Full Prescribing Info
Contents
Elvitegravir, cobicistat, emtricitabine, tenofovir alfenamide.
Description
Each Genvoya tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Elvitegravir, an antiretroviral medicine known as an integrase inhibitor.
Cobicistat, a booster (pharmacokinetic enhancer) of the effects of elvitegravir.
Emtricitabine, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor (NRTI).
Tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI).
Excipients/Inactive Ingredients: Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulphate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, FD&C Blue #2/Indigo carmine aluminium lake and iron oxide yellow.
Indications/Uses
Genvoya is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg. Genvoya reduces the amount of HIV in the body. This will improve immune system and reduce the risk of developing illnesses linked to HIV infection.
Dosage/Direction for Use
The recommended dose is: Adults: one tablet each day with food.
Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with food.
Do not chew, crush or split the tablet.
Always take the dose recommended by the doctor. This is to make sure that the medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless it is advised by the doctor.
Do not take antacids or multivitamins at the same time as Genvoya. If patient is taking an antacid such as aluminium/magnesium hydroxide or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya.
It is important not to miss a dose of Genvoya.
If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, they should take Genvoya with food as soon as possible and resume the normal dosing schedule.
If the patient misses a dose of Genvoya by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
If the patient vomits less than 1 hour after taking Genvoya, another tablet should be taken with food.
Overdosage
If the patient accidentally takes more than the recommended dose of Genvoya they may be at increased risk of experiencing possible side effects with this medicine (see Adverse Reactions).
Contact a doctor or nearest emergency department immediately for advice. Keep the tablet bottle with the patient so that the patient can easily describe what the patient have taken.
Contraindications
Do not take Genvoya: If the patient is allergic to elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (see Description).
Special Precautions
Genvoya contains lactose.
Tell the doctor if the patient is lactose intolerant or intolerant to other sugars. Genvoya contains lactose monohydrate. If the patient is lactose-intolerant, or if they have been told that they have an intolerance to other sugars, talk to the doctor before taking this medicine.
Do not stop taking Genvoya.
Do not stop taking Genvoya without talking to the doctor. Stopping Genvoya can seriously affect response to future treatment. If Genvoya is stopped for any reason, speak to a doctor before restarting taking Genvoya tablets.
When the supply of Genvoya starts to run low, get more from the doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The disease may then become harder to treat.
If the patient has both HIV infection and hepatitis B, it is especially important not to stop the Genvoya treatment without talking to the doctor first. They may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of their hepatitis, which may be life-threatening.
Effects on the Ability to Drive and Use Machinery: Genvoya can cause dizziness. If the patient feels dizzy when taking Genvoya, do not drive and do not use any tools or machines.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks they may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.
Use effective contraception while taking Genvoya.
Ask a doctor or pharmacist for advice before taking any medicine when pregnant.
Do not breast-feed during treatment with Genvoya. This is because some of the active substances in this medicine pass into human breast milk. It is recommended that the patient do not breast-feed to avoid passing the virus to the baby in breast milk.
Adverse Reactions
The patient must remain under the care of their doctor while taking Genvoya.
They can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with a doctor, the precautions needed to avoid infecting other people. This medicine is not a cure for HIV infection. While taking Genvoya they may still develop infections or other illnesses associated with HIV infection.
Talk to a doctor before taking Genvoya. If the patient has liver problems or a history of liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If the patient has hepatitis B infection, the doctor will carefully consider the best treatment regimen for them.
If they have hepatitis B infection, liver problems may become worse after they stop taking Genvoya. It is important not to stop taking Genvoya without talking to the doctor (see Precautions).
If patient is intolerant to lactose (see Precautions).
While patient is taking Genvoya: Once they start taking Genvoya, look out for: Signs of inflammation or infection.
Joint pain, stiffness or bone problems.
If patient has noticed any of these symptoms, tell the doctor immediately.
