150 mg/150 mg/200 mg/245 mg film-coated tablets
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
What Stribild is and what it is used for
Stribild contains four active substances:
- elvitegravir, an antiretroviral medicine called an integrase inhibitor
- cobicistat, a booster ( pharmacokinetic enhancer) of the effects of elvitegravir
- emtricitabine, an antiretroviral medicine called a nucleoside reverse transcriptase inhibitor (NRTI)
- tenofovir disoproxil, an antiretroviral medicine called a nucleotide reverse transcriptase inhibitor (NtRTI).
Stribild is a one-table treatment for human immunodeficiency virus ( HIV ) infection in adults.
Stribild is also intended for the treatment of HIV – 1 infection in adolescents from 12 to < 18 years of age with a body weight of at least 35 kg and who have already been treated with other HIV medicines that have caused side effects.
Stribild reduces the amount of HIV in the body. This strengthens the immune system and reduces the risk of developing diseases associated with HIV infection.
What you need to know before taking Stribild
Do not take Stribild
- If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir, tenofovir disoproxil, or any other ingredient in this medicine (listed in section 6 of the leaflet).
- If you have stopped treatment with any medicine containing tenofovir disoproxil on the advice of a doctor after problems with kidney function.
- If you are taking any of these medicines:
- alfuzosin (used to treat enlarged prostate gland)
- amiodarone, quinidine (used to correct irregular heartbeats)
- dabigatran (used to prevent and treat blood clots)
- carbamazepine, phenobarbital, phenytoin (used to prevent seizures)
- rifampicin (used to prevent and treat tuberculosis and other infections )
- dihydroergotamine, ergotamine, ergometrine (used to treat migraine headaches)
- cisapride (used to relieve certain stomach problems)
- St. John’s wort (Hypericum perforatum, a natural remedy used for depression and anxiety) or products containing St. John’s wort
- lovastatin, simvastatin (used to lower blood cholesterol levels)
- pimozide, lurasidone (used to treat abnormal thoughts or feelings)
- sildenafil (used to treat pulmonary arterial hypertension – a lung disease that makes breathing difficult)
- midazolam (administered orally), triazolam (used to help you sleep and/or reduce anxiety)
→ If any of these apply to you, do not take Stribild and inform your doctor immediately.
Warnings and precautions
Your treatment with Stribild must be followed up by a doctor at all times.
You can still transmit HIV when taking this medicine, although the risk is reduced with effective antiviral treatment. Discuss with your doctor the necessary measures to avoid infecting others. This medicine does not cure HIV infection. While taking Stribild, you may still develop an infection or other diseases associated with HIV infection.
Talk to your doctor before taking Stribild:
- If you have kidney problems or have had kidney problems in the past or if tests have shown that you have kidney problems. The doctor carefully considers whether you should receive treatment with Stribild.
Stribild can affect your kidneys. Before starting treatment, your doctor will order some blood tests to check that your kidneys are working normally. Your doctor will also order blood tests during treatment to check your kidneys.
Stribild is not usually taken together with other medicines that can damage the kidneys (see Other medicines and Stribild). If unavoidable, your doctor will check your kidney function more often.
- Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures ) may also occur due to damage to renal tubule cells (see section 4, Possible side effects ). Tell your doctor if you have bone pain or a fracture.
Tenofovir disoproxil can also cause loss of bone mass.
Overall, the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adults and children are uncertain
Tell your doctor if you know you have osteoporosis. Patients with osteoporosis are at higher risk of fracture. - If you have liver problems or have had liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully choose the best treatment for you.
If you have a hepatitis B infection, your liver problems may get worse after you stop taking Stribild. You mustn’t stop taking Stribild without talking to your doctor (see section 3, Do not stop taking Stribild). - If you are over 65 years of age. Stribild has not been studied in patients over 65 years of age. If you are older than that and have been prescribed Stribild, your doctor will monitor you closely.
→ If any of these apply to you, talk to your doctor before taking Stribild.
