Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p292
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 292/312)
Character Range: 17323211–17330480

restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
                                                                                                                           Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.
C16191              P16191         CN16191          Molnupiravir                                                           SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16191
                                                                                                                           The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
                                                                                                                           Patient must have received a positive nucleic acid test result; OR
                                                                                                                           Patient must have received a positive rapid antigen test (RAT) result; AND
                                                                                                                           Patient must have at least one sign or symptom attributable to COVID-19; AND
                                                                                                                           Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
                                                                                                                           Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND
                                                                                                                           The treatment must be initiated within 5 days of symptom onset.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with:
                                                                                                                           1. Any primary or acquired immunodeficiency including:
                                                                                                                           a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
                                                                                                                           b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
                                                                                                                           c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR
                                                                                                                           2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
                                                                                                                           a. Chemotherapy or whole body radiotherapy,
                                                                                                                           b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
                                                                                                                           c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
                                                                                                                           d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR
                                                                                                                           3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR
                                                                                                                           4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR
                                                                                                                           5. People with disability with multiple comorbidities and/or frailty.
                                                                                                                           Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records
                                                                                                                           For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of