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All Possible Side Effects of Onglyza (saxagliptin), Type 2 Diabetes Drug

By Tamon

OnglyzaWhat is Onglyza?

Onglyza (saxagliptin) is a prescription oral diabetes medicine used with diet and exercise to help control hyperglycemia (high blood sugar) in adults with type 2 diabetes.

Onglyza works to lower blood sugar by regulating the levels of insulin produced after meals.

This medication may often be used in combination with other diabetes medicines, however, it is not formulated for treating type 1 diabetes.

Onglyza is a very effective drug and it is unlikely by itself to cause your blood sugar to drop far below normal (hypoglycemia). This is because the medication does not work well at lower blood sugar level. However, hypoglycemia has been recorded in patients undergoing Onglyza therapy. The potential risk for developing hypoglycemia is increased when you take Onglyza in combination with some other diabetes medicines, like insulin or a sulfonylurea.

 

Onglyza is not formulated for patients with increased ketones in your blood or urine (diabetic ketoacidosis).

There is no approved or supportive clinical or pharmacological evidence whether Onglyza is effective and safe in children under 18 years of age.

The uses of Onglyza may also include purposes not mentioned in this medication guide.

 

Important information

Patients at the state of diabetic ketoacidosis should not use Onglyza. If there need to control their blood glucose levels, insulin therapy will be a safe choice. Talk to your doctor about this.

Onglyza is formulated and approved for the treatment of type 2 diabetes and not safe for treating type 1 diabetes.

Before you take Onglyza, inform your healthcare provider if you have kidney disease or if you are on dialysis.

Onglyza should be taken as a part of a complete treatment program that also includes weight control, exercise, diet, and possibly other medications. It is vital to use this medicine regularly in order to achieve the most benefit out of it. Don’t wait to run out of the medicine completely before you get your prescription refilled.

 

Side Effects of Onglyza

Onglyza is an effective medication against Type 2 diabetes. However, its use may result in some adverse reaction to some people. These reactions may often times be less sever, although there have been some reported cases of severity. For these reasons, we are going to group the various side effects of Onglyza base on their severity.

 

Major (Sever but Less Common) Side Effects of Onglyza

If you notice any of these signs of an allergic reaction, discontinue the use of this drug promptly and get an emergency medical help. These include hives (raised, red areas on your skin), swelling of your face, lips, tongue, or throat, skin rash, flaking, itching, or peeling or difficulty breathing.

Other severe Onglyza side effects include:

  • Severe pain in the upper stomach spreading to your back, fast heart rate, nausea and vomiting.
  • Burning or pain during urinating.
  • Swelling in your feet, hands, or ankles
  • Easy bruising or bleeding.

We recommend that you call your doctor at once if you notice any sign of a serious side effect.

 

Pancreatitis

There have been some reports of pancreatitis (Inflammation of the pancreas)in patients using Onglyza. Once you start using ONGLYZA, observe the patients for signs and symptoms of pancreatitis. Once pancreatitis is suspected, immediately discontinue ONGLYZA and administer appropriate management.

Before you start taking Onglyza:

Make sure you inform your healthcare provider or doctor if you have ever had a history of pancreatitis (inflammation of the pancreas), alcoholism, gallstones (stones in your gallbladder), and/or high blood triglyceride levels

Stop taking Onglyza and contact your doctor immediately if you have severe pain in your stomach area (abdomen) that will not go away. This pain may happen with or without vomiting and also appear to be spreading going from your abdomen through to your back. These symptoms may be associated with pancreatitis.

While it remains unclear and uncertain whether patients with a history of pancreatitis are at high risk for the development of pancreatitis, people with such medical records should be given the lowers possible prescription and for the shortest possible duration possible.

 

Heart failure

This is a situation whereby your heart does not pump blood well enough. This is usually a fatal condition and needs prompt intervention by trained medical personnel to get the person to stable condition.

Before you start taking Onglyza:

Inform your healthcare provider if you have a history of heart failure (stroke) or any kidney problem.

