Ketek

Unless your doctor tells you otherwise, continue your normal diet.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the telithromycin, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take telithromycin with or without food.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Telithromycin will not treat a viral infection such as the flu or a common cold.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Included as part of the PRECAUTIONS section.

Ketek is a prescription medication used to treat certain types of pneumonia in people at least 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

• Myasthenia gravis [see CONTRAINDICATIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• QTc prolongation [see WARNINGS AND PRECAUTIONS]
• Visual disturbances and loss of consciousness [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phase 3 clinical trials, 4,780 patients (n=2702 in controlled trials) received oral dosages of KETEK 800 mg once daily for 5 days or 7 to 10 days. Note that treatment with KETEK for 5 days duration is not a recommended dosage regimen. [see DOSAGE AND ADMINISTRATION]

In the combined Phase 3 studies, discontinuation due to adverse reactions occurred in 4.4% of KETEKtreated patients and 4.3% of combined comparator-treated patients. Most discontinuations in the KETEK group were due to adverse reactions in the gastrointestinal body system, primarily diarrhea (0.9% for KETEK vs. 0.7% for comparators), and nausea (0.7% for KETEK vs. 0.5% for comparators).

Adverse reactions (ARs) occurring in clinical studies in 2% or more of KETEK patients are included below.

Table 1: Adverse Reactions Reported in 2% or more of Patients in Controlled Phase 3 Clinical Studies

Less Common Adverse Reactions

The following adverse reactions were observed at a frequency of 0.2% or more and less than 2% in KETEK-treated patients in clinical studies.

Gastrointestinal system: abdominal distension, dyspepsia, gastrointestinal upset, flatulence, constipation, gastroenteritis, gastritis, anorexia, oral candidiasis, glossitis, stomatitis.

Liver and biliary system: abnormal liver function tests: increased transaminases (i.e., ALT, AST). Hepatitis, with or without jaundice, occurred in 0.07% of patients treated with KETEK. [see WARNINGS AND PRECAUTIONS]

Nervous system: dry mouth, somnolence, insomnia, vertigo, increased sweating

Body as a whole: abdominal pain, fatigue

Special senses: Visual adverse reactions, some of them severe, most often included blurred vision, diplopia, or difficulty focusing. Some patients discontinued therapy due to these adverse reactions. Visual adverse reactions were reported as having occurred after any dose during treatment, but most (65%) occurred following the first or second dose. Visual adverse reactions lasted several hours and recurred upon subsequent dosing in some patients. For patients who continued treatment, some visual adverse reactions resolved on therapy while others persisted through the full course of treatment. [see WARNINGS AND PRECAUTIONS]

Females and patients under 40 years old experienced a higher incidence of KETEK-associated visual adverse reactions. Table 2 provides the incidence of all visual adverse reactions in controlled Phase 3 studies by age and gender. The group with the highest incidence was females under the age of 40, while males over the age of 40 had rates of visual adverse reactions similar to comparator-treated patients.

Table 2: Incidence of All Visual Adverse Reactions in Controlled Phase 3 Studies

Urogenital system: vaginal candidiasis, vaginitis, vaginosis fungal

Skin: rash

Hematologic: increased platelet count

Other clinically-significant adverse reactions occurring in less than 0.2% of patients treated with KETEK from the controlled Phase 3 studies included: anxiety, bradycardia, eczema, elevated blood bilirubin, erythema multiforme, flushing, hypotension, increased blood alkaline phosphatase, increased eosinophil count, paresthesia, pruritus, urticaria.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of KETEK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic: face edema, severe allergic (hypersensitivity) reactions, including angioedema and anaphylaxis

Cardiovascular: atrial arrhythmias, ventricular arrhythmias (including ventricular tachycardia and torsades de pointes) with potential fatal outcome, palpitation, ischemic cardiac events in the context of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Gastrointestinal system: pseudomembranous colitis, pancreatitis [see WARNINGS AND PRECAUTIONS]

