Frequently Asked Questions

Abacavir Sulfate/Lamivudine

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n: a-BAK-a-vir SUL-fate/la-MIV-ue-deen Class: Nucleoside analog reverse transcriptase inhibitor combination

Antiviral combinations


Trade Names

Epzicom
- Tablets abacavir 600 mg (as sulfate)/lamivudine 300 mg

Pharmacology

Inhibits replication of HIV by incorporating into HIV DNA and producing incomplete, nonfunctional DNA.

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Indications and Usage

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

Contraindications

Hypersensitivity to any component of product; hepatic function impairment.

Dosage and Administration

Adults

PO 1 tablet daily (abacavir sulfate 600 mg/lamivudine 300 mg), in combination with other antiretroviral agents.

General Advice

  • May be taken with or without food.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Ethanol

Ethanol decreases the elimination of abacavir, causing an increase in overall exposure.

Interferon alfa

Hepatic decomposition (some fatal) has occurred in HIV-1/HCV coinfected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Methadone

Methadone Cl increased 22% during coadministration. Methadone may delay the absorption of abacavir/lamivudine, resulting in a decrease in bioavailability.

Ribavirin

Ribavirin may reduce the phosphorylation of lamivudine.

Trimethoprim/Sulfamethoxazole

Lamivudine serum levels may be elevated, increasing the pharmacologic and adverse effects.

Zalcitabine

Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

MI (postmarketing).

CNS

Insomnia (9%); fatigue/malaise (8%); depression/depressed mood, headache/migraine (7%); dizziness/vertigo (6%); abnormal dreams, anxiety (5%); paresthesia, peripheral neuropathy, seizures (postmarketing).

Dermatologic

Rash (5%); alopecia, erythema multiforme, Stevens-Johnson syndrome, TEN (postmarketing).

GI

Diarrhea, nausea (6%); abdominal pain/gastritis (5%); pancreatitis, stomatitis (postmarketing).

Hematologic-Lymphatic

Anemia including pure red cell aplasia and severe anemia progressing with therapy, aplastic anemia, lymphadenopathy, splenomegaly (postmarketing).

Hepatic

Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B (postmarketing).

Hypersensitivity

Drug hypersensitivity (9%); sensitization reactions (including anaphylaxis), urticaria (postmarketing).

Lab Tests

Anemia; elevation of bilirubin, amylase, and lipase levels; elevations of blood glucose and triglycerides; LFT abnormalities; neutropenia; thrombocytopenia.

Metabolic

Hyperglycemia (postmarketing).

Musculoskeletal

CPK elevation, muscle weakness, rhabdomyolysis (postmarketing).

Respiratory

Abnormal breath sounds/wheezing (postmarketing).

Miscellaneous

Pyrexia (5%); redistribution/accumulation of body fat, weakness (postmarketing).

Precautions

Warnings

Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir. The hypersensitivity reaction is a multiorgan syndrome usually characterized by signs or symptoms in 2 or more of the following groups: fever, rash, GI (eg, abdominal pain, nausea, vomiting), constitutional (eg, aches, fatigue, malaise), and respiratory (eg, cough, dyspnea, pharyngitis). Permanently discontinue if hypersensitivity reaction occurs. Patients carrying the HLA-B*5710 allele are at a high risk for experiencing a hypersensitivity reaction to abacavir. Do not restart any abacavir-containing product following a hypersensitivity reaction. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, may occur. Severe acute exacerbation of hepatitis B has been reported in patient coinfected with hepatitis B virus (HBV) and HIV-1 and who have discontinued lamivudine. Closely monitor hepatic function for at least several months after discontinuation of abacavir/lamivudine in patients who are coinfected with HIV-1 and HBV.


Monitor

Prior to starting or reintroducing therapy with abacavir, screening for the HLA-B*5701 allele is recommended and may decrease the risk of hypersensitivity reactions. Patients who test negative for the allele may develop hypersensitivity reaction to abacavir; however, this occurs less frequently than in HLA-B*5701–postive patients.

Discontinuation

Ensure hepatic function is closely monitored for at least several months following discontinuation of abacavir/lamivudine in patients who are coinfected with HBV and HIV. Ensure an anti-HBV therapy has been considered.

