Epzicom Side Effects

Please note - some side effects for Epzicom may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Epzicom - for the Consumer

Epzicom

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Epzicom:

Dizziness; headache; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Epzicom:

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort, numbness of an arm or leg, shortness of breath, or sudden vision changes; decreased urination; exhaustion; fainting; flu-like illness; mental or mood problems (eg, depression); mouth ulcers; muscle pain, cramping, or weakness; numbness, tingling, or pain in the hands and feet; red, swollen, blistered, or peeling skin; seizures; severe dizziness; swelling; symptoms of lactic acidosis (eg, fast or irregular heartbeat; feeling cold, especially in your arms and legs; rapid or difficult breathing; stomach pain with nausea and vomiting; unusual dizziness or lightheadedness; unusual tiredness or weakness); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Epzicom Side Effects - for the Professional

Epzicom

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Serious and sometimes fatal hypersensitivity reaction. In one study, once-daily dosing of abacavir was associated with more severe hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.1)].
• Lactic acidosis and severe hepatomegaly [see Boxed Warning, Warnings and Precautions (5.2)].
• Acute exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.3)].
• Hepatic decompensation in patients co-infected with HIV-1 and Hepatitis C [see Warnings and Precautions (5.4)].
• Immune reconstitution syndrome [see Warnings and Precautions (5.5].
• Fat redistribution [see Warnings and Precautions (5.6].
• Myocardial infarction [see Warnings and Precautions (5.7)].

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Therapy-Naive Adults: Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥5% frequency during therapy with ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily are listed in Table 1.

Table 1. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2-4, ≥5% Frequency) in Therapy-Naive Adults (CNA30021) Through 48 Weeks of Treatment

Adverse Event	ZIAGEN 600 mg q.d. plus EPIVIR plus Efavirenz (n = 384)	ZIAGEN 300 mg b.i.d. plus EPIVIR plus Efavirenz (n = 386)
Drug hypersensitivitya,b	9%	7%
Insomnia	7%	9%
Depression/Depressed mood	7%	7%
Headache/Migraine	7%	6%
Fatigue/Malaise	6%	8%
Dizziness/Vertigo	6%	6%
Nausea	5%	6%
Diarrheaa	5%	6%
Rash	5%	5%
Pyrexia	5%	3%
Abdominal pain/gastritis	4%	5%
Abnormal dreams	4%	5%
Anxiety	3%	5%
aSubjects receiving ZIAGEN 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who received ZIAGEN 300 mg twice daily. Five percent (5%) of subjects receiving ZIAGEN 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving ZIAGEN 300 mg twice daily. Two percent (2%) of subjects receiving ZIAGEN 600 mg once daily had severe diarrhea while none of the subjects receiving ZIAGEN 300 mg twice daily had this event.
bStudy CNA30024 was a multi-center, double-blind, controlled study in which 649 HIV-1-infected, therapy-naive adults were randomized and received either ZIAGEN (300 mg twice daily), EPIVIR (150 mg twice daily), and efavirenz (600 mg once daily) or zidovudine (300 mg twice daily), EPIVIR (150 mg twice daily), and efavirenz (600 mg once daily). CNA30024 used double-blind ascertainment of suspected hypersensitivity reactions. During the blinded portion of the study, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 patients in the abacavir group and 3% of 325 patients in the zidovudine group.

Laboratory Abnormalities: Laboratory abnormalities observed in clinical studies of ZIAGEN were anemia, neutropenia, liver function test abnormalities, and elevations of CPK, blood glucose, and triglycerides. Additional laboratory abnormalities observed in clinical studies of EPIVIR were thrombocytopenia and elevated levels of bilirubin, amylase, and lipase.

The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in Study CNA30021.

Other Adverse Events: In addition to adverse reactions listed above, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.

Postmarketing Experience

In addition to adverse reactions reported from clinical studies, the following reactions have been identified during postmarketing use of abacavir, lamivudine, and/or Epzicom. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to abacavir, lamivudine, and/or Epzicom.

Abacavir:Cardiovascular: Myocardial infarction.

Skin: Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases.

There have also been reports of erythema multiforme with abacavir use.

Abacavir and Lamivudine:Body as a Whole: Redistribution/accumulation of body fat [see Warnings and Precautions (5.6)].

Digestive: Stomatitis.

Endocrine and Metabolic: Hyperglycemia.

