Ledipasivir + Sofosbuvir

Brand(s)

Manufacturer

• Natco Pharma Ltd.

Disease(s)

• Hepatitis C

Ledipasvir and Sofosbuvir tablet

What is ledipasvir and sofosbuvir?

Ledipasvir and sofosbuvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Ledipasvir and sofosbuvir is a combination medicine 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).

Ledipasvir and sofosbuvir is sometimes given in combination with another medicine called ribavirin.

Ledipasvir and sofosbuvir may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ledipasvir and sofosbuvir?

You should not use ledipasvir and sofosbuvir if you are also taking sofosbuvir tablets (Sovaldi).

If you have ever had hepatitis B, ledipasvir and sofosbuvir can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

What should I discuss with my healthcare provider before taking ledipasvir and sofosbuvir?

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

To make sure ledipasvir and sofosbuvir 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; or

• a heart rhythm problem for which you take a medicine called amiodarone (Cordarone, Pacerone).

You should not use ledipasvir and sofosbuvir with ribavirin if you have:

• severe kidney disease;

• a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia; or

• if you are pregnant, or if you are a man and your sexual partner is pregnant.

Ledipasvir and sofosbuvir is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ledipasvir and sofosbuvir 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.

How should I take ledipasvir and sofosbuvir?

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

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take ledipasvir and sofosbuvir with or without food. Take the medicine at the same time each day.

Ledipasvir and sofosbuvir 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 ledipasvir and sofosbuvir suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, ledipasvir and sofosbuvir 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.

Store this medicine in the original container at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking ledipasvir and sofosbuvir?

Avoid taking an antacid within 4 hours before or 4 hours after you take ledipasvir and sofosbuvir. This especially includes antacids that contain aluminum or magnesium (Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others).

Taking ledipasvir and sofosbuvir will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Ledipasvir and sofosbuvir side effects

Get emergency medical help if you have signs of an allergic reaction: 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; or

• chest pain, slow heartbeats, weak pulse.

Common side effects may include:

• weakness;

• headache; or

• tired feeling.

What other drugs will affect ledipasvir and sofosbuvir?

Many drugs can interact with ledipasvir and sofosbuvir. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• amiodarone;

• digoxin (digitalis);

• other drugs to treat hepatitis C, such as simeprevir (Olysio) or sofosbuvir (Sovaldi);

• rosuvastatin (Crestor);

• St. 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; or

• tuberculosis medicine--rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with ledipasvir and sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.