Lactic acidosis

Monitor patient for signs of lactic acidosis. If patient develops cold feeling, dizziness, light-headedness, profound weakness or tiredness, slow or irregular heartbeat, or unexpected stomach discomfort, withhold drug.


Pregnancy

Category C .

Lactation

HIV-infected mothers should not breast-feed their infants.

Abacavir

Undetermined.

Lamivudine

Excreted in breast milk.

Children

Safety and efficacy not established.

Elderly

Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hypersensitivity

Do not administer to patient who has had a suspected or documented hypersensitivity reaction to abacavir. Abacavir has been associated with fatal hypersensitivity reactions and should not be restarted following a hypersensitivity reaction to abacavir.

Renal Function

Because this is a fixed-dose tablet, do not use for patients requiring dosage adjustment (CrCl less than 50 mL/min).

Hepatic Function

Because this is a fixed-dose tablet and the dosage of the individual components cannot be altered, it is contraindicated in patients with hepatic function impairment.

Antiretroviral agents

Must be used in combination with other antiretroviral agents from different pharmacologic classes (not with other nucleoside/nucleotide reverse transcriptase inhibitors).

Fat redistribution

Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance, have been observed in patients receiving antiretroviral therapy.

Fixed-dose combination

Abacavir/lamivudine contains fixed doses of 2 nucleoside analogs, abacavir and lamivudine, and should not be coadministered with other abacavir- and/or lamivudine-containing products.

HIV-1 and HBV coinfection

Not appropriate for the treatment of chronic HBV in patients dually infected with HIV-1 and HBV.

Immune reconstitution syndrome

Has been reported in patients receiving combination antiretroviral therapy, including abacavir/lamivudine. During the initial phase of treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium ), necessitating further evaluation and treatment.

MI

Use of abacavir within the 6 mo prior to combined antiretroviral therapy may increase the risk of MI.

Posttreatment exacerbations of hepatitis

In patients treated with lamivudine for chronic HBV, clinical and laboratory evidence of hepatitis exacerbations have occurred after discontinuation of lamivudine.

Therapy-experienced patients

Patients with prolonged prior nucleoside reverse transcriptase inhibitor (NRTI) exposure or who have HIV-1 isolates containing multiple mutations conferring NRTI resistance have limited response to abacavir. Thus, consider potential cross-resistance between abacavir and other NRTIs when selecting new regimens for therapy-experienced patients.

Patient Information

  • Advise patient to review Medication Guide before starting therapy and with each refill of the medication.
  • Advise patient to review, and carry at all times, the Warning Card summarizing the symptoms of abacavir hypersensitivity reaction.
  • Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
  • Instruct patient to take 1 tablet once daily without regard to meals, but to take with food if stomach upset occurs.
  • Warn patient that this drug is not to be used by itself but is combined with other antiviral agents and to continue to take other HIV medications as prescribed by health care provider.
  • Instruct patient to discontinue use and notify health care provider immediately if a symptom from 2 or more of the following groups occurs: 1) fever; 2) rash; 3) nausea, vomiting, diarrhea, stomach pain; 4) generalized body discomfort, extreme tiredness, achiness; 5) sore throat, shortness of breath, cough.
  • Caution patient not to restart this medication or any other abacavir-containing medication if a hypersensitivity reaction to this medication has occurred. Explain to patient that restarting abacavir or an abacavir-containing product could cause a more serious, and possibly fatal, reaction.
  • Caution patient that if therapy is interrupted for a few days for reasons other than a hypersensitivity reaction (eg, interruption in drug supply) and is then restarted that there is a risk of experiencing a serious or fatal hypersensitivity reaction. Advise patient to talk with health care provider before restarting the medication. Advise patient that if health care provider tells them to take the medication again, to start taking it when they are around medical help or people who can call a doctor if necessary.
  • Caution patient that medication can cause a rare but serious condition called lactic acidosis with liver enlargement and that persistent nausea and tiredness may be symptoms of this condition. Instruct patient to inform health care provider if these symptoms develop.
  • Caution patient who has concurrent infection with HBV that hepatitis may worsen if abacavir/lamivudine is stopped and that liver function should be closely followed for several months after stopping abacavir/lamivudine. Advise patient that anti-HBV medications may be needed.
  • Advise patient that medication may cause changes in body fat distribution (eg, increased amount of fat in upper back and neck, breasts, and around the back, chest, and stomach area; or loss of fat from arms, legs, and face) and that the cause and long-term health effects of these changes are not known at this time. Advise patient to report changes in body fat distribution to health care provider.
  • Inform patient that drug does not completely eliminate HIV and, therefore, does not reduce the risk of transmitting HIV to others through sexual contact or blood contamination. Instruct patient that appropriate precautions must still be followed.
  • Advise patient that drug is not a cure for HIV infection and that illnesses associated with HIV infection, including opportunistic infections, may continue to be acquired. Patients should remain under a health care provider's care.
  • Instruct mother not to breast-feed her infant because of risk of transmitting HIV virus to the infant and the potential for serious adverse effects from medication transmitted to her infant through breast milk.

