Efavirenz

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Efavirenz should be taken orally once daily on an empty stomach, preferably at bedtime.
• ( 2 ) Recommended adult dose: 600 mg.
• ( 2.2 ) With voriconazole, increase voriconazole maintenance dose to 400 mg every 12 hours and decrease efavirenz dose to 300 mg once daily using the capsule formulation.
• ( 2.2 ) With rifampin, increase efavirenz dose to 800 mg once daily for patients weighing 50 kg or more.
• ( 2.2 ) Pediatric dosing is based on weight.
• ( 2.3 )
• 2.1 Hepatic Function Monitor hepatic function prior to and during treatment with efavirenz tablets [see Warnings and Precautions ( 5.9 )].
• Efavirenz tablets are not recommended in patients with moderate or severe hepatic impairment (Child Pugh B or C) [see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.6 )] .
• 2.2
• Adults The recommended dosage of efavirenz is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs).
• It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
• The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions [see Clinical Pharmacology ( 12.3 ) ] .
• Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions ( 5.6 ) , Adverse Reactions ( 6.1 ) , and Patient Counseling Information ( 17 )].
• Efavirenz tablets should be swallowed intact with liquid.
• Concomitant Antiretroviral Therapy Efavirenz must be given in combination with other antiretroviral medications [see Indications and Usage ( 1 ) , Warnings and Precautions ( 5.3 ) , Drug Interactions ( 7.1 ) , and Clinical Pharmacology ( 12.3 ) ] .
• Dosage Adjustment If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the efavirenz dose should be decreased to 300 mg once daily using the capsule formulation.
• Efavirenz tablets must not be broken [see Drug Interactions ( 7.1 , Table 5 ) and Clinical Pharmacology ( 12.3 , Tables 7 and 8 )] .
• If efavirenz is coadministered with rifampin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg once daily is recommended [see Drug Interactions ( 7.1 , Table 5 ) and Clinical Pharmacology ( 12.3 , Table 8 )].
• 2.3 Pediatric Patients It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
• Table 1 describes the recommended dose of efavirenz for pediatric patients weighing at least 40 kg [see Clinical Pharmacology ( 12.3 ) ] .
• The recommended dosage of efavirenz for pediatric patients weighing 40 kg or greater is 600 mg once daily.
• Table 1: Efavirenz Dosing in Pediatric Patients b Tablets must not be crushed.
• Patient Body Weight Efavirenz Daily Dose Number of Tablets b and Strength to Administer at least 40 kg 600 mg one 600 mg tablet

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety, pharmacokinetic profile, and virologic and immunologic responses of efavirenz were evaluated in antiretroviral-naive and -experienced HIV-1 infected pediatric patients 3 months to 21 years of age in three open-label clinical trials [see Adverse Reactions ( 6.2 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.2 ) ] .
• The type and frequency of adverse reactions in these trials were generally similar to those of adult patients with the exception of a higher frequency of rash, including a higher frequency of Grade 3 or 4 rash, in pediatric patients compared to
• adults [see Warnings and Precautions ( 5.8 ) and Adverse Reactions 6.2 ) ] .
• Use of efavirenz in patients younger than 3 months of age OR less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics, and antiviral activity of efavirenz have not been evaluated in this age group and there is a risk of developing HIV resistance if efavirenz is underdosed.
• See Dosage and Administration ( 2.2 ) for dosing recommendations for pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of efavirenz did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
• In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The most significant adverse reactions observed in patients treated with efavirenz are:
• psychiatric symptoms [see Warnings and Precautions ( 5.5 )] nervous system symptoms [see Warnings and Precautions ( 5.6 )] rash [see Warnings and Precautions ( 5.8 )] hepatotoxicity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>5%, moderate-severe) are impaired concentration, abnormal dreams, rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, the adverse reaction rates reported cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice.
