Trizivir

Generical name: abacavir, zidovudine, and lamivudine

Brand name: Trizivir
Drug class: Antiviral combinations

What is Trizivir?

Trizivir is a mixture that consists of Abacavir, lamivudine as well as zidovudine. Abacavir as well as lamivudine and zidovudine are antiviral medicines which prevent the human immunodeficiency virus (HIV) from multiplying within your body.

Trizivir serves to combat HIV, a virus that causes acquired immune deficiency syndrome (AIDS). This medication is not an effective treatment for HIV and AIDS.

Trizivir is used by itself or in conjunction with other antiviral drugs.

Warnings and precautions

Hypersensitivity Reactions

Hypersensitivity that is fatal and often severe reactions have been observed when abacavir is a component of the TRIZIVIR. The hypersensitivity reactions have included anaphylaxis, multi-organ failure and usually occurred within the first six weeks following treatment with Abacavir (median time to the onset of 9 days) however, abacavir hypersensitivity reactions can occur throughout treatment.

Patients with the HLA-B*5701 allele have a greater chance of experiencing hypersensitivity reactions to abacavir however, those who do not have the HLA-B*5701 allele are not at risk of developing hypersensitivity reactions. Hypersensitivity towards abacavir was found in around 206 (8%) of the 2,670 patients who participated in 9 clinical studies using Abacavir-containing drugs where HLA-B*5701 testing was not conducted.

The frequency of hypersensitivity reactions to abacavir suspected in clinical trials was 1 % when patients carrying the HLA B*5701 allele were ruled out. For any patient being receiving abacavir treatment, the medical diagnosis of hypersensitivity reaction remains the primary basis for the clinical decision-making process.¶

Due to the possibility of serious, severe hypersensitivity, possibly fatal reactions to abacavir

• Every patient should be tested for the HLA-B*5701 allele prior to the beginning of therapy using TRIZIVIR or the reinitiation of treatment using TRIZIVIR except for patients who have had a confirmed HLA-B*5701 allele test.TRIZIVIR is not recommended for patients who have a prior hypersensitivity reaction to abacavir, and those with HLA-B*5701 as a positive test. Before you begin TRIZIVIR examine your medical history to determine if you have been exposed to any product that contains abacavir.
• Never restart TRIZIVIR or any other product containing abacavir in the event of a hypersensitivity reaction Abacavir, regardless of HLA B*5701 status. To decrease the chance of a potentially life-threatening hypersensitivity reaction regardless of HLA-B*5701 status, stop TRIZIVIR as soon as possible in the event of a hypersensitivity reaction being suspected, regardless of whether other diagnoses may be possible (e.g. acute-onset respiratory illnesses like bronchitis, pneumonia or pharyngitis gastroenteritis, and reactions with other medicines).

• If a hypersensitivity reaction can’t be eliminated it is advised to not begin to restart TRIZIVIR as well as any products containing abacavir since more severe reactions, that can be life-threatening hypotension, or even death, could be experienced within hours. In the event that a reaction to hypersensitivity can be eliminated, patients can resume the TRIZIVIR.
• Infrequently, patients who put off abacavir for reasons other than the symptoms of hypersensitivity have also had dangerous reactions within the first few hours of restarting abacavir therapy.
• Thus, reintroduction to TRIZIVIR and any product containing abacavir is only recommended if medical assistance is readily accessible. A Medication Guide and a Warning Card which provide details on the symptoms of hypersensitivity to abacavir must be removed with every new prescription or refill.

Hematologic Toxicity/Bone Marrow Suppression

Zidovudine, which is a component of TRIZIVIR has been linked with hematologic toxicities, such as anemia and neutropenia, specifically in patients suffering from an advanced form of HIV-1. TRIZIVIR should be treated with caution for patients suffering from bone marrow dysfunction as evidenced by a granulocyte count of less than 1000 cells/millimetre or hemoglobin lower than 9.5 grams/dL.

A regular blood count is strongly advised for patients suffering from advanced HIV-1 disease treated with the TRIZIVIR. Regular blood counts are recommended for all HIV-1 patients. If neutropenia or anemia develops the need for a dose interruption is required.

• Myopathy

  Myositis and myopathy, which have the same pathological features caused by HIV-1 disease have been linked to the long-term treatment with zidovudine and could occur in conjunction with treatment with TRIZIVIR.

