Darunavir

By Medically reviewed by hellodoktor

Generic Name: Darunavir Brand Name(s): Darunavir. Avability: Rx Pregnancy Category: C

Uses

What is Darunavir used for?

Darunavir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase (“boost”) the levels of darunavir. This helps darunavir work better.

Darunavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

How should I take Darunavir?

Take this medication by mouth with food as directed by your doctor. Darunavir must be taken at the same time as certain other medications, usually once or twice a day.

The manufacturer recommends to swallow the tablets whole with a drink such as water or milk. If you cannot swallow whole tablets, ask your doctor if you can still use the tablets or if you should use the liquid form.

If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your age, laboratory tests, medical condition, and response to treatment. In children, the dosage is also based on body weight.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

How do I store Darunavir?

Darunavir is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Darunavir in the bathroom or the freezer. There may be different brands of Darunavir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Darunavir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Darunavir?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C), diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Darunavir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Darunavir. Darunavir is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Darunavir?

Since darunavir is always taken with other HIV medications, it may be difficult to tell whether darunavir is causing certain side effects. However, darunavir is known to cause diarrhea, nausea, vomiting, stomach pain, and headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Get medical help right away if any of these rare but serioussymptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but very serious side effects: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Darunavir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash, especially with symptoms such as fever, tiredness, muscle/joint pain, blisters, mouth sores, or red/swollen eyes.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Darunavir?

Some of the products that may interact with this drug include: orlistat, certain hepatitis C virus protease inhibitors (such as boceprevir, simeprevir, telaprevir), certain drugs used to treat seizures (such as carbamazepine, phenytoin, primidone), barbiturates (such as phenobarbital, secobarbital), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir).

Darunavir can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, tamsulosin), certain benzodiazepines (midazolam, triazolam), “blood thinners” (such as apixaban, rivaroxaban), bosutinib, dronedarone, ergot alkaloids (such as dihydroergotamine, ergotamine), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), lomitapide, pimozide, ranolazine, salmeterol, certain “statin” cholesterol drugs (such as lovastatin, simvastatin), tolvaptan, among others.

Other medications can affect the removal of darunavir from your body, which may affect how darunavir works. Examples include garlic supplements, certain rifamycins (rifampin, rifapentine), St. John’s Wort, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.

Do not take this medication with other products that contain darunavir.

Darunavir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Darunavir?

Darunavir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Darunavir?

Darunavir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Darunavir.

What is the dose of Darunavir for an adult?

Usual Adult Dose for HIV Infection

Therapy-naive Patients and Therapy-experienced Patients with No Darunavir Resistance Associated Substitutions: Darunavir 800 mg plus ritonavir 100 mg orally once a day with food

Therapy-experienced Patients with At Least 1 Darunavir Resistance Associated Substitution (including V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V): Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:

-Genotypic testing is recommended for therapy-experienced patients; however, when genotypic testing is not possible, darunavir 600 mg plus ritonavir 100 mg twice a day is recommended.

Use: In combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

Moderate renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.

Severe liver dysfunction: Not recommended.

Other Comments

Administration advice:

-Coadminister with ritonavir and food to get desired antiviral effect; failure to correctly administer this drug with ritonavir and food will result in reduced darunavir plasma levels and loss of efficacy may occur.

-Swallow tablets whole with a drink (e.g., water or milk).

-Consider using the oral suspension if a patient is unable to reliably swallow a tablet.

-Shake the oral suspension well before each dose; consult the manufacturer product information for further instructions.

-Consult the manufacturer product information regarding missed doses.

Storage requirements:

-Oral suspension: Do not refrigerate or freeze; avoid excessive heat; store in original container

General:

-Dose recommendations based on this drug (plus ritonavir) in combination with other antiretroviral drugs.

-The manufacturer product information for ritonavir should be consulted.

-In therapy-experienced adult and pediatric patients, the following should be taken into consideration when initiating therapy:

(a) Treatment history and, when available, genotypic or phenotypic testing should guide the use of this drug (plus ritonavir).

(b) The use of other active agents with this drug (plus ritonavir) is associated with a greater probability of treatment response.

Monitoring:

-Hematologic: Bleeding in hemophiliacs

-Hepatic: Liver function (before and during therapy)

-Metabolic: Blood glucose levels

What is the dose of Darunavir for a child?

Usual Pediatric Dose for HIV Infection

3 to less than 18 years:

Therapy-naive Patients and Therapy-experienced Patients with No Darunavir Resistance Associated Substitutions:

Oral suspension:

10 to less than 15 kg: Darunavir 35 mg/kg plus ritonavir 7 mg/kg orally once a day with food

-or-

10 to less than 11 kg: Darunavir 350 mg plus ritonavir 64 mg orally once a day with food

11 to less than 12 kg: Darunavir 385 mg plus ritonavir 64 mg orally once a day with food

12 to less than 13 kg: Darunavir 420 mg plus ritonavir 80 mg orally once a day with food

13 to less than 14 kg: Darunavir 455 mg plus ritonavir 80 mg orally once a day with food

14 to less than 15 kg: Darunavir 490 mg plus ritonavir 96 mg orally once a day with food

Tablets and oral suspension:

15 to less than 30 kg: Darunavir 600 mg plus ritonavir 100 mg orally once a day with food

30 to less than 40 kg: Darunavir 675 mg plus ritonavir 100 mg orally once a day with food

40 kg or more: Darunavir 800 mg plus ritonavir 100 mg orally once a day with food

Therapy-experienced Patients with At Least 1 Darunavir Resistance Associated Substitution (including V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V):

Oral suspension:

10 to less than 15 kg: Darunavir 20 mg/kg plus ritonavir 3 mg/kg orally twice a day with food

-or-

10 to less than 11 kg: Darunavir 200 mg plus ritonavir 32 mg orally twice a day with food

11 to less than 12 kg: Darunavir 220 mg plus ritonavir 32 mg orally twice a day with food

12 to less than 13 kg: Darunavir 240 mg plus ritonavir 40 mg orally twice a day with food

13 to less than 14 kg: Darunavir 260 mg plus ritonavir 40 mg orally twice a day with food

14 to less than 15 kg: Darunavir 280 mg plus ritonavir 48 mg orally twice a day with food

Tablets and oral suspension:

15 to less than 30 kg: Darunavir 375 mg plus ritonavir 48 mg orally twice a day with food

30 to less than 40 kg: Darunavir 450 mg plus ritonavir 60 mg orally twice a day with food

40 kg or more: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:

-Special vigilance recommended during dose selection, medication order transcription, dispensing information, and dosing instructions to reduce risk for medication errors, overdose, and underdose.

-Dose should not exceed the recommended adult dose.

Use: In combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection

Precautions

Safety and efficacy have not been established in patients weighing less than 10 kg. This drug should not be used in patients younger than 3 years.

How is Darunavir available?

Darunavir is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral suspension.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Darunavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 16, 2018 | Last Modified: September 12, 2019

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