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LamiVUDine

Pronunciation

Pronunciation

(la MI vyoo deen)

Index Terms

  • 3TC

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Oral:

Epivir: 10 mg/mL (240 mL) [contains methylparaben, propylene glycol, propylparaben; strawberry-banana flavor]

Epivir HBV: 5 mg/mL (240 mL) [contains methylparaben, propylene glycol, propylparaben; strawberry-banana flavor]

Generic: 10 mg/mL (240 mL)

Tablet, Oral:

Epivir: 150 mg [scored]

Epivir: 300 mg

Epivir HBV: 100 mg

Generic: 100 mg, 150 mg, 300 mg

Brand Names: U.S.

  • Epivir
  • Epivir HBV

Pharmacologic Category

  • Antihepadnaviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HBV)
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)

Pharmacology

Lamivudine is a cytosine analog. In vitro, lamivudine is triphosphorylated, the principle mode of action is inhibition of HIV reverse transcription via viral DNA chain termination; inhibits RNA- and DNA-dependent DNA polymerase activities of reverse transcriptase. In hepatitis B, the monophosphate form of lamivudine is incorporated into the viral DNA by hepatitis B virus polymerase, resulting in DNA chain termination.

Absorption

Rapid

Distribution

Into extravascular spaces

Children (n=38): CSF concentrations were 14.2 ± 7.9% of the serum concentration

Vd: 1.3 ± 0.4 L/kg

Metabolism

Minor; only known metabolite is trans-sulfoxide metabolite

Excretion

Primarily urine (majority as unchanged drug); weight-corrected oral clearance is highest at age 2 years, then declines from age 2 to 12 years, where values then remain comparable to adult values

Time to Peak

Pediatric patients 0.5 to 17 years: Median: 1.5 hours (range: 0.5 to 4 hours) (Lewis 1996)

Adolescents 13 to 17 years: 0.5 to 1 hour

Adults: Fed: 3.2 hours; Fasted: 0.9 hours

Half-Life Elimination

Intracellular: 10 to 15 hours

Elimination:

Children 4 months to 14 years: 2 ± 0.6 hours

Adults: 5 to 7 hours; increased with renal impairment

Protein Binding

Plasma: <36%

Special Populations: Renal Function Impairment

AUC, and Cmaxare increased.

Use: Labeled Indications

Chronic hepatitis B (Epivir HBV, Heptovir [Canadian product]): Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.

Limitations of use: Use only when an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate; has not been evaluated in patients with HBV-HIV-1 coinfection, hepatitis C virus or hepatitis delta virus; has also not been evaluated in patients with chronic HBV infection with decompensated liver disease or in liver transplant recipients.

HIV-1 infection (Epivir, 3TC [Canadian product]): Treatment of HIV-1 in combination with other antiretroviral agents

Use: Unlabeled

Postexposure prophylaxis for HIV exposure as part of a multidrug regimen

Contraindications

Hypersensitivity (eg, anaphylaxis) to lamivudine or any component of the formulation

Dosing: Adult

Note: The formulation and dosage of Epivir HBV or Heptovir [Canadian product] are not appropriate for patients infected with both HBV and HIV; tenofovir and lamivudine are a preferred NRTI backbone in a fully suppressive antiretroviral regimen and for the treatment of HBV coinfection (HHS [adult] 2015).

HIV-1 infection (Epivir, 3TC [Canadian product]): Oral (use in combination with other antiretroviral agents): 150 mg twice daily or 300 mg once daily.

Note: Lamivudine is a component of recommended initial regimens for any ART-naive patient (when coadministered with tenofovir plus dolutegravir, with tenofovir plus raltegravir, or with tenofovir plus darunavir/ritonavir) or for ART-naive patients who are HLA-B*5701 negative (when coadministered with abacavir plus dolutegravir) (HHS [adult] 2015).

