Description
Darunavir is used in combination with ritonavir (Norvir®) and other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is given to patients who have already had previous treatment for HIV or who have never taken HIV medicines in the past.
Darunavir will not cure or prevent HIV infection or AIDS. It works by lowering the amount of HIV in the blood and it will also help your immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. Darunavir will not keep you from spreading HIV to other people.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Suspension
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darunavir in children 3 years of age and older. Because of darunavir's toxicity, use in children younger than 3 years of age is not recommended.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darunavir in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving darunavir.
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.
- Alfuzosin
- Astemizole
- Bromocriptine
- Carbamazepine
- Cisapride
- Colchicine
- Dihydroergotamine
- Domperidone
- Dronedarone
- Elbasvir
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Flibanserin
- Fosphenytoin
- Grazoprevir
- Ivabradine
- Levoketoconazole
- Lisuride
- Lomitapide
- Lovastatin
- Lurasidone
- Maraviroc
- Metergoline
- Methylergonovine
- Methysergide
- Midazolam
- Naloxegol
- Nicergoline
- Phenobarbital
- Phenytoin
- Pimozide
- Primidone
- Ranolazine
- Rifampin
- Sildenafil
- Simvastatin
- St John's Wort
- Terfenadine
- Triazolam
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.
- Acebutolol
- Acecainide
- Adagrasib
- Adenosine
- Ajmaline
- Alfentanil
- Alprazolam
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amlodipine
- Amobarbital
- Amoxapine
- Amprenavir
- Apixaban
- Aprepitant
- Aprindine
- Aprobarbital
- Aranidipine
- Aripiprazole
- Artemether
- Atazanavir
- Atenolol
- Atidarsagene Autotemcel
- Atorvastatin
- Avacopan
- Avanafil
- Bedaquiline
- Benzhydrocodone
- Betamethasone
- Betaxolol
- Bisoprolol
- Boceprevir
- Bosentan
- Bosutinib
- Bretylium
- Budesonide
- Buprenorphine
- Butabarbital
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.
- Cobicistat
- Tenofovir Disoproxil Fumarate
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:
- Diabetes or
- Hemophilia (a bleeding problem) or
- Hyperglycemia (high blood sugar) or
- Liver disease (eg, cirrhosis, hepatitis)—Use with caution. May make these conditions worse.
- Liver disease, severe—Use is not recommended in patients with this condition.
- Sulfa allergy, known or suspected—Use with caution. May make side effects worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use 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 is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
You may take this medicine with food.
Swallow the tablet whole with water or milk. Do not crush, break, or chew it.
If you are using the oral liquid, shake the bottle well before measuring each dose. Use the dosing syringe that comes with the package to measure each dose.
If you also use didanosine (Videx®), take it at least 1 hour before or 2 hours after taking this medicine and ritonavir.
Keep using this medicine for the full treatment time, even if you begin to feel better. It is also important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.
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 (suspension or tablets):
- For HIV infection (patient already had HIV treatment):
- For patients with no darunavir resistance associated substitution:
- Adults—800 milligrams (mg) (one 800 mg tablet or 8 milliliters [mL]) once a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
- Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
- Weighing 40 kg or more—800 mg (8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
- Weighing 30 kg to less than 40 kg—675 mg (6.8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
- Weighing 15 kg to less than 30 kg—600 mg (6 mL) with 100 mg (1.25 mL) of ritonavir once a day.
- Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor.
- Weighing 14 kg to less than 15 kg—490 mg (5 mL) with 96 mg (1.2 mL) of ritonavir once a day.
- Weighing 13 kg to less than 14 kg—455 mg (4.6 mL) with 80 mg (1 mL) of ritonavir once a day.
- Weighing 12 kg to less than 13 kg—420 mg (4.2 mL) with 80 mg (1 mL) of ritonavir once a day.
- Weighing 11 kg to less than 12 kg—385 mg (4 mL) with 64 mg (0.8 mL) of ritonavir once a day.
- Weighing 10 kg to less than 11 kg—350 mg (3.6 mL) with 64 mg (0.8 mL) of ritonavir once a day.
- Children younger than 3 years of age—Use is not recommended.
- For patients with at least one darunavir resistance associated substitution:
- Adults—600 milligrams (mg) (one 600 mg tablet or 6 mL) 2 times a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
- Pregnant patients—600 mg taken with 100 mg of ritonavir (Norvir®) 2 times a day.
- Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
- Weighing 40 kg or more—600 mg (6 mL) with 100 mg (1.25 mL) of ritonavir 2 times a day.