• Adverse Reactions in
• Adults The most common (>5% in either efavirenz treatment group) adverse reactions of at least moderate severity among patients in Study 006 treated with efavirenz in combination with zidovudine/lamivudine or indinavir were rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting.
• Selected clinical adverse reactions of moderate or severe intensity observed in ≥2% of efavirenz-treated patients in two controlled clinical trials are presented in Table 2 .
• Table2:Selected Treatment-Emergent a Adverse Reactions of Moderate or Severe Intensity Reported in ≥2% of Efavirenz-Treated Patients in Studies 006 and ACTG364 a Includes adverse events at least possibly related to study drug or of unknown relationship for Study 006.
• Includes all adverse events regardless of relationship to study drug for Study ACTG 364. b Efavirenz provided as 600 mg once daily. c Median duration of treatment. d Includes erythema multiforme, rash, rash erythematous, rash follicular, rash maculopapular, rash petechial, rash pustular, and urticaria for Study 006 and macules, papules, rash, erythema, redness, inflammation, allergic rash, urticaria, welts, hives, itchy, and pruritus for ACTG 364. – = Not Specified.
• ZDV = zidovudine, LAM = lamivudine.
• Adverse Reactions Study 006 LAM-, NNRTI-, and Protease Inhibitor- Naive Patients Study ACTG 364 NNRTI- ,and Protease NRTI-experienced, Inhibitor-Naive Patients Efavirenz b +ZDV/LAM (n=412) 180 weeks c Efavirenz b +Indinavir (n=415) 102 weeks c Indinavir +ZDV/LAM (n=401) 76 weeks c Efavirenz b +Nelfinavir + NRTIs (n=64) 71.1 weeks c Efavirenz b +NRTIs (n=65) 70.9 weeks c Nelfinavir +NRTIs (n=66) 62.7 weeks c Body as a Whole Fatigue 8% 5% 9% 0 2% 3% Pain 1% 2% 8% 13% 6% 17% Central and Peripheral Nervous System Dizziness 9% 9% 2% 2% 6% 6% Headache 8% 5% 3% 5% 2% 3% Insomnia 7% 7% 2% 0 0 2% Concentration impaired 5% 3% <1% 0 0 0 Abnormal dreams 3% 1% 0 – – – Somnolence 2% 2% <1% 0 0 0 Anorexia 1% <1% <1% 0 2% 2% Gastrointestinal Nausea 10% 6% 24% 3% 2% 2% Vomiting 6% 3% 14% – – – Diarrhea 3% 5% 6% 14% 3% 9% Dyspepsia 4% 4% 6% 0 0 2% Abdominal pain 2% 2% 5% 3% 3% 3% Psychiatric Anxiety 2% 4% <1% – – – Depression 5% 4% <1% 3% 0 5% Nervousness 2% 2% 0 2% 0 2% Skin and Appendages Rash d 11% 16% 5% 9% 5% 9% Pruritus <1% 1% 1% 9% 5% 9% Pancreatitis has been reported, although a causal relationship with efavirenz has not been established.
• Asymptomatic increases in serum amylase levels were observed in a significantly higher number of patients treated with efavirenz 600 mg than in control patients (see Laboratory Abnormalities ).
• Nervous System Symptoms For 1008 patients treated with regimens containing efavirenz and 635 patients treated with a control regimen in controlled trials, Table 3 lists the frequency of symptoms of different degrees of severity and gives the discontinuation rates for one or more of the following nervous system symptoms:
• dizziness, insomnia, impaired concentration, somnolence, abnormal dreaming, euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal thinking, and depersonalization [see Warnings and Precautions ( 5.6 )].
• The frequencies of specific central and peripheral nervous system symptoms are provided in Table 2 .
• Table3:Percent of Patients with One or More Selected Nervous System Symptoms a,b a Includes events reported regardless of causality. b Data from Study 006 and three Phase 2/3 studies. c "Mild" = Symptoms which do not interfere with patient's daily activities. d "Moderate" = Symptoms which may interfere with daily activities. e "Severe" = Events which interrupt patient's usual daily activities.
