Lamivudine and Tenofovir

IMPORTANT WARNING:

Lamivudine and tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with lamivudine and tenofovir. If you have HBV and you take lamivudine and tenofovir, your condition may suddenly worsen when you stop taking lamivudine and tenofovir. Your doctor will examine you and order lab tests regularly for several months after you stop taking lamivudine and tenofovir to see if your HBV has worsened.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to lamivudine and tenofovir.

WHY is this medicine prescribed?

The combination of lamivudine and tenofovir is used along with other medications to treat HIV in adults and children. Lamivudine and tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although lamivudine and tenofovir will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.

Are there OTHER USES for this medicine?

The combination of lamivudine and tenofovir is also sometimes used along with other medications to treat healthcare workers or other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of lamivudine and tenofovir comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take lamivudine and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lamivudine and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take lamivudine and tenofovir even if you feel well. Do not stop taking lamivudine and tenofovir without talking to your doctor. If you stop taking lamivudine and tenofovir even for a short time, or if you skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking lamivudine and tenofovir,

• tell your doctor and pharmacist if you are allergic to lamivudine, tenofovir, any other medications, or any of the ingredients in lamivudine and tenofovir tablets. Ask your pharmacist for a list of the ingredients.

• you should know that lamivudine and tenofovir are also available individually with the brand names of Epivir, Epivir-HBV (used to treat hepatitis B), Vemlidy (used to treat hepatitis B), and Viread, as well as in combination with other medications with brand names of Atripla, Biktarvy, Combivir, Complera, Descovy, Epzicom, Genvoya, Odefsey, Stribild, Symfi, Triumeq, Trizivir, and Truvada. Tell your doctor if you are taking any of these medications to be sure you do not receive the same medication twice.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acyclovir (Sitavig, Zovirax); aminoglycosides such as amikacin, gentamicin, streptomycin, and tobramycin; aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); atazanavir (Reyataz, in Evotaz); cidofovir; darunavir and ritonavir (Prezista and Norvir); didanosine (Videx); ganciclovir (Cytovene); interferon alfa (Intron A, Roferon-A); ledipasvir/sofosbuvir (Harvoni); lopinavir/ritonavir (Kaletra); ribavirin (Copegus, Rebetol, Ribasphere); sofosbuvir/velpatasvir (Epculsa); sorbitol or medications that are sweetened with sorbitol; trimethoprim (Primsol, in Bactrim, Septra); valacyclovir (Valtrex); and valganciclovir (Valcyte). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lamivudine and tenofovir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, or if you have or have ever had bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, hepatitis C or other liver disease, or kidney disease. For children taking this medication, tell your doctor if they have or have ever had pancreatitis or have received treatment with a nucleoside analog medication such as an NRTI in the past.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lamivudine and tenofovir call your doctor. You should not breastfeed if you are infected with HIV or if you are taking lamivudine and tenofovir.

• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with lamivudine and tenofovir be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Lamivudine and tenofovir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• stomach pain
• nausea
• vomiting
• diarrhea
• heartburn
• lack of energy
• back pain
• muscle or joint pain
• depressed feeling
• anxiety
• trouble falling asleep or staying asleep
• dizziness
• stinging, burning, or painful feeling in arms or legs
• itching or rash

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• hives, difficulty breathing or swallowing, swelling of the face, throat, tongue, lips, or eyes, hoarseness
• unusual muscle pain, trouble breathing, stomach pain, nausea, vomiting, feeling cold especially in your arms or legs, feeling dizzy or lightheaded, extreme tiredness or weakness, fast or irregular heartbeat
• yellowing of skin or eyes, dark urine, light colored stools, nausea, vomiting, loss of appetite, or pain, aching, or tenderness in upper right part of stomach
• decreased urination, swelling of legs
• bone pain, pain in arms or legs, bone fracture, muscle pain or weakness, joint pain
• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, nausea, vomiting (in children patients only)

Lamivudine and tenofovir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of lamivudine and tenofovir on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.