Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate: Package Insert and Label Information (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are supplied as fixed-dose combination tablets containing efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are white to off-white, film-coated, oval, biconvex tablets debossed with “L40” on one side and plain on other side. They are supplied as follows:

HDPE bottles with Molecular sieve desiccant

Bottles of 30 NDC 42385-929-30
Bottles of 90 NDC 42385-929-90
Bottles of 180 NDC 42385-929-18

HDPE bottles with Silica gel canister desiccant

Bottles of 30 NDC 42385-929-31
Bottles of 90 NDC 42385-929-91
Bottles of 180 NDC 42385-929-82

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Dispense in original container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Drug Interactions: Efavirenz, lamivudine and tenofovir disoproxil fumarate may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription, nonprescription medication, or herbal products, particularly St. John’s wort [see Contraindications (4) and Drug Interactions (7)].
Post Treatment Acute Exacerbation of Hepatitis B in Patients with HBV Co-Infection: Inform patients that severe acute exacerbations of hepatitis have been reported in patients who are infected with HBV or coinfected with HBV and HIV-1 and have discontinued 3TC and TDF, components of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Test patients with HIV-1 for hepatitis B virus (HBV) before initiating antiretroviral therapy. In patients with chronic hepatitis B, it is important to obtain HIV antibody testing prior to initiating 3TC and TDF, components of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets [see Warnings and Precautions (5.1)].

Lactic Acidosis and Severe Hepatomegaly: Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) [see Warnings and Precautions (5.2)].

New Onset or Worsening Renal Impairment: Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported. Advise patients with impaired renal function (i.e., creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis to avoid efavirenz, lamivudine and tenofovir disoproxil fumarate with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) for patients [see Dosage and Administration (2.3), Warnings and Precautions (5.4)].

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 EFV [see Warnings and Precautions (5.5)]. Advise patients to seek immediate medical evaluation if they experience severe psychiatric adverse experiences. Advise patients to inform their physician of any history of mental illness or substance abuse.

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 EFV, a component of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets [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 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)].
Embryo-Fetal Toxicity: Advise female patients that EFV, a component of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets may cause fetal harm when administered during the first trimester to a pregnant woman. Advise females of reproductive potential to use effective contraception as well as a barrier method during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate and for 12 weeks after discontinuation of use. Advise patients to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate [see Warnings and Precautions (5.7),Use in Specific Populations (8.1, 8.3)].

Rash: Inform patients that rash is a common side effect of EFV [see Warnings and Precautions (5.8)]. Rashes usually go away without any change in treatment. However, since rash may be serious, patients should be advised 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 healthcare provider promptly if such symptoms occur [see Warnings and Precautions (5.9)].

Pancreatitis: Advise patients or guardians to monitor pediatric patients for signs and symptoms of pancreatitis [see Warnings and Precautions (5.10)].

Convulsions: Advise patients that convulsions have been observed in patients receiving EFV, a component of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, generally in patients with known medical history of seizures [see Warnings and Precautions (5.11)].

Lipid Elevations: Advise patients treatment with EFV, a component of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets has resulted in increases in the concentration of total cholesterol and triglycerides [see Warnings and Precautions (5.12)].

Bone Loss and Mineralization Effects: Inform patients that decreases in bone mineral density have been observed with the use of 3TC and TDF, components of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, in patients with HIV [see Warnings and Precautions (5.13)].

Immune Reconstitution Syndrome: Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.14)].

Fat Redistribution: Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including efavirenz, lamivudine and tenofovir disoproxil fumarate, and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.15)].

Administration Instructions: Inform patients that it is important to take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets once daily on a regular dosing schedule on an empty stomach, preferably at bedtime, and to avoid missing doses as it can result in development of resistance. Advise patients if a dose is missed, take it as soon as possible unless it is almost time for the next dose. Also advise patients that dosing at bedtime may improve the tolerability of nervous system symptoms [see Dosage and Administration (2.2)].

Pregnancy Registry: Advise patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate [see Use in Specific Populations (8.1)].

