Epzicom

Last updated on RxList: 7/6/2021
Epzicom Side Effects Center

What Is Epzicom?

Epzicom (abacavir sulfate and lamivudine) is a type of antiviral medication called a reverse transcriptase inhibitor used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Epzicom is not a cure for HIV or AIDS.

What Are Side Effects of Epzicom?

Common side effects of Epzicom include:

  • headache,
  • nausea,
  • diarrhea,
  • dizziness,
  • tiredness,
  • trouble sleeping,
  • strange dreams,
  • depression,
  • anxiety, or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

Tell your doctor if you have serious side effects of Epzicom including:

  • unexplained weight loss,
  • persistent muscle aches or weakness,
  • joint pain,
  • numbness or tingling of the hands/feet/arms/legs,
  • severe tiredness,
  • vision changes,
  • severe or persistent headaches,
  • signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores),
  • signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter),
  • signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech),
  • mental/mood changes (such as depression, anxiety),
  • easy bruising or bleeding, or
  • signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat).

Dosage for Epzicom

The recommended oral dose of Epzicom for adults is one tablet daily, in combination with other antiretroviral agents.

What Drugs, Substances, or Supplements Interact with Epzicom?

Epzicom may interact with methadone, ribavirin, interferon, or other medications that contain abacavir or lamivudine. Tell your doctor all medications and supplements you use.

Epzicom During Pregnancy and Breastfeeding

During pregnancy, Epzicom should be used only when prescribed. HIV medicines are usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if abacavir passes into breast milk. Lamivudine passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Epzicom (abacavir sulfate and lamivudine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Epzicom Consumer Information

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Call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

  • Group 1 - fever;
  • Group 2 - rash;
  • Group 3 - nausea, vomiting, diarrhea, stomach pain;
  • Group 4 - general ill feeling, extreme tiredness, body aches;
  • Group 5 - shortness of breath, cough, sore throat.

Once you have an allergic reaction to abacavir, you must never use it again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Also call your doctor at once if you have:

  • other signs of allergic reaction--hives, swelling in your face or throat, trouble breathing;
  • lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, feeling very weak or tired; or
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Abacavir and lamivudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects include:

  • allergic reaction;
  • depression, trouble sleeping;
  • feeling weak or tired;
  • headache, dizziness, migraine;
  • nausea, diarrhea; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Epzicom (Abacavir Sulfate and Lamivudine Tablets)

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Epzicom Professional Information

SIDE EFFECTS

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

  • Serious and sometimes fatal hypersensitivity reactions [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
  • Exacerbations of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
  • Lactic acidosis and severe hepatomegaly with steatosis [see WARNINGS AND PRECAUTIONS].
  • Immune reconstitution syndrome [see WARNINGS AND PRECAUTIONS].
  • Myocardial infarction [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience In Adult Subjects

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

Serious And Fatal Abacavir-Associated Hypersensitivity Reactions

In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of EPZICOM [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. These reactions have been characterized by 2 or more of the following signs or symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, or abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, or achiness); (5) respiratory symptoms (including dyspnea, cough, or pharyngitis). Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome.

Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions. Physical findings have included lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and maculopapular or urticarial rash (although some patients had other types of rashes and others did not have a rash). There were reports of erythema multiforme. Laboratory abnormalities included elevated liver chemistries, elevated creatine phosphokinase, elevated creatinine, and lymphopenia and abnormal chest x-ray findings (predominantly infiltrates, which were localized).

Additional Adverse Reactions With Use Of EPZICOM

Therapy-Naive Adults

Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with greater than or equal to 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, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA30021) through 48 Weeks of Treatment

Adverse EventZIAGEN 600 mg q.d. plus EPIVIR plus Efavirenz
(n = 384)
ZIAGEN 300 mg b.i.d. plus EPIVIR plus Efavirenz
(n = 386)
Drug hypersensitivityab9%7%
Insomnia7%9%
Depression/Depressed mood7%7%
Headache/Mi grai ne7%6%
Fatigue/Malaise6%8%
Dizziness/Vertigo6%6%
Nausea5%6%
Diarrheaa5%6%
Rash5%5%
Pyrexia5%3%
Abdominal pain/gastritis4%5%
Abnormal dreams4%5%
Anxiety3%5%
a Subjects 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.
b CNA30024 was a multi-center, double-blind, controlled trial 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 trial, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 subjects in the abacavir group and 3% of 325 subjects in the zidovudine group.

Laboratory Abnormalities

Laboratory abnormalities observed in clinical trials of ZIAGEN were anemia, neutropenia, liver function test abnormalities, and elevations of CPK, blood glucose, and triglycerides. Additional laboratory abnormalities observed in clinical trials 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 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.

Clinical Trials Experience In Pediatric Subjects

The safety of once-daily compared with twice-daily dosing of abacavir and lamivudine, administered as either single products or as EPZICOM, was assessed in the ARROW trial (n = 336). Primary safety assessment in the ARROW (COL105677) trial was based on Grade 3 and Grade 4 adverse events. The frequency of Grade 3 and 4 adverse events was similar among subjects randomized to once-daily dosing compared with subjects randomized to twice-daily dosing. One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator. No additional safety issues were identified in pediatric subjects receiving abacavir and lamivudine once-daily compared with historical data in adults [see ADVERSE REACTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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 [see ADVERSE REACTIONS].

Abacavir And Lamivudine

Body as a Whole: Redistribution/accumulation of body fat.

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], posttreatment exacerbations of hepatitis B [see WARNINGS AND PRECAUTIONS].

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.

Read the entire FDA prescribing information for Epzicom (Abacavir Sulfate and Lamivudine Tablets)

© Epzicom Patient Information is supplied by Cerner Multum, Inc. and Epzicom Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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