Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
glecaprevir, Quantity: 50 mg; pibrentasvir, Quantity: 20 mg
Abbvie Pty Ltd
Granules
Excipient Ingredients: copovidone; tocofersolan; propylene glycol monocaprylate; colloidal anhydrous silica; croscarmellose sodium; sodium stearylfumarate; purified water; titanium dioxide; lactose monohydrate; hypromellose; iron oxide red; macrogol 3350; iron oxide yellow
Oral
28
(S4) Prescription Only Medicine
MAVIRET is indicated for the treatment of adult and paediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV GT1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors (see 4.2 DOSE AND METHOD OF ADMINISTRATION and 5.1 PHARMACODYNAMIC PROPERTIES ? Clinical trials).
Visual Identification: Pink (glecaprevir) and yellow (pibrentasvir), round and biconvex granules; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-02-07
MAVIRET ® M A V I R E T ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I TAKING MAVIRET? Maviret contains the active ingredients glecaprevir and pibrentasvir. Maviret is used to treat chronic hepatitis C. For more information, see Section 1. Why am I taking Maviret? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE MAVIRET? Check the list of ingredients at the end of this CMI. Do not take Maviret if you have ever had an allergic reaction to any of them. There are certain medicines that should not be taken together with Maviret. Talk to your doctor before you take this medicine if he/she is not aware that you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take Maviret? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Maviret and affect how it works. Maviret may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE MAVIRET? TABLETS • Take 3 tablets all together, once every day. Take the tablets with food. • Do not break, crush or chew the tablets. Swallow them whole with a full glass of water. GRAULES Mix the required amount of granules with recommended food. Take this once a day, before or after a snack or meal. More instructions can be found in Section 4. How do I take Maviret? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING MAVIRET? THINGS YOU SHOULD DO • Call your doctor straight away if you become pregnant while taking Maviret. • Keep all your doctor’s appointments so that your progress can be checked. • Remind any doctor or dentist you vis Read the complete document
MAVIRET PI Version 11 14 September 2022 Page 1 of 37 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PI – MAVIRET ® (GLECAPREVIR / PIBRENTASVIR) TABLETS AND GRANULES 1 NAME OF THE MEDICINE Glecaprevir and pibrentasvir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2-7 at 37 C and is practically insoluble in water, but is sparingly soluble in ethanol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1-7 at 37 C and is practically insoluble in water, but is freely soluble in ethanol. Tablets MAVIRET is a fixed-dose combination tablet containing glecaprevir 100 mg and pibrentasvir 40 mg. Granules MAVIRET granules in sachets are a fixed-dose combination product containing glecaprevir 50 mg and pibrentasvir 20 mg. Both MAVIRET tablets and granules do not contain gluten. Both MAVIRET tablets and granules contain lactose. For the full list of excipients, see 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablets MAVIRET immediate release tablets are pink-coloured, film-coated, oblong biconvex shaped, and debossed with “NXT” on one side. MAVIRET PI Version 11 14 September 2022 Page 2 of 37 Granules MAVIRET granules are available as pink granules (glecaprevir) and yellow granules (pibrentasvir). Both granules are round and biconvex. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MAVIRET is indicated for the treatment of adult and paediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV GT1 infection who were previously treated with either a regimen of an NS Read the complete document