ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Abacavir, lamivudine, and zidovudine: Drug information

Abacavir, lamivudine, and zidovudine: Drug information
(For additional information see "Abacavir, lamivudine, and zidovudine: Patient drug information" and see "Abacavir, lamivudine, and zidovudine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Hypersensitivity reactions:

Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele.

Abacavir/lamivudine/zidovudine is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir/lamivudine/zidovudine or reinitiation of therapy with abacavir/lamivudine/zidovudine, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir/lamivudine/zidovudine immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir, never restart abacavir/lamivudine/zidovudine or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patient who have no history of abacavir hypersensitivity.

Hematologic toxicity:

Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease.

Myopathy:

Prolonged use of zidovudine has been associated with symptomatic myopathy.

Lactic acidosis and severe hepatomegaly with steatosis:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. Discontinue abacavir/lamivudine/zidovudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Exacerbations of hepatitis B:

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of abacavir/lamivudine/zidovudine. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months in patients who discontinue abacavir/lamivudine/zidovudine and are coinfected with HIV-1 and HBV. If appropriate, initiation of anti-HBV therapy may be warranted.

Brand Names: US
  • Trizivir [DSC]
Brand Names: Canada
  • APO-Abacavir-Lamivud-Zidovud [DSC]
Pharmacologic Category
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
Dosing: Adult
HIV-1 infection, treatment

HIV-1 infection, treatment: Oral: One tablet (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg) twice daily. Note: Triple NRTI regimens are not recommended in HIV treatment guidelines due to suboptimal virologic activity (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: Use is not recommended (use dose-adjusted individual components).

Dosing: Hepatic Impairment: Adult

Mild impairment (Child-Pugh class A): Use is not recommended (use dose-adjusted individual components).

Moderate to severe hepatic impairment (Child-Pugh Class B or C): Use is contraindicated.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Abacavir, lamivudine, and zidovudine: Pediatric drug information")

HIV-1 infection, treatment

HIV-1 infection, treatment: May use alone or in combination with other antiretroviral agents:

Children and Adolescents <40 kg: Not recommended; product is a fixed-dose combination

Children and Adolescents ≥40 kg: Oral: 1 tablet twice daily

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Pediatric patients ≥40 kg:

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: Use not recommended (use individual antiretroviral agents to reduce dosage).

Dosing: Hepatic Impairment: Pediatric

Pediatric patients ≥40 kg:

Mild impairment: Use is not recommended; use individual antiretroviral agents to reduce dosage.

Moderate to severe impairment: Use is contraindicated; safety, efficacy, and pharmacokinetic properties of abacavir have not been established.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. See individual agents as well as other combination products for additional information. Frequency not always defined.

Central nervous system: Headache (13%), fatigue (12%), malaise (12%), depression (6%), anxiety (5%)

Dermatologic: Skin rash (5%)

Endocrine & metabolic: Increased amylase (2%), increased serum triglycerides (grade 3-4: 2%), increased gamma-glutamyl transferase, redistribution of body fat

Gastrointestinal: Nausea (19%), nausea and vomiting (10%), diarrhea (7%), pancreatitis

Hematologic & oncologic: Neutropenia (5%)

Hepatic: Increased serum ALT (6%)

Hypersensitivity: Hypersensitivity (1% to 9%; based on abacavir component; higher risk in carriers of the HLA-B*5701 allele)

Immunologic: Immune reconstitution syndrome

Infection: Viral infection (5%)

Miscellaneous: Fever and chills (6%)

Neuromuscular & skeletal: Increased creatine phosphokinase (7%)

Respiratory: ENT infection (5%)

<1%, postmarketing, and/or case reports: Abdominal pain, abnormal breath sounds, allergic sensitization (including anaphylaxis), alopecia, anemia, anorexia, aplastic anemia, arthralgia, cardiomyopathy, decreased appetite, dizziness, dyspepsia, erythema multiforme, exacerbation of hepatitis B (posttreatment), gynecomastia, increased serum bilirubin, increased serum transaminases, insomnia, lactic acidosis, liver steatosis, lymphadenopathy, myalgia, myasthenia, oral mucosa hyperpigmentation, paresthesia, peripheral neuropathy, rhabdomyolysis, seizure, sleep disorder, splenomegaly, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, urticaria, vasculitis, weakness, wheezing

Contraindications

Hypersensitivity to abacavir, lamivudine, zidovudine, or any component of the formulation; patients positive for HLA-B*5701 allele; moderate or severe hepatic impairment.

