SYNAGIS, Palivizumab Form

Palivizumab (Synagis®) is a recombinant humanized monoclonal antibody with anti-respiratory syncytial virus (RSV) activity. FDA Approved Indication(s) Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients:
• With a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season; • With bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season; • With hemodynamically significant congenital heart disease and who are 24 months of age or younger at the beginning of RSV season. Limitation(s) of use: The safety and efficacy of Synagis have not been established for treatment of RSV disease.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Synagis is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Preterm Infant (must meet all):

1. Diagnosis of preterm infant with gestational age < 29 weeks;
   2. Age at onset of RSV season < 12 months;
   3. Request is for RSV prophylaxis;
   4. Member must use Beyfortus®, if available, unless contraindicated or clinically significant adverse effects are experienced;

2. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative Page 1 of 13

   CLINICAL POLICY Palivizumab statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

3. Member has not been hospitalized with RSV disease during the current RSV season;
   7. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
4. Dose does not exceed 15 mg/kg once a month by intramuscular (IM) administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season B. Chronic Lung Disease of Prematurity (must meet all):
5. Diagnosis of chronic lung disease (CLD) of prematurity (i.e., BPD) defined as both of the following (a and b): a. Gestational age < 32 weeks; b. Requirement for > 21% oxygen for ≥ 28 days after birth;
6. Age at onset of RSV season (a or b): a. Age < 12 months; b. Age ≥ 12 months to < 24 months and continues to require supplemental oxygen, chronic corticosteroid therapy, bronchodilator therapy, or diuretic therapy within 6 months of the start of the RSV season;
7. Request is for RSV prophylaxis;
   4. Member must use Beyfortus, if available, unless contraindicated or clinically significant adverse effects are experienced;
8. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.
9. Member has not been hospitalized with RSV disease during the current RSV season;
   7. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
   8. Dose does not exceed 15 mg/kg once a month by IM administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season C. Congenital Heart Disease (must meet all):

10. Age and diagnosis at onset of RSV season (a or b): a. Age < 12 months and either (i or ii); i. Diagnosis of acyanotic heart disease and either (a or b): Page 2 of 13

    CLINICAL POLICY Palivizumab a) Receiving medication to control congestive heart failure AND will require a cardiac surgical procedure; b) Diagnosis of moderate to severe pulmonary hypertension; ii. Diagnosis of a cyanotic heart defect and RSV prophylaxis is recommended by a pediatric cardiologist; b. Age < 24 months and undergoing cardiac transplantation or cardio-pulmonary bypass during the current RSV season;

11. Request is for RSV prophylaxis;
    3. Member must use Beyfortus, if available, unless contraindicated or clinically significant adverse effects are experienced;
12. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.
13. Member has not been hospitalized with RSV disease during the current RSV season;
    6. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
    7. Dose does not exceed 15 mg/kg once a month by IM administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season (6 doses if cardio-pulmonary bypass) Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season D. Anatomic Pulmonary Abnormalities, Neuromuscular Disorders, Infants Profoundly Immunocompromised (off-label) (must meet all):
    8. Age and diagnosis at onset of RSV season (a or b): a. Age < 12 months and diagnosis of an anatomic pulmonary abnormality or neuromuscular disorder that impairs the ability to clear secretions from the upper airway (e.g., due to ineffective cough); b. Age < 24 months and will be profoundly immunocompromised during the RSV season (e.g., due to solid organ or hematopoietic stem cell transplantation, chemotherapy, severe combined immunodeficiency, chronic granulomatous disease);
14. Request is for RSV prophylaxis;
    3. Member must use Beyfortus, if available, unless contraindicated or clinically significant adverse effects are experienced;

15. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when Page 3 of 13

    CLINICAL POLICY Palivizumab RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

16. Member has not been hospitalized with RSV disease during the current RSV season;
    6. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
    7. Dose does not exceed 15 mg/kg once a month by IM administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season E. Cystic Fibrosis (off-label) (must meet all):
17. Diagnosis of cystic fibrosis and one of the following (a or b):
    a. Clinical evidence of nutritional compromise; b. Diagnosis of CLD of prematurity defined as both of the following (i and ii):
    i. Gestational age < 32 weeks ii. Requirement for > 21% oxygen for ≥ 28 days after birth;
18. Age at onset of RSV season (a or b): a. Age < 12 months; b. Age < 24 months and (i or ii): i. Manifestations of severe lung disease (e.g., previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable); ii. Weight for length < 10th percentile;
19. Request is for RSV prophylaxis;
    4. Member must use Beyfortus, if available, unless contraindicated or clinically significant adverse effects are experienced;
20. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

21. Member has not been hospitalized with RSV disease during the current RSV season;

    7. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
    8. Dose does not exceed 15 mg/kg once a month by IM administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season Page 4 of 13