Liver and biliary system: Hepatic dysfunction, fulminant hepatitis, hepatic necrosis, and hepatic failure, chromaturia [see CONTRAINDICATIONS; WARNINGS AND PRECAUTIONS]

Musculoskeletal: muscle cramps, arthralgia, myalgia, exacerbation of myasthenia gravis [see CONTRAINDICATIONS]

Nervous system: loss of consciousness, in some cases associated with vagal syndrome, tremor, convulsions

Psychiatric disorders: confusion, hallucinations (mostly visual)

Special senses: taste/smell perversion and/or loss, hearing loss

Respiratory, thoracic and mediastinal disorders: dyspnea

Read the entire FDA prescribing information for Ketek (Telithromycin)

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• headache with chest pain and severe dizziness, fast or pounding heartbeats;

• a light-headed feeling, like you might pass out;

• problems with vision (difficulty focusing, double vision); or

• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• diarrhea;

• nausea, vomiting; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Any unexplained bruising or bleeding.
• Change in eyesight.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Muscle weakness.
• Vaginal itching or discharge.
• It is common to have diarrhea when taking this medicine. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking Ketek or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Ketek (telithromycin) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Ketek or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ketek. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Telithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Telithromycin was not teratogenic in the rat or rabbit. Reproduction studies have been performed in rats and rabbits, with effect on pre-post natal development studied in the rat. At doses of 150 and 20 mg/kg/day in rats and rabbits respectively (approximately 2 and 0.5 times the recommended clinical dose), no evidence of fetal terata was found. At doses higher than 150 or 20 mg/kg in rats and rabbits, respectively, maternal toxicity may have resulted in delayed fetal maturation. No adverse effects on prenatal and postnatal development of rat pups were observed at 125 mg/kg/day (1.5 times) the daily human dose.

Nursing Mothers

Telithromycin is excreted in breast milk of rats. Telithromycin may also be excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ketek is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of Ketek in pediatric patients less than18 years of age has not been established. Pediatric clinical trials were halted prematurely due to concern of serious postmarketing hepatic adverse reactions observed in adults. [see Warnings and Precautions (5.1)]

Geriatric Use

Of the total number of patients in Phase 3 clinical trials (n=4,780), Ketek was administered to 694 patients who were 65 years and older, including 231 patients who were 75 years and older. Efficacy and safety in patients 65 years and older were generally similar to that observed in younger patients; however, greater sensitivity of some older individuals cannot be ruled out. [see Clinical Pharmacology (12.3)]

Renal and/or Hepatic Impairment

Dose adjustment is required in patients with severe renal impairment (CLCr less than 30 mL/min) or on dialysis. Further dose adjustment is required in patients with severe renal impairment and coexisting hepatic impairment. [see Dosage and Administration (2.2)]

Advise the patient to read the FDA-approved patient labeling (MEDICATION GUIDE).

Communicate the following information and instructions to the patient:

• Drug Resistance

Antibacterial drugs including Ketek should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ketek is prescribed to treat a bacterial infection, inform patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ketek or other antibacterial drugs in the future.

• Myasthenia Gravis

Advise patients not to take Ketek if they have myasthenia gravis [see Contraindications (4.1)]

• Liver Injury

Advise patients of the possibility of severe liver injury, associated with Ketek. Instruct them to discontinue Ketek and seek medical attention immediately if they develop nausea, fatigue, anorexia, jaundice, dark urine, light-colored stools, pruritus, or tender abdomen. These problems may occur after any dose during treatment or after treatment had stopped. Advise patients not to take Ketek if they have a previous history of hepatitis/jaundice associated with the use of Ketek or macrolide antibacterials. [see Contraindications (4.2); Warnings and Precautions (5.1)]

• Changes in Electrocardiogram

Ketek may produce changes in the electrocardiogram (QTc interval prolongation). Advise patient to report any fainting or palpitations occurring during drug treatment. [see Warnings and Precautions (5.2); Adverse Reactions (6.2)]

Advise patients to avoid Ketek if they are receiving Class 1A (e.g., quinidine, procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.