Copyright © 2009 Wolters Kluwer Health.

Not all side effects for abacavir / lamivudine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abacavir / lamivudine: oral tablet

In addition to its needed effects, some unwanted effects may be caused by abacavir / lamivudine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking abacavir / lamivudine:

More common
  • Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of the face, feet, or hands; pain in the joints; pain in the muscles; shortness of breath; skin rash; sore throat; swelling of the feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • constipation
  • convulsions
  • dark urine
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • feeling of fullness
  • general feeling of discomfort
  • hives or welts
  • indigestion
  • itching
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • muscle cramping
  • muscle spasm or jerking of all extremities
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • redness of the skin
  • red skin lesions, often with a purple center
  • sleepiness
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden loss of consciousness
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing with exertion
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • weakness in the arms, hands, legs, or feet
  • wheezing
  • yellow eyes and skin

Some of the side effects that can occur with abacavir / lamivudine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abnormal dreams
  • burning feeling in the chest or stomach
  • fear
  • feeling of constant movement of self or surroundings
  • lightheadedness
  • nervousness
  • sensation of spinning
  • severe and throbbing headache
  • sleeplessness
  • stomach upset
  • tenderness in the stomach area
  • trouble with sleeping
  • unable to sleep
Incidence not known
  • Abnormal breathing sounds
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • gaining weight around your neck, upper back, breast, face, or waist
  • hair loss
  • increased hunger
  • increased thirst
  • increased urination
  • muscle weakness
  • sweating
  • swelling or inflammation of the mouth
  • thinning of the hair
  • unexplained weight loss

For Healthcare Professionals

Applies to abacavir / lamivudine: oral tablet

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Cardiovascular

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

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.

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.[Ref]

References

1. Eron J Jr, Yeni P, Gathe J Jr, et al. "The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial." Lancet 368 (2006): 476-82

2. "Product Information. Epzicom (abacavir-lamivudine)." GlaxoSmithKline, Research Triangle Park, NC.

3. Toerner JG, Cvetkovich T "Kawasaki-like Syndrome: Abacavir Hypersensitivity?" Clin Infect Dis 34 (2002): 131-2

4. Hetherington S, McGuirk S, Powell G, et al. "Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir." Clin Ther 23 (2001): 1603-14

5. Loeliger AE, Steel H, McGuirk S, Powell WS, Hetherington SV "The abacavir hypersensitivity reaction and interruptions in therapy." Aids 15 (2001): 1325

6. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: URL: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf." ([2011 Oct 14]):

7. Piacenti FJ "An update and review of antiretroviral therapy." Pharmacotherapy 26 (2006): 1111-33

8. Cutrell AG, Hernandez JE, Fleming JW, et al. "Updated clinical risk factor analysis of suspected hypersensitivity reactions to abacavir." Ann Pharmacother 38 (2004): 2171-2

9. Del Giudice P, Vandenbos F, Perrin C, Bernard E, Marq L, Dellamonica P "Sweet's syndrome following abacavir therapy." J Am Acad Dermatol 51 (2004): 474-5

10. Sankatsing SU, Prins JM "Agranulocytosis and fever seven weeks after starting abacavir." AIDS 15 (2001): 2464-5

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