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Eviplera

300 mg tenofovir disoproxil fumarate / 200 mg emtricitabine / 25 mg rilpivirine

CMI, dosage, igredients, description, price, photo

WHAT IS EVIPLERA?

EVIPLERA consists of three medicines VIREAD® (tenofovir disoproxil fumarate, also called tenofovir DF), EMTRIVA® (emtricitabine or FTC) and EDURANT® (rilpivirine) combined in one tablet.

VIREAD and EMTRIVA belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI) and EDURANT belongs to a group of antiviral medicines known as non-nucleoside reverse transcriptase inhibitors (NNRTI). Tenofovir DF and emtricitabine are the components of TRUVADA® and ATRIPLA® tablets.

EVIPLERA is used to treat Human Immunodeficiency Virus (HIV-1) infection in adults aged 18 years and over. EVIPLERA has not been studied in children under the age of 18, and in only a small number of adults over the age of 65.

HIV-1 infection destroys CD4 T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

EVIPLERA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. EVIPLERA lowers the amount of HIV-1 in the blood (viral load). EVIPLERA may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

DOES EVIPLERA CURE HIV OR AIDS?

EVIPLERA does not cure HIV-1 infection or AIDS. The long-term effects of EVIPLERA are not known at this time. People taking EVIPLERA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection.

This medicine is only available from a pharmacist after it has been prescribed by a doctor who specialises in the treatment of HIV-1 infection. If you wish to continue receiving treatment with EVIPLERA it is important you remain under the care of a hospital or doctor who specialises in the treatment of HIV-1 infection.

DOES EVIPLERA REDUCE THE RISK OF TRANSMITTING HIV TO OTHERS?

  • EVIPLERA does not stop you from transmitting HIV-1 to others. For your health and the health of others, it is important to always practice safe sex by using a latex or polyurethane condom of other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never re-use or share needles.

BEFORE YOU TAKE EVIPLERA

Who should not take EVIPLERA?

Together with your doctor, you need to decide whether EVIPLERA is right for you.

  • Do not take EVIPLERA if you are allergic to tenofovir, tenofovir DF, emtricitabine, rilpivirine or any of the other ingredients of EVIPLERA. The ingredients of EVIPLERA are listed in the product description section of this leaflet.
  • Do not take EVIPLERA if you are already taking any of the components of EVIPLERA (tenofovir DF, emtricitabine or rilpivirine).
  • Do not take EVIPLERA to treat your HIV-1 infection if you are also taking HEPSERA® to treat your hepatitis B virus infection.

What should I tell my doctor before taking EVIPLERA?

Tell your doctor if you:

  • Are allergic to foods, dyes, preservatives or any other medicines.
  • Are pregnant or planning to become pregnant. We do not know if EVIPLERA can harm your unborn child. You and your doctor will need to decide if EVIPLERA is right for you.
  • Are breast-feeding or plan to breast-feed. You should not breast-feed if you are HIV-1 positive because of the chance of passing the HIV-1 virus to your baby. Two active substances in this medicine (tenofovir disoproxil fumarate and emtricitabine) have been found in breast milk at low concentrations. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.
  • Have kidney problems or are undergoing kidney dialysis treatment.
  • Have bone problems.
  • Have liver problems, including hepatitis B or C virus infection.
  • Have mental health problems.

WHAT IMPORTANT INFORMATION SHOULD I KNOW ABOUT TAKING OTHER MEDICINES WITH EVIPLERA?

Some medicines may affect the levels of EVIPLERA or EVIPLERA may affect the levels of other medicines in the body when they are taken at the same time as EVIPLERA. Your doctor may change your other medicines or change their doses. Other medicines, including herbal products may affect EVIPLERA.

For this reason, it is very important to let your doctor or pharmacist know what medications, herbal supplements, or vitamins you are taking.

