Epivir:

• HIV infection (in combination with other antiretrovirals).

Epivir HBV:

• Chronic hepatitis B virus (HBV) infection.

Unlabeled Uses:

• HIV-postexposure prophylaxis (in combination with other antiretrovirals).

Contraindicated in:

• Hypersensitivity
• Concurrent use of antiretroviral combination products containing lamivudine or emtricitabine
• Lactation: Breastfeeding not recommended for mothers with HIV.

Use Cautiously in:

• Renal impairment (↑ dosing interval/↓ dose if CCr <50 mL/min)
• Women and obesity (↑ risk of lactic acidosis and severe hepatomegaly with steatosis)
• Coinfection with HBV (hepatitis may recur after discontinuation of lamivudine; Epivir HBV is not indicated for treatment of HIV because lamivudine dosage is subtherapeutic)
• OB: Considered a preferred nucleoside reverse transcriptase inhibitor (NRTI) for pregnant patients with HIV infection who are antiretroviral-nave, who have had antiretroviral therapy in the past but are restarting, or who require a new antiretroviral regimen; use has also been studied in pregnant women with HBV
• Pedi: Safety and effectiveness not established in children <3 mo (HIV) or <2 yr (HBV)
• Geri: ↓dose may be necessary in older adults due to age-related ↓ in renal function.

Exercise Extreme Caution in:

• Pedi: Pediatric patients with a history of or significant risk factors for pancreatitis (use only if no alternative).

Derm: alopecia, erythema multiforme, rash, urticaria.

Endo: hyperglycemia.

F and E: lactic acidosis.

GI: anorexia, diarrhea, nausea, vomiting, ↑ liver enzymes, abdominal discomfort, dyspepsia, HEPATOMEGALY WITH STEATOSIS, PANCREATITIS (↑ IN PEDIATRIC PATIENTS).

Hemat: anemia, neutropenia, pure red cell aplasia.

MS: musculoskeletal pain, arthralgia, muscle weakness, myalgia, rhabdomyolysis.

Neuro: fatigue, headache, insomnia, malaise, neuropathy, depression, dizziness, SEIZURES.

Resp: cough.
Misc: (INCLUDING ANAPHYLAXIS)HYPERSENSITIVITY REACTIONS , immune reconstitution syndrome.

Drug-Drug:

• Trimethoprim/sulfamethoxazole may ↑ levels (dose alteration may be necessary in renal impairment).
• ↑risk of pancreatitis with concurrent use of other drugs causing pancreatitis.
• ↑risk of neuropathy with concurrent use of other drugs causing neuropathy.
• Combination therapy with tenofovir and abacavir may lead to virologic nonresponse and should not be used.
• Sorbitol may ↓ levels; avoid concurrent use.

(Generic available)

Epivir

• Tablets: 150 mg; 300 mg;
• Oral solution (strawberry-banana flavor): 10 mg/mL;
• In combination with: abacavir (generic only); abacavir and dolutegravir (Triumeq); abacavir and zidovudine (generic only); efavirenz and tenofovir disoproxil fumarate (Symfi); lamivudine (Dovato); tenofovir disoproxil fumarate (Cimduo, Temixys); zidovudine (Combivir). See Appendix [not included in this PDA edition].

Epivir-HBV

• Tablets: 100 mg;
• Oral solution (strawberry-banana flavor): 5 mg/mL;

HIV–1 Infection (Epivir)

• PO (Adults): 150 mg twice daily or 300 mg once daily.
• PO (Children 3 mo): Oral solution: 5 mg/kg twice daily or 10 mg/kg once daily (max dose = 300 mg/day); Tablets: 14–19 kg: 75 mg twice daily or 150 mg once daily; 20–24 kg: 75 mg in AM, 150 mg in PM or 225 mg once daily; 25 kg: 150 mg twice daily or 300 mg once daily.

Chronic Hepatitis B (Epivir HBV)

• PO (Adults): 100 mg once daily.
• PO (Children 2–17 yr): 3 mg/kg once daily (up to 100 mg/day).

Epivir, Epivir-HBV

• After intracellular conversion to its active form (lamivudine-5-triphosphate), inhibits viral DNA synthesis by inhibiting the enzyme reverse transcriptase.

• Slows the progression of HIV infection and decreases the occurrence of its sequelae.
• Increases CD4 cell counts and decreases viral load.
• Protection from liver damage caused by chronic HBV infection; decreases viral load.

Therapeutic Classification: antiretrovirals, antivirals

Pharmacologic Classification: nucleoside reverse transcriptase inhibitors

Absorption: Well absorbed after oral administration (86% in adults, 66% in infants and children).

Distribution: Distributes into the extravascular space. Some penetration into CSF; remainder of distribution unknown.

Metabolism/Excretion: Mostly excreted unchanged in urine; <5% metabolized by the liver.

Half-life: Epivir: 5–7 hr; Epivir HBV: 13–19 hr.

(blood levels)

†On an empty stomach; peak levels occur at 3.2 hr if lamivudine is taken with food. Food does not affect total amount of drug absorbed.

• Instruct patient to take lamivudine as directed, every 12 hr. Explain the difference between Epivir and Epivir-HBV to patients. Emphasize the importance of compliance with full course of therapy, not taking more than the prescribed amount, and not discontinuing without consulting health care professional; discontinuation may lead to deterioration of liver disease. Take missed doses as soon as possible unless almost time for next dose. Do not double doses. Caution patient not to share medication with others. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
  • Inform patient that lamivudine does not cure HIV disease or prevent associated or opportunistic infections. Lamivudine may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and avoid sharing needles or donating blood to prevent spreading HIV to others. Advise patient that the long-term effects of lamivudine are unknown at this time.
  • Instruct patient to notify health care professional promptly if signs of peripheral neuropathy, pancreatitis, lactic acidosis (feel very weak or tired; feel cold, especially in arms and legs; unusual muscle pain; feel dizzy or lightheaded; trouble breathing; fast or irregular heartbeat; stomach pain with nausea and vomiting), liver problems (yellowing of skin or white part of eyes; loss of appetite; nausea; dark or "tea-colored" urine; pain, aching, or tenderness on right side of abdomen; light-colored stools) or Immune Reconstitution Syndrome (signs and symptoms of an infection, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, tuberculosis) occur.
  • Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
  • Advise females of reproductive potential using hormonal contraceptives to use an alternative nonhormonal method of contraception. Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding. If pregnant patient is exposed to lamivudine, register patient in Antiretroviral Pregnancy Registry by calling 1-800-258-4263.
  • Emphasize the importance of regular follow-up exams and blood tests to determine progress and monitor for side effects.

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