Children and adolescents: Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. The use of Genvoya in children aged 11 years or under has not yet been studied.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. The doctor will test for these 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 tell whether some of the unwanted effects are caused by Genvoya or by other medicines that the patient is taking at the same time, or by the HIV disease itself.
Possible serious side effects: Tell a doctor immediately.
Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is thought 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.
Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after the patient start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as: muscle weakness; weakness beginning in the hands and feet and moving up towards the trunk of the body; palpitations, tremor or hyperactivity.
If the patient notices the side effects described above, tell the doctor immediately.
Very common side effects (may affect more than 1 in 10 people): feeling sick (nausea).
Common side effects (may affect up to 1 in 10 people): abnormal dreams, headache, dizziness, diarrhoea, vomiting, stomach pain, wind (flatulence), rash, tiredness (fatigue).
Uncommon side effects (may affect up to 1 in 100 people): low red blood cell count (anaemia), depression, problems with digestion resulting in discomfort after meals (dyspepsia), swelling of the face, lips, tongue or throat (angioedema), itching (pruritus).
If any of the side effects get serious, tell the doctor.
Other effects that may be seen during HIV treatment: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Bone problems. Some patients taking combination antiretroviral medicines such as Genvoya may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are: joint stiffness; joint aches and pains (especially of the hip, knee and shoulder); difficulty with movement.
If the patient notices any of these symptoms tell the doctor.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. They can also report side effects directly via the national reporting system or via the Marketing Authorisation Holder (Telephone number: 02-257-3500).
Drug Interactions
Do not take Genvoya: If the patient is taking one of these medicines: alfuzosin (used to treat an enlarged prostate gland).
Amiodarone, quinidine (used to correct irregular heartbeats).
Carbamazepine, phenobarbital, phenytoin (used to prevent seizures).
Rifampicin (used to prevent and treat tuberculosis and other infections).
Dihydroergotamine, ergometrine, ergotamine (used to treat migraine headache).
Cisapride (used to relieve certain stomach problems).
St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it.
Lovastatin, simvastatin (used to lower blood cholesterol).
Pimozide (used to treat abnormal thoughts or feelings).
Sildenafil (when used to treat pulmonary arterial hypertension – a lung disease that makes breathing difficult).
Orally administered midazolam, triazolam (used to help the patient sleep and/or relieve anxiety).
If the patient is taking any of these medicines, do not take Genvoya and tell the doctor immediately.
Medicines used in treating hepatitis B infection: The patient should not take Genvoya with medicines containing: tenofovir disoproxil fumarate, lamivudine, adefovir dipivoxil. Tell the doctor if the patient is taking any of these medicines.
Other types of medicine: Talk to a doctor if the patient is taking: antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole.
Antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin.
Antiviral medicines used to treat hepatitis C: telaprevir and boceprevir.
Antidepressants, used to treat depression: medicines containing trazodone or escitalopram.
Sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam.
Immunosuppressants, used to control the body's immune response after a transplant, such as: ciclosporin, sirolimus and tacrolimus.
Inhaled steroids, used to treat hay fever (allergic rhinitis): fluticasone.
Medicines used to treat diabetes: metformin.
Contraceptive pill, used to prevent pregnancy.
Erectile dysfunction medicines, used to treat impotence, such as: sildenafil, tadalafil and vardenafil.
Heart medicines, such as: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil.
Medicines used to treat pulmonary arterial hypertension: bosentan and tadalafil.
Anticoagulants, used to thin the blood, such as: warfarin and dabigatran.
Bronchodilators, used to treat asthma and other lung-related problems: salmeterol.
Cholesterol lowering medicines, such as: atorvastatin and pitavastatin.
Medicines used to treat gout: colchicine.
Tell the physician if the patient is taking these or any other medicines. Do not stop treatment without contacting the doctor.
Antacids, used to treat heartburn or acid reflux (see Storage).
Storage
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
MIMS Class
ATC Classification
J05AR18 - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
FC tab 30's.
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