Discontinue the use of Onglyza and contact your healthcare provider at once if you have any of the following symptoms (associated with heart failure) while using Onglyza:

  • trouble breathing or increasing shortness of breath which becomes intense when you lie down
  • fluid retention or swelling in the extremities that is in the legs, feet, or ankles
  • unusual tiredness
  • an unusually fast increase in weight

 

Joint pain

DPP-4 inhibitors such as Onglyza can cause severe joint pain to some people. Call your doctor if you develop severe joint pain.

 

Skin reaction 

DPP-4 inhibitors such as Onglyza may result in the skin reaction known as bullous pemphigoid in some users.  Inform your doctor immediately if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor should be able to determine if you have to discontinue Onglyza.

 

Hypoglycemia (Low blood sugar) 

Onglyza alone may not cause hypoglycemia, however, if given to patients who have already taken or are taking another medication to treat diabetes, such as insulin or sulfonylureas, it may result in worse or severe cases of hypoglycemia. Very low blood sugar is a medical emergency. Inform your doctor if you take other diabetes medicines. If you have any of the signs or symptoms of hypoglycemia, you should monitor your blood sugar level and treat if it’s low, then talk to your healthcare provider. Symptoms of low blood sugar include: Inability to concentrate, confusion and irritability, slurred speech, blurry vision, rapid heartbeat, headache, sudden nervousness, unexplained fatigue, shaking, pale skin, hunger, dizziness, sweating, unsteadiness when standing or walking, muscle twitching, seizure, loss of consciousness (coma), stroke and personality changes such as anger or crying.

 

Swelling or fluid retention 

Diabetic patients taking a thiazolidinedione as a remedy may attract some other adverse reaction with Onglyza. This may include swelling in the hands, feet, or ankles also known as peripheral edema which may become worse or severe.

Before taking Onglyza, let your doctor know all the medications you have been or are taking.

 

Minor (Less Severe but Common) Onglyza Side Effects

There are also some less serious but more common Onglyza side effects. These symptoms are often associated with early use of this medication. However, they normally subside as the body adapt to the treatment.  Some of these common side effects may include: runny or stuffy nose, cough, sore throat, and headache.

This is not a complete list of all the possible side effects of Onglyza. You should talk to your doctor about the various side effects. You may also report other side effects associated with Onglyza to FDA at 1-800-FDA-1088

 

Warnings and Precautions

Hypersensitivity Reactions

Onglza has been said to pose serious hypersensitivity reactions in patients being treated. These adverse reactions include exfoliative, anaphylaxis, and angioedema skin conditions. The onset of these conditions is said to occur within the first 3 months after the first administration of the drug, with some reports directing the onset after the first dose.

If you suspect any serious hypersensitivity reaction, discontinue Onglza immediately. Verify the exact cause (if you are on other drugs), and such patient should administer with an alternative treatment for diabetes. Onglza should be used with caution, especially in a patient with a history of angioedema to another dipeptidyl peptidase-4 (DPP4) inhibitor. This is simple because it’s not clear whether such patients will be predisposed to angioedema when given Onglza.

Severe and Disabling Arthralgia

There have been several postmarketing documented reports of the disabling and severe arthralgia in patients taking DPP4 inhibitors. However, the time to onset of symptoms after the initiation of Onglza therapy vary from a day to years. Such patients have been said to experienced relief from the symptoms following the discontinuation of the drug. Some patients have known to experience a recurrence of the symptoms after Onglza or another DPP4 inhibitor was given to the same patients. Note that DPP4 inhibitors, such as Onglza are the possible cause of severe joint pain and stop administering the drug if appropriate.

Macrovascular Outcomes

There have been no satisfactory clinical and pharmacological studies to be able to establish a conclusive evidence of the risk reduction to macrovascular effect with Onglza or any other antidiabetic drug.

Pancreatitis (See Side effects of Onglza): While it remains unclear whether patients with a history of a pancreatitis may be at high risk of a recurrence of pancreatitis with Onglyza, it is essential that such patient be administered the lowers possible dose and at the shortest possible duration. Keep close eyes on all patients undergoing Onglyza therapy, especially following the initiation of the drug for signs and symptoms of pancreatitis.