Lactation: Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].
Brands listed are the trademarks of their respective owners and are not trademarks of Laurus Labs Limited.
Manufactured for:
Laurus Generics Inc.
400 Connell Drive
Suite 5200
Berkeley Heights, NJ 07922
Manufactured by:
Laurus Labs Limited
Visakhapatnam-531011India

PATIENT INFORMATION

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate (ef-a-vir-enz, la-MIV-ue-deen and ten-OF-oh-vir DYE-soe-PROX-il FUE-ma-rate) Tablets
What is the most important information I should know about efavirenz, lamivudine and tenofovir disoproxil fumarate tablets? Efa virenz, lamivudine and tenofovir disoproxil fumarate tablets can cause serious side effects, including:
  • Worsening of Hepatitis B virus infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and Hepatitis B Virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
o It is not known if efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are safe and effective in people who have both HIV-1 and HBV infection. o Do not run out of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Refill your prescription or talk to your healthcare provider before your efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are all gone. o Do not stop efavirenz, lamivudine and tenofovir disoproxil fumarate tablets without first talking to your healthcare provider. If you stop taking efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check our liver.For more information about side effects, see “What are the possible side effects of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets?”
What are efavirenz, lamivudine and tenofovir disoproxil fumarate tablets? Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people weighing at least 35 kg. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contains the prescription medicines efavirenz, lamivudine and tenofovir disoproxil fumarate.Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are not for use in children weighing less than 35 kg.
Do not take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets if you:
  • are allergic to efavirenz, lamivudine, tenofovir disoproxil fumarate, or any of the ingredients in efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. See the end of this Patient Information leaflet for a complete list of ingredients in efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
  • are currently taking elbasvir and grazoprevir.
Before you take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, tell your healthcare provider about all of your medical conditions, including if you:
  • have liver problems, including hepatitis B or C infection
  • have kidney problems, including end-stage renal disease (ESRD) that requires dialysis
  • have a history of mental health problems
  • have a history of drug or alcohol abuse
  • have a heart problem, including QT prolongation
  • have bone problems, including a history of bone fractures
  • have a history of seizures
  • are pregnant or plan to become pregnant. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets may harm your unborn baby.
    • You should not become pregnant during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Tell your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
    • Females who are able to become pregnant should use effective birth control during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets and for 12 weeks after stopping treatment. A barrier form of birth control should always be used along with another type of birth control.
    • If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
Pregnancy Registry. There is a pregnancy registry for women who take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines interact with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets may affect the way other medicines work, and other medicines may affect how efavirenz, lamivudine and tenofovir disoproxil fumarate tablets works. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets with other medicines.
How should I take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets?
  • Take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets exactly as your healthcare provider tells you to take it.
  • Take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets 1 time each day, preferably at bedtime. Taking efavirenz, lamivudine and tenofovir disoproxil fumarate tablets at bedtime might help to make some of the side effects less bothersome.
  • Take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets on an empty stomach.
  • Do not miss a dose of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, do not take the missed dose. Take the next dose at your regular time.
  • Stay under the care of your healthcare provider during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
  • Do not run out of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you take too much efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, go to the nearest hospital emergency room right away.
What should I avoid while taking efavirenz, lamivudine and tenofovir disoproxil fumarate tablets? You should avoid taking medicines that contain sorbitol during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
What are the possible side effects of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets? Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets may cause serious side effects, including:
  • See “What is the most important information I should know about efavirenz, lamivudine and tenofovir disoproxil fumarate tablets?”
  • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Lactic acidosis is a serious medical emergency that can lead to death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
    • feel very weak or tired ο feel cold, especially in your arms and legs
    • unusual (not normal) muscle pain ο feel dizzy or lightheaded
    • trouble breathing ο have a fast or irregular heartbeat
    • stomach pain with nausea or vomiting