General: Weakness.

Hemic and Lymphatic: Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.

Hepatic: Lactic acidosis and hepatic steatosis [see Warnings and Precautions (5.2)], posttreatment exacerbation of hepatitis B [see Warnings and Precautions (5.3)].

Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria.

Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis.

Nervous: Paresthesia, peripheral neuropathy, seizures.

Respiratory: Abnormal breath sounds/wheezing.

Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.

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Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity side effects associated with abacavir have included serious and sometimes fatal hypersensitivity reactions. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, fatigue, achiness, dyspnea, and cough. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia. Lamivudine has been associated with angioedema, urticaria, and anaphylactoid reactions. Sensitization reactions (including anaphylaxis) and urticaria have been reported during postmarketing experience with abacavir and lamivudine.

Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(1) Fever
(2) Rash
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)

A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.

Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction.

Hepatic

Hepatic side effects associated with abacavir have included liver function test abnormalities and elevated gamma-glutamyltransferase. Elevated hepatic enzymes, elevated bilirubin, and rare cases of hepatic decompensation have been reported with lamivudine. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Lactic acidosis, hepatic steatosis, and posttreatment exacerbation of hepatitis B have been reported during postmarketing experience with abacavir and lamivudine.

Hepatic decompensation, sometimes fatal, has been reported in patients coinfected with HIV-1 and hepatitis C virus. These patients were receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients coinfected with hepatitis B virus and HIV-1 who have discontinued antihepatitis B therapy, including lamivudine. The causal relationship to stopping lamivudine treatment is unknown.

Gastrointestinal

Pancreatitis has been rarely reported in adults (less than 0.5%), but may be more common in pediatric patients (up to 15% in 2 limited studies) receiving lamivudine.

Gastrointestinal side effects of at least moderate intensity have included nausea (up to 6%), diarrhea (up to 6%), and abdominal pain/gastritis (up to 5%) with abacavir/lamivudine/efavirenz therapy. Pancreatitis has been reported with abacavir and lamivudine. Stomatitis has been reported during postmarketing experience with abacavir and lamivudine.

Dermatologic

Dermatologic side effects of at least moderate intensity have included rash (5%) with abacavir/lamivudine/efavirenz therapy. Sweet's syndrome has been reported with abacavir. Lamivudine has been associated with rash, pruritus, and alopecia. Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience with abacavir (alone or in combination with other drugs). Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with abacavir and lamivudine.

Hematologic

Hematologic side effects associated with abacavir have included anemia, neutropenia, and agranulocytosis. Thrombocytopenia has been reported with lamivudine. Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, and splenomegaly have been reported during postmarketing experience with abacavir and lamivudine.

Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.

Nervous system

Nervous system side effects of at least moderate intensity have included insomnia (up to 9%), headache/migraine (up to 7%), and dizziness/vertigo (6%) with abacavir/lamivudine/efavirenz combination therapy. Peripheral neuropathy, paresthesia, and seizures have been reported during postmarketing experience with abacavir and lamivudine.

Other

Other side effects of at least moderate intensity have included fatigue/malaise (up to 8%) and pyrexia (up to 5%) with abacavir/lamivudine/efavirenz therapy. Weakness has been reported during postmarketing experience with abacavir and lamivudine.

Psychiatric

Psychiatric side effects of at least moderate intensity have included depression/depressed mood (7%), abnormal dreams (up to 5%), and anxiety (up to 5%) with abacavir/lamivudine/efavirenz therapy.

Metabolic

Metabolic side effects associated with abacavir have included elevated blood glucose and triglycerides. Elevated amylase and lipase have been reported with lamivudine. Redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience with abacavir and lamivudine.

Musculoskeletal

Musculoskeletal side effects associated with abacavir have included elevated creatine phosphokinase (CPK). Muscle weakness, CPK elevation, and rhabdomyolysis have been reported during postmarketing experience with abacavir and lamivudine.

Cardiovascular

A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.

Cardiovascular side effects have included myocardial infarction during postmarketing experience with abacavir.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution. The emergence of lamivudine-resistant hepatitis B virus (HBV) has been reported in HIV-1-infected patients who were treated with lamivudine-containing regimens in the presence of coinfection with HBV.

Respiratory

Respiratory side effects have included abnormal breath sounds/wheezing during postmarketing experience with abacavir and lamivudine.

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