Nirmatrelvir150+RTV100mg tab/4+2/PAC-5

General Description:
Nirmatrelvir 150 mg tablets, co-packaged with Ritonavir 100 mg tablets.
Each carton pack contains 5 daily-dose blister cards with a total of 30 tablets packaged in a carton.
Each daily blister card contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each).

NOTE:
This product description is standard. It makes no reference to product specific regulatory status, WHO Prequalification status, patent status and pricing policies that may apply at global or country level. For more information, please contact Supply Division at psid@unicef.org

Caution & Warning:
This medicine has been given “Emergency Use Authorisation” or ‘conditional approval’. This means that there is more evidence to come about this medicine.

Technical specifications:
Each co-packaged blister card/strip contains,
4 tablets of Nirmatrelvir 150mg + 2 tablets of Ritonavir 100mg.

Each film-coated nirmatrelvir tablet contains 150 mg of nirmatrelvir.
Each film-coated ritonavir tablet contains 100 mg of ritonavir

Therapeutic class:
Antiviral Agents, Protease inhibitor antiviral therapy.

Therapeutic Indications:
This medicinal product is indicated for the treatment for patients with non-severe COVID-19 at highest risk of hospitalization. i.e., treatment of COVID 19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID 19.
https:/ /app.magicapp.org/#/guideline/nBkO1E/rec/LwrMyv

Dosage, Instructions for use:
Route, dosage, and duration:
The recommended dose for nirmatrelvir-ritonavir is 300 mg (two 150 mg tablets) of nirmatrelvir and 100 mg of ritonavir every 12 hours daily for 5 days.

In renal insufficiency (GFR 30–59 mL/min) the dose reduction is 150 mg of nirmatrelvir and 100 mg of ritonavir every 12hours daily for 5 days.

Administration should be as early as possible in the time course of the disease. In the included studies, nirmatrelvir-ritonavir was administered within 5 days of disease onset.

Nirmatrelvir-ritonavir should not be offered to children, breastfeeding or pregnant women with
COVID-19.
https:/ /app.magicapp.org/#/guideline/nBkO1E/rec/LwrMyv

Reporting of adverse events:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions and advise patients to enroll and report adverse events to local pharmacovigilance programs. These are intended to recognize side-effects and potential harms not detected in clinical trials.

Warnings and precautions:
NOT recommended in pediatric patients younger than 18 years of age, during pregnancy and in women of childbearing potential not using effective contraception.

Pediatric patients:
NOT recommended in pediatric patients younger than 18 years of age.

Pregnancy & Breastfeeding:
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice. If you can become pregnant, it is recommended that you refrain from sexual activity or use effective barrier contraception while taking Nirmatrelvir 150mg tablets, co-packaged with Ritonavir 100 mg tablets and until after one full menstrual cycle is completed after stopping Nirmatrelvir 150mg tablets, co-packaged with Ritonavir 100 mg tablets treatment.

Breast feeding should be discontinued during treatment and for 7 days after the last dose of Nirmatrelvir 150mg tablets, co-packaged with Ritonavir 100 mg tablets. This is because
it is not known if this medicine gets into breast milk and will be passed to the baby.

For more information
1.WHO Therapeutics and COVID-19: living guideline 14 July 2022 | COVID-19: Clinical care https://www.who.int/publications/i/i tem/WHO-2019-n CoV-therapeutics-2022.3

Standard shelf life:
12 months
Actual shelf life at the time of supply may be different.

Storage:
Store below 25 °C. Do not refrigerate or freeze.
Ideally to be transported between +15°C to +25°C.

Component of a KIT:
No

Alternative products:
Molnupiravir 200mg caps/PAC-40

For more information, please refer to the link to the Information Note-
Information on pharmaceutical products for management of COVID-19
https://www.unicef.org/suppl y/documents/information-pharmaceutical-products-management-covid-19