    CLINICAL POLICY Palivizumab F. Alaska Native and Other American Indian Infants (off-label) (must meet all):

22. Medical director consultation is required for requests relating to Alaska native and other American Indian infants that fall outside the criteria outlined above;
23. Alaska native infants: Eligibility for prophylaxis may differ from the remainder of the U.S. on the basis of epidemiology of RSV in Alaska, particularly in remote regions where the burden of RSV disease is significantly greater than in the general U.S. population,
24. Other American Indian infants: Limited information is available concerning the burden of RSV disease among American Indian populations. However, special consideration may be prudent for Navajo and White Mountain Apache infants in the first year of life.
25. Request is for RSV prophylaxis;
    5. Member must use Beyfortus, if available, unless contraindicated or clinically significant adverse effects are experienced;
26. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.
27. Member has not been hospitalized with RSV disease during the current RSV season;
    8. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
    9. Dose does not exceed 15 mg/kg once a month by IM administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season G. Other diagnoses/indications (must meet 1 or 2):
28. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

29. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line Page 5 of 13

    CLINICAL POLICY Palivizumab of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    II. Continued Therapy
    A. All Indications in Section I (must meet all):

30. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
31. Request is for RSV prophylaxis;
    3. Member must use Beyfortus, if available, unless contraindicated or clinically significant adverse effects are experienced;
32. Member will not reach 24 months of age at the start of RSV season;
    5. Medical justification supports requests for RSV prophylaxis outside the identified season duration for the specific region (see Appendix D); Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season (e.g., September through May) by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.
33. Member has not yet received 5 Synagis doses in the current RSV season (6 doses if cardio-pulmonary bypass);
34. Member has not been hospitalized with RSV disease during the current RSV season;
    8. For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;
    9. If request is for a dose increase, new dose does not exceed 15 mg/kg once a month by IM administration (see Appendix E for dose rounding guidelines). Approval duration: up to 5 doses per RSV season (6 doses if cardio-pulmonary bypass) Overlap of two seasons due to elevated interseasonal RSV activity does not preclude a member from receiving more than 5 consecutive doses, so long as doses are limited to 5 per season B. Other diagnoses/indications (must meet 1 or 2):

35. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 6 of 13

    CLINICAL POLICY Palivizumab b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

36. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BPD: bronchopulmonary dysplasia CLD: chronic lung disease of prematurity FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Dosing Regimen Drug Name HHS: Health and Human Services RSV: respiratory syncytial virus Beyfortus® (nirsevimab) Prophylaxis - First RSV Season Single IM injection of:
    • Weight < 5 kg: 50 mg • Weight ≥ 5 kg: 100 mg Prophylaxis - Second RSV Season Single 200 mg dose IM Dose Limit/ Maximum Dose First RSV Season: 1 dose Second RSV Season: 1 dose (2 doses per lifetime if member is at increased risk of severe disease) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): previous significant hypersensitivity reaction to Synagis • Boxed warning(s): none reported Appendix D: RSV Seasonal Durations across the United States - Initiation and Termination of RSV Prophylaxis • Historical 2014-2017 CDC data from the 10 U.S. Department of Health and Human Services (HHS) regions, with the exception of Florida, shows RSV seasons commencing as early as September in some regions and ending as late as May in others.2-3 • Because 5 monthly Synagis doses at 15 mg/kg/dose will provide more than 6 months of serum palivizumab concentrations above the threshold for protection for most infants, Page 7 of 13

