Tenvir-EM

Tenvir-EM general information

What is Tenvir-EM used for?

Tenvir-EM tablets are a fixed dose combination treatment for Human Immunodeficiency Virus (HIV) infection in adults over age 18. Tenvir-EM tablets are used combination with other medications that have a different mechanism of action to the components in Tenvir-EM, and are used to treat patients with HIV infection who have either already received treatment with other medications for HIV or as first line therapy for treatment-inexperienced patients. HIV impairs the immune system by attacking specific immune cells called CD4+ cells that are involved in fighting infection and this can lead to opportunistic life-threatening infection (infections that would not normally be harmful); also if too many CD4+ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS). Tenvir-EM tablets prevent or slow down the ability of HIV to replicate and spread, which keeps the amount of virus down to a low level and this results in an increase in CD4 cell numbers, so that the immune system can recover, reducing the risk of disease progression. Tenvir-EM may be used for Pre-exposure prophylaxis (PrEP) treatment.  PrEP is a new prevention method in which people who do not have an HIV infection, but may be at high risk, take a Tenvir-EM tablet every day to reduce their risk of becoming infected. Anyone undergoing PrEp treatment should see their healthcare provider every three months for follow-up and testing.

What is PrEP?

PrEP stands for Pre-exposure Prophylaxis. PrEP is a new treatment to help prevent the spread of the human immunodeficiency virus (HIV-1) that causes AIDS. Taken as a once-a-day tablet, along with safe sex practices, Tenvir-EM can help reduce the risk of contracting HIV-1, the virus responsible for AIDS. PrEP is for… 1. HIV-negative men who have sex with men and who are at high risk of contracting HIV-1. 2. Male-Female sex partners where one partner has HIV-1 and the other doesn’t. 3. Males or females that have sex with intravenous drug users at risk of contracting HIV-1. You must commit to taking Tenvir-EM every day and seeing your doctor every three months for follow up care and testing. How to Get Started: Please contact your doctor to discuss and have a HIV test as soon as possible. Tenvir-EM is for individuals for high exposure risk for HIV-1. Tenvir-EM must be taken every day along with safer sex practices. Please take the time to educate yourself about safe sex and ask your doctor for advice.

How does Tenvir-EM work?

Tenvir-EM tablets contain a combination of two antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, which are only effective against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV). These drugs each work by inhibiting the action of the viral-specific enzyme reverse transcriptase (RT), which is needed for the virus to be able to replicate. Retroviruses convert RNA to DNA, which is then integrated into the DNA of infected immune cells so that the virus can replicate. Emtricitabine and tenofovir disoproxil fumarate are both nucleoside analogue reverse transcriptase inhibitors (NRTI), which means that they block the action of RT by competing with one of the nucleosides needed to transcribe the viral RNA into DNA, becoming incorporated into the chain of newly synthesized viral DNA and preventing it from growing (chain termination). Emtricitabine is an analogue of cytidine and tenofovir is an analogue of adenosine. The combined action of these two antiiretroviral drugs in Tenvir-EM tablets prevents the integration of the virus into the DNA of the infected CD4+ immune cell, which inhibits the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Tenvir-EM tablets slow down the replication of HIV within your body but does not kill the virus already incorporated in the CD4+ cells or prevent the spread of the infection to others.

What does Tenvir-EM contain?

Tenvir-EM tablets contain two active ingredients, the antiretrovirals emtricitabine (200mg) and tenofovir disoproxil fumarate (300mg) and used to treat HIV infection.

Treating HIV infection with Tenvir-EM

Tenvir-EM tablets contain a combination of two antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, which are only effective against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV). HIV impairs the immune system by attacking specific immune cells called CD4+ cells that are involved in fighting infection and this can lead to opportunistic life-threatening infection (infections that would not normally be harmful), including pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. If too many CD4+ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS). The two antiretroviral drugs in Tenvir-EM tablets each work by inhibiting the action of the viral-specific enzyme reverse transcriptase (RT) which is needed for the virus to be able to replicate. Retroviruses convert RNA to DNA, which is then integrated into the DNA of infected immune cells so that the virus can replicate. The combined action of the two antiretroviral drugs in Tenvir-EM tablets prevents the integration of the virus into the DNA of the infected CD4+ immune cell, which inhibits the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Tenvir-EM tablets slow down the replication of HIV within your body but does not kill the virus already incorporated in the CD4+ cells or prevent the spread of the infection to others.

What are the side effects of Tenvir-EM?

The most commonly reported side effects when taking Tenvir-EM include: headache, gastrointestinal upset (nausea, diarrhoea, constipation, stomach pain), dizziness, fatigue, rash, difficulty sleeping, abnormal dreams, depression. A more serious but less common side effect is a condition called lactic acidosis which is excess lactic acid in the blood due to liver damage, which may cause pancreatitis, liver failure, or renal failure.

What are the health risks when taking Tenvir-EM?

Lactic acidosis is a rare but potentially fatal condition that has been reported when taking Tenvir-EM tablets. It is caused by a build up of excess of lactic acid in the blood due to liver damage, which is usually associated with hepatomegaly (liver enlargement) with steatosis (build up of fat in the liver) and may cause pancreatitis, liver failure, or renal failure. Symptoms begin within a few months of treatment and include: nausea, vomiting and abdominal pain, difficulty breathing, loss of appetite, weight loss, motor weakness.

When should Tenvir-EM not be used?

You should not use Tenvir-EM if you:

• are allergic to emtricitabine or tenofovir or any ingredients in Tenvir-EM
• are pregnant or are breastfeeding
• have kidney or liver disease
• have chronic hepatitis B (HBV) infection
• have a bone disease like osteoporosis without discussion with your doctor
• are using antiretroviral drugs containing lamivudine or other antiretroviral drugs that work by the same mechanism (nucleoside analogue reverse transcriptase inhibitors NRTI)
• are taking medicines that interact with Tenvir-EM, including:other retrovirals like didanosine, atazanavir, and ritonavir

What medications interact with Tenvir-EM?

Several medications interact with Tenvir-EM and should either not be taken while you are taking Tenvir-EM or only after discussion and instruction from your doctor:

• Drugs that cause a serious reaction with Tenvir-EM: didanosine for HIV
• Drugs that affect Tenvir-EM: other retrovirals like ritonavir
• Drugs that are affected by Tenvir-EM: atazanavir for HIV

How should Tenvir-EM be taken?

You should take your Tenvir-EM tablets with a glass of water once a day with or without food. You should continue to take your Tenvir-EM tablets regularly for as long as your doctor recommends, and you condition should be monitored. Do not suddenly stop taking your Tenvir-EM tablets as this may increase risk of HIV resistance.

How long should you take Tenvir-EM?

You should continue to take your Tenvir-EM tablets regularly for as long as your doctor recommends, and you condition should be monitored. Do not suddenly stop taking your Tenvir-EM tablets as this may increase risk of HIV resistance.

Missed dose of Tenvir-EM

If you miss a dose of Tenvir-EM take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose. Do not take a double dose.

How should Tenvir-EM be stored?

You should store your Tenvir-EM below 25°C in a cool dry place.