When you take Stribild
Once you have started taking Stribild, you must be observant of:
- any signs of inflammation or infection
- leg problems
→ Contact a doctor immediately if you experience any of these symptoms.
Children and young people
Do not give this medicine to children under 12 years of age. The use of Stribild in children under 12 years of age and weighing less than 35 kg has not been studied.
Other medicines and Stribild
There are certain medicines that you must never take with Stribild
These are mentioned under the heading above “Do not take Stribild – If you are taking any of these medicines”.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Stribild can affect or be affected by other medicines. This can lead to the amount of Stribild or other medicines in the blood being affected. The medicines may then not work properly or any side effects may worsen. In some cases, the doctor may need to change the dose or check the amount of medicine in the blood.
You must talk to your doctor if you are taking any of the following:
- all other medicines containing:
- tenofovir disoproxil
- tenofovir alafenamide
- lamivudine
- adefovir dipivoxil
- medicines that can damage the kidneys, such as:
- aminoglycosides (eg streptomycin, neomycin, and gentamicin), vancomycin (for bacterial infections)
- foscarnet, ganciclovir, cidofovir (for viral infections)
- amphotericin B, pentamidine (for fungal infections)
- interleukin 2 (also called aldesleukin) (to treat cancer)
- non-steroidal anti-inflammatory agents ( NSAIDs, to relieve bone or muscle pain)
It is also important that you tell the doctor if you are taking any of the following types of medicine:
- antifungals used to treat fungal infections, such as:
- ketoconazole , itraconazole, voriconazole, fluconazole and posaconazole
- antiviral agents, used to treat hepatitis C infection:
- ledipasvir/sofosbuvir, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir
- antibiotics used to treat bacterial infections such as tuberculosis and include:
- rifabutin, clarithromycin, or telithromycin
- antidepressants used to treat depression:
- medicines containing trazodone or escitalopram
- sedatives and hypnotics used to treat anxiety:
- buspirone, clorazepate, diazepam , estazolam, flurazepam and zolpidem
- immunosuppressants used to control the body’s immune system after a transplant, e.g.:
- ciclosporin, sirolimus and tacrolimus
- corticosteroids, including:
- betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions in the skin, inflammation in the eyes, joints, and muscles, and other inflammatory conditions. These drugs are usually taken orally, inhaled, injected, or applied to the skin or eye. If there are no alternatives, the drug should be used only after medical judgment and under close monitoring by your doctor for side effects of corticosteroids.
- medicines used to treat diabetes:
- metformin
- birth control pills used to prevent pregnancy
- drugs against erectile dysfunction used to treat impotence, eg:
- sildenafil, tadalafil, and vardenafil
- heart medicines, eg:
- digoxin , disopyramide , flecainide , lidocaine , mexilitine, propafenone , metoprolol , timolol , amlodipine, diltiazem , felodipine, nicardipine, nifedipine and verapamil
- drugs used to treat pulmonary arterial hypertension:
- anticoagulant , used to prevent and treat blood clots, eg:
- warfarin , edoxaban, apixaban and rivaroxaban
- bronchodilators used to treat asthma and other lung problems:
- salmeterol
- cholesterol-lowering medicines, such as:
- rosuvastatin, atorvastatin, pravastatin, fluvastatin and pitavastatin
- drugs used to treat gout:
- colchicine
- antiplatelet medicines used to reduce the risk of blood clots, e.g.:
- clopidogrel
- medicines or dietary supplements containing minerals (such as magnesium, aluminum, calcium, iron, and zinc), for example:
- mineral supplements, vitamins (including multivitamins), antacids (medicines for stomach acid), and laxatives
→ If you take medicines, dietary supplements, antacids, or laxatives that contain minerals (such as magnesium, aluminum, calcium, iron, and zinc), take them at least 4 hours after Stribild.
→ Tell the doctor if you are taking any of these or other medicines. You should not stop treatment without talking to your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
- Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby. Pregnant women should not take Stribild. The amount of this medicine in the blood may decrease during pregnancy, which may cause it to stop working properly.
