Juluca

What is Juluca used for?

Juluca is a prescription medicine that is  used to treat HIV infection.

Description

JULUCA is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an INSTI, and rilpivirine (as rilpivirine hydrochloride), an NNRTI.

The chemical name of dolutegravir sodium is sodium (4R,12aS)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazin-7-olate. The empirical formula is C20H18F2N3NaO5 and the molecular weight is 441.36 g per mol. It has the following structural formula:

Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water.

The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C22H18N6 • HCl and its molecular weight is 402.88g per mol. Rilpivirine hydrochloride has the following structural formula:

Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.

JULUCA tablets are for oral administration. Each film-coated tablet contains the active ingredients 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride) and the 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 the inactive ingredients iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

Before taking Juluca, tell your doctor:

• If you are allergic to Juluca; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Juluca, like some other drugs used for HIV or certain drugs used for seizures, infection, or stomach or bowel problems. There are many drugs that must not be taken with Juluca.
• If you are trying to get pregnant.
• If you are pregnant or may be pregnant. Do not take Juluca if you are in the first trimester of pregnancy.
• If you are breast-feeding. Do not breast-feed while you take Juluca.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Juluca with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Juluca?

• Tell all of your health care providers that you take Juluca. This includes your doctors, nurses, pharmacists, and dentists.
• If you have had hepatitis B or C, talk with your doctor.
• Some other drugs may need to be taken at some other time than Juluca. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Juluca.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Juluca. Talk with your doctor.
• This medicine may cause harm to an unborn baby. Women must use birth control while taking Juluca. If you get pregnant, call your doctor right away.

How is Juluca best taken?

Use Juluca as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with a meal.
• Do not use a protein drink in place of a meal.
• Keep taking Juluca as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of Juluca during treatment.
• If you take products that have iron, aluminum, calcium, or magnesium in them (like some antacids or vitamins), you may need to take them at some other time than Juluca. Talk with your doctor or pharmacist.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with a meal.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of Juluca that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
• Restlessness.
• Muscle or joint pain.
• Shortness of breath.
• Feeling very tired or weak.
• Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take Juluca. Tell your doctor right away if you have any new signs after you start Juluca, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
• Very bad skin and allergic reactions have happened with Juluca. Skin reactions have happened along with fever or problems in body organs like the liver. Call your doctor right away if you have red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in your mouth, throat, nose, or eyes; trouble swallowing; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Juluca?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Juluca?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• NDC 49702-242-13
• JULUCA
• (dolutegravir and rilpivirine)
• Tablets
• 50 mg/25 mg
• Rx Only
• Note to pharmacist: Do not cover ALERT box with pharmacy label.
• ALERT: Find out about medicines that should NOT be taken with JULUCA.
• 30 tablets
• Each film-coated tablet contains 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride).
• Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) (see USP Controlled Room Temperature).
• Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.
• See prescribing information for dosage information.
• Mfd for:
• ViiV Healthcare
• RTP, NC 27709
• by:
• GlaxoSmithKline, RTP NC 27709
• Made in UK
• Rev. 11/17
• 10000000146014

SRC: NLM .