Know the medicines you take. Keep a list of medicines and show it to your doctor and pharmacist when you get a new medicine. Your doctor and your pharmacist can tell you if you can take these medicines with EVIPLERA. Do not start any new medicines while you are taking EVIPLERA without first talking with your doctor or pharmacist.

MEDICINES YOU SHOULD NOT TAKE WITH EVIPLERA

  • ATRIPLA, VIREAD, EMTRIVA, TRUVADA, STRIBILD STOCRIN, Combivir, Zeffix, Kivexa, Trizivir, any other medicines containing lamivudine or EDURANT
  • HEPSERA (adefovir dipivoxil).

Tell your doctor if you are taking any of the following medicines. Some of these medicines may be obtained without a prescription and some of these may be available under other names. These medicines may alter the amount of EVIPLERA in your blood or EVIPLERA may alter the amount of these medicines in your blood. It is important that you carefully read the package leaflets that are provided with these medicines.

  • Antiretrovirals (to treat HIV-1 infection): etravirine (e.g. Intelence), delavirdine (e.g. Rescriptor), efavirenz (e.g. Stocrin, ATRIPLA), nevirapine (e.g. Viramune), didanosine (e.g. Videx, Videx EC), atazanavir sulfate (e.g. Reyataz), lopinavir/ritonavir (e.g. Kaletra).
  • Antacids (to treat heartburn from acid reflux): aluminium / magnesium hydroxide, calcium carbonate.
  • Anticonvulsants (to treat epilepsy and prevent seizures): carbamazepine (e.g. Tegretol, Teril), oxcarbazepine (e.g. Trieptal), phenobarbital, phenytoin (e.g. Dilantin).
  • Antimycobacterials (to treat bacterial infections, including tuberculosis [TB]): rifabutin (e.g. Mycobutin), rifampin (e.g. Rifadin, Rimycin), rifapentine.
  • Corticosteroids (used in a variety of conditions such as inflammation and allergic reactions):dexamethasone when taken by the mouth or injected).
  • H2-Receptor Antagonists (to treat stomach ulcers or used to relieve heartburn from acid reflux): ranitidine (e.g. Zantac), famotidine (e.g. Pepcidine, Pepzan), cimetidine (e.g. Tagamet, Magicul), nizatidine (e.g. Nizac, Tazac).
  • Macrolide Antibiotics (to treat bacterial infections): clarithromycin (e.g. Charihexal, Clarac), erythromycin (e.g. E-Mycin, Eryc, EES), troleandomycin.
  • Narcotic Analgesic: methadone (e.g. Biodone, Physeptone).
  • Proton Pump Inhibitors (prevent or treat stomach ulcers, heartburn or acid reflux disease): omeprazole (e.g. APO-Omeprazole, Meprazol), lansoprazole (e.g. Zoton, Lanzopran), rabeprazole (e.g. Pariet), pantoprazole (e.g. Somac), esomeprazole (e.g. Nexium).
  • Herbal Products: St. John’s Wort (Hypericum perforatum).

This is not a complete list of medicines that you should tell your doctor about.

HOW TO TAKE EVIPLERA

  • Take the exact amount of EVIPLERA your doctor has prescribed for you. Never change the dose on your own. Do not stop this medicine unless your healthcare provider tells you to stop. The usual dose is one EVIPLERA tablet orally, once daily.
  • Always take EVIPLERA with food. This is important to get the right drug levels in your body. A nutritional drink alone does not replace food.

If you forget to take EVIPLERA

Do not miss a dose of EVIPLERA If you forget to take EVIPLERA within 12 hours of the time you usually take it, take your dose of EVIPLERA with food as soon as possible. Then take your next dose of EVIPLERA at the regularly scheduled time. If you miss a dose of EVIPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of EVIPLERA at the regularly scheduled time.

Do not take a double dose to make up for a forgotten dose.

When your EVIPLERA supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to EVIPLERA and become harder to treat.

Do not change your dose or stop taking EVIPLERA without first talking to your doctor.

