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Teflaro

  • Generic Name: ceftaroline fosamil injection for intravenous (iv) use
  • Brand Name: Teflaro

Teflaro (Ceftaroline Fosamil Injection for Intravenous (IV) Use) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Teflaro Side Effects Center

What Is Teflaro?

Teflaro (ceftaroline fosamil) is a cephalosporin antibiotic used to treat skin infections or pneumonia caused by bacteria.

What Are Side Effects of Teflaro?

Common side effects of Teflaro include:

  • nausea
  • vomiting
  • constipation
  • diarrhea
  • dizziness
  • itching

Tell your doctor if you experience serious side effects of Teflaro including:

  • watery or bloody diarrhea
  • chest pain
  • fever
  • chills
  • body aches
  • flu symptoms
  • unusual bleeding
  • seizures (convulsions)
  • pale skin
  • dark colored urine
  • confusion
  • weakness
  • jaundice (yellowing of the skin or eyes)
  • sore throat
  • headache with a severe blistering, peeling, and red skin rash
  • increased thirst
  • loss of appetite
  • swelling
  • weight gain
  • feeling short of breath
  • urinating less than usual or not at all
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling)

Dosage for Teflaro

The recommended dosage of Teflaro is 600 mg every 12 hours. Do not stop taking Teflaro until you have taken the full recommended dose.

What Drugs, Substances, or Supplements Interact with Teflaro?

Other drugs may interact with Teflaro. Tell your doctor all medications you take. Before taking Teflaro tell your doctor if you have kidney disease or a history of intestinal problems. Teflaro will not treat a viral infection such as the common cold or flu. If you are pregnant only take Teflaro if the potential benefit outweighs the potential risk to the fetus.

Teflaro During Pregnancy and Breastfeeding

Exercise caution while taking Teflaro if you are breastfeeding.

Additional Information

Our Teflaro (ceftaroline fosamil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Teflaro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 (even if it occurs months after your last dose);
  • little or no urination;
  • a seizure;
  • drowsiness, tiredness, confusion, thinking problems;
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, muscle weakness or limp feeling; or
  • low blood cell counts-- sudden weakness or ill feeling, fever, chills, cold or flu symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • nausea;
  • diarrhea; or
  • rash.

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.

Read the entire detailed patient monograph for Teflaro (Ceftaroline Fosamil Injection for Intravenous (IV) Use)

 

Teflaro Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Clostridioides difficile-Associated diarrhea [see WARNINGS AND PRECAUTIONS]
  • Neurological Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Direct Coombs' Test Seroconversion [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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

Adult Patients

Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days. The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated with Teflaro were predominantly male (63%) and Caucasian (82%).

Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation

In the four pooled adult Phase 3 clinical trials, serious adverse reactions (SARs) occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the Teflaro group and 0.5% in comparator group.

Most Common Adverse Reactions

No adverse reactions occurred in greater than 5% of adult patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled adult phase 3 clinical trials were diarrhea, nausea, and rash.

Table 6 lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled adult Phase 3 clinical trials.

Table 6: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Teflaro in the Pooled Adult Phase 3 Clinical Trials

Adverse ReactionsPooled Phase 3 Clinical Trials (four trials, two in ABSSSIand two in CABP)
Teflaro
(N=1300)		Pooled Comparatorsa
(N=1297)
Gastrointestinal Disorders
Diarrhea5 %3 %
Nausea4 %4 %
Constipation2 %2 %
Vomiting2 %2 %
Laboratory Investigations
Increased transaminases2%3 %
Metabolism and Nutrition disorders
Hypokalemia2 %3 %
Skin and Subcutaneous Tissue Disorders
Rash3%2%
Vascular Disorders
Phlebitis2%1%
a Comparators included vancomycin 1gram IV every 12h plus aztreonam 1 gram IV every 12 hin the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24 hin the Phase 3 CABP trials.