- Use an effective method of contraception while taking Stribild.
Do not breastfeed during treatment with Stribild. This is because some of the active substances in this medicine are excreted in human breast milk. If you are an HIV -infected woman, you should not breastfeed your infant to avoid transmission of HIV to the baby through breast milk.
Driving ability and use of machinery
Stribild may cause dizziness, fatigue, or insomnia. Do not drive or use tools or machines if you feel affected by taking Stribild.
Stribild contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Stribild contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Stribild
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults and adolescents aged 12 to less than 18 years who weigh at least 35 kg:
- One tablet a day by mouth with food. You must not chew, crush or split the tablet.
Always take the dose prescribed by the doctor to ensure that the medicine is effective and to reduce the development of resistance to the treatment. Do not change the dose unless your doctor tells you to.
If you take medicines, dietary supplements, antacids, or laxatives that contain minerals (such as magnesium, aluminum, calcium, iron, and zinc), take them at least 4 hours before or at least 4 hours after Stribild.
If you have taken too much Stribild
If you accidentally take more than the prescribed dose of Stribild, the risk of side effects with this medicine may increase (see section 4, Possible side effects ).
Contact your doctor or nearest emergency department immediately for advice. Save the jar so you can easily describe what you have taken.
If you forget to take Stribild
You mustn’t miss a dose of Stribild.
If you miss a dose:
- and you notice it within 18 hours of the time you usually take Stribild, you must take the tablet as soon as possible. The tablet must always be taken with food. Then take the next dose as usual.
- If you notice it 18 hours or more after the time you usually take Stribild, do not take the missed dose. Wait and take the next dose with food at its regular time.
If you vomit within less than 1 hour after a dose of Stribild, take another tablet with food.
Do not stop taking Stribild
Do not stop taking Stribild without talking to your doctor. If you stop taking Stribild, it may seriously affect your response to future treatment. If you stop taking Stribild for any reason, talk to your doctor before you start taking Stribild tablets again.
When your supply of Stribild starts to run out, get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop the drug for a short time. The disease can then become more difficult to treat.
If you have HIV infection and chronic hepatitis B infection, it is especially important that you do not stop Stribild treatment without first talking to your doctor. You may need to provide blood samples for several months after the end of treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of hepatitis A, which may be life-threatening.
→ Tell your doctor immediately about any new and unexpected symptoms that appear after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection (e.g. if your skin or the whites of your eyes turn yellow, you have dark “tea-colored” urine, light stools, loss of appetite for several days or longer, nausea or vomiting, or stomach pain).
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with the HIV drugs. The doctor will do tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to know which of the unwanted effects are caused by Stribild, by other medicines you are taking, or by the HIV disease.
Any serious side effects: Contact a doctor immediately
- Lactic acidosis (too much lactic acid in the blood) is a rare but potentially life-threatening side effect of some HIV drugs. Lactic acidosis occurs more often in women – especially if they are overweight and in people with liver disease. The following may be signs of lactic acidosis:
- deep, rapid breathing
- tiredness or drowsiness
- nausea, vomiting
- stomach pain
→ Contact your doctor immediately if you think you may have lactic acidosis.
- Any sign of inflammation or infection. In some patients with advanced HIV infection ( AIDS ) who previously had opportunistic infections ( infections that occur in people with weakened immune systems), signs and symptoms of inflammation from previous infections may appear shortly after HIV treatment is started. It is believed that these symptoms are due to the body’s immune system having been strengthened so that the body can fight infections that may have existed without giving any obvious symptoms. In addition to the opportunistic ones infections , autoimmune diseases (a condition that occurs when the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection. Autoimmune diseases can appear many months after treatment has begun. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands and feet and moves to the trunk, palpitations, tremors, or hyperactivity, see a doctor immediately to get the necessary treatment.
→ If you notice any symptoms of inflammation or infection, inform your doctor immediately.
