Harvoni

Uses

What is Harvoni® (ledipasvir and sofosbuvir) used for?

Harvoni® contains a combination of ledipasvir and sofosbuvir. Ledipasvir and sofosbuvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Harvoni® is used to treat hepatitis C genotypes 1, 4, 5, or 6. This medicine is for use in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms).

Harvoni® is sometimes given in combination with another medicine called ribavirin.

How should I take Harvoni® (ledipasvir and sofosbuvir)?

Take Harvoni® exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Harvoni®.

You may take Harvoni® with or without food. Take the medicine at the same time each day.

Harvoni® is usually taken once per day for 12 to 24 weeks. Follow your doctor’s dosing instructions very carefully.

You will need frequent blood tests to check your liver function.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Harvoni® suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, Harvoni® can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

How do I store Harvoni® (ledipasvir and sofosbuvir)?

Harvoni® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Harvoni® in the bathroom or the freezer. There may be different brands of Harvoni® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Harvoni® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Harvoni® (ledipasvir and sofosbuvir)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Harvoni® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not use Harvoni® if you are allergic to ledipasvir or sofosbuvir, or if you are also taking sofosbuvir tablets (Sovaldi).

To make sure Harvoni is safe for you, tell your doctor if you have:

• A history of hepatitis B
• Liver problems other than hepatitis
• A history of liver transplant
• Kidney disease (or if you are on dialysis)
• HIV or AIDS
• A heart rhythm problem for which you take a medicine called amiodarone (Cordarone, Pacerone)

You should not use Harvoni® with ribavirin if you have:

• Severe kidney disease
• A hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia

Harvoni® is sometimes used together with another medicine called ribavirin. Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.

If you are a woman, do not take ribavirin if you are pregnant. If you are a man, do not take ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

Use at least 2 effective forms of birth control to prevent pregnancy while either sexual partner is taking ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

It is not known whether ledipasvir and sofosbuvir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Harvoni is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Harvoni® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Harvoni®. Harvoni® is pregnancy risk category B, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Harvoni® (ledipasvir and sofosbuvir)?

Get emergency medical help if you have signs of an allergic reaction to Harvoni®: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you also take a heart medication called amiodarone, call your doctor at once if you have:

• Extreme tiredness
• Unusual weakness, general ill feeling
• Confusion or memory problems
• A light-headed feeling, like you might pass out
• Slowed breathing, feeling short of breath
• Chest pain, slow heartbeats, weak pulse

Common side effects may include:

• Weakness
• Headache
• Tired feeling

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Harvoni® (ledipasvir and sofosbuvir)?

Harvoni® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• Amiodarone
• Digoxin (digitalis)
• Other drugs to treat hepatitis C, such as simeprevir (Olysio) or sofosbuvir (Sovaldi)
• Rosuvastatin (Crestor)
• John’s wort
• HIV or AIDS medications – atazanavir, cobicistat, darunavir, elvitegravir, emtricitabine, lopinavir, ritonavir, tenofovir, tipranavir
• Seizure medicine – carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• Stomach acid reducers – cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid) lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), ranitidine (Zantac), and others
• Tuberculosis medicine – rifabutin, rifampin, rifapentine

Does food or alcohol interact with Harvoni® (ledipasvir and sofosbuvir)?

Harvoni® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Harvoni® (ledipasvir and sofosbuvir)?

Harvoni® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Harvoni® (ledipasvir and sofosbuvir).

What is the dose of Harvoni® (ledipasvir and sofosbuvir) for an adult?

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day

Duration of Therapy:

Therapy-naive patients without cirrhosis: 12 weeks; 8 weeks can be considered if pretreatment HCV RNA less than 6 million international units/mL

Therapy-naive patients with cirrhosis: 12 weeks

Therapy-experienced patients without cirrhosis: 12 weeks

Therapy-experienced patients with cirrhosis: 24 weeks

What is the dose of Harvoni® (ledipasvir and sofosbuvir) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Harvoni® (ledipasvir and sofosbuvir) available?

Harvoni® is available in the following dosage forms and strengths:

• Tablet, film coated: ledipasvir 90mg, sofosbuvir 400mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Harvoni®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

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