5.3.6 nMABs and other antiviral drugs

Neutralising monoclonal antibodies (nMABs) and antivirals for COVID-19 for non-hospitalised patients

Antivirals or neutralising monoclonal antibodies (nMABs) are recommended for non-hospitalised patients with COVID-19 who are considered to be at highest risk of progression to severe disease, hospital admission or death. Eligibility criteria for treatment are outlined in a national clinical commissioning policy. The treatment options from 10 February 2022 are:

  • First-line: Paxlovid (oral antiviral) OR sotrovimab (nMAB given by intravenous infusion)
  • Second-line: Remdesivir (antiviral given by intravenous infusion)
  • Third-line: Molnupiravir (oral antiviral)

GPs must not prescribe nMABs or antivirals for COVID-19. Community pharmacies and dispensing practices will not have access to stocks of these medicines.

Access to these medicines for non-hospitalised patients is through the local COVID Medicine Delivery Units (CMDU).

Referral to a CMDU

See the clinical referral guidelines below for information on which patients require referral to a CMDU and how to refer:

Please do not email referrals to DRSS (as previously advised) as this may introduce a delay in the referral reaching the service.

Where will patients receive nMABs or antiviral treatment?
nMABs are administered intravenously so a patient will need to safely travel to a CMDU site. If the CMDU decides that an antiviral is the most appropriate treatment option, these will be dropped off to a patient’s home, either via a friend or family member of the patient, or via a delivery service.

PANORAMIC study
Oral antivirals will be made available to a wider cohort of at-risk patients through a national study known as the PANORAMIC study. Further information is available here: PANORAMICtrial. Patients eligible for nMABs or oral antivirals under the UK interim commissioning policies must first be referred to the CMDU.

Neutralising monoclonal antibodies (nMABs)

Ronapreve

(casirivimab and imdevimab)

Concentrate solution for subcutaneous injection or intravenous infusion

  • Ronapreve 6ml single-use vials: each pack contains two vials:
    • One 6ml vial contains 300mg of casirivimab per 2.5ml (120mg/ml)
    • One 6ml vial contains 300mg of imdevimab per 2.5ml (120mg/ml)
  • Ronapreve 20ml multidose vials: each pack contains two vials:
    • One 20ml vial contains 1,332mg of casirivimab per 11.1ml (120mg/ml)
    • One 20ml vial contains 1,332mg of imdevimab per 11.1ml (120mg/ml)

Notes

  1. Ronapreve has been withdrawn from the national commissioning policy as a treatment option for patients hospitalised due to COVID-19 (24 February 2022).
  2. Patients who are potentially suitable for monoclonal antibody treatment may instead be considered for entry into the RECOVERY trial, which is studying sotrovimab versus standard of care. Refer to the clinical guide for patients hospitalised due to Covid-19 for treatment options.
Sotrovimab
  • Concentrate for solution for intravenous infusion 500mg in 8ml (62.5mg/ml) vials

Notes

  1. The monoclonal antibody sotrovimab is recommended as a treatment option for:
    1. adults and children (aged 12 years and above) with hospital-onset COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 February 2022) and clinical guide (24 February 2022). See note 2 for patients hospitalised due to COVID-19
    2. non-hospitalised adults and children (aged 12 years and above) with COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 February 2022) and clinical guide (10 February 2022)
  2. Patients hospitalised due to COVID-19 who are potentially suitable for monoclonal antibody treatment may instead be considered for entry into the RECOVERY trial, which is studying sotrovimab versus standard of care. Refer to the clinical guide for patients hospitalised due to COVID-19 for treatment options.
  3. Information on dose and administration is included in the policies.
  4. Preparation and administration of sotrovimab should be initiated and monitored by a qualified healthcare provider using aseptic technique. Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored post intravenous infusion according to local medical practice. Refer to the Specialist Pharmacy Services institutional readiness document for further information on the handling, reconstitution and administration of the product.
  5. Pre-authorised use of sotrovimab for individual patients with COVID-19 is required using Blueteq (CEM/CMO/2022/001; CEM/CMO/2022/005)
  6. Use alongside other therapies for treating COVID-19 in hospitalised patients is addressed in the UK commissioning policy (24 February 2022)
  7. Further information on the timing of COVID-19 vaccination following administration of sotrovimab is available at the following site: Interactions information for COVID-19 vaccines – SPS – Specialist Pharmacy Services
  8. For information on recording the use of sotrovimab in discharge letters to primary care, see CEM/CMO/2022/001 and CEM/CMO/2022/005

Antivirals

MHRA Drug Safety Update (February 2022): COVID-19 antivirals: reporting to the UK COVID-19 Antivirals Pregnancy Registry

  • Healthcare professionals (as well as patients and their partners) can report an exposure to a COVID-19 antiviral during pregnancy or around the time of conception, or of partners on a COVID-19 antiviral around the time of conception.
  • To report to the registry, telephone: 0344 892 0909 (available 9:00am to 5:00pm, Monday to Friday, excluding bank holidays) – for more information see the UKTIS website
Molnupiravir
  • Capsules 200mg