Canadian labeling: Additional contraindications (not in US labeling): Hepatic impairment (regardless of severity of impairment); ANC <750 cells/mm3; hemoglobin <7.5 g/dL or 4.65 mmol/L

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic toxicity: [US Boxed Warning]: Zidovudine has been associated with hematologic toxicities (eg, neutropenia, anemia); use with caution in patients with bone marrow compromise (eg, granulocyte count <1,000 cells/mm3 or hemoglobin <9.5 g/dL). Frequent complete blood counts are recommended in patients with advanced HIV-1 disease. Dosage interruption may be needed if anemia or neutropenia develops.

• Hypersensitivity reactions: [US Boxed Warning]: Serious hypersensitivity reactions (sometimes fatal) have occurred in patients taking abacavir (in Trizivir). Patients who carry the HLA-B*5701 allele are at a higher risk for a hypersensitivity reaction to abacavir, although hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with Trizivir or reinitiation of therapy with Trizivir unless patients have had a previously documented HLA-B*5701 allele assessment. Discontinue Trizivir if a hypersensitivity reaction is suspected. Trizivir is contraindicated in patients who have the HLA-B*5701 allele or in patients with a prior hypersensitivity reaction to abacavir. Reintroduction of Trizivir or any other abacavir-containing product can result in life-threatening or fatal hypersensitivity reactions, even in patients who have no history of hypersensitivity to abacavir therapy. Such reactions can occur within hours. Additionally, allele-positive patients (including abacavir treatment naive) should have an allergy to abacavir documented in their medical record. Reactions usually occur within 9 days of starting abacavir; ~90% occur within 6 weeks, although these reactions may occur at any time during therapy (HHS [adult] 2019). These reactions usually include signs or symptoms in 2 or more of the following groups: fever; rash; gastrointestinal (eg, nausea, vomiting, diarrhea, abdominal pain); constitutional (eg, generalized malaise, fatigue, achiness); respiratory (eg, dyspnea, cough, pharyngitis). Other signs and symptoms include lethargy, headache, myalgia, edema, abnormal chest x-ray findings, arthralgia and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with hypersensitivity reactions. Physical findings (lymphadenopathy, mucous membrane lesions, and rash [maculopapular, urticarial or variable]) may occur. Erythema multiforme has also been reported. Laboratory abnormalities (eg, elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia) may occur. Trizivir should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Following a hypersensitivity reaction, Trizivir SHOULD NOT be restarted because more severe symptoms may occur within hours, including LIFE-THREATENING HYPOTENSION AND DEATH. If Trizivir is to be restarted following an interruption in therapy not associated with symptoms of a hypersensitivity reaction, carefully evaluate the patient for previously unsuspected symptoms of hypersensitivity. Do not restart if hypersensitivity is suspected or cannot be ruled out regardless of HLA-B*5701 status. If Trizivir is restarted, continually monitor for symptoms of a hypersensitivity reaction. Make the patient aware that reintroduction should only take place if medical care is readily accessible.

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. Female gender and obesity may increase the risk for development. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).

• Lipoatrophy: May cause loss of subcutaneous fat, especially in the face, limbs, and buttocks. Lipoatrophy incidence and severity are related to cumulative exposure and may be only partially reversible; improvement may take months to years after switching to a regimen that does not contain zidovudine. Monitor patients for signs of lipoatrophy and consider switching to a non-zidovudine-containing regimen if lipoatrophy occurs.

• Myopathy: [US Boxed Warning]: Prolonged use of zidovudine has been associated with symptomatic myopathy and myositis.

• Pancreatitis: Pancreatitis has been observed with abacavir, lamivudine and zidovudine; rule out pancreatitis in patients who develop signs/symptoms (eg, nausea/vomiting, abdominal pain, elevated lipase, and amylase) during therapy.

Disease-related concerns:

• Chronic hepatitis B: [US Boxed Warning]: Exacerbation of hepatitis B (including fatalities) has been reported with discontinuation of lamivudine in coinfected HIV/HBV patients; monitor hepatic function (eg, serum ALT) and HBV viral DNA closely for several months after discontinuing Trizivir in coinfected patients.

• Coronary heart disease: Abacavir use has been associated with an increased risk of MI in some cohort studies (Elion 2018; HHS [adult] 2019). Consider using with caution in patients with risks for coronary heart disease and minimizing modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking) prior to use.