• Lactic Acidosis and Severe Hepatomegaly with Steatosis

  Lactic acidosis and severe Hepatomegaly with steatosis, which includes deaths have been documented using nucleoside analogues such as zidovudine, abacavir, and lamivudine (components of the drug TRIZIVIR). Most of these cases occurred in females.

  Obesity and female sex may be risk factors in the formation of lactic acidosis as well as severe hepatomegaly, steatosis and severe hep patients receiving antiretroviral analogues of nucleosides. Find the full prescribing guidelines on ZIAGEN (abacavir) EPIVIR (lamivudine) as well as RETROVIR (zidovudine).

  Treatment with TRIZIVIR is recommended to be stopped in patients who show lab or clinical signs that are indicative of lactic acidosis, or an increase in liver toxicities (which could include hepatomegaly or an increase in steatosis in spite of transaminase elevations that are significant).

• Patients suffering from Hepatitis B Virus Co-infection

  Posttreatment Exacerbations of Hepatitis

  Evidence from clinical and laboratory tests of the occurrence of acute hepatitis has occurred following the stopping of lamivudine. Check out the complete prescribing guidelines regarding EPIVIR (lamivudine). Patients must be monitored closely through both laboratory and clinical monitors for at minimum a few months after discontinuing treatment.

  The emergence of Lamivudine-Resistant HBV

  Lamivudine’s efficacy and safety have not been proven for the treatment of chronic Hepatitis B in patients who are both affected by HIV-1 or HBV. The emergence of hepatitis B virus variants associated with resistance to lamivudine has been reported in HIV-1-infected subjects who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus. Check out the complete prescribing guidelines on EPIVIR (lamivudine).

• Use in conjunction with Interferon and Ribavirin-based Regimens

  Patients who receive interferon alfa treatment either with or without ribavirin or TRIZIVIR must be monitored closely for the presence of toxicities related to treatment, including the effects of hepatic dysfunction, neutropenia and anemia. Read the full prescribing instructions on RETROVIR (zidovudine). Removing TRIZIVIR is medically appropriate.

  Reduction in dosage or the removal of interferon alfa, ribavirin or both of them should be considered in the event that more severe clinical toxicities are detected, for example, the liver’s decompensation.

  Anemia-related anemia exacerbation has been seen in patients suffering from HIV/HCV co-infection who are taking zidovudine and ribavirin. The combination of ribavirin and TRIZIVIR is not recommended.

• Immune Reconstitution Syndrome

  Immune reconstitution disorder has been identified in patients receiving combination antiretroviral therapy such as the TRIZIVIR. In the beginning phase of the combination treatment those whose immune systems respond might develop an inflammatory response to the indolent or opportunistic residual illnesses (such as Mycobacterium avium and cytomegalovirus Pneumocystis PCP, jirovecii pneumonia or tuberculosis) and may require additional assessment and treatment.

  Autoimmune diseases (such as Graves Polymyositis, ‘Disease, or Guillain-Barre syndrome) are also reported to be present in the context of immune reconstitution. However, the time it takes to develop is much more variable and may occur for a long time following the initiation of treatment.

• Lipoatrophy

  Treatment with zidovudine(a component of TRIZIVIR is associated with the loss of subcutaneous fat. The frequency and severity of lipoatrophy can be attributed to cumulative exposure. This fat loss, which is most evident in the face, limbs, and buttocks, maybe only be partially reversible and improvement may take months to years after switching to a non-zidovudine-containing regimen.

  Patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine-containing products, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy.

• Myocardial Infarction

  Many observational, prospective studies on epidemiology have found the connection between taking abacavir and the risk of myocardial ischemia (MI). Meta-analyses of controlled, randomized clinical trials have found no increased risk of MI in patients treated with abacavir as in comparison to subjects who were not. At present, there is no scientifically proven mechanism that could explain an increased risk.

  All the evidence from observational studies as well as the controlled clinical trials do not agree and, therefore, evidence of a causal link between treatment with abacavir in relation to the likelihood of MI isn’t conclusive.

  To protect yourself in the event of a heart attack, the danger of heart attack needs to be taken into consideration when prescribing antiretroviral treatments, such as Abacavir, and actions taken to limit the risk of any modifiable risk factors (e.g. hypertension, hyperlipidemia and smoking, diabetes mellitus).