Heart failure

Based on reports, there is greater risk of patients being treated with Onglyza to experience a heart failure, especially if it was their first time to receive this drug. Patients who have a history of heart failure and those with renal impairment had a higher risk of heart failure, irrespective of treatment dosage or regimen.

Before considering Onglyza for such patients (patients with a history of heart failure and those with renal impairment), you may have to weigh the benefits and risks. Monitor patients for signs and symptoms of heart failure during Onglyza therapy. The doctor and pharmacist should be able to advise patients about the various symptoms of heart failure and for patients to report such symptoms promptly. If heart failure is suspected or develops, discontinue Onglyza immediately, evaluate and manage according to current standards of care.

 

Other points to note, while using Onglza are the possibilities of:

Hypoglycemia

Onglyza used in combination with insulin or with a sulfonylurea medication, is known to cause hypoglycemia (low glucose level). Therefore, a lower dose of insulin or the insulin secretagogue may be needed to minimize the risk of hypoglycemia when administered in combination with Omglyza

Bullous Pemphigoid

DPP-4 inhibitors, including Onglyza have been associated with the cause of the adverse reaction known as bullous pemphigoid. In reported cases, patients typically recovered following discontinuation of the DPP-4 inhibitor and an initiation of systemic or topical immunosuppressive treatment. The doctor and pharmacist should advise patients about the various signs and symptoms of bullous Pemphigoid and to report development of erosions or blisters while receiving this drug.

In any situation where bullous Pemphigoid is suspected, discontinued Onglyza immediately and referred to a dermatologist for considerable diagnosis and appropriate treatment.

Vital Signs

No clinically verified studies have recorded significant changes in vital signs have been recorded in patients treated with ONGLYZA.

 

Over Dosage of Onglyza

In one clinically control trial, once-daily regimen of Onglyza was administered orally in healthy subjects at doses as high as 400 mg for a period of 2 weeks (80 times the MRHD). They recorded no dose-related side effects and no clinically useful effect on the heart rate or the QTc interval.

However, in case of an overdose with Onglyza, appropriate supportive treatment should be initiated immediately and following the patient’s clinical status. Onglyza (saxagliptin) and its active metabolite are eliminated from the blood by hemodialysis at a rate of about 23% of the dose in 4 hours.  

If, however, the overdosed subject shows some serious symptoms such as trouble breathing, confusion, fast heart rate, nausea, sweating, seizure, or passing out, be quick to call the emergency services.

Recommended Dosage of Onglyza

The safe recommended dosage of Onglyza is 5 mg or 2.5 mg once daily medication regimen and taken regardless of meals. Do not split or cut Onglyza tablets. Talk to your doctor about the prescription that best suit your clinical report.

Dosage Forms and Strengths

Onglyza (saxagliptin) 2.5 mg tablets comes as pale yellow to light yellow color, round, biconvex, film-coated tablets having “2.5” printed on one side and “4214” on the opposite side, in blue ink.

Onglyza (saxagliptin) 5 mg tablets comes as pink color, round, biconvex, film-coated tablets having “5” printed on one side and “4215” on the opposite side, in blue ink.

 

Missed Dose

If you miss a dose, take it immediately as you remember it, but if it is near the time of the next dose, leave the missed dose out and resume your usual dosing schedule, unless otherwise instructed by their healthcare provider. Never double the dose or take an extra dose the next day in an attempt to catch up.

 

Storage and Handling

Onglyza is preferably stored at room temperature, 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) and away from the direct rays of the sun and moisture. 

Never store this drug in the bathroom.

Never flush medications, including Onglyza down the toilet nor pour them into a drain unless you are instructed by your healthcare provider to do so.

Properly discard this product when it has gone pass the expiring date. (NEVER TAKE AN EXPIRED DRUG) or no longer needed.

Consult your healthcare provider, pharmacist or local waste disposal company for best ways to dispose of medications.

Keep all medications, including Onglyza out of the reach of children and pets.

 

Before taking this medicine

Onglyza is a safe drug though it also has some serious side effects. Thus, you should not take Onglyza if you have ever had a history of a severe allergic reaction to saxagliptin, or if you are currently in a state of diabetic ketoacidosis (treatment with insulin should be prefer for you thus, call your doctor).

