DARUNAVIR/COBICISTAT - ORAL

DARUNAVIR/COBICISTAT - ORAL

PHONETIC PRONUNCIATION: (dar-UE-na-vir/koe-BIK-i-stat)

COMMON BRAND NAME(S): Prezcobix

GENERIC NAME(S): darunavir ethanolate/cobicistat

Uses

USES: This product 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. This product is a combination of two different drugs: darunavir and cobicistat. Darunavir belongs to a class of drugs known as protease inhibitors. Cobicistat is used to increase ("boost") the levels of darunavir. Darunavir/cobicistat 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.


How to use DARUNAVIR/COBICISTAT - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking darunavir/cobicistat and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually once daily. The manufacturer directs not to crush or break the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed or broken. Follow your doctor's directions on how to take this medication. It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time 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. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side Effects

SIDE EFFECTS: Diarrhea may occur. If this persists or worsens, 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. Darunavir/cobicistat may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding. 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. This medication 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. 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. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking darunavir/cobicistat, tell your doctor or pharmacist if you are allergic to either of the medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including hepatitis B, C), kidney disease, a certain bleeding problem (hemophilia), diabetes, heart problems (coronary artery disease, heart attack), lipid problems (high cholesterol or triglycerides/fats). 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 or plan to become pregnant. You should not become pregnant while using darunavir/cobicistat. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. Your doctor should prescribe other medications to lower the risk of passing HIV infection to your baby. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: elvitegravir, certain hepatitis C virus protease inhibitors (such as boceprevir, simeprevir, telaprevir), orlistat, ritonavir. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, tamsulosin), certain benzodiazepines (such as midazolam, triazolam), "blood thinners" (such as apixaban, rivaroxaban), dronedarone, ergot alkaloids (such as dihydroergotamine, ergotamine), quinidine, pimozide, ranolazine, salmeterol, certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), certain "statin" cholesterol drugs (lovastatin, simvastatin), among others. Other medications can affect the removal of this medication from your body, which may affect how this medication works. Examples include certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), garlic supplements, certain HIV NNRTI drugs (such as efavirenz, etravirine, nevirapine), rifamycins (such as rifabutin, rifampin), 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 or cobicistat.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Images

PREZCOBIX 800 MG-150 MG TABLET

color
pink
shape
oblong
imprint
800, TG

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Faq for DARUNAVIR/COBICISTAT - ORAL

Darunavir/cobicistat is a combination medication used in the treatment of HIV infection. It contains two active ingredients: darunavir, which is an antiretroviral medication, and cobicistat, which is a pharmacokinetic enhancer.

Darunavir works by inhibiting the protease enzyme, which is essential for the replication of HIV. Cobicistat acts as a booster by increasing the levels of darunavir in the blood, allowing it to be more effective in preventing the progression of HIV infection.

Darunavir/cobicistat is used in the treatment of HIV infection in adults and pediatric patients aged 12 years and older. It is typically prescribed as part of a combination therapy regimen with other antiretroviral drugs.

Darunavir/cobicistat is usually taken once daily with food. It is important to follow the prescribed dosing instructions provided by your healthcare provider.

Common side effects may include diarrhea, nausea, headache, rash, and abdominal pain. It is important to notify your doctor if any side effects become severe or persistent.

Yes, darunavir/cobicistat can interact with other medications. It is important to inform your healthcare provider about all the medications you are currently taking, including prescription drugs, over-the-counter medications, and herbal supplements.

No, darunavir/cobicistat cannot cure HIV infection. It is an antiretroviral medication that helps to manage the virus and slow down its progression.

The effectiveness of darunavir/cobicistat varies from individual to individual. It is important to take the medication as prescribed by your doctor and undergo regular monitoring of your viral load and CD4 cell count to assess its efficacy.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.