If you take an antacid (a medicine to treat heartburn from acid reflux such as aluminum/magnesium hydroxide, calcium carbonate), take the antacid either at least 2 hours before or at least 4 hours after EVIPLERA If you take an H2-receptor antagonist (medicines use to treat stomach ulcers, heartburn or acid reflux disease such as cimetidine, famotidine, nizatidine or ranitidine), take the H2-receptor antagonist at least 12 hours before or at least 4 hours after EVIPLERA. Importantly, proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole) also available for these conditions should not be taken with EVIPLERA.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or in New Zealand the Poisons Centre (telephone 0800 764 766) or go to the accident and emergency department at your nearest hospital if you think you or anyone else may have taken too many EVIPLERA tablets. Do this even if there are no signs of discomfort or poisoning. This may need urgent medical attention.

Things you must not do

  • Do not breast-feed. See “What should I tell my doctor before taking EVIPLERA?”.
  • Avoid doing things that can spread HIV infection since EVIPLERA does not stop you from passing the HIV-1 Infection to others.
    - Do not share needles or other injection equipment.
    - Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
    - Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.
    - Do not take EVIPLERA after the expiry or “use by” date (EXP) printed on the bottle. If you take it after the expiry date has passed, it may not work as well.
    - Do not take EVIPLERA if the packaging is torn or shows signs of tampering.

Things to be careful of

Be careful driving or operating machinery until you know how EVIPLERA affects you. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

POSSIBLE SIDE EFFECTS

Like all medicines, EVIPLERA can have side effects, although not everybody gets them. Some may be serious and need medical attention.

Check with your doctor as soon as possible if you have any problems while taking EVIPLERA, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

EVIPLERA may cause the following serious side effects:

Lactic Acidosis
If you have any of the following symptoms after taking your medication, tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital.

  • You feel very weak or tired
  • You have unusual (not normal) muscle pain
  • You have trouble breathing
  • You have stomach pain with nausea and vomiting
  • You feel cold, especially in your arms and legs
  • You feel dizzy or light headed
  • You have a fast or irregular heartbeat

These side effects may be due to a condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital.

Serious Liver Problems (hepatotoxicity)
If you have any of the following symptoms while taking your medication, tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital.

  • Your skin or the white part of your eyes turns yellow (jaundice)
  • Your urine turns dark
  • Your bowel movements (stools) turn light in colour
  • You don’t feel like eating food for several days or longer
  • You feel sick to your stomach (nausea)
  • You have lower stomach area (abdominal) pain

These side effects may be due to a condition called hepatotoxicity with liver enlargement (hepatomegaly) and fat deposits in the liver (steatosis) which sometimes occurs in patients taking anti-HIV medicines.

You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like EVIPLERA for a long time.

Hepatic Flares
If you have HIV-1 infection and hepatitis B virus (HBV) infection you should not stop your EVIPLERA treatment without first discussing this with your doctor, as some patients have had blood tests or symptoms indicating a worsening of their hepatitis (“hepatic flare”) after stopping individual components (tenofovir DF, and emtricitabine) of EVIPLERA. You may require medical exams and blood tests for several months after stopping treatment. EVIPLERA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your doctor.

Kidney Problems
If you have had kidney problems in the past or take other medicines that can cause kidney problems, your doctor should do regular blood tests to check your kidneys. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.

Changes in Bone Mineral Density (thinning bones)
Laboratory tests show changes in the bones of patients treated with tenofovir DF, a component of EVIPLERA. Some HIV-1 positive patients treated with VIREAD developed thinning of the bones (osteopenia) which could lead to fractures. If you have had bone problems in the past, your doctor may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.

Changes in body fat
Changes in body fat develop in some people receiving anti HIV-1 therapy. These changes may include an increased amount of fat in the upper back and neck (‘buffalo hump’), in the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these fat changes are not known.

Signs and symptoms of inflammation
In some patients with advanced HIV-1 infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV-1 treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please tell your doctor immediately.

