Teflaro

1-10%

Diarrhea (5%)

Nausea (4%)

Rash (3%)

Constipation (2%)

Vomiting (2%)

Increased transaminases (2%)

Hypokalemia (2%)

Phlebitis (2%)

Pyrexia (3%)

Pruritus (<3%)

Postmarketing reports

Agranulocytosis

Leukopenia

Teflaro is part of the drug class:

• Other cephalosporins and penems

Before receiving Teflaro, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Teflaro or to any of its ingredients
• are allergic to similar antibiotics (penicillins, cephalosporins)
• have any other type of allergy
• have kidney problems
• are pregnant or breastfeeding

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

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Teflaro crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Teflaro.

You should not use this medicine if you are allergic to ceftaroline or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);

• cefadroxil (Duricef);

• cefazolin (Ancef);

• cefdinir (Omnicef);

• cefditoren (Spectracef);

• cefpodoxime (Vantin);

• cefprozil (Cefzil);

• ceftibuten (Cedax);

• cefuroxime (Ceftin);

• cephalexin (Keflex); or

• cephradine (Velosef); and others.

To make sure ceftaroline is safe for you, tell your doctor if you have:

• an allergy to any drugs (especially penicillins);

• kidney disease (or if you are on dialysis); or

• a history of intestinal problems, such as colitis.

Ceftaroline is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ceftaroline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Other drugs may interact with ceftaroline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Antibacterial; β-lactam antibiotic;1 5 6 7 fifth generation cephalosporin.5 6 7 8 27

• Advise patients that antibacterials (including ceftaroline) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1

• Importance of completing full course of therapy, even if feeling better after a few days.1

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ceftaroline or other antibacterials in the future.1

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually resolves when the drug is discontinued.1 Importance of contacting a clinician if watery or bloody diarrhea occurs.1

• Importance of informing clinicians of prior hypersensitivity reactions to ceftaroline, other cephalosporins, other β-lactam antibiotics, or other allergens.1 Importance of discontinuing the drug and immediately informing clinician if an allergic or hypersensitivity reaction occurs.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In the U.S.

• Teflaro

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: 5th Generation Cephalosporin

• If you have an allergy to ceftaroline or any other part of Teflaro (ceftaroline fosamil).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

Teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline.

Teflaro (ceftaroline fosamil) for injection is supplied in single-dose, clear glass vials containing:

• 600 mg - individual vial (NDC 0456-0600-01) and carton containing 10 vials (NDC 0456-0600-10)
• 400 mg - individual vial (NDC 0456-0400-01) and carton containing 10 vials (NDC 0456-0400-10)

Unreconstituted Teflaro vials should be stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

Teflaro (ceftaroline) is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Teflaro is used to treat skin infections or pneumonia caused by bacteria.

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

You should not use Teflaro if you are allergic to ceftaroline or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others. Tell your doctor if you are allergic to any drugs, especially penicillins or other antibiotics.

Use Teflaro 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. Ceftaroline will not treat a viral infection such as the common cold or flu.

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

Common side effects of Teflaro include: positive direct coombs test. Other side effects include: diarrhea. See below for a comprehensive list of adverse effects.