Notes

  1. Molnupiravir is recommended as a treatment option for:
    1. non-hospitalised adults aged 18 years and above with COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 February 2022) and clinical guide (10 February 2022)
  2. GPs must not prescribe antivirals for COVID-19. Community pharmacies and dispensing practices will not have access to stocks of these medicines. Access to molnupiravir for patients is described above the entry for Ronapreve
  3. Molnupiravir is not recommended during pregnancy.
    1. Individuals of childbearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of molnupiravir.
    2. All healthcare professionals are asked to ensure that any patients who receive a COVID antiviral while pregnant are reported to the UK COVID-19 antivirals in pregnancy registry on 0344 892 0909 so that they can be followed up. For more information go to http://www.uktis.org.
    3. Clinicians are advised to refer to the Summary of Product Characteristics for molnupiravir for more information on use during pregnancy or lactation.
  4. Pre-authorised use of molnupiravir for individual patients with COVID-19 is required using Blueteq (CEM/CMO/2022/001)
  5. For information on recording the use of molnupiravir in discharge letters to primary care, see CEM/CMO/2022/001
Paxlovid

PF-07321332 (nirmatrelvir) and ritonavir

  • Each pack contains five daily blister cards (total of 30 tablets). Each daily blister card contains:
    • four PF-07321332 (nirmatrelvir) 150mg tablets
    • two ritonavir 100mg tablets

Notes

  1. Paxlovid is recommended as a treatment option for:
    1. adults aged 18 years and above with hospital-onset COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 February 2022) and clinical guide (24 February 2022).
    2. non-hospitalised adults aged 18 years and above with COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 February 2022) and clinical guide (10 February 2022).
  2. GPs must not prescribe antivirals for COVID-19. Community pharmacies and dispensing practices will not have access to stocks of these medicines. Access to Paxlovid is described above the entry for Ronapreve.
  3. Paxlovid is not recommended during pregnancy and in women of child-bearing potential not using effective contraception:
    1. Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Patients using combined hormonal contraceptives should be advised to use an effective alternative contraceptive method or an additional barrier method of contraception during treatment and until after one complete menstrual cycle after stopping PF-07321332 (nirmatrelvir) plus ritonavir.
    2. All healthcare professionals are asked to ensure that any patients who receive a COVID antiviral while pregnant are reported to the UK COVID-19 antivirals in pregnancy registry on 0344 892 0909 so that they can be followed up. For more information go to http://www.uktis.org.
    3. Clinicians are advised to refer to the Summary of Product Characteristics for Paxlovid for more information on use during pregnancy or lactation.
  4. Paxlovid has a risk of serious adverse reactions due to interactions with other medicinal products:
    1. Appendix 2 of the commissioning policies for non-hospitalised patients includes drug interactions with Paxlovid listed by drug and by indication. This list is not comprehensive. If a medicine is not listed also check University of Liverpool COVID-19 Drug Interaction checker (https://covid19-druginteractions.org/checker)
    2. Co-administration with other medicines for COVID-19 is addressed in the clinical commissioning policies and further information is available from: https://covid19-druginteractions.org/checker.
  5. Pre-authorised use of Paxlovid for individual patients with COVID-19 is required using Blueteq (CEM/CMO/2022/001; CEM/CMO/2022/005).
  6. Use alongside other therapies for treating COVID-19 in hospitalised patients is addressed in the UK commissioning policy (24 February 2022).
  7. For information on recording the use of Paxlovid in discharge letters to primary care, see CEM/CMO/2022/001 and CEM/CMO/2022/005.
Remdesivir
  • Concentrate for solution for intravenous infusion 5mg/ml vials
  • Powder for concentrate for solution for intravenous infusion 100mg vials

Notes

  1. Remdesivir is recommended as a treatment option for:
    1. adults and children (12 years and above) hospitalised due to COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy for remdesivir for patients hospitalised due to COVID-19 (24 February 2022). See note 2.
    2. adults and children (12 years and above) with hospital-onset COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy for nMABs and antivirals in the treatment of COVID-19 in hospitalised patients (24 February 2022) and clinical guide (24 February 2022). See note 3.
    3. non-hospitalised adults and children (12 years and above) with COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 February 2022) and clinical guide (10 February 2022)
  2. Refer to the clinical guide for patients hospitalised due to COVID-19 for treatment options.
  3. Use of remdesivir for hospital-onset COVID-19 in children aged 12 to 17 years is off-label under the national commissioning policy for treatments for hospital-onset COVID-19.
  4. Information on dose and administration is included in the policies.
  5. Patients should be monitored for hypersensitivity reactions during and following administration of remdesivir as clinically appropriate (refer to individual policies above).
  6. Renal and liver function should be monitored carefully during treatment with remdesivir as clinically appropriate (refer to individual policies above).
  7. Remdesivir should be avoided in pregnancy unless clinicians believe the benefits of treatment outweigh the risks to the individual. Women of child-bearing potential have to use effective contraception during treatment.
    1. All healthcare professionals are asked to ensure that any patients who receive a COVID antiviral while pregnant are reported to the UK COVID-19 antivirals in pregnancy registry on 0344 892 0909 so that they can be followed up. For more information go to http://www.uktis.org.
    2. Clinicians are advised to refer to the Summary of Product Characteristics for remdesivir for more information on use during pregnancy or lactation.
  8. Further information on the timing of COVID-19 vaccination following administration of remdesivir is available at the following site: Interactions information for COVID-19 vaccines – SPS – Specialist Pharmacy Services.
  9. Pre-authorised use of remdesivir for individual patients is required using Blueteq (CEM/CMO/2022/001; CEM/CMO/2022/006).
  10. Use alongside other therapies for treating COVID-19 is addressed in the UK commissioning policy for nMABs and antivirals in hospitalised patients with COVID-19 (24 February 2022).
  11. For information on recording the use of remdesivir in discharge letters to primary care, see CEM/CMO/2022/001 and CEM/CMO/2022/006.
Last updated: 17-03-2022

 

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