Description
Bictegravir and lenacapavir combination is used to treat human immunodeficiency virus (HIV) infection. This medicine is usually given to patients to replace their current medicine provided that they meet certain requirements. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Bictegravir and lenacapavir combination will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and helps the immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 bictegravir and lenacapavir combination in the pediatric population. 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 bictegravir and lenacapavir combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Apalutamide
- Carbamazepine
- Colchicine
- Dofetilide
- Encorafenib
- Ensitrelvir
- Enzalutamide
- Fosphenytoin
- Ivosidenib
- Lomitapide
- Lumacaftor
- Mitotane
- Phenytoin
- Rifampin
- Rifapentine
- St John's Wort
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.
- Abametapir
- Abemaciclib
- Acalabrutinib
- Afatinib
- Alfentanil
- Aliskiren
- Alpelisib
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amlodipine
- Apalutamide
- Apixaban
- Artemether
- Atazanavir
- Atidarsagene Autotemcel
- Atogepant
- Avacopan
- Avanafil
- Avapritinib
- Benzhydrocodone
- Betrixaban
- Boceprevir
- Bosentan
- Bosutinib
- Brexpiprazole
- Bromocriptine
- Budesonide
- Buprenorphine
- Buspirone
- Calcium
- Calcium Silicate
- Carbamazepine
- Cariprazine
- Cenobamate
- Ceritinib
- Clarithromycin
- Clozapine
- Cobicistat
- Cobimetinib
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.
- Kratom
- Sparsentan
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:
- Hepatitis B infection—Use with caution. May make this condition worse.
Proper Use
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. Also, do not change the dose or 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.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully.
You may take this medicine with or without food.
Take this medicine at least 2 hours before or 6 hours after taking an antacid that contains aluminum or magnesium.
You may take an antacid or supplement containing calcium or iron together with this medicine if you take them with food.
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—At first, 600 milligrams (mg) or 2 tablets of Sunlenca® and 1 tablet of Bixlenvo™ once a day on Days 1 and 2. For maintenance, 1 tablet of Bixlenvo™ only once a day on Day 3 and thereafter. Each tablet of Bixlenvo™ contains 75 mg bictegravir and 50 mg lenacapavir.
- Children—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.
If you miss a dose of this medicine on Day 1 or Day 2, take it as soon as possible. Do not take Day 1 and Day 2 doses on the same day.
If you miss a maintenance dose, take it as soon as possible. If you miss a dose and it is more than 7 days, call your doctor.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with carbamazepine (Tegretol®), dofetilide (Tikosyn®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), or St. John’s wort. Using these medicines together may cause serious or life-threatening side effects.
Tell your doctor if you are pregnant or become pregnant during treatment with this medicine.
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.
Always practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. Do not re-use or share needles with anyone. Diseases or infections could be passed on through used or shared needles.
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:
Incidence not known
- Blistering, peeling, or loosening of the skin
- chills
- cough
- diarrhea
- itching
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness or weakness
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:
Less common
- Diarrhea
- headache
- nausea
Incidence not known
- Weight increased
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.
DRG-80012062
