Spinraza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Spinraza?

Spinraza (nusinersen) injection is a survival motor neuron-2 (SMN2)- directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

What Are Side Effects of Spinraza?

Spinraza may cause serious side effects including:

hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
easy bruising,
unusual bleeding (nose, mouth, vagina, or rectum),
purple or red pinpoint spots under your skin,
chest pain,
shortness of breath,
red skin rash,
foamy urine,
red or brown colored urine, and
swelling in your face, stomach, hands, or feet

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Spinraza include:

lower respiratory infection,
upper respiratory infection, and
constipation,
teething,
congestion,
ear infection, and
scoliosis.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Spinraza

The recommended dosage of Spinraza is 12 mg (5 mL) per administration. Initiate Spinraza treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose. A maintenance dose should be administered once every 4 months thereafter.

What Drugs, Substances, or Supplements Interact with Spinraza?

Spinraza may interact with other drugs. Tell your doctor all medications and supplements you use.

Spinraza During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Spinraza; it is unknown if it will affect a fetus. It is unknown if Spinraza passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Spinraza (nusinersen) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Spinraza Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
chest pain, shortness of breath;
a red skin rash; or
kidney problems--foamy urine; red or brown colored urine; swelling in your face, stomach, hands, or feet.

Nusinersen may affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

headache;
back pain;
nausea, vomiting, constipation; or
cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Spinraza Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in detail in other sections of the labeling:

Thrombocytopenia and Coagulation Abnormalities [see WARNINGS AND PRECAUTIONS]
Renal Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of SPINRAZA cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

In clinical studies, 346 patients (47% male, 76% Caucasian) were treated with SPINRAZA, including 314 exposed for at least 6 months, 258 exposed for at least 1 year, and 138 exposed for at least 2 years. The safety of SPINRAZA was studied in presymptomatic infants with SMA; pediatric patients (approximately 3 days to 16 years of age at first dose) with symptomatic SMA; in a sham-controlled trial in infants with symptomatic SMA (Study 1; n=80 for SPINRAZA, n=41 for control); in a sham-controlled trial in children with symptomatic SMA (Study 2; n=84 for SPINRAZA, n=42 for control); in an open-label study in presymptomatic infants (Study 3, n=25) and other studies in symptomatic infants (n=54) and later-onset patients (n=103). In Study 1, 58 patients were exposed for at least 6 months and 28 patients were exposed for at least 12 months. In Study 2, 84 patients were exposed for at least 6 months and 82 patients were exposed for at least 12 months.

Clinical Trial in Infantile-Onset SMA (Study 1)

In Study 1, baseline disease characteristics were largely similar in the SPINRAZA-treated patients and sham-control patients except that SPINRAZA-treated patients at baseline had a higher percentage compared to sham-control patients of paradoxical breathing (89% vs 66%), pneumonia or respiratory symptoms (35% vs 22%), swallowing or feeding difficulties (51% vs 29%), and requirement for respiratory support (26% vs 15%).

The most common adverse reactions that occurred in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients 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 Study 1 were infants, adverse reactions that are verbally reported could not be assessed in this study.

Table 1: Adverse Reactions that Occurred in at Least 5% of SPINRAZA Patients and Occurred at Least 5% More Frequently or At Least 2 Times as Frequently Than in Control Patients with Infantile-Onset SMA (Study 1)

Adverse Reactions	SPINRAZA 12 mg¹ N = 80 %	Sham-Procedure Control N = 41 %
Lower respiratory infection²	55	37
Constipation	35	22
Teething	18	7
Urinary tract infection	9	0
Upper respiratory tract congestion	8	2
Ear infection	6	2
Flatulence	5	2
Decreased weight	5	2
¹ Loading doses followed by 12 mg (5 mL) once every 4 months ² Includes adenovirus infection, bronchiolitis, bronchitis, bronchitis viral, corona virus infection, Influenza, lower respiratory tract infection, lower respiratory tract infection viral, lung infection, parainfluenzae virus infection, pneumonia, pneumonia bacterial, pneumonia influenzal, pneumonia moraxella, pneumonia parainfluenzae viral, pneumonia pneumococcal, pneumonia pseudomonal, pneumonia respiratory syncytial viral, pneumonia viral, and respiratory syncytial virus bronchiolitis.

In an open-label clinical study in infants with symptomatic SMA, severe hyponatremia was reported in a patient treated with SPINRAZA requiring salt supplementation for 14 months.

Cases of rash were reported in patients treated with SPINRAZA. One patient, 8 months after starting SPINRAZA treatment, developed painless red macular lesions on the forearm, leg, and foot over an 8-week period. The lesions ulcerated and scabbed over within 4 weeks, and resolved over several months. A second patient developed red macular skin lesions on the cheek and hand ten months after the start of SPINRAZA treatment, which resolved over 3 months. Both cases continued to receive SPINRAZA and had spontaneous resolution of the rash. 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.

Clinical Trial In Later-Onset SMA (Study 2)

In Study 2, baseline disease characteristics were largely similar in the SPINRAZA-treated patients and sham-control patients except for the proportion of SPINRAZA-treated patients who had ever achieved the ability to stand without support (13% vs 29%) or walk with support (24% vs 33%).

The most common adverse reactions that occurred in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were pyrexia, headache, vomiting, and back pain.

Table 2: Adverse Reactions that Occurred in at Least 5% of SPINRAZA Patients and Occurred at Least 5% More Frequently or At Least 2 Times as Frequently Than in Control Patients with Later-Onset SMA (Study 2)

Adverse Reactions	SPINRAZA 12 mg¹ N=84 %	Sham-Procedure Control N=42 %
Pyrexia	43	36
Headache	29	7
Vomiting	29	12
Back pain	25	0
Epistaxis	7	0
Fall	5	0
Respiratory tract congestion	5	2
Seasonal allergy	5	2
¹ Loading doses followed by 12 mg (5 mL) once every 6 months

Post-lumbar puncture syndrome has also been observed after administration of SPINRAZA.

Immunogenicity

As with all oligonucleotides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to nusinersen in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

The immunogenic response to nusinersen was evaluated in 294 patients with post-baseline plasma samples for anti-drug antibodies (ADAs). Seventeen patients (6%) developed treatment-emergent ADAs, of which 5 were transient, 12 were considered to be persistent. Persistent was defined as having one positive test followed by another one more than 100 days after the first positive test. In addition, “persistent” is also defined as having one or more positive samples and no sample more than 100 days after the first positive sample. Transient was defined as having one or more positive results and not confirmed to be persistent. There are insufficient data to evaluate an effect of ADAs on clinical response, adverse events, or the pharmacokinetic profile of nusinersen.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SPINRAZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious infections associated with lumbar puncture, such as meningitis, have been observed. Hydrocephalus, aseptic meningitis, and hypersensitivity reactions (e.g. angioedema, urticaria, rash) have also been reported.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Spinraza (Nusinersen)

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