Onglyza (saxagliptin) is a prescription for adults suffering from type 2 diabetes. The drug is taken as part of a recovery program. This drug is administered alongside with diet and exercise to help control hyperglycemia (high blood sugar). Onglyza is effective in lowering blood sugar levels thus it act as a regulatory medicine which regulate the level or activity of insulin produced after meals. This medication may be used in combination with other diabetes medicines. However, it is not recommended for treating subjects with type 1 diabetes. Onglyza is known to be 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 together or in combination with some other diabetes medicines, like insulin or a sulfonyl urea. Onglyza is not formulated for patients with increased ketones in blood or urine (diabetic ketoacidosis) and there is no approved or supportive clinical or pharmacological evidence whether Onglyza is effective and safe in children under 18 years of age. However, the uses of Onglyza may also include purposes not mentioned in this article.
Onglyza works by lowering the quantity of glucose secreted by the liver into the blood stream during night time. It also helps the pancreas to produce normal insulin or increase the activities of insulin produced. Insulin acts on glucose thereby reducing the quantity of glucose in blood.
Before you start taking Onglyza
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 is preferred for you. Thus, you should talk with your doctor about the best treatment for you if you have diabetes.
Before initiating Onglyza therapy, let your doctor know all the medications you have been taking. Also make sure you inform him 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. You should stop taking Onglyza and contact your doctor immediately if you have severe (prolong) pain in your stomach area (abdomen). This pain may happen with or without vomiting and also appear to spread from your abdomen 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, people with such medical records should be given the lowest possible dose and for the shortest possible duration. You should also 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 health care provider at once if you have any of the following symptoms (associated with heart failure) while using Onglyza:
- Difficulty in 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
Stick to your doctor's advice and prescription when using Onglyza especially when breastfeeding or pregnant. Due to the importance of blood sugar control during pregnancy, your dose regimen may vary 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. This drug is not approved for use by people younger than 18 years old.
Warning and Precaution
There have been no satisfactory clinical and pharmacological studies to be able to establish any conclusive data on the risk reduction to macrovascular effect with Onglyza or any other anti- diabetic drug. However, patients with some history of such disease can be treated with caution and if there is any suspected macrovascular effects, consider discontinuing the medicine immediately.
Pancreatitis: 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 patients be administered the lowest 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.
Based on reports, patients on Onglyza therapy may be at greater risk 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 have a higher risk of heart failure, irrespective of treatment dosage or regimen.
Before considering Onglyza for such patients, 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. Patients who experience such symptoms should report promptly. If heart failure is suspected or develops, discontinue Onglyza immediately, evaluate and manage according to current standards of care.
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 then talk to your healthcare provider. Symptoms of low blood sugar include: Inability to concentrate, confusion and irritability, blurry vision, rapid heartbeat,headache, sudden nervousness, slurred speech, 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.
Side Effects of Onglyza
Onglyza is an effective medication against Type 2 diabetes. However, Onglyza use may result in some adverse reaction in some people. These reactions may often be less sever, although there have been some reported cases of increased severity. For these reasons, we are going to group the various side effects of Onglyza based on their severity.
Major (Severe but Less Common) Side Effects of Onglyza
The following symptoms have been associated with severe side effects of Onglyza. If you suspect or notice any, you should discontinue the use of this drug promptly and get an emergency medical help.
- hives (raised, red areas on your skin)
- swelling of your face, lips, tongue,throator sex organs
- skin rash
- feeling weak or tired, rapid weight gain, or midsection
- slurred speech
- cool, pale skin
- frequent urge to urinate
- increased hunger
- darkened urine
- decreased urine output
- difficulty with swallowing
- dilated neck veins
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- yellow eyes or skin
- swelling of face, fingers, feet, or lower leg
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- difficulty breathing
- heart problems - shortness of breath
- difficult, burning, or painful urination
- difficulty with breathing
- rapid weight gain
- runny nose
- unusual tiredness or weakness
- unusual weight gain or loss
- Chest pain
- irregular breathing
- irregular heartbeat
- large, hard skin blisters
- tightness in the chest
- troubled breathing
- weight gain
- itching, or peeling
- severe or ongoing pain in your joints;
- pain or burning when you urinate
- blurred vision
- body aches or pain
- cold sweats
- ear congestion
- fast heartbeat
- loss of voice
- lower back or side pain
- nasal congestion
- sore throat
- tingling of the hands or feet
- extreme fatigue
- flaking or peeling of the skin
- hives or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe joint pain
Other severe but less common side effects of Onglyza include:
Onglyza may be said to pose serious hypersensitivity reactions in patients being treated. Such 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 Onglyza immediately. Verify the exact cause (if you are on other drugs). Such patients should be administered an alternative treatment for diabetes. Onglyza should be used with caution, especially in a patient with a history of angioedema to another dipeptidylpeptidase-4 (DPP4) inhibitor. This is simple because it’s not clear whether such patients will be predisposed to angioedema when given Onglyza.
