogen access to the status of the
    prescription should assistance be required

*SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.

Questions about support
or treatment logistics?

Contact your Biogen Rare Disease Account Executive

1-844-4SPINRAZA
(1-844-477-4672)

SPINRAZA should be administered by, or under
the direction of, a specially trained healthcare
professional able to perform lumbar punctures1

Find a treatment center
Explore dosing & administration

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.

In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 SPINRAZA-treated patients (16%) with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 sham-controlled patients (14%). Two SPINRAZA-treated patients developed platelet counts <50,000 cells per microliter, with the lowest level of 10,000 cells per microliter recorded on study day 28.

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 the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 SPINRAZA-treated patients (58%) had elevated urine protein, compared to 22 of 65 sham-controlled patients (34%).

Laboratory testing and monitoring to assess safety should be conducted. Perform a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing at baseline and prior to each dose of SPINRAZA and as clinically needed.

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 (≥20% of SPINRAZA-treated patients and ≥5% more frequently than in control patients) that occurred in the infantile-onset controlled study were lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (18%) than in control patients (10%). Because patients in this controlled study were infants, adverse reactions that are verbally reported could not be assessed. The most common adverse reactions that occurred in the later-onset controlled study were pyrexia, headache, vomiting, and back pain. Post-lumbar puncture syndrome has also been observed after the administration of SPINRAZA.

INDICATION

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

Please see full Prescribing Information.

As a courtesy, our full Prescribing Information is also available en Español. For prescribing decisions, please refer to official approved labeling.

References

1. SPINRAZA. Prescribing Information. Cambridge, MA: Biogen; 2020.

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ABOUT SMA
What Is SMA Multidisciplinary Care
Why SPINRAZA
About SPINRAZA How SPINRAZA Works Later-Onset Efficacy Early-Onset Efficacy Presymptomatic Efficacy Safety
Starting SPINRAZA
How to Start Find a Treatment Center Dosing & Administration
Patients on Therapy
Adults on SPINRAZA Children on SPINRAZA
Support
Access & Reimbursement SMA360°™ Patient Support

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This site is intended for US Healthcare Professionals only.
SPZ-US-3383 v8 12/22