Other Adverse Reactions Observed During Clinical Trials Of Teflaro

Following is a list of additional adverse reactions reported by the 1740 adult patients who received Teflaro in any clinical trial with incidences less than 2%.

Blood and lymphatic system disorders -Anemia, Eosinophilia, Neutropenia, Thrombocytopenia

Cardiac disorders -Bradycardia, Palpitations

Gastrointestinal disorders -Abdominal pain

General disorders and administration site conditions -Pyrexia

Hepatobiliary disorders -Hepatitis

Immune system disorders -Hypersensitivity, Anaphylaxis

Infections and infestations -Clostridioides difficile colitis

Metabolism and nutrition disorders -Hyperglycemia, Hyperkalemia

Nervous system disorders -Dizziness, Convulsion

Renal and urinary disorders -Renal failure

Skin and subcutaneous tissue disorders -Urticaria

Pediatric Patients

Teflaro was evaluated in three clinical trials (one in ABSSSI and two in CABP) which included 257 pediatric patients 2 months to < 18 years of age treated with Teflaro, and 102 patients treated with comparator agents for a treatment period up to 21 days. In two trials, one in ABSSSI and one in CABP, the dose was selected to result in exposures comparable to adult exposure with 600 mg administered by IV infusion every 12h. In an additional pediatric trial in complicated CABP the dose was higher. The median age of pediatric patients treated with Teflaro was 5 years, ranging from 2 months to < 18 years of age. Patients treated with Teflaro were predominantly male (55%) and Caucasian (92%).

A single study enrolled 11 pediatric patients with a gestational age of ≥34 weeks and a postnatal age of 12 days to less than 2 months of age. The safety findings were similar to those observed in adult and pediatric patients 2 months of age and older.

Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation

In the three pooled pediatric clinical trials, SARs occurred in 10/257 (4%) of patients receiving Teflaro and 3/102 (3%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 10/257 (3.9%) of patients receiving Teflaro and 2/102 (2%) of patients receiving comparator drugs with the most common adverse reaction leading to discontinuation being rash in 2/257 (0.8%) of patients treated with Teflaro.

Most Common Adverse Reactions

No adverse reactions occurred in greater than 8% of pediatric patients receiving Teflaro. The most common adverse reactions occurring in ≥ 3% of patients receiving Teflaro in the pooled pediatric clinical trials were diarrhea, nausea, vomiting, pyrexia and rash.

Table 7 lists adverse reactions occurring in ≥ 3% of patients receiving Teflaro in the pooled pediatric clinical trials.

Table 7: Adverse Reactions Occurring in ≥ 3% of Patients Receiving Teflaroin the Pooled Pediatric Clinical Trials

Adverse ReactionsPooled Pediatric Clinical Trials (three trials, one in AB SSSI and two in CABP)
Teflaro
(N=257)		Pooled Comparatorsa
(N=l 02)
Gastrointestinal Disorders
Diarrhea8 %10 %
Nausea3 %1 %
Vomiting5 %12 %
General and Administrative Site disorders
Pyrexia3%2 %
Skin and Subcutaneous Tissue Disorders
Rash7%4%
a Comparators included vancomycin or cefazolin with or without aztreonam in the ABSSSI trial and ceftriaxone alone or ceftriaxone plus vancomycin in the CABP trials

Following is a list of additional adverse reactions reported by the 257 patients who received Teflaro in the pediatric clinical trials with incidences less than 3%.

Investigations - Alanine aminotransferase increased, Aspartate aminotransferase increased

Nervous system disorders - Headache

Skin and subcutaneous tissue disorders-Pruritus

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Teflaro in adult patients. Because these adverse 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.

Blood and lymphatic system disorders: Agranulocytosis, leukopenia, eosinophilic pneumonia.

Nervous system disorders: Encephalopathy, seizures [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Teflaro (Ceftaroline Fosamil Injection for Intravenous (IV) Use)

&Copy; Teflaro Patient Information is supplied by Cerner Multum, Inc. and Teflaro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.