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Epivir

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Epivir




Epivir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Epivir (lamivudine) is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Lamivudine is not a cure for HIV or AIDS. The Epivir-HBV brand of lamivudine is used to treat chronic hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV. It is an antiviral medication. This medication is available in generic form. Common side effects include headache, dizziness, nausea, diarrhea, or trouble sleeping.

The recommended oral dose of Epivir in HIV-1-infected adults and adolescents over 16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. Epivir may interact with interferon-alfa, trimethoprim, or ribavirin. Tell your doctor all medications you use. During pregnancy, Epivir should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Our Epivir (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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Epivir in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stop using lamivudine and call your doctor at once if you have a serious side effect such as:

  • signs of a new infection such as fever, chills, sore throat, flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid);
  • problems with walking, breathing, speech, swallowing, or eye movement; or
  • severe lower back pain, loss of bladder or bowel control.

Less serious side effects may include:

  • cough;
  • headache;
  • mild tired feeling;
  • runny or stuffy nose;
  • mild 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 Epivir (Lamivudine)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Epivir Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Headache, dizziness, nausea, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/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).

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression), stomach/back pain with nausea (pancreatitis).

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of anemia (unusual tiredness, rapid heartbeat, pale/bluish skin).

Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Epivir (Lamivudine)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Epivir FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Clinical Trials Experience

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 practice.

Adults - Clinical Trials in HIV-1

The safety profile of EPIVIR in adults is primarily based on 3,568 HIV-1-infected subjects in 7 clinical trials.

The most common adverse reactions are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea and cough.

Selected clinical adverse reactions in greater than or equal to 5% of subjects during therapy with EPIVIR 150 mg twice daily plus RETROVIR® 200 mg 3 times daily for up to 24 weeks are listed in Table 3.

Table 3: Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in Four Controlled Clinical Trials (NUCA3001, NUCA3002, NUCB3001, NUCB3002)

Adverse Reaction EPIVIR 150 mg Twice Daily plus RETROVIR
(n = 251)
RETROVIRa
(n = 230)
Body as a Whole
  Headache 35% 27%
  Malaise & fatigue 27% 23%
  Fever or chills 10% 12%
Digestive
  Nausea 33% 29%
  Diarrhea 18% 22%
  Nausea & vomiting 13% 12%
  Anorexia and/or decreased appetite 10% 7%
  Abdominal pain 9% 11%
  Abdominal cramps 6% 3%
  Dyspepsia 5% 5%
Nervous System
  Neuropathy 12% 10%
  Insomnia & other sleep disorders 11% 7%
  Dizziness 10% 4%
  Depressive disorders 9% 4%
Respiratory
  Nasal signs & symptoms 20% 11%
  Cough 18% 13%
Skin
  Skin rashes 9% 6%
Musculoskeletal
  Musculoskeletal pain 12% 10%
  Myalgia 8% 6%
  Arthralgia 5% 5%
a Either zidovudine monotherapy or zidovudine in combination with zalcitabine.

Pancreatitis: Pancreatitis was observed in 9 out of 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials EPV20001, NUCA3001, NUCB3001, NUCA3002, NUCB3002, and NUCB3007 [see WARNINGS AND PRECAUTIONS].

EPIVIR 300 mg Once Daily: The types and frequencies of clinical adverse reactions reported in subjects receiving EPIVIR 300 mg once daily or EPIVIR 150 mg twice daily (in 3-drug combination regimens in EPV20001 and EPV40001) for 48 weeks were similar. Selected laboratory abnormalities observed during therapy are summarized in Table 4.

Table 4: Frequencies of Selected Grade 3-4 Laboratory Abnormalities in Adults in Four 24-Week Surrogate Endpoint Trials (NUCA3001, NUCA3002, NUCB3001, NUCB3002) and a Clinical Endpoint Trial (NUCB3007)

Test (Threshold Level) 24-Week Surrogate Endpoint Trialsa Clinical Endpoint Triala
EPIVIR plus RETROVIR RETROVIRb EPIVIR plus Current Therapy Placebo plus Current Therapyc
Absolute neutrophil count ( < 750/mm³) 7.2% 5.4% 15% 13%
Hemoglobin ( < 8.0 g/dL) 2.9% 1.8% 2.2% 3.4%
Platelets ( < 50,000/mm³) 0.4% 1.3% 2.8% 3.8%
ALT ( > 5.0 x ULN) 3.7% 3.6% 3.8% 1.9%
AST ( > 5.0 x ULN) 1.7% 1.8% 4.0% 2.1%
Bilirubin ( > 2.5 x ULN) 0.8% 0.4% ND ND
Amylase ( > 2.0 x ULN) 4.2% 1.5% 2.2% 1.1%
a The median duration on study was 12 months.
b Either zidovudine monotherapy or zidovudine in combination with zalcitabine.
c Current therapy was either zidovudine, zidovudine plus didanosine, or zidovudine plus zalcitabine.
ULN = Upper limit of normal.
ND = Not done.