Postexposure prophylaxis for HIV exposure (off-label use [CDC 2005]): Oral: 150 mg twice daily or 300 mg once daily (in combination with zidovudine, tenofovir, stavudine, or didanosine, with or without a protease inhibitor depending on risk)

Treatment of hepatitis B (Epivir HBV, Heptovir [Canadian product]): Note: Not a preferred agent in chronic HBV treatment due to high rates of resistance; consider alternative agents. Oral: 100 mg once daily

Treatment duration (AASLD practice guidelines):

Hepatitis Be antigen (HBeAg) positive chronic hepatitis: Treat ≥1 year until HBeAg seroconversion and undetectable serum HBV DNA; continue therapy for ≥6 months after HBeAg seroconversion

HBeAg negative chronic hepatitis: Treat >1 year until hepatitis B surface antigen (HBsAg) clearance

Note: Patients not achieving <2 log decrease in serum HBV DNA after at least 6 months of therapy should either receive additional treatment or be switched to an alternative therapy (Lok 2009).

Treatment of hepatitis B/HIV coinfection (in patients with both infections requiring treatment): Note: The formulation and dosage of Epivir HBV or Heptovir [Canadian product] are not appropriate for patients infected with both HBV and HIV. Tenofovir and lamivudine are a preferred NRTI backbone in a fully suppressive antiretroviral regimen for the treatment of HIV/HBV coinfection (HHS [adult] 2015).

Oral: 150 mg twice daily or 300 mg/dose once daily, in combination with other antiretrovirals in an antiretroviral (ARV) regimen (HHS [adult] 2015)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

HIV-1 infection: (Epivir, 3TC [Canadian product]): Note: Use in combination with other antiretroviral agents when treating HIV; scored tablet is preferred formulation in patients weighing ≥14 kg who are able to take a solid oral dosage form (use of oral solution has been associated with lower rates of virologic suppression, lower plasma exposure, and increase rates of resistance).

Infants 1 to 3 months (off-label use; HHS [pediatric] 2014): Oral: 4 mg/kg/dose twice daily

Manufacturer’s labeling:

Infants ≥3 months, Children, and Adolescents: Note: In clinical studies data regarding efficacy of once-daily dosing are limited to subjects transitioned from twice daily dosing to once daily dosing after 36 weeks of treatment.

Oral solution:

US labeling: 8 mg/kg/day in 1 to 2 divided doses (maximum: 300 mg/day)

Canadian labeling:

<25 kg: 8 mg/kg/day in 1 to 2 divided doses (maximum: 300 mg/day)

≥25 kg: 150 mg twice daily or 300 mg once daily (maximum: 300 mg/day)

Oral tablets:

14 to <20 kg: 75 mg twice daily or 150 mg once daily

≥20 to <25 kg: 75 mg in the morning, 150 mg in the evening or 225 mg once daily

≥25 kg: 150 mg twice daily or 300 mg once daily

Alternate dosing (weight-based dosing) (HHS [pediatric] 2014): Note: Use scored 150 mg tablets for dosing.

14 to 21 kg: 75 mg twice daily (150 mg/day)

22 to 29 kg: 75 mg in the morning, 150 mg in the evening (225 mg/day)

≥30 kg: 150 mg twice daily (300 mg/day)

Postexposure prophylaxis for HIV exposure (off-label use [CDC 2005]): Adolescents ≥16 years: Refer to adult dosing.

Treatment of hepatitis B/HIV coinfection (in patients with both infections requiring treatment): Note: The formulation and dosage of Epivir HBV or Heptovir [Canadian product] are not appropriate for patients infected with both HBV and HIV.

Infants and Children: Oral: 4 mg/kg/dose (maximum: 150 mg) twice daily, in combination with other antiretrovirals in an ARV regimen (DHHS [pediatric] 2013)

Adolescents: Refer to adult dosing.

Treatment of hepatitis B (Epivir HBV, Heptovir [Canadian product]): Note: Not a preferred agent in chronic HBV treatment due to high rates of resistance; consider alternative agents: Tablets and oral solution may be used interchangeably; for doses <100 mg, oral solution is recommended.