• Problems with Vision and Loss of Consciousness

Ketek may cause blurred vision, difficulty focusing, and objects looking doubled. These problems may occur after any dose during treatment, last for several hours, and come back with the next dose. [See Warnings and Precautions (5.3); Adverse Reactions (6.1)]

Ketek may also cause transient loss of consciousness. [See Warnings and Precautions (5.3)]

Advise patients to avoid quick changes in viewing between objects in the distance and objects nearby to help decrease the effects of these visual difficulties.

Advise patients to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Ketek, because of potential visual difficulties, loss of consciousness, confusion or hallucinations.

Advise patients that if visual difficulties, loss of consciousness / fainting, confusion or hallucination occur, to seek advice from their physician before taking another dose and to refrain from hazardous activities.

• Drug/Food Interactions

Advise patients that Ketek tablets can be taken with or without food.

Colchicine should be avoided in patients receiving Ketek. Advise patients with normal kidney and liver function that the dose of colchicine should be reduced while they are taking Ketek. [see Warnings and Precautions (5.4); Drug Interactions (7)]

Simvastatin, lovastatin, or atorvastatin should be avoided in patients receiving Ketek. Advise patients that Ketek therapy with simvastatin, lovastatin, or atorvastatin should be stopped during the course of treatment with Ketek due to increased risk of rhabdomyolysis. [see Warnings and Precautions (5.4); Drug Interactions (7)]

Taking Ketek with calcium channel blockers may cause severe hypotension, bradycardia and loss of consciousness. Advise patients that if these symptoms occur to contact their physician as soon as possible. [see Warnings and Precautions (5.4); Drug Interactions (7)]

Advise patients to inform their physician of any other medications taken concurrently with Ketek, including over-the-counter medications and dietary supplements.

• Diarrhea

Diarrhea is a common problem caused by antibacterials including Ketek which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible. [see Warnings and Precautions (5.5)]

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

© 2015 sanofi-aventis U.S. LLC

Ketek® (KEE tek)
(telithromycin)
Tablets

Read this Medication Guide before you start taking Ketek and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT Ketek?

Ketek can cause serious side effects, including:

• Worsening of myasthenia gravis symptoms in people who already have myasthenia gravis (a disease which causes muscle weakness). Worsening of myasthenia gravis symptoms, including life-threatening breathing problems, have happened in people with myasthenia gravis after taking Ketek. Some life-threatening breathing problems have caused death. Do not take Ketek if you have myasthenia gravis.

WHAT IS Ketek?

Ketek is a prescription medication used to treat mild to moderate community-acquired pneumonia in adults 18 years of age and older.

• Ketek is only used to treat certain types of bacteria and is not meant for use to treat all types of bacterial infections.
  It is not known if Ketek is safe and effective in children.

Who should not take Ketek?

Do not take Ketek if you:

• have myasthenia gravis.
• have had liver problems or yellowing of your eyes and/or skin (jaundice) while taking Ketek or macrolide antibacterials.
• are allergic to Ketek, or macrolide antibacterials.
• take cisapride or pimozide.
• take colchicine and have kidney or liver problems.

What should I tell my doctor before taking Ketek?

Before you take Ketek, tell your doctor if you:

• have or have had liver or kidney problems
• have a heart problem called "QTc prolongation" or have a family history of QTc prolongation
• have other heart problems
• are pregnant or plan to become pregnant. It is not known if Ketek will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed. It is not known if Ketek passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Ketek.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Ketek with other medicines can cause serious side effects. Ask your doctor for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Ketek?

• Take Ketek exactly as your doctor tells you to take it.
• If you have kidney problems, your doctor may prescribe a lower dose of Ketek for you.
• Take Ketek with or without food.
• If you take too much Ketek, call your doctor, or go to the nearest hospital emergency room right away.

