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Lamivudine

Lamivudine Prescription
Generic Name: lamivudine (la MIV ue deen)
Brand Name: Epivir, Epivir HBV
Physician reviewed lamivudine patient information - includes lamivudine description, dosage and directions.
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Lamivudine Drug Information:

Lamivudine is an antiviral medicine that prevents human immunodeficiency virus (HIV) or hepatitis B virus from multiplying in your body. Epivir is for treating HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Epivir is not a cure for HIV or AIDS. Epivir-HBV is for treating hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV. Lamivudine may also be used for purposes not listed in this medication guide. You should not take Epivir-HBV (for treating hepatitis B) if you also take other medicine that contains lamivudine or emtricitabine. Learn more

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Lamivudine Side Effects

For the Consumer

Applies to lamivudine: oral solution, oral tablet

Warning

Oral route (Tablet; Solution)

Epivir®Exacerbations of Hepatitis B, and Different Formulations of LamivudineExacerbations of Hepatitis BSevere acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.Important Differences Among Lamivudine-Containing ProductsEpivir® tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than Epivir-HBV® tablets and oral solution (used to treat chronic hepatitis B virus infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.

Oral route (Tablet; Solution)

Epivir-HBV®Lactic Acidosis and Severe Hepatomegaly with Steatosis, Exacerbations of Hepatitis B, and Risk of HIV-1 Resistance if Lamivudine is Used in Patients with Unrecognized or Untreated HIV-1Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue lamivudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including lamivudine). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.Lamivudine is not approved for the treatment of HIV-1 infection because the lamivudine dosage in lamivudine is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine and periodically during treatment.

Along with its needed effects, lamivudine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lamivudine:

Incidence not known

  • Abdominal or stomach discomfort
  • black, tarry stools
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • chills
  • constipation
  • cough
  • darkened urine
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort
  • general tiredness and weakness
  • indigestion
  • light-colored stools
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea and vomiting
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • right upper abdominal or stomach pain and fullness
  • skin rash, hives, or itching
  • sleepiness
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some side effects of lamivudine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Acid or sour stomach
  • belching
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • depression
  • general feeling of discomfort or illness
  • headache
  • heartburn
  • indigestion
  • muscle or joint pain
  • sensation of pins and needles
  • sore throat
  • stabbing pain
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • trouble sleeping
  • weight loss

Incidence not known

  • Blurred vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • hair loss or thinning of the hair
  • increased hunger
  • increased thirst
  • increased urination
  • pale skin
  • sweating
  • troubled breathing with exertion
  • unexplained weight loss
  • weight gain around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to lamivudine: oral solution, oral tablet

General

The most common side effects reported with this drug have included headache, nausea, malaise, fatigue, nasal signs and symptoms, respiratory tract infections, throat and tonsil discomfort, abdominal discomfort and pain, vomiting, diarrhea, and cough. During clinical studies in HIV-1-infected patients, this drug was used with zidovudine (with or without other antiretroviral agents). Patients with hepatitis B virus (HBV) infection received lamivudine monotherapy.

Gastrointestinal

Increased serum lipase (at least 2.5 times the upper limit of normal [2.5 x ULN]) and amylase (greater than 2 x ULN) have been reported in 10% and up to 4.2% of patients, respectively. Amylase increases greater than 3 x ULN have also been reported.

Pancreatitis has been reported infrequently in adults, but has been more common in pediatric patients (up to 18% in 2 limited studies).

Pancreatitis has also been reported during postmarketing experience.

Very common (10% or more): Nausea (up to 42%), diarrhea (up to 18%), vomiting (up to 15%), nausea and vomiting (up to 13%), abdominal discomfort and pain (up to 11.3%)

Common (1% to 10%): Abdominal pain, increased serum lipase, dyspeptic symptoms, abdominal cramps, taste disorders, abdominal discomfort, dyspepsia, increased amylase, upper abdominal pain, fungal gastrointestinal (GI) infection, GI discomfort and pain, gaseous symptoms

Uncommon (0.1% to 1%): Pancreatitis

Rare (0.01% to 0.1%): Abnormal pancreatic enzymes

Frequency not reported: Oral ulcerations, lesions

Postmarketing reports: Stomatitis

Nervous system

Very common (10% or more): Headache (up to 35.1%), dizziness (up to 35%), neuropathy (12.4%)

Common (1% to 10%): Hypnagogic effects, peripheral paresthesia

Uncommon (0.1% to 1%): Paresthesia, hypoesthesia

Very rare (less than 0.01%): Peripheral neuropathy

Peripheral neuropathy and paresthesia have also been reported during postmarketing experience.

