Safety

Factive (Gemifloxacin Mesylate) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

Summary View

BOX WARNING (revised)

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including FACTIVE®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue FACTIVE immediately and avoid the use of fluoroquinolones, including FACTIVE, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including FACTIVE, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid FACTIVE in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions, reserve FACTIVE for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

WARNINGS AND PRECAUTIONS

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects (addition)
  • Fluoroquinolones, including FACTIVE, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting FACTIVE. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue FACTIVE immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including FACTIVE, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture replaces Tendinopathy
  • Fluoroquinolones, including FACTIVE, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting FACTIVE, or as long as several months after completion of fluoroquinolone therapy ...Tendinitis and tendon rupture can occur bilaterally.
  • The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue FACTIVE immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including FACTIVE, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Peripheral Neuropathy (new sentences added)
  • Fluoroquinolones, including FACTIVE, have been associated with an increased risk of peripheral neuropathy. Cases of sensory…
  • …minimize the development of an irreversible condition…Avoid fluoroquinolones, including FACTIVE, in patients who have previously experienced peripheral neuropathy.

ADVERSE REACTIONS

  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
    • Disabling and Potentially Irreversible Serious Adverse Reactions (addition)
    • Tendinitis and Tendon Rupture (replaces Tendon Effects)

PATIENT COUNSELING INFORMATION

Serious Adverse Reactions
  • Advise patients to stop taking FACTIVE if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with FACTIVE or other fluoroquinolone use:
  • Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of FACTIVE and may occur together in the same patient. Inform patients to stop taking FACTIVE immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
  • Tendinitis and tendon rupture replaces Tendon Disorders

MEDICATION GUIDE

What is the most important information I should know about FACTIVE?

  • Tendon rupture or swelling of the tendon (tendinitis).
    • Stop taking FACTIVE immediately and get medical help right away…
    • Worsening of myasthenia gravis (a problem that causes muscle weakness). Tell your healthcare provider if you have a history of myasthenia gravis before you start taking FACTIVE. (addition)

What is FACTIVE?

  • FACTIVE should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • FACTIVE should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.
  • Before you take FACTIVE, tell your healthcare provider if you:
    • have a disease that causes muscle weakness (myasthenia gravis); FACTIVE should not be used in patients who have a known history of myasthenia gravis.
    • have nerve problems; FACTIVE should not be used in patients who have a history of a nerve problem called peripheral neuropathy

How should I take FACTIVE?

  • Do not skip any doses of FACTIVE, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:
    • you have nerve problems. See “What is the most important information I should know about FACTIVE?”
    • you have central nervous system problems. See “What is the most important information I should know about FACTIVE?”

 

August 2013

Summary View

WARNINGS AND PRECAUTIONS

Peripheral Neuropathy
  • Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Factive…
 

ADVERSE REACTIONS

Serious and Otherwise Important Adverse Reactions
  • Peripheral Neuropathy that may be irreversible
Postmarketing Experience
Nervous Disorders
  • Peripheral neuropathy (that may be irreversible)
 

MEDICATION GUIDE

What are the possible side effects of Factive?
  • Changes in sensation and nerve damage (Peripheral Neuropathy) - Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including Factive…

 

Page Last Updated: 08/15/2016
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