Allergy
Some people are allergic to medicines. If you have any of the following symptoms soon after taking your medicine, DO NOT TAKE ANY MORE EVIPLERA and tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital:

  • Skin troubles such as lumpy skin rash or “hives”
  • Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • Wheezing, chest pain or tightness
  • Fainting

These are very serious effects. If you have them, you may have a serious allergic reaction. You may need urgent medical attention or hospitalisation. Hypersensitivity reactions are very rare.

Pancreatitis
If you have any of the following symptoms after starting your medication, tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital.

  • Severe stomach pain or cramps
  • Nausea
  • Vomiting

These side effects may be due to a condition called pancreatitis which sometimes occurs in patients taking anti-HIV-1 medicines.

Clinical studies: The most common side effects of EVIPLERA are depression and diarrhoea. Other side effects include vomiting, nausea, intestinal gas, dizziness, allergic reaction, headache, sleeping problems (including difficulty to fall asleep or sleepiness), abnormal dreams, stomach pain or discomfort, indigestion, rash, skin discoloration (small spots or freckles), pain, weakness, decreased appetite, and fatigue.

Marketing experience: Other side effects reported since emtricitabine and/or tenofovir DF, two components of EVIPLERA, have been marketed include: allergic reaction (including swelling of the face, lips, tongue, or throat), inflammation of the pancreas, inflammation of the liver, shortness of breath, fatty liver, kidney problems (including decline or failure of kidney function), and high volume of urine and thirst caused by kidney problems. Muscle pain and muscle weakness, bone pain, and softening of the bone (which may contribute to fractures) as a consequence of kidney problems have been reported.

Ask your doctor or pharmacist if you don’t understand anything in this list. This is not a complete list of side effects possible with EVIPLERA. Ask your doctor or pharmacist for a more complete list of side effects of EVIPLERA and all the medicines you will take.

HOW DO I STORE EVIPLERA?

Keep EVIPLERA tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store them.

Keep EVIPLERA tablets in a cool, dry place where it stays below 30°C.

Do not store EVIPLERA or any other medicine in a bathroom or near a sink.

Do not leave EVIPLERA in the car or on a window sill - heat and dampness can destroy some medicines.

Keep your EVIPLERA tablets in the bottle with the cap tightly closed until you take them. If you take EVIPLERA tablets out of their pack they may not keep well.

GENERAL ADVICE ABOUT PRESCRIPTION MEDICINES:

Talk to your doctor or pharmacist if you have any questions about this medicine or your condition.

Medicines are sometimes prescribed for conditions that are not mentioned in this leaflet. Do not use EVIPLERA for a condition for which it was not prescribed. Do not give EVIPLERA to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarises the most important information about EVIPLERA. If you would like more information, ask your doctor or pharmacist. Your doctor or pharmacist can give you information about this medicine that was written for doctors or pharmacists (Product Information).

PRODUCT DESCRIPTION

What EVIPLERA tablets look like?

EVIPLERA tablets are capsule-shaped and purplish-pink in colour. Each tablet is debossed with “GSI” on one side and plain on the other side. EVIPLERA tablets are supplied in bottles containing 30 tablets.

EVIPLERA tablet ingredients

Active Ingredients:

  • tenofovir disoproxil fumarate,
  • emtricitabine and
  • rilpivirine.

Inactive Ingredients:

  • pregelatinized starch,
  • lactose,
  • microcrystalline cellulose,
  • croscarmellose sodium,
  • magnesium stearate,
  • povidone,
  • polysorbate 20.

The film coating contains

  • macrogol 3350,
  • hypromellose,
  • lactose,
  • glycerol triacetate,
  • titanium dioxide,
  • iron oxide red,
  • indigo carmine aluminium lake,
  • sunset yellow FCF aluminium lake.

Note: This information may not be actual at the time of reading. Always look for actual instructions in the package with the medication.
It is forbidden to use these materials without the advice of healthcare professional.

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