Epivir HBV: Children and Adolescents 2 to 17 years: Oral: 3 mg/kg/dose once daily (maximum: 100 mg/day)

Treatment duration (AASLD practice guidelines):

Hepatitis Be antigen (HBeAg) positive chronic hepatitis: Treat ≥1 year until HBeAg seroconversion and undetectable serum HBV DNA; continue therapy for ≥6 months after HBeAg seroconversion

HBeAg negative chronic hepatitis: Treat >1 year until hepatitis B surface antigen (HBsAg) clearance

Note: Patients not achieving <2 log decrease in serum HBV DNA after at least 6 months of therapy should either receive additional treatment or be switched to an alternative therapy (Lok 2009).

Heptovir [Canadian product]: Adolescents ≥16 years: Refer to adult dosing.

Dosing: Renal Impairment

HIV-1 infection:

Adults:

End stage renal disease (ESRD) requiring hemodialysis: Administer 50 mg first dose, then 25 mg once daily (IDSA [Lucas 2014]). Negligible amounts are removed by 4-hour hemodialysis or peritoneal dialysis. Supplemental dosing not needed; however, dosing after dialysis is recommended (HHS [adult] 2015).

Adolescents ≥25 kg and Adults:

Manufacturer’s labeling:

CrCl ≥50 mL/minute: No dosage adjustment necessary

CrCl 30 to 49 mL/minute: Administer 150 mg once daily

CrCl 15 to 29 mL/minute: Administer 150 mg first dose, then 100 mg once daily

CrCl 5 to 14 mL/minute: Administer 150 mg first dose, then 50 mg once daily

CrCl <5 mL/minute: Administer 50 mg first dose, then 25 mg once daily

Infants ≥3 months, Children, and Adolescents <25 kg:

US labeling: There are no dosage adjustments provided in the manufacturer’s labeling (insufficient data); however, dose reduction should be considered.

Canadian labeling:

CrCl 30 to 50 mL/minute: Administer 4 mg/kg once daily

CrCl 15 to 29 mL/minute: Administer 4 mg/kg first dose, then 2.6 mg/kg once daily

CrCl 5 to 14 mL/minute: Administer 4 mg/kg first dose, then 1.3 mg/kg once daily

CrCl <5 mL/minute: Administer 1.3 mg/kg first dose, then 0.7 mg/kg once daily

Treatment of hepatitis B patients: Adults (US labeling) or Adolescents ≥16 years and Adults (Canadian labeling):

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 49 mL/minute: Administer 100 mg first dose, then 50 mg once daily.

CrCl 15 to 29 mL/minute: Administer 100 mg first dose, then 25 mg once daily.

CrCl 5 to 14 mL/minute: Administer 35 mg first dose, then 15 mg once daily.

CrCl <5 mL/minute: Administer 35 mg first dose, then 10 mg once daily.

ESRD requiring hemodialysis: Negligible amounts are removed by 4-hour hemodialysis or peritoneal dialysis. Supplemental dosing not needed; however, dosing after dialysis is recommended (HHS [adult] 2015).

Dosing: Hepatic Impairment

No dosage adjustment necessary. However, has not been studied in the setting of decompensated liver disease.

Administration

Oral: May be administered without regard to meals.

Dietary Considerations

Some products may contain sucrose.

Storage

Oral solution:

Epivir: Store at 25°C (77°F) tightly closed.

Epivir HBV: Store at 20°C to 25°C (68°F to 77°F) tightly closed.

3TC [Canadian product]: Store at 2°C to 25°C (35.6°F to 77°F).

Heptovir [Canadian product]: Store at 15°C and 25°C (59°F and 77°F).

Tablet:

Epivir, Epivir HBV: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

3TC, Heptovir [Canadian products]: Store at 2°C to 30°C (35.6°F to 86°F).