    CLINICAL POLICY Palivizumab administration of more than 5 monthly doses is not recommended within the continental U.S. Children who qualify for Synagis prophylaxis should receive the first dose at the onset of the RSV season. For qualifying infants born during the RSV season, fewer than 5 Synagis doses will be needed to provide protection until the RSV season ends in their region. A small number of sporadic RSV hospitalizations will occur before or after the main season in many areas of the U.S., but the greatest benefit from prophylaxis is derived during peak season and not when the incidence of RSV hospitalization is low.4-7 • Data from the Florida Department of Health (http://www.floridahealth.gov/diseases-and- conditions/respiratory-syncytial-virus/) may be used to determine the appropriate timing of Synagis prophylaxis across Florida’s regions where RSV seasons may begin at different times throughout the year. However, despite Florida’s variable region-specific RSV seasons, a maximum of 5 monthly Synagis doses should be adequate.4-7 • The Centers for Disease Control and Prevention (CDC) is issuing this health advisory to notify clinicians and caregivers about increased interseasonal respiratory syncytial virus (RSV) activity across parts of the Southern United States. Compared with previous years, RSV activity remained relatively low from May 2020 to March 2021. However, since late March, CDC has observed an increase in RSV detections reported to the National Respiratory and Enteric Virus Surveillance System (NREVSS). CDC noted increases in laboratory detections and in the percentages of positive detections for both antigen and PCR testing in parts of HHS Region 4 (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee) and Region 6 (Arkansas, Louisiana, New Mexico, Oklahoma, and Texas). Due to limited testing outside of the typical RSV season, data are limited in some jurisdictions and may be incomplete for the most recent weeks. Since this elevated interseasonal activity is a deviation in the typical circulation patterns for RSV, at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty. • Traditionally, the RSV season was defined by consecutive weeks when RSV antigen- based tests exceeded 10% positivity; however, since 2008, laboratories have shifted away from antigen-based RSV testing, and since 2014 the majority of tests and RSV detections among consistently reporting laboratories are determined by polymerase chain reaction (PCR). The method that consistently captured the highest percentage of PCR detections for retrospectively characterizing RSV seasons was determined to be the retrospective slope 10 (RS10) method. This method uses a centered 5-week moving average of RSV detections normalized to a season peak of 1,000 detections. The season onset was defined as the second of 2 consecutive weeks when the slope, or normalized 5-week moving average of RSV detections between subsequent weeks, exceeded 10. The season offset was the last week when the standardized (normalized) detections exceeded the standardized detections at onset. The peak was the week with the most standardized detections. The season duration was the inclusive weeks between onset and offset. The RS10 method captures a high proportion of RSV PCR detections for retrospectively determining RSV seasonality, but cannot be used to determine seasonal onset and offset in real time, and can only be employed after the season ends. Alternative statistical methods, including the tenfold baseline or 3% threshold methods might be used to determine seasonality in real time or near real time. Page 8 of 13

    CLINICAL POLICY Palivizumab • The American Academy of Pediatrics (AAP) updated guidance for the 2021-2022 RSV season states the following: o For the current (2021-2022) fall and winter season, the AAP recommends beginning administration of palivizumab prophylaxis in all regions of the country at the usual time, regardless of whether an area experienced unusual interseasonal RSV activity. Initiating palivizumab prophylaxis to eligible infants similar to a typical winter season is consistent with AAP policy. The 2021-22 winter RSV season is considered a new season, rather than a continuation of the interseason spread in the spring and summer of 2021. o These considerations could reasonably lead to providing more than five consecutive doses of palivizumab to eligible children in some regions and less than five doses in other areas in the current fall and winter season. Although there is a paucity of data on the provision of more than 5 consecutive doses, there is no evidence of increased frequency or severity of adverse events with later doses in a 5-dose series nor with doses beyond 5 doses in the few published data. Given this information, together with the known efficacy and recent unpredictable epidemiology, the AAP recommends programmatic consideration of providing more than five consecutive doses from the atypical interseason period through the 2021-2022 winter season. • The updated guidance provided by the AAP for the 2022-2023 RSV seasons states because of the continued variability in RSV circulation, the AAP continues to support the use of palivizumab in eligible patients in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP continues to recommend programmatic consideration of providing more than 5 consecutive doses of palivizumab depending on the duration of the current RSV surge in a given region of the country. • ACIP and AAP 2023 recommendations for the use of nirsevimab state the following regarding palivizumab: o If palivizumab was administered initially for the season and < 5 doses were administered, the infant should receive 1 dose of nirsevimab. No further palivizumab should be administered. o If palivizumab was administered in season 1 and the child is eligible for RSV prophylaxis in season 2, the child should receive nirsevimab in season 2, if available. If nirsevimab is not available, palivizumab should be administered as previously recommended. • AAP frequently asked questions regarding nirsevimab state if both nirsevimab and palivizumab are available for high risk patients (including those born at < 29 weeks gestational age), while either product may be administered, the ability to provide one dose of nirsevimab versus monthly doses of palivizumab make it the better choice. Appendix E: Dose Rounding Guidelines Weight-based Dose Range Vial Quantity Recommendation ≤ 52.49 mg
    52.5 mg – 104.99 mg
    105 mg – 157.49 mg
    157.5 mg – 209.99 mg
    210 mg – 262.49 mg
    1 vial of 50 mg/0.5 mL 1 vial of 100 mg/1 mL 1 vial of 50 mg/0.5 mL and 1 vial of 100 mg/1 mL 2 vials of 100 mg/1 mL 1 vial of 50 mg/0.5 mL and 2 vials of 100 mg/1 mL Page 9 of 13

    CLINICAL POLICY Palivizumab Weight-based Dose Range Vial Quantity Recommendation 262.5 mg – 314.99 mg 3 vials of 100 mg/1 mL V. Dosage and Administration
    Indication RSV prophylaxis in pediatric patients Dosing Regimen Maximum Dose 15 mg/kg IM once a month
    15 mg/kg/month; up to 5 doses per RSV season (1 extra dose if cardio-pulmonary bypass) VI. Product Availability
    Single-dose vials: 50 mg/0.5 mL, 100 mg/1 mL VII.