• Lamivudine-resistant HBV: Emergence of HBV virus variants associated with resistance to lamivudine have been reported in HIV-1 infected subjects who have received lamivudine-containing antiretroviral regimens in the presence of HBV coinfection.

• Renal impairment: Trizivir, as a fixed-dose combination tablet, should not be used in patients with CrCl <50 mL/minute.

Special populations:

• Pediatric patients <40 kg: Trizivir, as a fixed-dose combination tablet, should not be used in patients <40 kg or those requiring dosage adjustment.

• Therapy-experienced patients: Patients with prolonged prior nucleoside reverse transcriptase inhibitor (NRTI) exposure or presence of HIV-1 isolates containing multiple mutations conferring resistance to NRTIs have limited response to abacavir. The potential for cross resistance between abacavir and other NRTIs should be considered when evaluating new regimens in therapy experienced patients.

Warnings: Additional Pediatric Considerations

The major clinical toxicity of lamivudine in pediatric patients is pancreatitis; discontinue therapy if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur. Abacavir may cause mild hyperglycemia; more common in pediatric patients.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Trizivir: Abacavir sulfate 300 mg, lamivudine 150 mg, and zidovudine 300 mg [DSC] [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic: Abacavir sulfate 300 mg, lamivudine 150 mg, and zidovudine 300 mg [DSC]

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Trizivir Oral)

300-150-300 mg (per each): $32.19

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Generic: Abacavir sulfate 300 mg, lamivudine 150 mg, and zidovudine 300 mg [DSC]

Administration: Adult

Administer without regard to food.

Administration: Pediatric

Oral: May be administered without regard to meals.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Abacavir is a hazardous agent. Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf#page=34, must be dispensed with this medication. A Warning Card (summarizing symptoms of hypersensitivity), which is available with the product information, must also be dispensed with this medication for each new outpatient prescription and refill.

Use: Labeled Indications

HIV infection: Treatment of HIV-1 infection in combination with other antiretroviral agents.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Acemetacin: May enhance the adverse/toxic effect of Zidovudine. Specifically, the risk for hematologic toxicity may be increased. Risk C: Monitor therapy

Amodiaquine: Zidovudine may enhance the neutropenic effect of Amodiaquine. Management: Avoid coadministration of zidovudine-containing antiretroviral therapy with amodiaquine when possible. If combined, monitor closely for neutropenia. Risk D: Consider therapy modification

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Risk C: Monitor therapy

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

Clarithromycin: May enhance the myelosuppressive effect of Zidovudine. Clarithromycin may decrease the serum concentration of Zidovudine. Management: Monitor response to zidovudine closely when used with clarithromycin, and consider staggering zidovudine and clarithromycin doses when possible in order to minimize the potential for interaction. Risk D: Consider therapy modification

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dexketoprofen: May enhance the adverse/toxic effect of Zidovudine. Risk C: Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

DOXOrubicin (Conventional): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Conventional) may diminish the therapeutic effect of Zidovudine. Management: Avoid concomitant use of doxorubicin and zidovudine due to the possibility of reduced zidovudine efficacy and increased myelosuppressive effects. Risk D: Consider therapy modification

DOXOrubicin (Liposomal): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Liposomal) may diminish the therapeutic effect of Zidovudine. Management: Avoid concomitant use of doxorubicin and zidovudine. Reduced efficacy of zidovudine is possible based on in vitro data. Also, increased myelosuppressive effects are possible with combined administration. Risk D: Consider therapy modification

Elivaldogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid combination

Erdafitinib: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Consider alternatives to this combination when possible. If combined, monitor for increased effects/toxicities of OCT2 substrates and consider OCT2 substrate dose reductions when appropriate. Risk D: Consider therapy modification

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Foslevodopa: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Ganciclovir-Valganciclovir: May enhance the adverse/toxic effect of Zidovudine. Specifically, hematologic toxicity may be enhanced. Risk C: Monitor therapy

Gilteritinib: May increase the serum concentration of OCT1 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Interferons: May enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Risk C: Monitor therapy

Levomethadone: May increase the serum concentration of Zidovudine. Risk C: Monitor therapy

Levomethadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Levomethadone. Risk C: Monitor therapy

Lopinavir: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy

Lovotibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Lovotibeglogene Autotemcel. Risk X: Avoid combination

Methadone: May increase the serum concentration of Zidovudine. Risk C: Monitor therapy

Methadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Methadone. Risk C: Monitor therapy

