ledipasvir 90 mg-sofosbuvir 400 mg tablet

Generic name:
Ledipasvir/sofosbuvir - oral

Pronunciation
(le-DIP-as-vir/soe-FOS-buer-vir)

Brand name(s)
Harvoni

Although this medication is used to treat hepatitis C, it may rarely make another liver problem called hepatitis B get worse. Before starting this medication, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.

This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking ledipasvir/sofosbuvir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

If you are using the pellet form of this medication, gently shake the packet before use. To take this medication without food, open the packet and pour the pellets directly into your mouth. Swallow the pellets without chewing. You may drink water after swallowing the pellets if needed. Repeat these steps if your dose is for more than one packet. If you are taking this medication with food, open the packet(s) and pour the pellets into a small bowl with one or more spoonfuls of non-acidic soft food (such as pudding, mashed potato, ice cream). The soft food should be at or below room temperature. After gently mixing, take all of the mixture without chewing within 30 minutes.

This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Tell your doctor if you vomit within 5 hours after taking this medication. You may need to take another dose.

Continue to take ledipasvir/sofosbuvir for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Antacids lower the absorption of ledipasvir. If you are taking an antacid, take it at least 4 hours before or 4 hours after this medication.

Other acid-lowering medications for indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent ledipasvir from working. Ask your doctor or pharmacist how to use these medications safely.

See also Warning section.

Tiredness, headache, nausea, diarrhea, or difficulty sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking ledipasvir/sofosbuvir, tell your doctor or pharmacist if you are allergic to either of the drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other liver problems (such as hepatitis B)
• diabetes

If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Ledipasvir/sofosbuvir, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Reliable forms of birth control must be used whenever at least one sexual partner is using these medicines together. Female patients should keep using birth control for 9 months after stopping treatment. Male patients should keep using birth control for 6 months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• amiodarone

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples include flibanserin, rosuvastatin, among others.

Other medications can affect the removal of ledipasvir/sofosbuvir from your body, which may affect how this medication works. Examples include apalutamide, rifamycins (such as rifampin, rifabutin), St. John's wort, tipranavir/ritonavir, drugs used to treat seizures (such as phenobarbital, carbamazepine, phenytoin, primidone), among others.

Do not take this medication with other products that contain sofosbuvir.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.

If you are using this medication with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. Pregnancy tests should continue to be done while using this medication and for some time after this medication is stopped to make sure no pregnancy occurs (for 9 months for female patients and for 6 months for female partners of male patients).

If you miss a dose, take it as soon as you remember. If it is less than 6 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Store the tablets in the original container. For the pellets, do not open the packets until you are ready to use the medication. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.