Tenofovir alafenamide (Oral)

Tenofovir alafenamide is used to treat chronic hepatitis B virus (HBV) infection in patients with compensated liver disease.

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

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working correctly. Blood and urine tests may be needed to check for side effects.

If you also have HIV, your doctor may perform tests before starting this medicine.

Do not stop using this medicine without first consulting your doctor. Stopping suddenly may worsen your infection.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These reactions are more common if you are female, obese, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you experience stomach pain, nausea, vomiting, decreased appetite, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

Check with your doctor immediately if you have bloody urine, a decrease in the frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be signs of a serious kidney problem.

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 (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about:

Allergies

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

Pediatric

There have not been enough studies to determine how tenofovir alafenamide affects children younger than 12 years old. Its safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of tenofovir alafenamide.

Breast Feeding

There are not enough studies 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 taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or may change some of your other medicines.

• Carbamazepine
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

Using this medicine with any of the following medicines is usually 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
• Acyclovir
• Adagrasib
• Amikacin
• Amikacin Liposome
• Amiodarone
• Amtolmetin Guacil
• Apalutamide
• Aspirin
• Bromfenac
• Bufexamac
• Capmatinib
• Capreomycin
• Carvedilol
• Celecoxib
• Choline Salicylate
• Cidofovir
• Clarithromycin
• Clonazepam
• Clonixin
• Cobicistat
• Conivaptan
• Cyclosporine
• Darolutamide
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Dronedarone
• Droxicam
• Enasidenib
• Encorafenib
• Erythromycin
• Eslicarbazepine Acetate
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ganciclovir
• Gentamicin
• Ibuprofen
• Indomethacin
• Itraconazole
• Kanamycin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Leflunomide
• Leniolisib
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Midostaurin
• Momelotinib
• Morniflumate
• Nabumetone
• Naproxen
• Neomycin
• Nepafenac
• Netilmicin
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Parecoxib
• Paromomycin
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Plazomicin
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinidine
• Ranolazine
• Rifabutin
• Rifapentine
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Spectinomycin
• Streptomycin
• Sulindac
• Tafamidis
• Telaprevir
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Tipranavir
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Valacyclovir
• Valdecoxib
• Valganciclovir
• Vemurafenib
• Verapamil

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may be necessary to use both drugs. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Eltrombopag

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Fanconi syndrome (a type of kidney disease) or
• Kidney failure, acute—Use with caution. May worsen these conditions.

• HIV infection or
• Kidney disease, end-stage (not on dialysis) or
• Liver disease, decompensated—Use is not recommended in patients with these conditions.

Along with its necessary 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:

Incidence not known

• Agitation
• bloody urine
• coma
• confusion
• dark urine
• decreased appetite
• decreased frequency or amount of urine
• diarrhea
• dizziness
• fast, shallow breathing
• general feeling of discomfort
• headache
• hostility
• increased blood pressure
• increased thirst
• irritability
• lethargy
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle pain, cramping, or twitching
• nausea and vomiting
• right upper abdominal or stomach pain and fullness
• seizures
• sleepiness
• stomach discomfort
• stupor
• swelling of the face, fingers, or lower legs
• trouble breathing
• unusual tiredness or weakness
• weight gain
• yellow eyes and 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

• Acid or sour stomach
• belching
• cough
• difficulty in moving
• heartburn
• indigestion
• joint pain
• muscle stiffness

Less common

• Back pain

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.

• Vemlidy

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleotide Reverse Transcriptase Inhibitor

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 these 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.

Keep taking tenofovir for the full time of treatment, even if you or your child begins to feel better. Do not change the dose or stop using this medicine 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.

It is best to take this medicine with food.

Swallow the tablet whole. Do not crush, break, or chew it.

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 chronic hepatitis B infection: Adults and children 12 years of age and older—25 milligrams (mg) once a day. Children younger than 12 years of age—Use and dose must be determined by your doctor.

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.

Keep the bottle tightly closed. Use the medicine dispensed only in its original container.

• Does Biktarvy increase cholesterol?
• What drugs are contained in the HIV treatment Symtuza?
• What is the difference between HIV treatments Odefsey and Complera?
• Genvoya vs Stribild for HIV - How do they compare?
• How much does HIV treatment Cimduo cost?