Nelfinavir: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy

Pacritinib: May increase the serum concentration of OCT1 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Probenecid: May increase the serum concentration of Zidovudine. Risk C: Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Zidovudine. Risk C: Monitor therapy

Ribavirin (Oral Inhalation): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Oral Inhalation). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Risk D: Consider therapy modification

Ribavirin (Systemic): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Systemic). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended for ribavirin. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Risk D: Consider therapy modification

RifAMPin: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy

Riociguat: Abacavir may increase the serum concentration of Riociguat. Risk C: Monitor therapy

Risdiplam: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of risdiplam with MATE substrates if possible. If the combination cannot be avoided, monitor closely for adverse effects. Consider a reduced dose of the MATE substrate according to that substrate's labeling if appropriate. Risk D: Consider therapy modification

Ritonavir: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Sorbitol: May decrease the serum concentration of LamiVUDine. Management: When possible, avoid chronic coadministration of sorbitol-containing solutions with lamivudine, but if this combination cannot be avoided, monitor patients more closely for possible therapeutic failure associated with decreased lamivudine exposure. Risk D: Consider therapy modification

Stavudine: Zidovudine may diminish the therapeutic effect of Stavudine. Risk X: Avoid combination

Tafenoquine: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of MATE substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the MATE substrate and consider a reduced dose of the MATE substrate according to that substrate's labeling. Risk D: Consider therapy modification

Tafenoquine: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of OCT2 substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the OCT2 substrate and consider a reduced dose of the OCT2 substrate according to that substrate's labeling. Risk D: Consider therapy modification

Tenoxicam: May enhance the adverse/toxic effect of Zidovudine. Risk C: Monitor therapy

Tipranavir: May decrease the serum concentration of Zidovudine. Risk C: Monitor therapy

Trimethoprim: May increase the serum concentration of LamiVUDine. Risk C: Monitor therapy

Trimethoprim: Zidovudine may enhance the neutropenic effect of Trimethoprim. Trimethoprim may increase the serum concentration of Zidovudine. Risk C: Monitor therapy

Valproate Products: May increase the serum concentration of Zidovudine. Risk C: Monitor therapy

Reproductive Considerations

The Health and Human Services (HHS) perinatal HIV guidelines do not list this fixed-dose combination as a preferred or alternative regimen in patients who are not yet pregnant but are trying to conceive (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Pregnancy Considerations

The Health and Human Services (HHS) perinatal HIV guidelines do not recommend use of this fixed-dose combination regimen in pregnancy. Patients who become pregnant while taking this combination should be changed to a recommended regimen (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Breastfeeding Considerations

Abacavir, lamivudine, and zidovudine are present in breast milk.

Refer to individual monographs for additional information.

Monitoring Parameters

Blood glucose, CBC with differential, serum creatine kinase, CD4 count, HIV RNA plasma levels, bilirubin, serum transaminases, triglycerides, serum amylase; HLA-B*5701 genotype status prior to initiation of therapy and prior to reinitiation of therapy in patients of unknown HLA-B*5701 status; signs and symptoms of hypersensitivity, particularly in patients untested for the HLA-B*5701 allele; signs and symptoms of pancreatitis; observe for appearance of opportunistic infections

Mechanism of Action

The combination of abacavir, lamivudine, and zidovudine is believed to act synergistically to inhibit reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue as well as to delay the emergence of mutations conferring resistance.

Pharmacokinetics (Adult Data Unless Noted)

