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4 December, 2017 00:00 00 AM
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FDA approves Juluca

drugs.com
FDA approves Juluca

The U.S. Food and Drug Administration (FDA) has approved Juluca (dolutegravir and rilpivirine) is a HIV-1 integrase strand transfer inhibitor (INSTI) and a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) combination indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed.

What is Juluca?

Juluca is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if Juluca is safe and effective in children.

Do not take Juluca if you:

have ever had an allergic reaction to a medicine that contains dolutegravir or rilpivirine.

are taking any of the following medicines:

dofetilide

carbamazepine

oxcarbazepine

phenobarbital

phenytoin

rifampin

rifapentine

proton pump inhibitors, including:

esomeprazole

lansoprazole

omeprazole

pantoprazole sodium

rabeprazole

St. John's wort (Hypericum perforatum)

more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

have ever had a severe skin rash or an allergic reaction to medicines that contain dolutegravir or rilpivirine.

have or have had liver problems, including hepatitis B or C infection.

have ever had a mental health problem.

are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.

Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medications, including Juluca during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

Talk to your healthcare provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. Do not breastfeed if you take Juluca.

You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

It is not known if this medicine can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with Juluca. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with Juluca.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Juluca with other medicines.

Juluca side effects

Juluca can cause serious side effects, including:

Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash during treatment. Stop taking the tablets and get medical help right away if you develop a rash with any of the following signs or symptoms:

fever

generally ill feeling

tiredness

muscle or joint aches

blisters or sores in mouth

blisters or peeling of the skin

redness or swelling of the eyes

welling of the mouth, face, lips, or tongue

problems breathing

Liver problems. People with a history of hepatitis B or C virus who have certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during treatment. Liver problems, including liver failure, have also happened in people without history of liver disease or other risk factors.

Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:

your skin or the white part of your eyes turns yellow (jaundice)

dark or “tea-colored” urine

light-colored stools (bowel movements)

nausea or vomiting

loss of appetite

pain, aching, or tenderness on the right side of your stomach area

Depression or mood changes. Tell your healthcare provider right away or get medical help if you have any of the following symptoms:

feeling sad or hopeless

feeling anxious or restless

have thoughts of hurting yourself (suicide) or have tried to hurt yourself

The most common side effects include diarrhea and headache.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

What are the ingredients in Juluca?

Active ingredients: dolutegravir and rilpivirine.

Inactive ingredients: croscarmellose sodium, D-mannitol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K29/32 and K30, silicified microcrystalline cellulose, sodium starch glycolate, and sodium stearyl fumarate.

The tablet film-coating contains: iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

 

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Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

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