- Weighing 30 kg to less than 40 kg—450 mg (4.6 mL) with 60 mg (0.75 mL) of ritonavir 2 times a day.
- Weighing 15 kg to less than 30 kg—375 mg (3.8 mL) with 48 mg (0.6 mL) of ritonavir 2 times a day.
- Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor.
- Weighing 14 kg to less than 15 kg—280 (2.8 mL) with 48 mg (0.6 mL) of ritonavir 2 times a day.
- Weighing 13 kg to less than 14 kg—260 mg (2.6 mL) with 40 mg (0.5 mL) of ritonavir 2 times a day.
- Weighing 12 kg to less than 13 kg—240 mg (2.4 mL) with 40 mg (0.5 mL) of ritonavir 2 times a day.
- Weighing 11 kg to less than 12 kg—220 mg (2.2 mL) with 32 mg (0.4 mL) of ritonavir 2 times a day.
- Weighing 10 kg to less than 11 kg—200 mg (2 mL) with 32 mg (0.4 mL) of ritonavir 2 times a day.
- Children younger than 3 years of age—Use is not recommended.
- For patients with no darunavir resistance associated substitution:
- For HIV infection (patient never had HIV treatment):
- Adults—800 milligrams (mg) (one 800 mg tablet or 8 milliliters [mL]) of darunavir once a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
- Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
- Weighing 40 kg or more—800 mg (8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
- Weighing 30 kg to less than 40 kg—675 mg (6.8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
- Weighing 15 kg to less than 30 kg—600 mg (6 mL) with 100 mg (1.25 mL) of ritonavir once a day.
- Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor.
- Weighing 14 kg to less than 15 kg—490 mg (5 mL) with 96 mg (1.2 mL) of ritonavir once a day.
- Weighing 13 kg to less than 14 kg—455 mg (4.6 mL) with 80 mg (1 mL) of ritonavir once a day.
- Weighing 12 kg to less than 13 kg—420 mg (4.2 mL) with 80 mg (1 mL) of ritonavir once a day.
- Weighing 11 kg to less than 12 kg—385 mg (4 mL) with 64 mg (0.8 mL) of ritonavir once a day.
- Weighing 10 kg to less than 11 kg—350 mg (3.6 mL) with 64 mg (0.8 mL) of ritonavir once a day.
- Children younger than 3 years of age—Use is not recommended.
- For HIV infection (patient already had HIV treatment):
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 oral liquid in its original container. Do not refrigerate or freeze it.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ivabradine (Corlaonor®), lomitapide (Juxtapid®, Lojuxta®), lovastatin (Altocor®, Altoprev®, Mevacor®), lurasidone (Latuda®), naloxegol (Movantik®, Moventig®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Methergine®, Migranal®, Wigraine®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.
Birth control pills may not work as well while you are using darunavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragm, contraceptive foam, or jelly. If you think you have become pregnant while using this medicine, tell your doctor right away.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase blood sugar levels. Check with your doctor right away if you or your child have increased thirst or increased urination. If you notice a change in the results of your or your child's blood or urine sugar tests, or if you have any questions, check with your doctor.
Your immune system may get stronger when you start taking 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, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, 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, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may cause you to have excess body fat. Tell your doctor if you or your child 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 may increase the risk of bleeding in patients with hemophilia (a bleeding disorder). Talk with your doctor about this risk.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) 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
- Blistering, peeling, or loosening of the skin
- blurred vision
- chills
- cough
- diarrhea
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- 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
- skin rash
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sweating
- trouble breathing
- unexplained weight loss
- unusual tiredness or weakness
Rare
- Belching
- black, tarry stools
- bloating
- constipation
- dark urine
- decreased appetite
- difficulty with moving
- dizziness
- excess air or gas in the stomach or bowels
- fast heartbeat
- feeling of fullness
- fever
- headache
- heartburn
- indigestion
- lack or loss of strength
- light-colored stools
- loss of appetite
- muscle aching or cramping
- nausea
- painful or difficult urination
- passing gas
- stomach pain or tenderness
- swelling of the feet or lower legs
- swollen glands
- swollen joints
- unpleasant breath odor
- unusual bleeding or bruising
- vomiting
- vomiting of blood
- yellow eyes or skin
Incidence not known
- Lower back pain
- muscle pain, spasms, or stiffness
- pain or burning while urinating
- sudden decrease in amount of urine
- swelling or puffiness of the face
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
- Stuffy or runny nose
Less common
- Gaining weight around your neck, upper back, breast, face, or waist
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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