Temixys (Oral)

Lamivudine and tenofovir combination is used along with other antiviral medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

This medicine does not cure or prevent HIV or AIDS. It helps stop HIV from reproducing and seems to slow down the damage to the immune system. This may help delay the development of problems that usually come from AIDS or HIV disease. It will not stop you from spreading HIV to other people. People taking this medicine may still experience some of the problems usually associated with AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check you and your child's progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.

Do not take Temixys™ together with adefovir (Hepsera®).

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. Call your doctor right away if you or your child have abdominal or stomach discomfort, cramping, nausea, vomiting, diarrhea, or a decreased appetite, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

This medicine may cause a hepatitis B infection to worsen if you stop using it. Your doctor may check for the presence of hepatitis B before and during treatment with this medicine and for at least several months after your last dose.

This medicine may increase the risk of kidney problems. To lower this risk, avoid other medicines that can be harmful to the kidneys such as aminoglycoside antibiotics, certain other antiviral medicines, and NSAID pain medicines.

Check with your doctor right away if you or your child have loss of appetite, nausea, or pains in the stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

This medicine may also increase your or your child's risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.

In deciding to use this medicine, you and your doctor will need to consider the risks versus the benefits. Here are some important points to keep in mind:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies show that there are no specific problems related to children that would limit the use of lamivudine and tenofovir combination in children weighing 35 kilograms (kg) or more. It is considered safe and effective.

Geriatric

Current studies indicate that there are no specific problems related to older adults that would limit the use of lamivudine and tenofovir combination in the elderly. However, older patients may be more likely to have age-related kidney, liver, or heart issues, which may require caution when using lamivudine and tenofovir combination.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are taking this medicine, it is crucial for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions are significant but may not be exhaustive.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Bromfenac
• Bufexamac
• Cabotegravir
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Didanosine
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Horsetail
• Ibuprofen
• Indomethacin
• Itraconazole
• Ketoprofen
• Ketorolac
• Ledipasvir
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sorbitol
• Sulindac
• Tacrolimus
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Darunavir
• Lopinavir
• Nirmatrelvir
• Ritonavir
• Tipranavir

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to potential interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform your doctor about any other medical issues you have, especially:

• Bone problems (e.g., fractures, osteoporosis), history of or
• Fanconi syndrome (kidney disease), history of or
• Hepatitis B infection, history of or
• Kidney failure, acute or
• Liver disease or
• Pancreatitis (swelling of the pancreas), history of—Use with caution. This may worsen these conditions.

• End-stage kidney disease or
• Kidney disease, severe—Use is not recommended in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fever
• Pain
• Stomach pain

Less common

• Chest pain
• Chills
• Cough
• Difficulty in moving
• Joint pain or swelling
• Muscle ache, cramp, pain, or stiffness
• Sneezing
• Sore throat
• Tightness in the chest
• Troubled breathing

Incidence not known

• Bloating
• Bloody urine
• Blurred vision
• Bone fractures, especially of the femur
• Bone pain
• Cloudy urine
• Constipation
• Dark urine
• Decreased appetite
• Decreased frequency or amount of urine
• Diarrhea
• Difficulty swallowing
• Dizziness
• Dry mouth
• Fast heartbeat
• Fast, shallow breathing
• Flushed, dry skin
• Frequent urination
• Fruit-like breath odor
• General feeling of discomfort
• Hives, itching, skin rash
• Increased blood pressure
• Increased hunger
• Increased thirst
• Increased urination
• Increased volume of pale, dilute urine
• Indigestion
• Irregular heartbeat
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Light-colored stools
• Loss of appetite
• Lower back or side pain
• Mood changes
• Muscle weakness
• Nausea
• Numbness or tingling in the hands, feet, or lips
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Seizures
• Sleepiness
• Stomach discomfort
• Sweating
• Swelling of the face, fingers, or lower legs
• Troubled breathing with exertion
• Unexplained weight loss
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Upper right abdominal or stomach pain
• Vomiting
• Weight gain
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety
• Back pain
• Belching
• Burning, numbness, tingling, or painful sensations
• Discouragement
• Feeling sad or empty
• Headache
• Heartburn
• Indigestion
• Irritability
• Lack or loss of strength
• Loss of interest or pleasure
• Redistribution or accumulation of body fat
• Stomach upset
• Tiredness
• Trouble concentrating
• Trouble sleeping
• Unsteadiness or awkwardness
• Weakness in the arms, hands, legs, or feet

Incidence not known

• Hair loss or thinning of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cimduo
• Temixys

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Do not stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

You may take this medicine with or without food.

Keep taking this medicine for the full time of treatment even if you begin to feel better. If you stop the medicine even briefly, the virus may become harder to treat.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treatment of HIV infection: Adults and children weighing 35 kilograms (kg) or more—1 tablet once a day. This medicine contains 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg tenofovir disoproxil). Children weighing less than 35 kg—Use is not indicated in these patients.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in its original bottle and keep it tightly closed.

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