Drug Interactions

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy

Emtricitabine: LamiVUDine may enhance the adverse/toxic effect of Emtricitabine. Avoid combination

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy

Trimethoprim: May increase the serum concentration of LamiVUDine. Monitor therapy

Adverse Reactions

Incidence data include patients on combination therapy with other antiretroviral agents.

>10%:

Central nervous system: Headache (21% to 35%), fatigue (24% to 27%), neuropathy (12%), insomnia (11%)

Gastrointestinal: Nausea (15% to 33%), diarrhea (14% to 18%), pancreatitis (≤18%; higher percentage in pediatric patients), abdominal pain (9% to 16%), vomiting (13% to 15%), sore throat (13%)

Hematologic & oncologic: Neutropenia (7% to 15%)

Hepatic: Increased serum transaminases (2% to 11%)

Infection: Infection (25%; includes ear, nose, and throat)

Neuromuscular & skeletal: Myalgia (8% to 14%), musculoskeletal pain (12%)

Respiratory: Nasal signs and symptoms (20%), cough (18%)

1% to 10%:

Central nervous system: Dizziness (10%), depression (9%), chills (7% to 10%)

Dermatologic: Skin rash (5% to 9%)

Gastrointestinal: Anorexia (10%), increased serum lipase (10%), abdominal cramps (6%), dyspepsia (5%), increased amylase (≤4%), heartburn

Hematologic & oncologic: Thrombocytopenia (1% to 4%), hemoglobinemia (2% to 3%)

Neuromuscular & skeletal: Increased creatine phosphokinase (9%), arthralgia (5% to 7%)

Miscellaneous: Fever (7% to 10%)

<1% (Limited to important or life-threatening): Alopecia, anaphylaxis, anemia, exacerbation of hepatitis B, hepatomegaly, hyperbilirubinemia, hyperglycemia, immune reconstitution syndrome, lactic acidosis, liver steatosis, lymphadenopathy, myasthenia, paresthesia, peripheral neuropathy, pruritus, pure red cell aplasia, redistribution of body fat, rhabdomyolysis, splenomegaly, stomatitis, urticaria, weakness, wheezing

ALERT: U.S. Boxed Warning

Lactic acidosis and severe hepatomegaly with steatosis:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination, including lamivudine and other antiretrovirals. Discontinue lamivudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Exacerbations of hepatitis B:

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti–hepatitis B therapy (including lamivudine-HBV) or are coinfected with hepatitis B virus (HBV) and HIV 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 anti–hepatitis B therapy or who discontinue lamivudine and are coinfected with HIV-1 and HBV. If appropriate, initiation of anti–hepatitis B therapy may be warranted.

Important differences among lamivudine-containing products:

Lamivudine tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of lamivudine than lamivudine-HBV tablets and oral solution (used to treat chronic hepatitis B infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.

HIV counseling/testing:

Offer HIV counseling and testing to all patients before beginning lamivudine-HBV and periodically during treatment because lamivudine-HBV contains a lower dose of the same active ingredient as lamivudine tablets and oral solution used to treat HIV-1. If treatment with lamivudine-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely because of the subtherapeutic dose and inappropriate monotherapy.

Warnings/Precautions

Concerns related to adverse effects:

• Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance).

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis have been reported with nucleoside analogues, including fatal cases; suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity; use with caution in patients with risk factors for liver disease (risk may be increased with female gender, obesity, pregnancy or prolonged exposure); transaminase elevation may/may not accompany hepatomegaly and steatosis.

• Pancreatitis: Has been reported, particularly in HIV-infected children with a history of nucleoside use.

Disease-related concerns:

• Chronic hepatitis B: [US Boxed Warning]: Monitor patients closely for several months following discontinuation of therapy for chronic hepatitis B; clinical exacerbations may occur, including fatal cases. Monitor hepatic function with clinical and laboratory follow up for at least several months after hepatitis B treatment discontinuation. Initiate antihepatitis B (HBV) medications if clinically appropriate.

