Brand Name

Onglyza {Bristol-Myers Squibb}

Generic Name

saxagliptin, pronounced SAX a GLIP tin

 

What is Onglyza?

Onglyza is an oral diabetes medication for people with type 2 di1etes. Onglyza can help to control your blood sugar levels. Onglyza should not be used to treat patients with type 1 diabetes. Oglyza is indicated as an adjunct to other diabetes medication, such as metformin or a sulfonylurea, plus diet and exercise when a patient is not getting adequate control of sugars.

Onglyza may also be used for purposes not described in this medication guide.

 

How Onglyza works

Onglyza works by enhancing the incretin system in the body. This system senses when there is increased sugars in the body due to food. It then stimulates the beta cells in the pancrase to release insulin. This will help the sugars in the blood to be absorbed into the body. This will also inhibit glucagon secretion from the alpha cells which will reduce hepatic glucose production. Onglyza does this by blocking the DPP-4 inhibitors (gliptins) from breaking down incretin circulating in the body. This results in more active incretin circulating and better sugar control.

 

Warnings and Precautions

You should avoid drinking alcohol while taking Onglyza.

PREGNANCY: You should not use Onglyza if you are pregnant, planning to become pregnant or nursing. We do not yet know the effects Onglyza has on an unborn baby. We do not know if Onglyza passes into breast milk, so you should not breast-feed while taking Onglyza.

CARDIOVASCULAR: People with congestive heart failure should not use Onglyza as there has been limited information on the use of Onglyza in this population.

LOSS OF SUGAR CONTROL:

Onglyza may need to be adjusted or temporarily discontinued during episodes of stress such as fever, trauma, infection or surgery. At that time a patient may need to be stabilized with insulin.

You should always keep a source of sugar available in case you experience symptoms of low blood sugar. Sources of sugar include hard candy, orange juice, glucose gel, or milk.

LACTOSE: Onglyza contains lactose.

Onglyza is only a part of a complete program of treatment to help your blood sugar condition. Your doctor may prescribe a treatment plan for you which may include diet, exercise, weight control, foot care, eye care, and dental care, as well as regular testing of your blood sugar. You should follow your doctor’s instructions carefully.

You will need to check your blood sugar often, particularly during a time of illness, if you travel, exercise more than usual, drink alcohol, skip meals or are under great stress. These factors can affect your glucose levels. Tell your doctor if your levels are not where they should be and you may need a dose adjustment of Onglyza. Your doctor will decide if you need a dosage change, and how much of a change you may need. Do not attempt to change your dose of Onglyza without consulting your doctor first.

Children younger than 18 years of age should not take Onglyza.

 

Before You Take Onglyza

If you are allergic to saxagliptin you should not take Onglyza.

If you are in a state of diabetic ketoacidosis or if you have type 1 diabetes you should not take Onglyza.

Tell your doctor if you are on dialysis or have kidney disease before starting treatment with Onglyza.

 

Onglyza Drug Interactions

You should inform your doctor if you are taking any of the following medications:

• antibiotics like ciprofloxacin (Cipro), clarithromycin (Biaxin), levofloxacin (Levaquin), norfloxacin (Noroxin) and ofloxacin (Floxin)
• antidepressants such as nefazodone
• antifungal medications like itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig) and voriconazole (Vfend)
• oral diabetes medications like acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), and rosiglitazone (Avandia)
• heart or blood pressure medications (Cartia, Cardizem, Nifedical, Covera, Verelan)
• HIV/AIDS medications like atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), and ritonavir (Norvir, Kaletra)
• insulin

You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

 

Directions for Taking Onglyza

The recommended dose of Onglyza is 5mg once daily.

RENAL IMPAIRMENT: In patients with moderate to severe renal impairment the recommended dose is reduced to 2.5mg once daily.

You should take Onglyza exactly your doctor has told you to. It is important that you do not take Onglyza in larger or smaller amounts, or for longer or shorter than recommended. Follow the directions on your prescription label and follow any dose changes carefully if your doctor instructs you to change your dose.

Onglyza can be taken with or without food.

PEDIATRICS: Onglyza is not recommended for people under the age of 18.

While you are taking Onglyza you will need to have your blood sugar checked regularly. Plan to see your doctor often to be sure that Onglyza is working for you. You should know the signs of low blood sugar (hypoglycemia) and how to recognize them. These signs are headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Onglyza is part of a complete program of treatment that your doctor may have prescribed for you. This program may include may also include diet, exercise, weight control, foot care, eye care, dental care, and regular monitoring of your blood sugar. You should follow your diet, medication, and exercise routines exactly as your doctor has prescribed.

Onglyza should be stored at room temperature, and away from both moisture and heat.

If you miss a dose of Onglyza you should attempt to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, or if your next dose is less than 12 hours away you should skip the dose you missed.

 

Onglyza Side Effects

If you experience any of the following adverse effects you should stop taking Onglyza and seek emergency medical help immediately:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips, throat or tongue
• bleeding or bruising easily
• burning or pain when you urinate
• nausea and vomiting
• swelling in your ankles, feet or hands
• upper stomach pain that is severe

Less serious Onglyza side effects may include:

• cough
• headache
• runny or stuffy nose
• sore throat
• stomach pain

It should be noted that this is not a complete list of possible side effects of Onglyza. You should contact your physician for a complete list and medical advice regarding these effects.

 

Onglyza Description and Dosing

Onglyza is available as film-coated tablets in strengths of 2.5 mg and 5 mg.

The 2.5 mg tablets are pale yellow to light yellow, biconvex, round and have “2.5” printed on one side and “4214” printed on the reverse side, in blue ink.

The 5 mg tablets are pink, biconvex, round and have “5” printed on one side and “4215” printed on the reverse side, in blue ink.

Your doctor will decide what dose of Onglyza is right for you. Do not attempt to alter or change your dose without your physician’s consent.

If you suspect that you have overdosed with Onglyza you should seek emergency help immediately.

 

Ingredients in Onglyza

The main ingredient in Onglyza is saxagliptin monohydrate. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.

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