To be sure that Onglyza is safe for you, inform your doctor if you have:

  • heart disease,
  • pancreatitis,
  • gallstones,
  • high triglycerides (a type of fat in the blood),
  • a history of alcoholism, or
  • kidney disease (or if you are on dialysis).

Stick to your doctor's advice and prescription about using Onglyza if you are breastfeeding a baby or pregnant. Due to the importance of blood sugar control during pregnancy, and your dose regimen may be varies during each trimester of pregnancy. This is also true for breastfeeding women.

While it is not certain if saxagliptin is passed into breast milk or whether it could affect the nursing baby, you have to inform your doctor in case you are breastfeeding.

Onglyza is not formulated, thus not approved for use by people younger than 18 years old.

 

Uses of Onglyza in Specific Population

Pregnancy

The clinical investigation of Onglyza involving pregnant women didn’t involve a satisfactory number of women. Thus, no significant result was recorded to determine the drug-associated for major miscarriages or birth defects. However, there are some risk to the mother and fetus that are likening to poorly controlled diabetes during pregnancy.

There was no adverse developmental effects recorded when Onglyza (saxagliptin) was administered to pregnant rabbits and rats during organogenesis period and breastfeeding rats during the pre- and postnatal period.  

Nursing/Breastfeeding Mothers

There is no verified evidence regarding the passing of Onglyza into human milk, its effects on breastfeeding children, or its effect on the quantity or quality of milk produced.

However, because many medicines are pass into human milk, Onglyza should be administered with caution to nursing women.

Saxagliptin was detected in the milk of breastfeeding rats. Thus, the health and developmental benefits of breastfeeding rats should be taken into account along with the potential side effects on the breastfed child from Onglyza and the mother’s clinical need for Onglyza or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of Onglyza have not been determined for pediatric patients under 18 years of age. Also, studies about the pharmacokinetics of ONGLYZA in pediatric patients (under 18 years) have not been performed. Thus, Onglyza (saxagliptin) is not approved for people younger than 18 years of age.

Geriatric Use

Onglyza and its active metabolites are eliminated (removed) in part by the kidney. Geriatric (people age 65 years and above) often suffer from decrease renal function. For this reason, Onglyza should be administered with caution to elderly people (age > 65 years).

Renal Impairment

In a 12-week randomized, placebo-controlled clinical trial, ONGLYZA 2.5 mg was administered to 85 subjects with severe (n=18) or moderate (n=48) renal impairment or end-stage renal disease (ESRD) (n=19). The incidence of adverse reactions, including severe side effects and discontinuations due to adverse reactions, was similar between placebo and ONGLYZA. The overall outcome of this study reported a 20% hypoglycemia among subjects treated with ONGLYZA 2.5 mg and 22% among subjects treated with placebo. Also, 4 ONGLYZA-administered subjects (4.7%) and three placebo subjects (3.5%) reported at least one episode of confirmed symptomatic low blood glucose (accompanying fingerstick glucose ≤ 50 mg/dL).

Drug Interactions

Other medicines may interact to either decrease or increase the effects of Onglyza on controlling blood sugar. Inform your healthcare provider about all the medications you are using. This includes both prescription and non –prescription drugs, herbal products, and vitamins.

 

Limitation of the Uses of Onglyza

Onglyza is not effective and hence, not approved for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

 

Medication Guide

Healthcare providers should advise their patients to carefully read the Medication Guide before initiating ONGLYZA therapy. They should also be advised to reread this guide each time the prescription is renewed.

Patients should be instructed or advised to inform their healthcare provider whenever they develop any unusual symptom or whether any existing symptom persists or worsens.

Patients should be provided with information about the potential benefits and risks associated with ONGLYZA therapy and of alternative modes of therapy.

Patients should also be informed about the necessity of adherence to dietary instructions, regular periodic blood glucose monitoring, physical activity and A1C testing, recognition and management of hyperglycemia and hypoglycemia, and assessment of diabetes complications.

During periods of stress like trauma, fever, surgery, or infection, medication requirements may change, thus patients should be advised to seek medical advice immediately.

A disclaimer: This article is aimed as a guide only and should “NOT” replace a doctor’s advice and prescription. 

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