Other

Very common (10% or more): Fatigue (up to 29%); malaise and fatigue (up to 27%); ear, nose, and throat infections (up to 25%)

Common (1% to 10%): Fever/chills; fever; malaise; viral ear, nose, and throat infection; viral infection

Postmarketing reports: Weakness

Antiretroviral therapy:

-Frequency not reported: Increased weight

Hepatic

Very common (10% or more): Posttreatment ALT elevations (up to 27%), ALT elevations

Common (1% to 10%): Increased liver function tests, elevated AST, elevated ALT, abnormal liver function tests

Uncommon (0.1% to 1%): Elevated bilirubin, transient elevations in liver enzymes (AST, ALT)

Rare (0.01% to 0.1%): Hepatitis

Frequency not reported: Severe hepatomegaly with steatosis, hepatic decompensation, exacerbations of hepatitis/recurrent hepatitis

Postmarketing reports: Hepatic steatosis, posttreatment exacerbation of hepatitis B

In HBV patients monitored for up to 16 weeks after discontinuing therapy, posttreatment ALT elevations occurred more often in those who had taken the HBV-specific product than subjects who had taken placebo.

Elevated AST (greater than 5 x ULN), ALT (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) have been reported in up to 4%, up to 3.8%, and up to 0.8% of patients, respectively. ALT increases greater than 3 x ULN have also been reported.

Exacerbations of hepatitis (primarily detected by serum ALT elevations) have been reported during HBV therapy and after drug discontinuation. Most events were self-limited; however, fatalities were reported in some cases.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis B (including fatalities) have been reported in HBV-infected patients (including those coinfected with HIV-1) who have discontinued this drug. The causal relationship to stopping therapy was unknown.

Psychiatric

Very common (10% or more): Dreams (up to 26%), sleep disorders (up to 16%), insomnia and other sleep disorders (11%), mood disorders (up to 11%)

Common (1% to 10%): Depressive disorders, anxiety

Dermatologic

Rash, pruritus, and alopecia have also been reported during postmarketing experience.

Very common (10% or more): Rash (up to 23%)

Common (1% to 10%): Alopecia, pruritus, sweating, fungal skin infections, acne and folliculitis, viral skin infection

Rare (0.01% to 0.1%): Angioedema

Frequency not reported: Paronychia, periungual pyogenic granulomata

Postmarketing reports: Urticaria

Respiratory

Very common (10% or more): Nasal signs and symptoms (20%), cough (up to 18%), viral respiratory infections (up to 15%), sore throat (13%), throat and tonsil discomfort and pain (up to 11.6%)

Common (1% to 10%): Bronchitis, sinus disorders, sinusitis, throat signs and symptoms, upper respiratory inflammation, breathing disorders

Frequency not reported: Respiratory tract infections, throat and tonsil discomfort

Postmarketing reports: Abnormal breath sounds/wheezing

Hematologic

Very common (10% or more): Decreased absolute neutrophil count (up to 15%)

Common (1% to 10%): Lymphatic signs and symptoms, neutropenia, decreased white cells, anemia, decreased platelets, decreased hemoglobin

Uncommon (0.1% to 1%): Thrombocytopenia

Very rare (less than 0.01%): Pure red cell aplasia

Postmarketing reports: Severe anemias progressing on therapy, lymphadenopathy, splenomegaly

Decreased absolute neutrophil count (less than 750/mm3), platelets (less than 50,000/mm3), and hemoglobin (less than 8 g/dL) have been reported in up to 15%, up to 4%, and up to 2.9% of patients, respectively.

Severe neutropenia and severe anemia have been reported infrequently.

Anemia (including pure red cell aplasia) and thrombocytopenia have also been reported during postmarketing experience.

Musculoskeletal

Elevated CPK (at least 7 x baseline) has been reported in 9% of patients.

Elevated CPK, rhabdomyolysis, and muscle disorders (including myalgia and cramps) have also been reported during postmarketing experience.

Very common (10% or more): Musculoskeletal pain (up to 13.5%)

Common (1% to 10%): Elevated creatine phosphokinase (CPK), myalgia, arthralgia, muscle disorders, cramps

Rare (0.01% to 0.1%): Rhabdomyolysis

Frequency not reported: Osteonecrosis

Postmarketing reports: Muscle weakness

Metabolic

Very common (10% or more): Anorexia (up to 12%)

Common (1% to 10%): Anorexia and/or decreased appetite, hypertriglyceridemia, hyperamylasemia, hyperlactatemia, abnormal enzyme levels

Uncommon (0.1% to 1%): Eating problems, disorders of thirst/fluid intake

Rare (0.01% to 0.1%): Lactic acidosis

Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat

Antiretroviral therapy:

-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.

Hypersensitivity

Frequency not reported: Anaphylactoid reaction

Postmarketing reports: Anaphylaxis

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Renal

Frequency not reported: Fanconi syndrome (at least 1 case)

Ocular

Frequency not reported: Eye redness

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Lamivudine (www.drugs.com/mtm/lamivudine.html).

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