• Renal impairment: Use with caution in patients with renal impairment; dosage reduction recommended.

• Risk of resistance: [US Boxed Warning]: HIV-1 resistance may emerge in chronic hepatitis B-infection patients with unrecognized or untreated HIV-1 infection. Counseling and (HIV) testing should be offered to all patients before beginning treatment with lamivudine for hepatitis B and then periodically during treatment. Lamivudine dosing for hepatitis B is subtherapeutic if used for HIV-1 infection treatment. Lamivudine monotherapy is not appropriate for HIV-1 infection treatment. Lamivudine resistant HIV-1 can develop rapidly and limit treatment options if used in unrecognized or untreated HIV-1 infection or if a patient becomes coinfected during HBV treatment. Lamivudine dosing for hepatitis B is also subtherapeutic if used for HIV-1/HBV coinfection treatment. If lamivudine is chosen as part of a HIV-1 treatment regimen in coinfected patients, the higher lamivudine dosage indicated for HIV-1 therapy should be used, with other drugs, in an appropriate combination regimen. Emergence of lamivudine resistant HBV variants has also been reported in HIV-1 /HBV coinfected patients who have received lamivudine-containing antiretroviral regimens.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information

• Duplicate therapy: Concomitant use of other lamivudine-containing products should be avoided.

• Emtricitabine: Concomitant use of emtricitabine-containing products should be avoided; cross-resistance may develop.

• Interferon alfa: Use with caution in combination with interferon alfa with or without ribavirin in HIV/HBV coinfected patients; monitor closely for hepatic decompensation, anemia, or neutropenia; dose reduction or discontinuation of interferon and/or ribavirin may be required if toxicity evident.

Special populations:

• Pediatric: Use with extreme caution in children with history of pancreatitis or risk factors for development of pancreatitis.

Dosage form specific issues:

• Appropriate product selection: Epivir HBV: [US Boxed Warning]: Do not use Epivir HBV tablets or Epivir HBV oral solution for the treatment of HIV. In Canada, Heptovir tablets and oral solution are not approved for treatment of HIV.

• Oral solution: Use of lamivudine oral solution has been associated with lower rates of virologic suppression, lower plasma lamivudine exposure, and increased rates of resistance when compared to lamivudine tablets in pediatric clinical trials. Lamivudine scored tablet is the preferred formulation for HIV-1 infected pediatric patients weighing ≥14 kg and for whom a solid dosage form is appropriate; consider more frequent monitoring of HIV-1 viral load if oral solution is used.

• Sucrose: Lamivudine oral solutions contains 3 g of sucrose/15 mL; advise diabetic patients of sucrose content.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP, 1997; Zar, 2007).

Other warnings/precautions:

• Appropriate use:

HIV: Do not use as monotherapy in treatment of HIV. Treatment of HIV in patients with unrecognized/untreated HBV may lead to rapid HBV resistance. Lamivudine combined with emtricitabine is not recommended as a dual-NRTI combination due to similar resistance patterns and negligible additive antiviral activity; lamivudine in combination with abacavir or tenofovir is recommended as the NRTIs in a fully suppressive antiretroviral regimen. Do not use lamivudine/abacavir (plus efavirenz or plus atazanavir/ritonavir) in adolescent and adult HIV-1 patients with a pre-ART HIV RNA >100,000 copies/mL (HHS [adult] 2015).

HBV: Not recommended as first line therapy of chronic HBV due to high rate of resistance; consider use only if other anti-HBV antiviral agents with more favorable resistance patterns cannot be used. Use may be appropriate in short-term treatment of acute HBV (Lok 2009). Potential compliance problems, frequency of administration, and adverse effects should be discussed with patients before initiating therapy to help prevent the emergence of resistance.

HIV/HBV coinfection: Lamivudine and tenofovir are a recommended NRTI backbone in a fully suppressive antiretroviral regimen to provide activity against both HIV and HBV (HHS [adult] 2015).