  • Severe liver problems can happen in people who take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. In some cases, these severe liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Inflammation of your liver (hepatitis) that can lead to liver failure requiring a liver transplant has been reported in some people treated with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Your healthcare provider may do blood tests to check your liver before and during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
  • your skin or the white part of your eyes turns ο loss of appetite for several days or longer
yellow (jaundice) ο nausea and vomiting
  • dark or “tea-colored” urine ο pain, aching, or tenderness on the right
  • light-colored stools (bowel movements) side of your stomach-area
  • confusion ο weakness
  • tiredness ο stomach (abdomen) swelling
You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).
  • New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys before and during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Tell your healthcare provider if you get signs and symptoms of kidney problems, including bone pain that does not go away or worsening bone pain, pain in your arms, hands, legs or feet, broken (fractured) bones, muscle pain or weakness.
  • Serious mental health problems. Get medical help right away if you get any of the following symptoms:
    • feel sad or hopeless ο are not able to move or speak normally
    • feel anxious or restless ο have thoughts of hurting yourself (suicide) or
    • do not trust other people have tried to hurt yourself or others
    • hear or see things that are not real ο are not able to tell the difference between what is
true or real and what is false or unreal
  • Nervous system symptoms are common in people who take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets and can be severe. These symptoms usually begin during the first or second day of treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets and usually go away after 2 to 4 weeks of treatment. Some symptoms may occur months to years after beginning efavirenz, lamivudine and tenofovir disoproxil fumarate tablets therapy. These symptoms may become worse if you drink alcohol, take a medicine for mental health problems, or use certain street drugs during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Symptoms may include:
    • dizziness ο trouble concentrating
    • trouble sleeping ο drowsiness
    • unusual dreams ο lack of coordination or balance
If you have dizziness, trouble concentrating or drowsiness, do not drive a car, use machinery, or do anything that needs you to be alert. Some nervous system symptoms (e.g., confusion, slow thoughts and physical movement, and delusions [false beliefs] or hallucinations [seeing or hearing things that others do not see or hear]) may occur months to years after beginning efavirenz, lamivudine and tenofovir disoproxil fumarate tablets therapy. Promptly contact your health care provider should any of these symptoms occur.
  • Skin reactions and allergic reactions. Skin reactions or rash can happen and can sometimes be severe. Skin rash usually goes away without any change in treatment. If you develop a rash or a rash with any of the following symptoms, call your healthcare provider right away:
    • itching ο peeling skin
    • fever ο mouth sores
    • swelling of your face ο red or inflamed eyes
    • blisters or skin lesions
  • Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets if they:
    • have taken nucleoside analogue medicines in the past
    • have a history of pancreatitis
    • have other risk factors for pancreatitis
Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving efavirenz, lamivudine and tenofovir disoproxil fumarate tablets to your child if their symptoms and blood test results show that your child may have pancreatitis.
  • Seizures. Seizures are more likely to happen if you have had seizures in the past.
  • Increases in blood fat levels (cholesterol and triglycerides). Your healthcare provider will check your blood fat levels before and during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
  • Bone problems can happen in some people who take efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones. Tell your healthcare provider if you have any bone pain, pain in your hands or feet, or muscle pain or weakness during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.
  • Changes in body fat can happen in some people who take HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with efavirenz, lamivudine and tenofovir disoproxil fumarate tablets.
The most common side effects of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are rash and dizziness. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store efavirenz, lamivudine and tenofovir disoproxil fumarate tablets?
  • Store efavirenz, lamivudine and tenofovir disoproxil fumarate tablets at 20° to 25°C (68° to 77°F).
  • Keep efavirenz, lamivudine and tenofovir disoproxil fumarate tablets in the original container.
Keep efavirenz, lamivudine and tenofovir disoproxil fumarate tablets and all medicines out of the reach of children.
General information about the safe and effective use of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use efavirenz, lamivudine and tenofovir disoproxil fumarate tablets for a condition for which it was not prescribed. Do not give efavirenz, lamivudine and tenofovir disoproxil fumarate tablets to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about efavirenz, lamivudine and tenofovir disoproxil fumarate tablets that is written for health professionals.
What are the ingredients in efavirenz, lamivudine and tenofovir disoproxil fumarate tablets? Active ingredients: efavirenz USP, lamivudine USP, and tenofovir disoproxil fumarateInactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide.Brands listed are the trademarks of their respective owners and are not trademarks of Laurus Labs Limited.For more information, call Laurus Generics Inc. at 1-833-3-LAURUS (1-833-352-8787).This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for:Laurus Generics Inc. 400 Connell DriveSuite 5200Berkeley Heights, NJ 07922Manufactured by:Laurus Labs Limited Visakhapatnam-531011IndiaRevised: 01/2020

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.