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Oseni Warnings and Precautions

Specific Precautions and Warnings for Oseni

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Very preliminary data suggests incretin mimetics, such as Oseni, may increase the risk of precancerous cellular changes (called pancreatic duct metaplasia) in people with type 2 diabetes. Researchers are continuing to study the possibility that incretin mimetics might increase the risk of pancreatic cancer, although at this time there is not enough information to know for sure if there is any increased risk.
 
  • Oseni can cause swelling due to fluid retention (edema), which could lead to or worsen heart failure. Fluid retention is more likely to occur at higher doses and when the medication is used in combination with insulin. Let your healthcare provider know if you develop any signs of heart failure, such as:
 
  • Alogliptin (Nesina®), one of the medicines in Oseni, has been reported to cause inflammation of the pancreas (known medically as pancreatitis), which can be severe enough to be life-threatening. Contact your healthcare provider right away if you have severe abdominal (stomach) pain, which may be a sign of this condition. The pain may radiate to your back and can occur with or without nausea and vomiting.

    People who have kidney or liver problems or who have a history of pancreatitis, gallstones, or alcoholism are at a higher risk for pancreatitis. Let your healthcare provider know if any of these conditions apply to you.  
 
  • There have been rare reports of serious allergic reactions occurring in people treated with alogliptin, one of the active ingredients in Oseni. Stop taking Oseni and contact your healthcare provider right away if you have signs of an allergic reaction, such as:
    • An unexplained skin rash, itching, flaking, or peeling
    • Hives
    • Difficulty breathing or swallowing
    • Swelling of the face, lips, or throat.
 
  • This medication may cause liver problems, which could lead to death in some cases. Your healthcare provider will likely do tests to check your liver function before starting treatment. Let him or her know if you develop signs of liver problems, such as:
    • Upper-right abdominal (stomach) pain
    • Loss of appetite
    • Fatigue or unusual tiredness
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice).
 
  • In a clinical study, women who took pioglitazone, one of the medications in Oseni, were more likely to break a bone. The bone fractures primarily occurred in the hand, upper arm, and foot. Talk to your healthcare provider about the risk for bone fracture with this medication, as well as the steps you can take to keep your bones healthy.
 
  • This medication may increase the risk for developing bladder cancer, especially when used for longer than 12 months. People who have bladder cancer should not use Oseni. In addition, the risks and benefits of using it should be carefully considered in people who had bladder cancer in the past.
 
  • Your risk for low blood sugar (hypoglycemia) is higher if you take Oseni in combination with other diabetes medicines that lower blood sugar, such as insulin or a sulfonylurea medicine (see Oseni Drug Interactions). Your healthcare provider may need to lower the dose of your other diabetes medicines when you begin Oseni treatment.
 
  • This medication may cause an eye condition known as macular edema. Macular edema is swelling of the macula, a part of the retina essential for central vision. Let your healthcare provider know if you have any vision changes during Oseni treatment. It is important that people who have diabetes have regular eye exams. Talk to your healthcare provider about how often you should have your eyes checked.
 
  • Premenopausal women who are not ovulating may begin ovulating during Oseni treatment and could become pregnant. Talk to your healthcare provider about ways to prevent pregnancy when taking this drug, even if you do not currently ovulate.
 
  • While Oseni is quite effective at controlling blood glucose levels, it is not known whether the drug lowers the risk for coronary artery disease, strokes, or other heart and blood vessel problems associated with diabetes.
   
  • Oseni is a pregnancy Category C medication, which means it may not be safe for use during pregnancy, although the full risks are currently unknown. Talk to your healthcare provider before using this medication when pregnant (see Oseni and Pregnancy).
 
  • It is not known whether Oseni passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Oseni and Breastfeeding).
 
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Oseni Medication Information

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