• Percent of Patients with:
• Efavirenz 600 mg Once Daily (n=1008) % Control Groups (n=635) % Symptoms of any severity 52.7
• 24.6 Mild symptoms c 33.3
• 15.6 Moderate symptoms d 17.4
• 7.7 Severe symptoms e 2.0
• 1.3 Treatment discontinuation as a result of symptoms 2.1
• 1.1 Psychiatric Symptoms Serious psychiatric adverse experiences have been reported in patients treated with efavirenz.
• In controlled trials, psychiatric symptoms observed at a frequency greater than 2% among patients treated with efavirenz or control regimens, respectively, were depression (19%, 16%), anxiety (13%, 9%), and nervousness (7%, 2%).
• Rash In controlled clinical trials, the frequency of rash (all grades, regardless of causality) was 26% for 1008
• adults treated with regimens containing efavirenz and 17% for 635
• adults treated with a control regimen.
• Most reports of rash were mild or moderate in severity.
• The frequency of Grade 3 rash was 0.8% for efavirenz-treated patients and 0.3% for control groups, and the frequency of Grade 4 rash was 0.1% for efavirenz and 0 for control groups.
• The discontinuation rates as a result of rash were 1.7% for efavirenz-treated patients and 0.3% for control groups [see Warnings and Precautions ( 5.8 ) ] .
• Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
• Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz.
• Nine of these patients developed mild-to-moderate rash while receiving therapy with efavirenz, and two of these patients discontinued because of rash.
• Laboratory Abnormalities Selected Grade 3-4 laboratory abnormalities reported in ≥2% of efavirenz-treated patients in two clinical trials are presented in Table 4 .
• Table4:Selected Grade 3-4 Laboratory Abnormalites Reported in ≥2% of Efavirenz-Treated Patients in Studies 006 and ACTG364 a Efavirenz provided as 600 mg once daily. b Median duration of treatment. c Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction not associated with liver toxicity. d Nonfasting.
• ZDV = zidovudine, LAM = lamivudine, ULN = upper limit of normal, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyltransferase.
• Variable Limit Study 006 LAM-, NNRTI -, Naive Patients and Protease Inhibitor- Study ACTG 364, NRTI-experienced, Protease Inhibitor NNRTI- and - Naive Patients Efavirenz a +ZDV/LAM (n=412) 180 weeks b Efavirenz a + Indinavir (n=415) 102 weeks b Indinavir + ZDV/ LAM (n=401) 76 weeks b Efavirenz a + Nelfinavir + NRTIs (n=64) 71.1 weeks b Efavirenz a + NRTIs (n=65) 70.9 weeks b Nelfinavir + NRTIs (n=66) 62.7 weeks b Chemistry ALT >5 × ULN 5% 8% 5% 2% 6% 3% AST >5 × ULN 5% 6% 5% 6% 8% 8% GGT c >5 × ULN 8% 7% 3% 5% 0 5% Amylase >2 × ULN 4% 4% 1% 0 6% 2% Glucose >250 mg/dL 3% 3% 3% 5% 2% 3% Triglycerides d ≥751 mg/dL 9% 6% 6% 11% 8% 17% Hematology Neutrophils <750/ mm 3 10% 3% 5% 2% 3% 2% Patients Coinfected with Hepatitis B or C Liver function tests should be monitored in patients with a history of hepatitis B and/or C.
• In the long-term data set from Study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive).
• Among these coinfected patients, elevations in AST to greater than five times ULN developed in 13% of patients in the efavirenz arms and 7% of those in the control arm, and elevations in ALT to greater than five times ULN developed in 20% of patients in the efavirenz arms and 7% of patients in the control arm.
• Among coinfected patients, 3% of those treated with efavirenz-containing regimens and 2% in the control arm discontinued from the study because of liver or biliary system disorders [see Warnings and Precautions ( 5.9 )].
