Description
Tenofovir is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
Tenofovir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Tenofovir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.
Tenofovir is also used to treat chronic (long-term) hepatitis B virus (HBV) infection.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Powder
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tenofovir in children younger than 2 years of age and weighing less than 10 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tenofovir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tenofovir.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aceclofenac
- Acemetacin
- Amtolmetin Guacil
- Aspirin
- Atazanavir
- Atidarsagene Autotemcel
- Bromfenac
- Bufexamac
- Bupropion
- 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
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs 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
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bone problems (eg, fractures), history of or
- Fanconi syndrome (type of kidney disease) or
- Kidney failure, acute or
- Liver disease (including hepatitis) or
- Osteomalacia (soft bones) or
- Osteoporosis (weak or brittle bones)—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe (requires dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. 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. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
It is important to take tenofovir as part of a combination regimen. Take all of the medicines your doctor prescribed at the right time of day. This will make your medicines work better.
Keep using tenofovir for the full time of treatment, even if you or your child begin to feel better. Do not stop using it without first checking with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.
You may take this medicine with or without food.
For patients who cannot swallow the tablets, tell your doctor right away. Your doctor may want you to take the oral powder.
If you are using the oral powder:
- Measure the oral powder correctly using the dosing scoop that comes with the package. If you have any questions about this, ask your doctor or pharmacist.
- Mix the oral powder with 2 to 4 ounces of soft food (eg, applesauce, baby food, yogurt).
- After mixing, swallow it right away to avoid bitter taste.
- Do not mix the oral powder with any liquid. The powder will not mix correctly and will float on top.
- Do not store the scoop inside the package with the powder.
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 forms (oral powder or tablets):
- For treatment of HIV infection:
- Adults and children 2 years of age and older and weighs 35 kilograms (kg) or more—300 milligrams (mg) once a day.
- Children 2 years of age and older and weighing 28 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is one 250 mg tablet once a day.
- Children 2 years of age and older and weighing 22 to less than 28 kg—Dose is based on body weight and must be determined by your doctor. The dose is one 200 mg tablet once a day.
- Children 2 years of age and older and weighing 17 to less than 22 kg—Dose is based on body weight and must be determined by your doctor. The dose is one 150 mg tablet once a day.
- Children younger than 2 years of age and weighing less than 10 kg—Use and dose must be determined by your doctor.
- For treatment of chronic hepatitis B infection:
- Adults and children 2 years of age and older weighing 35 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is 300 milligrams (mg) (7.5 scoops) once a day.
- Children 2 years of age and older and weighing 34 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is 280 mg (7 scoops) once a day.
- Children 2 years of age and older and weighing 32 to less than 34 kg—Dose is based on body weight and must be determined by your doctor. The dose is 260 mg (6.5 scoops) once a day.
- Children 2 years of age and older and weighing 29 to less than 32 kg—Dose is based on body weight and must be determined by your doctor. The dose is 240 mg (6 scoops) once a day.
- Children 2 years of age and older and weighing 27 to less than 29 kg—Dose is based on body weight and must be determined by your doctor. The dose is 220 mg (5.5 scoops) once a day.
- Children 2 years of age and older and weighing 24 to less than 27 kg—Dose is based on body weight and must be determined by your doctor. The dose is 200 mg (5 scoops) once a day.
- Children 2 years of age and older and weighing 22 to less than 24 kg—Dose is based on body weight and must be determined by your doctor. The dose is 180 mg (4.5 scoops) once a day.
- Children 2 years of age and older and weighing 19 to less than 22 kg—Dose is based on body weight and must be determined by your doctor. The dose is 160 mg (4 scoops) once a day.
- Children 2 years of age and older and weighing 17 to less than 19 kg—Dose is based on body weight and must be determined by your doctor. The dose is 140 mg (3.5 scoops) once a day.
- Children 2 years of age and older and weighing 14 to less than 17 kg—Dose is based on body weight and must be determined by your doctor. The dose is 120 mg (3 scoops) once a day.
- Children 2 years of age and older and weighing 12 to less than 14 kg—Dose is based on body weight and must be determined by your doctor. The dose is 100 mg (2.5 scoops) once a day.
- Children 2 years of age and older and weighing 10 to less than 12 kg—Dose is based on body weight and must be determined by your doctor. The dose is 80 mg (2 scoops) once a day.
- Children younger than 2 years of age and weighing less than 10 kg—Use and dose must be determined by your doctor.
- For treatment of HIV infection:
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.
Do not use this medicine if the seal on the bottle is broken or missing. Keep the bottle tightly closed. Use the medicine dispensed only in its original container.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also taking adefovir, Atripla®, Biktarvy®, Complera®, Descovy®, Genvoya®, Hepsera®, Odefsey®, Stribild®, Truvada®, or Vemlidy®. Tell your doctor right away if you or your child are using any of these medicines. Do not start using tenofovir until your doctor tells you to.
Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking antiviral medicines for a long time. Call your doctor right away if you or your child have stomach discomfort or cramping, nausea, vomiting, diarrhea, a decreased appetite, general feeling of discomfort, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.
Do not change your dose or stop using this medicine, even for a short time, without talking to your doctor.
This medicine may increase your risk of having broken bones (fractures). Ask your doctor if you or your child have any concerns about this.
This medicine may increase the risk for kidney problems, including kidney failure. To reduce this risk, be sure to follow up with all blood tests your doctor may order, and avoid other medications that may injure the kidneys, such as certain other antiviral medicines or NSAID pain medicines.
Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.
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 or vitamin supplements.
Side Effects
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:
Less common
- Chest pain
- chills
- cough
- fever
- tightness in the chest
- troubled breathing
Rare
- Decreased appetite
- diarrhea
- fast, shallow breathing
- general feeling of discomfort
- muscle pain or cramping
- stomach discomfort
- unusual tiredness or weakness
Incidence not known
- Agitation
- bone pain
- changes in urination
- confusion
- decreased awareness or responsiveness
- depression
- fast heartbeat
- hives or welts, itching, skin rash
- increased blood pressure
- increased thirst
- muscle twitching
- pains in the stomach, side, or abdomen, possibly radiating to the back
- seizures
- severe sleepiness
- swelling of the face, fingers, or lower legs
- 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
- Back pain
- headache
- lack or loss of strength
- pain
- redness of the skin
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- heartburn
- indigestion
- joint pain or swelling
- loss of appetite
- muscle stiffness
- passing of gas
- weight loss
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.
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