The frequencies of selected laboratory abnormalities reported in subjects receiving EPIVIR 300 mg once daily or EPIVIR 150 mg twice daily (in 3-drug combination regimens in EPV20001 and EPV40001) were similar.

Pediatric Subjects - Clinical Trials in HIV-1

EPIVIR oral solution has been studied in 638 pediatric subjects aged 3 months to 18 years in 3 clinical trials.

Selected clinical adverse reactions and physical findings with a greater than or equal to 5% frequency during therapy with EPIVIR 4 mg per kg twice daily plus RETROVIR 160 mg per m² 3 times daily in therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 5.

Table 5: Selected Clinical Adverse Reactions and Physical Findings (Greater than or Equal to 5% Frequency) in Pediatric Subjects in Trial ACTG300

Adverse Reaction EPIVIR plus RETROVIR
(n = 236)
Didanosine
(n = 235)
Body as a Whole
  Fever 25% 32%
Digestive
  Hepatomegaly 11% 11%
  Nausea & vomiting 8% 7%
  Diarrhea 8% 6%
  Stomatitis 6% 12%
  Splenomegaly 5% 8%
Respiratory
  Cough 15% 18%
  Abnormal breath sounds/wheezing 7% 9%
Ear, Nose, and Throat
  Signs or symptoms of earsa 7% 6%
  Nasal discharge or congestion 8% 11%
Other
  Skin rashes 12% 14%
  Lymphadenopathy 9% 11%
a Includes pain, discharge, erythema, or swelling of an ear.

Pancreatitis: Pancreatitis, which has been fatal in some cases, has been observed in antiretroviral nucleoside-experienced pediatric subjects receiving EPIVIR alone or in combination with other antiretroviral agents. In an open-label dose-escalation trial (NUCA2002), 14 subjects (14%) developed pancreatitis while receiving monotherapy with EPIVIR. Three of these subjects died of complications of pancreatitis. In a second open-label trial (NUCA2005), 12 subjects (18%) developed pancreatitis. In Trial ACTG300, pancreatitis was not observed in 236 subjects randomized to EPIVIR plus RETROVIR. Pancreatitis was observed in 1 subject in this trial who received open-label EPIVIR in combination with RETROVIR and ritonavir following discontinuation of didanosine monotherapy [see WARNINGS AND PRECAUTIONS].

Paresthesias and Peripheral Neuropathies: Paresthesias and peripheral neuropathies were reported in 15 subjects (15%) in Trial NUCA2002, 6 subjects (9%) in Trial NUCA2005, and 2 subjects (less than 1%) in Trial ACTG300.

Selected laboratory abnormalities experienced by therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 6.

Table 6: Frequencies of Selected Grade 3-4 Laboratory Abnormalities in Pediatric Subjects in Trial ACTG300

Test (Threshold Level) EPIVIR plus
RETROVIR Didanosine
Absolute neutrophil count ( < 400/mm³) 8% 3%
Hemoglobin ( < 7.0 g/dL) 4% 2%
Platelets ( < 50,000/mm³) 1% 3%
ALT ( > 10 x ULN) 1% 3%
AST ( > 10 x ULN) 2% 4%
Lipase ( > 2.5 x ULN) 3% 3%
Total Amylase ( > 2.5 x ULN) 3% 3%
ULN = Upper limit of normal.

Neonates - Clinical Trials in HIV-1

Limited short-term safety information is available from 2 small, uncontrolled trials in South Africa in neonates receiving lamivudine with or without zidovudine for the first week of life following maternal treatment starting at Week 38 or 36 of gestation [see CLINICAL PHARMACOLOGY]. Selected adverse reactions reported in these neonates included increased liver function tests, anemia, diarrhea, electrolyte disturbances, hypoglycemia, jaundice and hepatomegaly, rash, respiratory infections, and sepsis; 3 neonates died (1 from gastroenteritis with acidosis and convulsions, 1 from traumatic injury, and 1 from unknown causes). Two other nonfatal gastroenteritis or diarrhea cases were reported, including 1 with convulsions; 1 infant had transient renal insufficiency associated with dehydration. The absence of control groups limits assessments of causality, but it should be assumed that perinatally exposed infants may be at risk for adverse reactions comparable to those reported in pediatric and adult HIV-1-infected patients treated with lamivudine-containing combination regimens. Long-term effects of in utero and infant lamivudine exposure are not known.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of EPIVIR. 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. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine.

Body as a Whole

Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Endocrine and Metabolic

Hyperglycemia.

General

Weakness.

Hemic and Lymphatic

Anemia (including pure red cell aplasia and severe anemias progressing on therapy).

Hepatic and Pancreatic

Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Hypersensitivity

Anaphylaxis, urticaria.

Musculoskeletal

Muscle weakness, CPK elevation, rhabdomyolysis.

Skin

Alopecia, pruritus.

Read the entire FDA prescribing information for Epivir (Lamivudine)

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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