Pronunciation:

glek-A-pre-vir, pi-BRENT-as-vir

Brand Names:

• Mavyret

Dosage Forms:

• Packet
• Tablet

Warnings:

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with glecaprevir/pibrentasvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Hepatitis C Virus NS5A Inhibitor

Uses of This Medicine:

Glecaprevir and pibrentasvir combination is used to treat chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis (liver problem) or with compensated cirrhosis. It is also used to treat HCV genotype 1 infection in patients who have been previously treated with other medicine (eg, HCV NS5A inhibitor or NS3/4A protease inhibitor, but not both).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of glecaprevir and pibrentasvir combination in children younger than 3 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glecaprevir and pibrentasvir combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Rifampin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Atorvastatin
• Capmatinib
• Carbamazepine
• Cyclosporine
• Darunavir
• Drospirenone
• Efavirenz
• Ethinyl Estradiol
• Fosphenytoin
• Itraconazole
• Lopinavir
• Lovastatin
• Nirmatrelvir
• Norgestimate
• Phenytoin
• Ritonavir
• Rosuvastatin
• Simvastatin
• St John's Wort
• Tacrolimus
• Venetoclax

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Pravastatin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B infection, history of—Use with caution. May cause this condition to become active again.

• Liver disease, moderate or severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, this medicine must be used on a regular schedule.

Take this medicine with food.

To use the oral pellets:

• Mix the medicine on a small amount of soft food (eg, peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt) with little amount of water that will stick to a spoon and should be swallowed without chewing.
• Swallow the mixture within 15 minutes after preparation. Do not crush or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For hepatitis C virus infection that has been previously treated with other medicines:
    • Adults and children 12 years of age and older or weighing 45 kilograms (kg) or more—3 tablets (total dose of 300 milligrams [mg] glecaprevir and 120 mg pibrentasvir) once a day for 8 to 16 weeks in patients without cirrhosis and 12 to 16 weeks for patients with cirrhosis. Each tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
    • Children 3 to younger than 12 years of age weighing less than 45 kg—Use of oral pellets is recommended.
    • Children younger than 3 years of age or weighing less than 45 kg—Use and dose must be determined by your doctor.
  • For hepatitis C virus infection that has not been treated with other medicines:
    • Adults and children 12 years of age and older or weighing 45 kilograms (kg) or more—3 tablets (total dose of 300 milligrams [mg] glecaprevir and 120 mg pibrentasvir) once a day for 8 weeks. Each tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
    • Children 3 to younger than 12 years of age weighing less than 45 kg—Use of oral pellets is recommended.
    • Children younger than 3 years of age or weighing less than 45 kg—Use and dose must be determined by your doctor.
  • For patients receiving a kidney or liver transplant:
    • Adults and children 12 years of age and older or weighing 45 kilograms (kg) or more—3 tablets (total dose of 300 milligrams [mg] glecaprevir and 120 mg pibrentasvir) once a day for 12 or 16 weeks. Each tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
    • Children 3 to younger than 12 years of age weighing less than 45 kg—Use of oral pellets is recommended.
    • Children younger than 3 years of age or weighing less than 45 kg—Use and dose must be determined by your doctor.

• For oral dosage form (pellets):
  • For hepatitis C virus infection that has been previously treated with other medicines:
    • Children 3 to younger than 12 years of age weighing less than 45 kg—Dose is base on weight and must be determined by your doctor.
      • Weighing 30 to less than 45 kg—5 packets (total dose of 250 mg glecaprevir and 100 mg pibrentasvir once a day for 8 to 16 weeks in patients without cirrhosis and 12 to 16 weeks for patients with cirrhosis. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
      • Weighing 20 to less than 30 kg—4 packets (total dose of 200 mg glecaprevir and 80 mg pibrentasvir once a day for 8 to 16 weeks in patients without cirrhosis and 12 to 16 weeks for patients with cirrhosis. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
      • Weighing less than 20 kg—3 packets (total dose of 150 mg glecaprevir and 60 mg pibrentasvir once a day for 8 to 16 weeks in patients without cirrhosis and 12 to 16 weeks for patients with cirrhosis. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
    • Children younger than 3 years of age or weighing less than 45 kg—Use and dose must be determined by your doctor.
  • For hepatitis C virus infection that has not been treated with other medicines:
    • Children 3 to younger than 12 years of age weighing less than 45 kg—Dose is base on weight and must be determined by your doctor.
      • Weighing 30 to less than 45 kg—5 packets (total dose of 250 mg glecaprevir and 100 mg pibrentasvir once a day for 8 weeks. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
      • Weighing 20 to less than 30 kg—4 packets (total dose of 200 mg glecaprevir and 80 mg pibrentasvir once a day for 8 weeks. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
      • Weighing less than 20 kg—3 packets (total dose of 150 mg glecaprevir and 60 mg pibrentasvir once a day for 8 weeks. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
    • Children younger than 3 years of age or weighing less than 45 kg—Use and dose must be determined by your doctor.
  • For patients receiving a kidney or liver transplant:
    • Children 3 to younger than 12 years of age weighing less than 45 kg—Dose is base on weight and must be determined by your doctor.
      • Weighing 30 to less than 45 kg—5 packets (total dose of 250 mg glecaprevir and 100 mg pibrentasvir once a day for 12 to 16 weeks. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
      • Weighing 20 to less than 30 kg—4 packets (total dose of 200 mg glecaprevir and 80 mg pibrentasvir once a day for 12 to 16 weeks. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
      • Weighing less than 20 kg—3 packets (total dose of 150 mg glecaprevir and 60 mg pibrentasvir once a day for 12 to 16 weeks. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.
    • Children younger than 3 years of age or weighing less than 45 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 18 hours from your usual time, take the missed dose as soon as possible, and then go back to your regular schedule.

If you miss a dose and it is more than 18 hours from your usual time, skip the missed dose and take your next dose at your regular schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep this medicine in its original container until you are ready to use it. Throw away any unused medicine. Do not store and reuse any leftover mixture.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine together with atazanavir (eg, Evotaz®, Reyataz®) or rifampin (eg, Rifadin®, Rifamate®, Rifater®, Rimactane®).

If you have ever had a hepatitis B infection, the virus could become active again during treatment with glecaprevir and pibrentasvir combination. You should be tested for hepatitis B infection before starting treatment with this medicine. Talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Dark-colored urine

headache

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

stomach pain, continuing

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

itching skin

lack or loss of strength

nausea

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.