onasemnogene abeparvovec (Rx)

Brand and Other Names:Zolgensma, onasemnogene abeparvovec-xioi
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Dosing & Uses

AdultPediatric

See Pediatric Dosing

Dosage Forms & Strengths

suspension for IV infusion

  • Provided in a kit containing 2 to 9 vials, as a combination of 2 vial fill volumes (either 5.5 mL or 8.3 mL)
  • All vials have a nominal concentration of 2 x 10^13 vector genomes (vg) per mL
  • Each vial contains an extractable volume of not less than either 5.5 mL or 8.3 mL

Spinal Muscular Atrophy Type 1

Indicated for gene replacement therapy in children aged <2 years with spinal muscular atrophy (SMA) type 1 (also called Werdnig-Hoffman disease) who have biallelic mutation in the survival motor neuron 1 (SNM1) gene

≥2 years: Safety and efficacy not established

Administered as a one-time, single IV infusion through a venous catheter

1.1 x 10^14 vector genomes per kilogram (vg/kg) of body weight

Dose calculation

  • See prescribing information for weight-range dosing chart
  • Age <2 yr weighing 2.6-13.5 kg: Dose volume calculated using upper limit of patient weight range
  • Age <2 yr weighing ≥13.6 kg: Dose volume will require a combination of onasemnogene abeparvovec kits

Prior to infusion

  • Assess liver function
  • Measure creatinine, CBC (including HgB and platelet counts), and troponin-I
  • Perform baseline testing for presence of anti-AAV9 antibodies
  • 1 day before infusion: Begin systemic corticosteroids equivalent to oral prednisolone 1 mg/kg/day for a total of 30 days

Dosing Considerations

Limitations of use

  • Safety and effectiveness of repeat administration has not been evaluated
  • Use for advanced SMA (eg, complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated
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Interactions

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            Contraindicated (16)

            • adenovirus types 4 and 7 live, oral

              onasemnogene abeparvovec decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • BCG vaccine live

              onasemnogene abeparvovec decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • cholera vaccine

              onasemnogene abeparvovec decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • dengue vaccine

              onasemnogene abeparvovec decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • influenza virus vaccine quadrivalent, intranasal

              onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • measles (rubeola) vaccine

              onasemnogene abeparvovec decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • measles mumps and rubella vaccine, live

              onasemnogene abeparvovec decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • measles, mumps, rubella and varicella vaccine, live

              onasemnogene abeparvovec decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • rotavirus oral vaccine, live

              onasemnogene abeparvovec decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • rubella vaccine

              onasemnogene abeparvovec decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • smallpox (vaccinia) vaccine, live

              onasemnogene abeparvovec decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • typhoid polysaccharide vaccine

              onasemnogene abeparvovec decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • typhoid vaccine live

              onasemnogene abeparvovec decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • varicella virus vaccine live

              onasemnogene abeparvovec decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • yellow fever vaccine

              onasemnogene abeparvovec decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • zoster vaccine live

              onasemnogene abeparvovec decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            Serious - Use Alternative (0)

              Monitor Closely (31)

              • anthrax vaccine adsorbed

                onasemnogene abeparvovec decreases effects of anthrax vaccine adsorbed by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • haemophilus influenzae type b vaccine

                onasemnogene abeparvovec decreases effects of haemophilus influenzae type b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • hepatitis A vaccine inactivated

                onasemnogene abeparvovec decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • hepatitis a/b vaccine

                onasemnogene abeparvovec decreases effects of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • hepatitis b vaccine

                onasemnogene abeparvovec decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • HIV vaccine

                onasemnogene abeparvovec decreases effects of HIV vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • human papillomavirus vaccine, nonavalent

                onasemnogene abeparvovec decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • human papillomavirus vaccine, quadrivalent

                onasemnogene abeparvovec decreases effects of human papillomavirus vaccine, quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza A (H5N1) vaccine

                onasemnogene abeparvovec decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                onasemnogene abeparvovec decreases effects of influenza virus vaccine (H5N1), adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine quadrivalent

                onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine quadrivalent, adjuvanted

                onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine quadrivalent, cell-cultured

                onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent, cell-cultured by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine quadrivalent, recombinant

                onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine trivalent

                onasemnogene abeparvovec decreases effects of influenza virus vaccine trivalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                onasemnogene abeparvovec decreases effects of influenza virus vaccine trivalent, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • influenza virus vaccine trivalent, recombinant

                onasemnogene abeparvovec decreases effects of influenza virus vaccine trivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • Japanese encephalitis virus vaccine

                onasemnogene abeparvovec decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • meningococcal A C Y and W-135 diphtheria conjugate vaccine

                onasemnogene abeparvovec decreases effects of meningococcal A C Y and W-135 diphtheria conjugate vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • meningococcal A C Y and W-135 polysaccharide vaccine combined

                onasemnogene abeparvovec decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • meningococcal group B vaccine