• Lipids Increases from baseline in total cholesterol of 10-20% have been observed in some uninfected volunteers receiving efavirenz.
• In patients treated with efavirenz + zidovudine + lamivudine, increases from baseline in nonfasting total cholesterol and HDL of approximately 20% and 25%, respectively, were observed.
• In patients treated with efavirenz + indinavir, increases from baseline in nonfasting cholesterol and HDL of approximately 40% and 35%, respectively, were observed.
• Nonfasting total cholesterol levels ≥240 mg/dL and ≥300 mg/dL were reported in 34% and 9%, respectively, of patients treated with efavirenz + zidovudine + lamivudine; 54% and 20%, respectively, of patients treated with efavirenz + indinavir; and 28% and 4%, respectively, of patients treated with indinavir + zidovudine + lamivudine.
• The effects of efavirenz on triglycerides and LDL in this study were not well characterized since samples were taken from nonfasting patients.
• The clinical significance of these findings is unknown [see Warnings and Precautions ( 5.11 )].
• Adverse Reactions in Pediatric Patients Because clinical studies are conducted under widely varying conditions, the adverse reaction rates reported cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice.
• Assessment of adverse reactions is based on three clinical trials in 182 HIV-1 infected pediatric patients (3 months to 21 years of age) who received efavirenz in combination with other antiretroviral agents for a median of 123 weeks.
• The adverse reactions observed in the three trials were similar to those observed in clinical trials in
• adults except that rash was more common in pediatric patients (32% for all grades regardless of causality) and more often of higher grade (ie, more severe).
• Two (1.1%) pediatric patients experienced Grade 3 rash (confluent rash with fever, generalized rash), and four (2.2%) pediatric patients had Grade 4 rash (all erythema multiforme).
• Five pediatric patients (2.7%) discontinued from the study because of rash [see Warnings and Precautions ( 5.8 ) ] .
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of efavirenz.
• 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.
• Body as a Whole:
• allergic reactions, asthenia, redistribution/accumulation of body fat [see Warnings and Precautions ( 5.13 ) ] .
• Central and Peripheral Nervous System:
• abnormal coordination, ataxia, encephalopathy, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor, vertigo Endocrine:
• gynecomastia Gastrointestinal:
• constipation, malabsorption Cardiovascular:
• flushing, palpitations Liver and Biliary System:
• hepatic enzyme increase, hepatic failure, hepatitis.
• Metabolic and Nutritional:
• hypercholesterolemia, hypertriglyceridemia Musculoskeletal:
• arthralgia, myalgia, myopathy Psychiatric:
• aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide, catatonia Respiratory:
• dyspnea Skin and Appendages:
• erythema multiforme, photoallergic dermatitis, Stevens-Johnson syndrome Special Senses:
• abnormal vision, tinnitus

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Drug Interactions A statement to patients and healthcare providers is included on the product's bottle labels:
• ALERT:
• Find out about medicines that should NOT be taken with Efavirenz.
• Efavirenz may interact with some drugs; therefore, advise patients to report to their doctor the use of any other prescription or nonprescription medication.
• General Information for Patients Inform patients that efavirenz is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.
• Patients should remain under the care of a physician while taking efavirenz.
• Advise patients to avoid doing things that can spread HIV-1 infection to others.
• Do not share or reuse needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection.
• Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
• Do not breastfeed.
• Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.
• Dosing Instructions Advise patients to take efavirenz every day as prescribed.
• If a patient forgets to take efavirenz, tell the patient to take the missed dose right away, unless it is almost time for the next dose.
• Advise the patient not to
• take 2 doses at one time and to take the next dose at the regularly scheduled time.
• Advise the patient to ask a healthcare provider if he/she needs help in planning the best times to take his/her medicine.
• Efavirenz must always be used in combination with other antiretroviral drugs.
