Pronunciation:

soe-FOS-bue-vir, vel-PAT-as-vir

Brand Names:

• Epclusa

Dosage Forms:

• Packet
• Tablet

Warnings:

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir/velpatasvir. 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:

Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection (including with or without cirrhosis).

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sofosbuvir and velpatasvir combination in children 3 years of age and older or weighing at least 17 kilograms (kg). However, safety and efficacy have not been established in children younger than 3 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sofosbuvir and velpatasvir combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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.

• Levoketoconazole
• 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.

• Abametapir
• Adagrasib
• Alpelisib
• Amiodarone
• Atazanavir
• Berotralstat
• Bosentan
• Capmatinib
• Carbamazepine
• Crizotinib
• Dexamethasone
• Dexlansoprazole
• Efavirenz
• Enzalutamide
• Esomeprazole
• Etravirine
• Fedratinib
• Fexinidazole
• Fosphenytoin
• Itraconazole
• Lansoprazole
• Lumacaftor
• Mavacamten
• Mitotane
• Modafinil
• Momelotinib
• Nafcillin
• Nevirapine
• Omaveloxolone
• Omeprazole
• Ozanimod
• Pantoprazole
• Phenobarbital
• Phenytoin
• Primidone
• Rabeprazole
• Rifabutin
• Rifapentine
• Rosuvastatin
• St John's Wort
• Talazoparib
• Tipranavir
• Topotecan
• Ubrogepant
• Warfarin

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

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:

• Heart disease or
• Liver disease, advanced—May increase risk for bradycardia (slow heartbeat).

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

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 should come with a patient information leaflet. Read and follow the information 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.

You may take this medicine with or without food.

Swallow the tablet whole. Do not crush, break, or chew it.

If you are taking an antacid containing aluminum or magnesium, take it 4 hours before or after you take this medicine.

To use oral pellets:

• You may take the oral pellets with food or directly in your mouth.
• If you take this medicine directly in your mouth, you may drink water after swallowing the pellets.
• Take the oral pellets with food for children younger than 6 years of age.
• If you take this medicine with food, shake the packet gently to settle the pellets to the bottom of packet. Mix the entire packet into a non-acidic soft food (eg, pudding, chocolate syrup, or ice cream) in a bowl and mix it with a spoon. Take the mixture within 15 minutes.
• Do not chew the oral pellets or the mixture to avoid bitter taste.

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:
    • Adults—One tablet once a day, taken for 12 weeks. Each tablet contains sofosbuvir 400 milligrams (mg) and velpatasvir 100 mg.
    • Children 3 years of age and older or weighing at least 30 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
      • Weighing at least 30 kilograms (kg)—One tablet (containing 400 mg sofosbuvir and 100 mg velpatasvir) once a day or two tablets (containing 200 mg sofosbuvir and 50 mg velpatasvir) taken for 12 weeks.
      • Weighing 17 to less than 30 kg—One tablet (containing 200 mg sofosbuvir and 50 mg velpatasvir) once a day taken for 12 weeks.
    • Children 3 years of age and older weighing less than 17 kg—Use of oral pellets is recommended.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (pellets):
  • For hepatitis C virus infection:
    • Children 3 years of age and older or weighing at least 30 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
      • Weighing at least 30 kilograms (kg)—Two packets (containing 200 mg sofosbuvir and 50 mg velpatasvir, total of 400 mg sofosbuvir and 100 mg velpatasvir) once a day taken for 12 weeks.
      • Weighing 17 to less than 30 kg—One packet (containing 200 mg sofosbuvir and 50 mg velpatasvir) once a day taken for 12 weeks.
      • Weighing less than 17 kg—One packet (containing 150 mg sofosbuvir and 37.5 mg velpatasvir) once a day taken for 12 weeks.
    • Children younger than 3 years of age—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.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not take this medicine together with other products containing sofosbuvir (eg, Sovaldi®).

Ribavirin may cause birth defects if either partner is using it together with this medicine during conception or pregnancy. Females who take this medicine with ribavirin should avoid becoming pregnant during treatment and for at least 6 months after the last dose. Tell your doctor right away if you or your partner becomes pregnant. Follow all directions about birth control.

If you have ever had a hepatitis B infection or if you have been coinfected with a hepatitis B or C virus and have or have not received treatment, the virus could become active again during treatment with sofosbuvir and velpatasvir combination. You should be tested for hepatitis B infection before starting treatment with this medicine. Talk with your doctor if you have concerns.

Amiodarone can cause serious side effects (eg, cardiac arrest, slow heartbeat, conditions that need pacemaker) if used together with medicines containing sofosbuvir (including ledipasvir and sofosbuvir combination, Harvoni®), or if you have used it recently. This is more likely to occur in patients with heart disease or advanced liver disease. Tell your doctor if you are taking amiodarone before using this medicine.

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

Chest pain or discomfort

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

lightheadedness, dizziness or fainting

skin rash, sometimes with blisters or hive-like swelling

slow or irregular heartbeat

trouble breathing

unconsciousness

unusual tiredness

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

Headache

unusual tiredness or weakness

Less common

Diarrhea

discouragement

feeling sad or empty

irritability

lack of appetite, nausea

lack or loss of strength

loss of interest or pleasure

rash

trouble concentrating

trouble sleeping

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.