Sofosbuvir, Oral

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KEY POINTS

• This medicine is taken by mouth, along with another medicine, to treat chronic hepatitis C. Take it exactly as directed.
• When this medicine is taken along with ribavirin, ribavirin can cause severe birth defects. It must not be used by women who are pregnant or by the male partners of women who are pregnant.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: HCV nucleotide analog NS5B polymerase inhibitor; antiviral

Generic and brand names: sofosbuvir, oral; Sovaldi

What is this medicine used for?

This medicine is taken by mouth to treat continuing (chronic) hepatitis C virus infections in adults. This medicine alone is not effective in the treatment of hepatitis C. Ribavirin or peginterferon/ribavirin must also be given in order for the treatment to be effective.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An organ transplant
• HIV infection (You may become resistant to another type of this medicine used to treat HIV if you take this medicine)
• Kidney disease
• Liver disease other than hepatitis C

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take, especially antibiotics, antipsychotics, sedatives, St. John's Wort, medicines for migraine headaches, birth control hormones, and medicines to treat cholesterol, an enlarged prostate, pulmonary hypertension, or seizures.

Females of childbearing age: Ribavirin can cause birth defects. Read the information that comes in the medicine package. Your healthcare provider will check that you are not pregnant before starting this treatment, each month during treatment, and for 6 months after stopping treatment. Use 2 or more forms of an effective birth control method while you are taking this medicine and for 6 months after stopping it. Hormonal forms of birth control may not work as well during treatment with this medicine. Talk to your healthcare provider about effective forms of birth control. Stop taking this medicine at the first sign that you may be pregnant. If you think you may be pregnant while taking this medicine or within 6 months after stopping this medicine, contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: Use 2 or more forms of an effective birth control method while you are taking this medicine and for 6 months after stopping it. Talk to your healthcare provider about effective forms of birth control. Do not use this medicine if your female partner is pregnant.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon. Do not run out of this medicine.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take the missed dose as soon as you remember the same day. Take your next dose at your regular time the next day. Do not take more than 1 tablet in a day. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

You should be tested for HIV infection before taking this medicine and while taking this medicine. If you have an HIV infection and take this medicine, the HIV infection can become more difficult to treat.

This medicine does not cure hepatitis C or keep you from spreading it to other people. Do not share needles, toothbrushes, or razor blades with others.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual tiredness or weakness, shortness of breath, coldness in your hands and feet, pale skin, chest pain, slow heartbeat, unusual bruising or bleeding, fever or other signs of infection.

Other: Nausea, vomiting, decreased appetite, mild tiredness, headache, drowsiness, dizziness, trouble sleeping, diarrhea, mild rash or itching, muscle cramps.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), trazodone, trimipramine (Surmontil), and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• Antipsychotic medicines such as haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), paliperidone (Invega), and pimozide (Orap)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ezogabine (Potiga), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni) and simeprevir (Olysio)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), lapatinib (Tykerb), nilotinib (Tasigna), sunitinib (Sutent), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and simvastatin (Zocor)
• Colchicine (Colcrys)
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), captopril, carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), felodipine, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), propafenone (Rythmol), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Medicines to block or prevent stomach acid such as lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as dipyridamole (Persantine) and ticagrelor (Brilinta)
• Methadone (Dolophine, Methadose)
• Natural remedies such as red yeast rice and St. John’s wort
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Prazosin (Minipress)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in its original container. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.