CHLORAMPHENICOL SODIUM SUCCINATE, Chloramphenicol Sodium Succinate Form

Chloramphenicol sodium succinate is an antibiotic that binds to 50S ribosomal subunits.
FDA Approved Indication(s) Chloramphenicol sodium succinate is indicated for the treatment of: • Acute infections caused by Salmonella typhiIn treatment of typhoid fever some authorities recommend that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse. • Serious infections caused by susceptible strains: o Salmonella species o H. influenza, specially meningeal infections o Rickettsia o Lymphogranuloma-psittacosis group o Various gram-negative bacteria causing bacteremia, meningitis or other serious gram- negative infections o Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents • Cystic fibrosis regimens Limitation(s) of use: Chloramphenicol sodium succinate is not recommended for the routine treatment of the typhoid carrier state.
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 chloramphenicol sodium succinate is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. All FDA-Approved Indications (must meet all):

1. Prescribed by or in consultation with an infectious disease specialist;
   2. Request is for continuation of intravenous therapy initiated in an acute care hospital from which member was discharged;

2. Dose does not exceed one of the following (a or b): a. Adults and pediatrics: 100 mg/kg per day; b. Neonates: 50 mg/kg per day. Page 1 of 6

   CLINICAL POLICY Chloramphenicol Sodium Succinate Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer
   B. Other diagnoses/indications (must meet 1 or 2):

3. 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
4. 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.
   II. Continued Therapy A. All FDA-Approved Indications (must meet all):
   
   1. Member meets one of the following (a, b, or c): 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); c. Request is for continuation of therapy initiated in an acute care hospital from which member was discharged;
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed:
      a. Adults and pediatrics: 100 mg/kg per day; b. Neonates: 50 mg/kg per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer
      B. Other diagnoses/indications (must meet 1 or 2):

5. 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: Page 2 of 6

   CLINICAL POLICY Chloramphenicol Sodium Succinate 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

6. 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 FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of previous hypersensitivity and/or toxic reaction to chloramphenicol, for the treatment of trivial infections or where it is not indicated (colds influenza, infections of the throat), as a prophylactic agent to prevent bacterial infections • Boxed warning(s): serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) V. Dosage and Administration
   Indication Dosing Regimen Infection Adult/Pediatric: 50 mg/kg/day IV in divided doses at 6-hour intervals Maximum Dose Adult/Pediatric: 100 mg/kg/day Neonate/Pediatric patients with immature metabolic processes: 25 to 50 mg/kg/day IV in 4 equal doses at 6-hour intervals
   Neonate: 50 mg/kg/day VI. Product Availability
   Vial for reconstitution: 1 g/10 mL Page 3 of 6

   CLINICAL POLICY Chloramphenicol Sodium Succinate VII.