• Therapy-Experienced Patients

  In clinical trials who had a long-term history of Nucleoside reverse transcriptase inhibitor (NRTI) exposure with HIV-1 isolates with multiple mutations that conferred resistance to NRTIs showed a limited response to the drug abacavir. The possibility of cross-resistance between Abacavir and other NRTIs must be taken into consideration when deciding on new treatment regimens for patients who have had therapy.

• It is not recommended to use Trizivir if ever experience reactions to an allergen in any medication which contains abacavir or if you are a victim of the gene mutation known as HLA-B*5701 allele. It is also not recommended to take this medication if you suffer from severe or moderate liver disease.
• Do not take Trizivir and consult your physician immediately if you exhibit symptoms that indicate an allergy to this medication: symptoms of rash, fever, vomiting, nausea and stomach pain, general ill feeling, fatigued to the point of being uncontrollable and body aches, shortness of breath as well as cough and sore throat.
• If you’ve had any experience with the virus B it could develop or become worse after stopping Trizivir. You could require regular liver tests for function for a period of time.
• Don’t allow your medication to completely run out before you have your prescription refill. It is essential to do not stop taking Trizivir after you’ve begun. If you do not take your doses, you could suffer an extremely dangerous, or even fatal allergic reaction if you begin taking the drug again. If you decide to stop taking this medication due to any reason, talk to your doctor prior to when you begin taking it again.
• Before you start taking this medicine, make sure to consult your doctor
• It is not recommended to use Trizivir if your body is allergic to lamivudine, abacavir or zidovudine. Also, if:
• You have severe or moderate liver disease.
• You have a genetic variation known as the HLA-B*5701 variant (your doctor will check for this) either
• You have an allergy history you have a history of allergic reaction Combivir, Epivir Epzicom Retrovir or Ziagen.
• There is a chance that you will suffer from an illness called lactic acidosis. This is which is a risky buildup of acid within your blood. It’s more likely if you suffer from any other medical condition or if you’ve been taking HIV medications for a long duration, or if you are a female. Consult your physician about the risks.
• To ensure that Trizivir is suitable for you, inform your doctor if:
• Liver disease (especially liver disease (especially hepatitis B as well as C);
• Other liver issues (especially when you are also taking the drug ribavirin and interferon alfa);
• suppression of bone marrow;
• heart issues or risk factors like the presence of diabetes tobacco smoking, high blood pressure, high cholesterol or
• kidney disease.
• It is possible to be diagnosed with an illness called lactic acidosis. This is an extremely dangerous accumulation of the acid lactic within your blood. It is more likely if you suffer from other medical issues and if you’re overweight or are a female. Talk to your doctor regarding your risks.
• Speak to your physician if you are expecting a baby, and take your medication correctly to prevent your infection. HIV is able to be transmitted to your baby if the virus is not managed during pregnancy. Your name might be recorded on a registry that tracks the effects of antiviral medications on the infant.
• Women who have HIV or AIDS shouldn’t breastfeed babies. Even if the baby is born with HIV or AIDS, the virus could be transmitted to your baby through breast milk.
• Trizivir is not recommended for the treatment of HIV in adolescents who weigh below 88 pounds (40 kgs).
• How to take Trizivir?
• Follow the exact dosage as directed by your physician. Follow the instructions on the prescription label and review all medication guides and instructions sheets.
• You can consume Trizivir either with or without meals.
• Trizivir is accompanied by a Medication Guide and a Warn Card with the symptoms that indicate the allergic reaction.
• Make sure to take all HIV medicines as directed. review all the medication instructions that you receive. Do not alter the dose or stop taking a medication without consulting your physician. Everyone suffering from HIV should be under the supervision of a medical professional.
• Place in a cool, dry place far from heat and moisture.
• If you’ve had any experience with the virus hepatitis B, the virus could be active or worsen during the time following your quit taking Trizivir. It is possible that you will require frequent tests of your liver function during the course of using this drug and for a few months following the last dose.
• Dosing information
• Usual Adult Dose for HIV Infection:
• 1 tablet, orally, twice each day
• Use: When used in conjunction with other antiretroviral drugs or by itself, for the treatment of HIV-1 infections.
• Usual Adult Dose for Nonoccupational Exposure:
• US CDC recommendations: 1 tablet, taken orally twice per day
  Therapy duration The duration of therapy is 28 days
• Comments:
