Tenofovir alafenamide (Oral route)
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including tenofovir alafenamide. Closely monitor hepatic function in these patients for several months following discontinuation and resume anti-HBV therapy if warranted .
Nucleotide Reverse Transcriptase Inhibitor
Uses of This Medicine:
Tenofovir alafenamide is used to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of tenofovir alafenamide in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of tenofovir alafenamide have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
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.
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.
- St John's Wort
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:
- Fanconi syndrome (type of kidney disease) or
- Kidney failure, acute—Use with caution. May make these conditions worse.
- Kidney disease, end-stage (requires dialysis) or
- Liver disease, decompensated—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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. Certain tests may be needed before you start this medicine. Talk to your doctor if you have questions.
This medicine comes with a patient information leaflet. Read and follow the information carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
Keep taking tenofovir for the full time of treatment, even if you begin to feel better. Do not stop taking it without checking first 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.
Swallow the tablet whole. Do not crush, break, or chew it. Take this medicine with food.
Do not change or stop using this medicine without checking first with your doctor.
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 chronic hepatitis B infection:
- Adults—25 milligrams (mg) once a day with food.
- Children—Use and dose must be determined by your doctor.
- For treatment of chronic hepatitis B infection:
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.
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.
Keep the bottle tightly closed. Use the medicine dispensed only in its original container.
Precautions While Using This Medicine:
It is very important that your doctor check your 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.
If you also have HIV, you must be on a combination antiretroviral regimen prescribed by your doctor before starting this medicine. Ask your doctor if you have questions about this. .
Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and liver toxicity, including an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have stomach discomfort or cramping, nausea, vomiting, or diarrhea, a decreased appetite, a general feeling of discomfort, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.
This medicine may increase the risk of injury to the kidneys. 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.
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 (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Abdominal or stomach discomfort
- bloody urine
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- fast, shallow breathing
- general feeling of discomfort
- increased blood pressure
- increased thirst
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle pain or cramping
- nausea and vomiting
- right upper abdominal or stomach pain and fullness
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual tiredness or weakness
- weight gain
- yellow eyes and skin
- More common
- Less common
- Back pain
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:
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:
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.
Last Updated: 9/4/2017