What should I avoid while taking Ketek?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Ketek affects you.

What are the possible side effects of Ketek?

Ketek may cause serious side effects, including:

• See "What is the most important information I should know about Ketek?"
• severe liver problems and severe liver damage (hepatotoxicity) that can lead to liver transplant or death. Severe liver problems can happen while you take Ketek, even after a few doses or right after you stop taking it. Symptoms of liver problems may include:
  • loss of appetite
  • increased tiredness
  • nausea
  • yellowing of your skin or white of your eyes
  • dark colored urine (tea colored)
  • light colored stools
  • right upper belly (abdomen) pain
• a heart problem called QTc prolongation that can lead to death. Symptoms of QTc prolongation include fainting and fast heartbeat (heart palpitations). Call your doctor right away if you have these symptoms.
• vision problems. Ketek may cause you to have blurred vision, trouble focusing your eyes, and double vision. You may especially notice vision problems if you look quickly between objects close to you and objects far away from you.
• fainting. Ketek may cause you to faint, especially if you also have nausea, vomiting, and lightheadedness (vagal syndrome). See "What should I avoid while taking Ketek?"
• drug interaction with colchicine in people with normal kidney and liver function that may lead to death.
• severe muscle damage (rhabdomyolysis). Ketek may cause rhabdomyolysis when you also take certain medicines used to treat high levels of cholesterol in your blood. These medicines include:
  • simvastatin
  • lovastatin
  • atorvastatin
• low blood pressure, slow heart rate, and fainting. Ketek may cause you to have low blood pressure, a slow heart rate, and fainting when you also take certain medicines called calcium channel blockers. Calcium channel blockers include:
  • verapamil
  • amlodipine
  • diltiazem
  • or other medicines containing these products
• an intestinal infection (Clostridium difficile-associated diarrhea). Clostridium difficile-associated diarrhea can happen up to 2 months after you have stopped taking Ketek. Symptoms of Clostridium difficile-associated diarrhea may include:
  • watery diarrhea
  • diarrhea that does not go away
  • bloody stools
  • stomach cramps
  • fever

Stop taking Ketek and call your doctor right away if you have any of these symptoms listed above. Do not take another dose of Ketek unless your doctor tells you to.

The most common side effects of Ketek include:

• diarrhea
• nausea
• dizziness
• vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Ketek. For more information ask your doctor or pharmacist.

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 Ketek?

• Store Ketek tablets at room temperature, between 59°F to 86°F (15°C to 30°C).
• Keep Ketek and all medicines out of the reach of children.

General information about the safe and effective use of Ketek

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ketek for a condition for which it was not prescribed. Do not share Ketek with other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Ketek. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Ketek that is written for health professionals. For more information, go to www.Ketek.com or call 1-800-446-6267.

What are the ingredients in Ketek?

Active Ingredient: telithromycin

Inactive Ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, red ferric oxide, talc, titanium dioxide, and yellow ferric oxide

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

Revised: December 2015

© 2015 sanofi-aventis U.S. LLC

Ketek (telithromycin) is an antibiotic that fights bacteria.

Ketek is used to treat mild to moderate pneumonia caused by certain types of bacteria.

Ketek may also be used for purposes not listed in this medication guide.

Take Ketek exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Ketek with or without food.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ketek will not treat a viral infection such as the flu or a common cold.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you also use theophylline, avoid using it within 1 hour before or 1 hour after you take Ketek.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ketek may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Get emergency medical help if you have signs of an allergic reaction to Ketek: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• headache with chest pain and severe dizziness, fast or pounding heartbeats;

• a light-headed feeling, like you might pass out;

• problems with vision (difficulty focusing, double vision); or

• liver problems - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Ketek side effects may include:

• diarrhea;

• nausea, vomiting; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Common side effects of Ketek include: diarrhea. Other side effects include: headache and nausea. See below for a comprehensive list of adverse effects.