                onasemnogene abeparvovec decreases effects of meningococcal group B vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • pneumococcal vaccine 13-valent

                onasemnogene abeparvovec decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • pneumococcal vaccine heptavalent

                onasemnogene abeparvovec decreases effects of pneumococcal vaccine heptavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • pneumococcal vaccine polyvalent

                onasemnogene abeparvovec decreases effects of pneumococcal vaccine polyvalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • poliovirus vaccine inactivated

                onasemnogene abeparvovec decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • rabies vaccine

                onasemnogene abeparvovec decreases effects of rabies vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • rabies vaccine chick embryo cell derived

                onasemnogene abeparvovec decreases effects of rabies vaccine chick embryo cell derived by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating

                onasemnogene abeparvovec decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • smallpox (vaccinia) vaccine, attenuated

                onasemnogene abeparvovec decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • tetanus toxoid adsorbed or fluid

                onasemnogene abeparvovec decreases effects of tetanus toxoid adsorbed or fluid by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • zoster vaccine recombinant

                onasemnogene abeparvovec decreases effects of zoster vaccine recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              Minor (0)

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                Adverse Effects

                >10%

                Elevated aminotransferases (>ULN) (27.3%)

                1-10%

                Vomiting (6.8%)

                Postmarketing Reports

                Blood and lymphatic system disorders: Thrombotic microangiopathy

                General disorders and administration site conditions: Pyrexia

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                Warnings

                Black Box Warnings

                Acute serious liver injury and elevated aminotransferases can occur

                Patients with pre-existing liver impairment may be at higher risk

                Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing (eg, AST, ALT, total bilirubin, prothrombin time)

                Administer systemic corticosteroid to all patients before and after onasemnogene abeparvovec infusion

                Continue monitoring liver function for at least 3 months after infusion

                Contraindications

                None

                Cautions

                Acute serious liver injury can occur; before infusion, assess liver function; continue monitoring liver function for at least 3 months after onasemnogene abeparvovec infusion; manage elevated aminotransferase with corticosteroids

                Transient decreases in platelet counts, some meeting criteria for thrombocytopenia, observed after infusion; monitor platelet counts before infusion and regularly afterwards (weekly for first month; q2wk for next 2 months)

                Thrombotic microangiopathy (TMA) reported ~1 week after infusion, characterized by thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury; concurrent immune system activation (eg, infections, vaccinations) were identified in some cases; monitor platelet counts and signs/symptoms of TMA (eg, hypertension, bruising, seizures, decreased urine output)

                Transient increases in cardiac troponin-I levels observed after infusion; clinical importance of these findings are unknown; cardiac toxicity observed in animal studies; monitor troponin-I before infusion and then for at least 3 months afterwards (weekly for first month; q2wk for next 2 months)

                Drug interaction overview

                • Where feasible, adjust vaccination schedule to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion
                • Certain vaccines (eg, MMR, varicella) are contraindicated for patients on a substantially immunosuppressive steroid dose (ie, ≥2 weeks of prednisone 2 mg/kg/day or 20 mg/day or equivalent)
                • Seasonal RSV prophylaxis is not precluded
                • Refer to CDC vaccination guidelines for immunosuppressed patients
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                Pregnancy

                Pregnancy

                There are no data regarding use in pregnant women

                No animal reproductive studies conducted

                Lactation

                Unknown if secreted in human milk

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Recombinant AAV9-based gene therapy designed to deliver a copy of the gene encoding the human survival motor neuron (SMN) protein

                Spinal muscular atrophy is caused by a bi-allelic mutation in the SMN1 gene, which results in insufficient SMN protein expression

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                Administration

                IV Preparation

                Thaw before use; contents of kit will thaw in ~12 hr if refrigerator or ~4 hr if at room temperature

                If thawed in refrigerator, remove from refrigerator on day of dosing

                When thawed, should appear clear to slightly opaque, colorless to faint white liquid, free of particles

                Visually inspect vials for particulate matter and discoloration before infusion

                Do not use vials if particulates or discoloration are present

                Do NOT shake

                Draw the appropriate dose volume from all vials into a syringe, remove air from the syringe, cap the syringe, and deliver the syringe at room temperature to the patient infusion location

                Use within 8 hr of drawing into syringe

                Discard the vector-containing syringe if the drug is not infused within the 8-hr time frame

                IV Administration

                For single-dose slow IV infusion only; do NOT infuse as an IV push or bolus

                Place primary catheter into vein (generally a peripheral vein in the arm or leg)

                Insertion of a back-up catheter is recommended

                Program syringe pump for saline priming, or prime tubing manually with saline

                Administer as a slow IV infusion over 60 minutes

                Flush line with saline following completion of infusion

                Storage

                Product is shipped and delivered frozen (≤ -60°C [-76°F]) in clear vials

                Upon receipt, immediately place the kit in refrigerator at 2-8°°C (36-46F)

                Stable for 14 days from receipt when stored refrigerated as directed

                Do NOT refreeze

                Must use within 14 days of receipt

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                Images

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.