Bioavailability studies of Trizivir® show no difference in AUC or Cmax when compared to abacavir, lamivudine, and zidovudine given together as individual agents. See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Trizivir;
  • (AR) Argentina: Tricivir;
  • (AT) Austria: Trizivir;
  • (AU) Australia: Trizivir;
  • (BE) Belgium: Trizivir;
  • (BF) Burkina Faso: Abac lz | Trizivir;
  • (BG) Bulgaria: Trizivir;
  • (BR) Brazil: Triovir;
  • (CH) Switzerland: Trizivir;
  • (CL) Chile: Tricivir;
  • (CN) China: Trizivir;
  • (CO) Colombia: Abacavir, lamivudina + zidovudina | Lamivudina + Zidovudina + Abacavir | Lavuzid ab | Terzala | Trivakavir | Triviral | Trizivir;
  • (CZ) Czech Republic: Trizivir;
  • (DE) Germany: Trizivir;
  • (EC) Ecuador: Trizivir;
  • (EE) Estonia: Trizivir;
  • (ES) Spain: Trizivir;
  • (FI) Finland: Trizivir;
  • (FR) France: Abacavir/lamivudine/zidovudine mylan | Trizivir;
  • (GB) United Kingdom: Trizivir;
  • (GR) Greece: Trizivir;
  • (HK) Hong Kong: Trizivir;
  • (HU) Hungary: Trizivir;
  • (IL) Israel: Trizivir;
  • (IT) Italy: Abacavir/lamivudina/zidovudina mylan | Trizivir;
  • (KE) Kenya: Abac lz | Abacavir sulfate + lamivudine + zidovudine | Trizivir;
  • (LT) Lithuania: Trizivir;
  • (LU) Luxembourg: Trizivir;
  • (LV) Latvia: Trizivir;
  • (MX) Mexico: Trizivir;
  • (NL) Netherlands: Abacavir/lamivudine/zidovudine mylan | Trizivir;
  • (NO) Norway: Trizivir;
  • (PE) Peru: Trizivir;
  • (PL) Poland: Trizivir;
  • (PR) Puerto Rico: Abacavir sulfate, lamivudine and zidovudine | Trizivir;
  • (PT) Portugal: Trizivir;
  • (QA) Qatar: Trizivir;
  • (RO) Romania: Trizivir;
  • (RU) Russian Federation: Abacavir+zidovudine+lamivudine | Akimasol | Trizivir;
  • (SE) Sweden: Trizivir;
  • (SK) Slovakia: Trizivir;
  • (TW) Taiwan: Trizivir;
  • (UG) Uganda: Abacavir sulfate + lamivudine + zidovudine;
  • (ZA) South Africa: Abaclamizid | Trizivar;
  • (ZM) Zambia: Abac lz;
  • (ZW) Zimbabwe: Abacavir sulphate/lamivudine/zidovudine
  1. Apo-Abacavir-Lamivudine-Zidovudine (Abacavir, Lamivudine and Zidovudine) [product monograph]. Toronto, Ontario, Canada: Apotex Inc; October 2019. [PubMed 11943262 ]
  2. Elion RA, Althoff KN, Zhang J, et al; North American AIDS Cohort Collaboration on Research and Design of IeDEA. Recent abacavir use increases risk of type 1 and type 2 myocardial infarctions among adults with HIV. J Acquir Immune Defic Syndr. 2018;78(1):62-72. doi: 10.1097/QAI.0000000000001642. [PubMed 29419568]
  3. Hetherington S, Hughes AR, Mosteller M, et al, "Genetic Variations in HLA-B Region and Hypersensitivity Reactions to Abacavir," Lancet, 2002, 359(9312):1121-2. [PubMed 11943262]
  4. Lucas A, Nolan D, and Mallal S, “HLA-B*5701 Screening for Susceptibility to Abacavir Hypersensitivity,” J Antimicrob Chemother, 2007, 59(4):591-3. [PubMed 17317695]
  5. Mallal S, Nolan D, Witt C, et al, "Association Between Presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and Hypersensitivity to HIV-1 Reverse-Transcriptase Inhibitor Abacavir," Lancet, 2002, 359(9308):727-32. [PubMed 11888582]
  6. Peyriére H, Nicolas J, Siffert M, et al, “Hypersensitivity Related to Abacavir in Two Members of a Family,” Ann Pharmacother, 2001, 35(10):1291-2. [PubMed 11675863]
  7. Saez-Llorens X, Nelson RP, Emmanuel P, et al, "A Randomized, Double-Blind Study of Triple Nucleoside Therapy of Abacavir, Lamivudine, and Zidovudine Versus Lamivudine and Zidovudine in Previously Treated Human Immunodeficiency Virus Type 1-Infected Children," Pediatrics, 2001, 107(1). Available at http://www.pediatrics.org/cgi/content/full/107/1/e4 [PubMed 11134468]
  8. Trizivir (abacavir/lamivudine/zidovudine) [prescribing information]. Research Triangle Park, NC: Viiv Healthcare; February 2021.
  9. Trizivir (abacavir/lamivudine/zidovudine) [product monograph]. Laval, Quebec, Canada: ViiV Healthcare ULC; July 2019.
  10. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
  11. US Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf. Updated December 18, 2019. Accessed December 18, 2019.
  12. US Department of Health and Human Services (HHS) Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. April 2017. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-arv/guidelines-pediatric-arv.pdf.
  13. US Department of Health and Human Services (HHS) Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Perinatal_GL.pdf. Updated January 31, 2023. Accessed February 23, 2023.
Topic 8700 Version 267.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