  Recommend as an alternative treatment for non-occupational postexposure prophylaxis HIV infected This triple NRTI regimen is suggested only when an NNRTI-based or protease inhibitor-based treatment should not or is not employed.
  The treatment should begin whenever possible and within 72 hours after exposure.
  The current guidelines should be read for further details.
• Usual Adult Dose for Occupational Exposure:
• US Public Health Service working group recommendations 1 tablet two times a day
  The duration of therapy is at least 28 days, provided that it is tolerated
• Comments:
  Only with the assistance of an expert, as an alternative treatment option to use for HIV prophylaxis postexposure
  The therapy should be initiated as soon as is possible and preferably within a few hours of the exposure.
  The optimal time for prophylaxis isn’t known and could vary based on the protocol of the institution.
  The current guidelines should be read for further details.
• Usual Pediatric Dose for HIV Infection:
• At least 40kg 2 tablets orally every day
• Comments: The use of individual components is suggested for patients who weigh less than 40 kilograms; information on the product’s manufacturer for Trizivir is to be read.
• Use: In conjunction with other antiretroviral agents, or by itself, to treat HIV-1 infection.
• What if I miss a dose?
• You should take the medication as quickly as you are able, but do not take any missed doses if you are close to the time of the next dose. Don’t take two doses at a time.
• Make sure you refill your prescription before you are out of medication completely. If you skip several doses, you could experience an extremely dangerous, or even fatal allergic reaction if you begin taking this medicine once more.
• What if I overdose?
• Get medical attention immediately or contact for help at the Poison Help line at 1-800-222-1222.
• What to avoid?
• The use of Trizivir does not stop the transmission of HIV to others. Be sure to not engage in unprotected sexual sex or share toothbrushes, razors or razors. Consult your doctor regarding safe methods to avoid HIV transmission during sexual contact. Sharing needles with medicine or drug is not safe, even for a healthy individual.
• Side Effects
• Contact your physician immediately if you experience signs of an allergy resulting from any of these adverse reaction groups:
• Group 1, fever
•  Group 2: rash
• Group 3 – nausea, vomiting, diarrhea, stomach pain;
• Group 4. General depressed feeling, severe fatigue and body aches
• Group 5 – breathlessness Sore throat, cough.
• If you’ve had a reaction of an allergic reaction to Trizivir it is not recommended to ever for the next time. If you stop using Trizivir due to any reason, speak to your physician prior to taking it once more.
• Make sure to contact your doctor anytime if you suffer from:
• Other signs of an allergic reaction Skin peeling or blisters eyes redness swelling on your throat or face Trouble breathing;
• Acidosis lactic – muscle pain that is unusual and breathing problems nausea, stomach pain and irregular heartbeat, dizziness, feeling cold or very fatigued or weak;
• lower white blood cells – – fever lips sores, scabs, cough, sore throat difficulty breathing;
• Red blood cell count is low (anemia) – pale skin, unusual fatigue and feeling lightheaded or weak, hand and feet cold and feet or
• liver issues swelling around the midsection area, left-hand stomach discomfort, lack of appetite dark urine, black or stool that is coloured with clay, jaundice (yellowing of the eyes or skin).
• Trizivir alters the immune system and can cause a variety of adverse reactions (even weeks or even months after the time you’ve taken the medicine). Inform your doctor whether you suffer from:
• indications of the onset of a new infection (fever, night sweats swelling of glands, cold sores cough, wheezing vomiting, weight loss;
• difficulty swallowing or speaking difficulties with balance, eye movement weak or prickly sensation trouble speaking or swallowing; or
• swelling in your throat or neck (enlarged thyroid) menstrual cycles, impotence.
• The most common Trizivir-related side effect include:
• headache;
• tiredness or weakness;
• nausea, vomiting; or
• change in the form or position of fat (especially the body, legs, facial and neck), breasts, and the waist).
• This isn’t a complete list of possible side effects, and other effects may also be present. Contact your physician for advice regarding medical adverse effects. You can report any side effects to the FDA at 1-800-FDA-1088.
• What other drugs can influence Trizivir?
• A variety of drugs interact with lamivudine, abacavir zidovudine, and lamivudine. This includes over-the-counter and prescription drugs, vitamins, and herbal remedies. The interactions of all drugs aren’t included in this list. Discuss with your physician all the medications you are currently taking as well as any new medication you are about to start or stop taking.
• More details
• Be sure to keep this and other medications out of reach of children. Do not let your medications be shared with anyone else Use Trizivir only in the prescribed dosage.
• Always consult your physician to confirm that the information provided on this page is applicable to your particular situation.