Monitoring Parameters

Amylase, bilirubin, liver enzymes (every 3 months during therapy), hematologic parameters, HIV viral load, and CD4 count; signs/symptoms of pancreatitis or hepatonecroinflammation (Epivir HBV), HBV DNA (regularly during therapy), HBeAg and anti-HBe (after 1 year of therapy and every 3 to 6 months thereafter); signs/symptoms of HBV relapse/exacerbation (for at least several months after stopping treatment)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Lamivudine has a high level of transfer across the human placenta. No increased risk of overall birth defects has been observed following first trimester exposure according to data collected by the antiretroviral pregnancy registry. Cases of lactic acidosis/hepatic steatosis syndrome related to mitochondrial toxicity have been reported with use of nucleoside analogues. In addition, these adverse events are similar to other rare but life-threatening syndromes which occur during pregnancy (eg, HELLP syndrome). In general, nucleoside reverse transcriptase inhibitors (NRTIs) are well tolerated and the benefits of use generally outweigh potential risk. The HHS Perinatal HIV Guidelines consider lamivudine in combination with either abacavir, tenofovir, or zidovudine to be a preferred NRTI backbone for antiretroviral-naive pregnant women. The lamivudine/abacavir backbone is not recommended with atazanavir or efavirenz if pretreatment HIV RNA is >100,000 copies/mL. The HHS Perinatal HIV Guidelines also consider lamivudine plus tenofovir a recommended dual NRTI/NtRTI backbone for HIV/HBV coinfected pregnant women. Use caution with hepatitis B coinfection; hepatitis B flare may occur if lamivudine is discontinued postpartum. The pharmacokinetics of lamivudine during pregnancy are not significantly altered and dosage adjustment is not required.

Combination antiretroviral therapy (cART) therapy is recommended for all HIV-infected pregnant women. The goal of therapy is to keep the viral load below the limit of detection and prevent perinatal transmission. Therapy must be individualized. In general, women who become pregnant on a stable cART regimen may continue that regimen if viral suppression is effective, contraindications for use in pregnancy are not present, and the regimen is well tolerated. For HIV-infected couples planning a pregnancy, maximum viral suppression with cART is recommended prior to conception for the HIV-infected partner(s). When HIV is diagnosed during pregnancy in a woman who has never received antiretroviral therapy, cART should be considered as soon as possible after diagnosis to reduce the risk of perinatal transmission. If antiretroviral drug-resistance testing is done, treatment may be started prior to obtaining results, then adjusted accordingly. Monitoring during pregnancy is more frequent than in nonpregnant adults. If cART must be interrupted for <24 hours, stop then restart all medications simultaneously in order to decrease the chance of developing resistance. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children who develop significant organ system abnormalities (particularly of the CNS or heart) should be evaluated for potential mitochondrial dysfunction.

HIV-infected women not planning a pregnancy may use any available type of contraception, considering possible drug interactions and contraindications of the specific method. In addition, consistent use of condoms is also recommended (even during pregnancy) to prevent transmission of HIV or other sexually transmitted diseases.

Health care providers are encouraged to enroll pregnant women exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263 or www.APRegistry.com). Health care providers caring for HIV-infected women and their infants may contact the National Perinatal HIV Hotline (888-448-8765) for clinical consultation (HHS [perinatal] 2016).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, diarrhea, loss of strength and energy, rhinitis, rhinorrhea, cough, dizziness, muscle pain, insomnia, pharyngitis, or ear irritation. Have patient report immediately to prescriber signs of too much lactic acid in the blood (lactic acidosis; fast breathing, fast heartbeat, abnormal heartbeat, vomiting, drowsiness, shortness of breath, feeling very tired or weak, severe dizziness, feeling cold, or muscle pain or cramps), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of a pancreas problem (pancreatitis; severe abdominal pain, severe back pain, severe nausea, vomiting), change in body fat, burning or numbness feeling, mood changes, or signs of infection (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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