Very common side effects are
(may occur in at least 1 in 10 treated patients)
- diarrhea
- vomiting
- nausea
- feeling of weakness
- headache, dizziness
- rash
Samples may also show:
- lowering of the phosphate level in the blood
- increased levels of creatine kinase in the blood which can cause muscle pain and muscle weakness
Common side effects are
( may occur in 1 to 10 out of 100 treated patients)
- reduced appetite
- difficulty sleeping (insomnia), abnormal dreams
- pain, abdominal pain
- indigestion resulting in discomfort after meals ( dyspepsia )
- feeling of bloating
- constipation , flatulence _
- skin rash (including red dots or patches of skin sometimes with blistering and swelling of the skin) which may be allergic reactions, itching, skin discoloration including dark spots on the skin
- other allergic reactions
- fatigue
Samples may also show:
- low white blood cell count (which may mean you are more likely to get an infection )
- increased blood sugar, increased levels of fatty acids ( triglycerides ), bilirubin in the blood
- liver and pancreas problems
- increased levels of creatinine in the blood
Less common side effects are
(may occur in up to 1 in 100 treated patients)
- suicidal thoughts and suicide attempts (in patients who have had depression or psychiatric problems in the past), depression
- back pain caused by kidney problems, including kidney failure. The doctor may take blood tests to see if the kidneys are working properly.
- damage to the kidney (renal tubule cells)
- swelling of the face, lips, tongue, or throat
- pain in the abdomen (stomach) caused by inflammation of the pancreas ( pancreatitis )
- muscle breakdown, muscle pain, or muscle weakness
Samples may also show:
- anemia (low red blood cell count )
- decreased levels of potassium in the blood
- changes in urine
Rare side effects ar
(may occur in up to 1 in 1,000 treated patients)
- lactic acidosis (see Possible serious side effects: Get medical attention immediately)
- yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver ( hepatitis )
- fatty liver
- kidney inflammation (nephritis)
- you urinate a lot and feel thirsty (nephrogenic diabetes insipidus )
- decreased bone hardness (which causes bone pain and sometimes leads to fractures )
Breakdown of muscle cells decreased bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and lowered potassium or phosphate levels in the blood can occur due to damage to the kidney (renal tubule cells).
→ If any side effects get worse, talk to the doctor.
Other effects that can be seen during HIV treatment
The frequency of the following side effects is not known (the frequency cannot be calculated from the available data).
- Leg problems. Some patients taking combination antiretroviral medicines such as Stribild may develop a bone disease called osteonecrosis (bone tissue dies due to loss of blood supply to the bone). Some of the many risk factors for developing this disease are long-term use of this type of medicine, treatment with corticosteroids, alcohol consumption, a very weak immune system, and being overweight. Signs of osteonecrosis are:
- joint stiffness
- aches and pains (especially in hips, knees, and shoulders)
- movement difficulties
Other effects on children
- It is very common in children who have received emtricitabine to experience changes in the color of their skin, including
- patchy darkening of the skin
- It is common for children to have a reduced number of red blood cells ( anemia )
- this can make the child tired or short of breath
→ Inform your doctor if you notice any of these symptoms.
→ If you experience side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
How Stribild should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after {EXP}. The expiration date is the last day of the specified month.
Store in the original packaging. Moisture sensitive. Close the jar well.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. One Stribild film-coated tablet contains 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 245 mg tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 136 mg tenofovir).
Other ingredients are
Tablet core:
Croscarmellose sodium, hydroxypropyl cellulose (E463), lactose monohydrate, magnesium stearate, microcrystalline cellulose (E460), silicon dioxide (E551), sodium lauryl sulfate.
Film coating:
Indigo carmine (E132), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolyzed) (E1203), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172).
Appearance and package sizes of the medicine
Stribild film-coated tablets are green, capsule-shaped tablets. Embossed on one side with “GSI” and on the other side with the number “1” surrounded by a square box. Stribild is supplied in tins containing 30 tablets (with silica gel desiccant which must be kept in the tin to protect the tablets from moisture). The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.
The following pack sizes are available: Outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
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