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ZOLGENSMA CopayAssist™ Program

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Novartis Gene Therapies offers the ZOLGENSMA CopayAssist™ Program to provide financial support for out-of-pocket costs associated with ZOLGENSMA® (onasemnogene abeparvovec-xioi) for your eligible patients. Please log in to submit a claim and access additional patient and provider information.

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If you have forgotten your Username or Password, please contact the Help Desk at 833-270-4327 (8 AM – 8 PM ET, Monday through Friday, except holidays).

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Health care providers may register for an account in order to submit claims on behalf of enrolled patients. If you are not currently registered with a username and password, please contact the ZOLGENSMA CopayAssist™ Program Help Desk (Monday through Friday, 8 AM – 8 PM ET, except holidays) to set up your account.

If you are a caregiver of a patient and would like to determine eligibility or enrollment status with the co-pay program, please contact the OneGene Program® at 855-441-GENE (4363), Monday–Friday (8 AM – 8 PM ET).

Indication and Important Safety Information for ZOLGENSMA® (onasemnogene abeparvovec-xioi)

Indication

ZOLGENSMA is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1  (SMN1 ) gene.

Limitations of Use

The safety and effectiveness of repeat administration or the use in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator dependence) has not been evaluated with ZOLGENSMA.

Important Safety Information

BOXED WARNING: Acute Serious Liver Injury and Acute Liver Failure
Acute serious liver injury, acute liver failure, and elevated aminotransferases can occur with ZOLGENSMA. Patients with preexisting liver impairment may be at higher risk. Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing (e.g., hepatic aminotransferases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], total bilirubin, and prothrombin time). Administer a systemic corticosteroid to all patients before and after ZOLGENSMA infusion. Continue to monitor liver function for at least 3 months after infusion.

WARNINGS AND PRECAUTIONS

Thrombocytopenia
Transient decreases in platelet counts, some of which met the criteria for thrombocytopenia, were typically observed within the first two weeks after ZOLGENSMA infusion. Monitor platelet counts before ZOLGENSMA infusion and on a regular basis for at least 3 months afterwards.

Thrombotic Microangiopathy
Cases of thrombotic microangiopathy (TMA) were reported approximately 1 week after ZOLGENSMA infusion. Obtain baseline creatinine and complete blood count before ZOLGENSMA infusion.  Following infusion, monitor for thrombocytopenia as well as other signs and symptoms of TMA.  Consult a pediatric hematologist and/or pediatric nephrologist immediately to manage if clinically indicated.

Elevated Troponin-I
Increases in cardiac troponin-I levels were observed following ZOLGENSMA infusion. Monitor troponin-I before ZOLGENSMA infusion and on a regular basis for at least 3 months afterwards.

ADVERSE REACTIONS

The most commonly observed adverse reactions (incidence ≥5%) in clinical studies were elevated aminotransferases and vomiting.

Please see accompanying Full Prescribing Information


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