• Advise patients to take efavirenz on an empty stomach, preferably at bedtime.
• Taking efavirenz with food increases efavirenz concentrations and may increase the frequency of adverse reactions.
• Dosing at bedtime may improve the tolerability of nervous system symptoms [see Dosage and Administration ( 2 ) and Adverse Reactions ( 6.1 )] .
• Healthcare providers should assist parents or caregivers in determining the best efavirenz dosing schedule for infants and young children.
• Patients should call their healthcare provider or pharmacist if they have any questions.
• Nervous System Symptoms Inform patients that central nervous system symptoms (NSS) including dizziness, insomnia, impaired concentration, drowsiness, and abnormal dreams are commonly reported during the first weeks of therapy with efavirenz [see Warnings and Precautions ( 5.6 )] .
• Dosing at bedtime may improve the tolerability of these symptoms, which are likely to improve with continued therapy.
• Alert patients to the potential for additive effects when efavirenz is used concomitantly with alcohol or psychoactive drugs.
• Instruct patients that if they experience NSS they should
• avoid potentially hazardous tasks such as driving or operating machinery.
• Inform patients that there is a risk of developing late-onset neurotoxicity, including ataxia and encephalopathy which may occur months to years after beginning efavirenz therapy [see Warnings and Precautions ( 5.6 )] .
• Psychiatric Symptoms Inform patients that serious psychiatric symptoms including severe depression, suicide attempts, aggressive behavior, delusions, paranoia, psychosis-like symptoms and catatonia have been reported in patients receiving efavirenz [see Warnings and Precautions ( 5.5 )] .
• If they experience severe psychiatric adverse experiences they should seek immediate medical evaluation.
• Advise patients to inform their physician of any history of mental illness or substance abuse.
• Rash Inform patients that a common side effect is rash [see Warnings and Precautions ( 5.8 )] .
• Rashes usually go away without any change in treatment.
• However, since rash may be serious, advise patients to contact their physician promptly if rash occurs.
• Hepatotoxicity Inform patients to watch for early warning signs of liver inflammation or failure, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice, confusion, abdominal swelling, and discolored feces, and to consult their health care professional without delay if such symptoms occur [see Warnings and Precautions ( 5.9 ) and Adverse Reactions ( 6.1 )] .
• Females of Reproductive Potential Advise females of reproductive potential to use effective contraception as well as a barrier method during treatment with efavirenz and for 12 weeks after discontinuing efavirenz.
• Advise patients to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with efavirenz [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 , 8.3 )] .
• Pregnancy Exposure Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz during pregnancy [see Use in Specific Populations ( 8.1 )] .
• Fat Redistribution Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known [see Warnings and Precautions ( 5.13 )] .
• Disclaimer:
• Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.
• Manufactured by: Cipla Ltd.
• Verna-403722, Goa, India Manufactured for:
• Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, New Jersey – 07059 Revised:
• 3/2024

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Tablets:
• 600 mg (3) Tablets 600-mg tablets are yellow coloured, capsule-shaped, biconvex, film coated tablets debossed with '301' on one side and 'CL' on other side.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.2 Tablets Efavirenz tablets, USP are available as follows:
• 600-mg tablets are yellow coloured, capsule-shaped, biconvex, film coated tablets debossed with '301' on one side and 'CL' on other side.
• Bottle of 30 tablets NDC 69097-301-02
• 16.3 Storage Efavirenz tablets, USP should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI).
• Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
• Its empirical formula is C 14 H 9 ClF 3 NO 2 and its structural formula is:
• Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68.
• It is practically insoluble in water (<10 microgram/mL).
• Tablets:
• Efavirenz tablets, USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients:
• Lactose monohydrate, croscarmellose sodium, povidone, anhydrous dibasic calcium phosphate, magnesium stearate.
• The film coating contains opadry yellow (consist of hypromellose, titanium dioxide, macrogol, iron oxide yellow).
• Efavirenz

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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