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BAXDELATM (Delafloxacin) – Oncopod- Chemotherapy Drugs Information, Acronyms, Side effects
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BAXDELATM
(Bax-de’-lah)
Delafloxacin)

Chemotherapy 

Have a Question ?

BAXDELATM
(Bax-de’-lah)
Delafloxacin)

Chemotherapy

Have a Question ?

What is BAXDELA?

BAXDELA is a fluoroquinolone antibacterial medicine used to treat certain types of skin infections caused by certain germs called bacteria in adults 18 years or older.

  • It is not known if BAXDELA is safe and effective in people under 18 years of age, and use in people under 18 years of age is not recommended. Children younger than 18 years of age may have a higher chance of getting bone, joint, and tendon (musculoskeletal) problems while taking fluoroquinolone antibacterial medicines.
  • Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibacterial medicines, including BAXDELA, do not kill viruses. Call your healthcare provider if you think your condition is not getting better while you are taking BAXDELA.

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

BAXDELA can cause serious side effects. These serious side effects include:

  • Tendon rupture or swelling of the tendon (tendinitis).
  • Tendon problems can happen in people of all ages who take BAXDELA. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
  • The risk of getting tendon problems while you take BAXDELA is higher if you: 1. are over 60 years of age, 2. are taking steroids (corticosteroids), 3. have had a kidney, heart or lung transplant.
  • Tendon problems can happen in people who do not have the above risk factors when they take BAXDELA. Other reasons that can increase your risk of tendon problems can include: 1. physical activity or exercise, 2. kidney failure, 3. tendon problems in the past, such as in people with rheumatoid arthritis (RA)
  • Stop taking BAXDELA immediately and call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking BAXDELA until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is in the Achilles tendon at the back of your ankle. This can also happen with other tendons.
  • Talk to your healthcare provider about the risk of tendon rupture with continued use of BAXDELA. You may need a different antibacterial that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking fluoroquinolone antibacterial medicines like BAXDELA. Tendon ruptures can happen within hours or days of taking a fluoroquinolone and have happened up to several months after patients have finished taking their fluoroquinolone.
  • Stop taking BAXDELA immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: 1. hear or feel a snap or pop in a tendon area, 2. bruising right after an injury in a tendon area, 3. unable to move the affected area or bear weight
  • Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including BAXDELA. Stop taking BAXDELA immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
  • pain
  • burning
  • numbness​
  • tingling
  • Weakness

BAXDELA may need to be stopped to prevent permanent nerve damage.

  • Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines. Tell your healthcare provider if you have a history of seizures before you start taking BAXDELA. CNS side effects may happen as soon as after taking the first dose of BAXDELA. Stop taking BAXDELA immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • seizures
  • hear voices, see things, or sense things that are not
  • there (hallucinations)​
  • depression
  • trouble sleeping
  • nightmares
  • feel lightheaded or dizzy
  • feel restless
  • tingling
  • Weakness
  • tremors
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts
  • feel anxious or nervous
  • confusion
  • headaches that will not go away, with or without blurred vision
  • Worsening of Myasthenia Gravis (a problem that causes muscle weakness). Fluoroquinolones like BAXDELA may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking BAXDELA. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

If you get any of the side effects while you take BAXDELA, you should stop taking BAXDELA immediately and get medical help right away.

How should I take BAXDELA?

  • Take BAXDELA tablets 2 times a day exactly as your healthcare provider tells you to take it.
  • If you have kidney problems, talk with your doctor about how you should take BAXDELA.
  • BAXDELA can be taken with or without food.
  • BAXDELA IV is given to you by intravenous (IV) infusion into your vein slowly, over 60 minutes, as prescribed by your healthcare provider.
  • Do not skip any doses, or stop taking BAXDELA even if you begin to feel better, until you finish your prescribed treatment, unless you have:
  • tendon problems, nerve problems, or central nervous system problems
  • a serious allergic reaction.
  • If you miss a dose of BAXDELA, take it as soon as you remember up to 8 hours before your next dose. If you have less than 8 hours before your next dose, wait to take your next dose at your regular time. Do not take more BAXDELA to make up for the missed dose.
  • If you take too much BAXDELA, call your healthcare provider or get medical help immediately.

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Important Safety Information

  • BAXDELA can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how BAXDELA affects you
  • Unless you are experiencing any of the harmful side effects listed in this medication guide, take your BAXDELA, as your healthcare provider tells you to take it, to help lower the chance that bacteria will become resistant to BAXDELA. If this happens, BAXDELA and other antibacterial medicines may not work in the future.

Ask your healthcare provider if you do not know.

What should I tell my healthcare provider before taking BAXDELA ?

Before you take BAXDELA, tell your healthcare provider about all your medical conditions, including if you:

  • have tendon problems. BAXDELA should not be used in patients who have a history of tendon problems.
  • have a disease that causes muscle weakness (myasthenia gravis). BAXDELA should not be used in patients who have a history of myasthenia gravis.
  • have central nervous system problems (such as epilepsy).
  • have nerve problems. BAXDELA should not be used in patients who have a history of a nerve problem called peripheral neuropathy.
  • have a history of seizures.
  • have kidney problems.
  • have rheumatoid arthritis (RA) or other history of joint problems.
  • are pregnant or planning to become pregnant. It is not known if BAXDELA will harm your unborn child.
  • are breast-feeding or planning to breastfeed. It is not known if BAXDELA passes into human breast milk. You and your healthcare provider should decide whether you will take BAXDELA or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal and dietary supplements. 

BAXDELA and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take: 

  • A steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury.
  • Certain medicines may keep BAXDELA from working correctly. BAXDELA Tablets should be taken at least 2 hours before or 6 hours after:
  • tendon problems, nerve problems, or central nervous system problems o an antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc
  • sucralfate
  • didanosine buffered tablets for oral suspension or the pediatric powder for oral solution
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General information about BAXDELA

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

What are the ingredients in BAXDELA?

 BAXDELA Tablets: 450 mg
Active ingredient: 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine)
Inactive ingredients: Citric acid, Crospovidone, Magnesium stearate, Microcrystalline Cellulose, Povidone, Sodium bicarbonate, and Sodium phosphate monobasic, monohydrate. 

BAXDELA for Injection: 300 mg

Active ingredient: delafloxacin

Inactive ingredients: Meglumine, beta-cyclodextrin sulfobutyl ether, and EDTA

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