Severe and Disabling Arthralgia
There have been a good number of post marketing reports pointing to the disabling and severe arthralgia in patients taking this medicine. However, the time to onset of symptoms after the initiation of Onglyza therapy vary from a day to several years. Such patients have been said to experience relief from the symptoms following the discontinuation of the drug. Others experience a recurrence of the symptoms after Onglyza or another DPP4 inhibitor. Note that DPP4 inhibitors, such as Onglyza are the possible cause of severe joint pains.
Bullous Pemphigoid or Skin Reactions
Onglyza can be associated with the cause of the side effect known as bullous pemphigoid. In reported cases, subjects usually recovered following discontinuation of the therapy 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. If any situation arises where bullous Pemphigoid is suspected, discontinued Onglyza immediately and consult a dermatologist for considerable diagnosis and appropriate treatment.
No clinically verified studies have recorded significant changes in vital signs in patients treated with Onglyza.
Onglyza can cause severe joint pains to some people. Call your doctor if you develop severe joint pain while on Onglyza.
Some patients may suffer decrease in lymphocyte count while on Onglyza therapy. Thus, subjects, especially those with an unusual or persistent infection, should be monitored regularly and have their blood lymphocyte counted at different times during treatment with Onglyza.
Pancreatitis: 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.
Minor (Less Severe but Common) Onglyza Side Effects
There are also some less serious but more common Onglyz aside 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, sore throat, cough;
- pain or tenderness around the eyes and cheekbones
- stomach pain.
- redness of the skin
while this may not be a complete list of all the possible side effects of Onglyza. You should talk to your health care provider about the various side effects.
Recommended Dosage of Onglyza
You should take this medicine according to your doctor’s advice. The safe and recommended dosage of Onglyza is a 5 mg or a 2.5 mg once daily medication regimen and taken regardless of meals. Do not split, cut or grind the tablets. For best results, you should not miss any dose. Continue taking this medicine as recommended by your health care provider even when all the symptoms of diabetes seem to have disappeared. You should talk to your doctor about the prescription that best suit your clinical report.
Over Dosage of Onglyza
If you suspect that you might have taken more than the required or prescribed dose of Onglyza, you should immediately call the poison help center or call your health care provider at once. Appropriate supportive treatment should be initiated immediately and following the patient’s clinical status. If 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.
If you miss a dose, take it immediately you recognize that, but if the time you remember is near the time of the next dose scheduled, leave the missed dose and resume your usual or normal 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) and away from the direct rays of the sun and moisture. You should not 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 all medicines when expired as indicated by the expiry date. (NEVER TAKE AN EXPIRED DRUG).
- 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.
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.
Before you take Onglyza, inform your health care provider if you have or have a history of having a kidney disease or if you are on dialysis.
It is vital to use this medicine regularly in order to achieve the most benefit out of it. Get a total refill of your medicine and don’t wait to completely run out of the medicine.
Uses of Onglyza in Specific Population
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 due to poorly controlled diabetes during pregnancy. Onglyza may only be prescribed to pregnant women if the underlying benefits justified the potential risk to the fetus.
There is no verified evidence regarding the passing of Onglyza into human milk, its effects on breastfeeding children, or its effects on the quantity or quality of milk produced. Due to the fact that many medicines are passed into human milk, Onglyza should be administered with caution to nursing women. However, the health and developmental benefits of breastfeeding infant 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.
The safety and effectiveness of Onglyza have not been determined for pediatric patients (patients younger than 18 years of age). Also, studies about the rate of metabolism of Onglyza in pediatric patients have not been performed. Thus, Onglyza (saxagliptin) is not approved for people younger than 18 years of age.
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.
There was no significant difference in the frequency of the resulted side effects in clinical studies involving Onglyza with renal impaired patients compared to normal patients.
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.
You should not take Onglyza if you are found to be allergic to saxagliptin or any other components of this drug.
You should not drive if you are on Onglyza treatment. Blur vision has been reported in some subjects. Hence, there is a higher risk of you running into an accident.
Healthcare providers should advise their patients to carefully read the Medication Guide or instruction leaflet that comes with the drug before initiating Onglyza therapy. They should also be advised to read this guide each time the prescription is renewed.
Patients should be instructed or advised to inform their healthcare provider whenever they develop any unusual symptoms or whether any existing symptoms persists or worsens.
Patients should be provided with information about the potential benefits and risks associated with Onglyza therapy and 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.
To be sure that Onglyza is safe for you, inform your doctor if you have or have a history of any of the following:
- heart disease,
- high triglycerides (a type of fat in the blood),
- a history of alcoholism, or
- kidney disease (or if you are on dialysis).
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: The information provided in this article does not contain all the possible side effects Onglyza, precautions, dosage regimen, and does not serve as a prescription for any dosage regimen. Only a health care professional or pharmacist has the right to endorse any treatment. Therefore, you should consult with your health care provider for any prescription or medical recommendation.