Trayenta Duo Side effects

• Side effects of Trayenta Duo in details
• Trayenta Duo contraindications
• Trayenta Duo reviews

What are the possible side effects of Trayenta Duo?

Get emergency medical help if you have signs of an allergic reaction to Trayenta Duo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking Metformin (Trayenta Duo). Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as:

• muscle pain or weakness;

• numb or cold feeling in your arms and legs;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, nausea with vomiting; or

• slow or uneven heart rate.

Call your doctor at once if you have:

• severe or ongoing pain in your joints;

• swelling, rapid weight gain; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Trayenta Duo side effects may include:

• cough, sore throat

• sinus pain, stuffy nose;

• upset stomach, diarrhea; or

• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Trayenta Duo in details

Summary of the Safety Profile: Fixed Dose Combination: The most frequently reported adverse reaction for Linagliptin (Trayenta Duo) plus Metformin (Trayenta Duo) was diarrhoea (0.9%) with a comparable rate on Metformin (Trayenta Duo) plus placebo (1.2%).

Hypoglycaemia may occur when Trayenta Duo is administered together with sulphonylurea (≥1 case per 10 patients).

The safety of Linagliptin (Trayenta Duo) 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with Metformin (Trayenta Duo) has been evaluated in over 3500 patients with type 2 diabetes mellitus. In placebo-controlled studies, more than 1300 patients were treated with the therapeutic dose of either 2.5 mg Linagliptin (Trayenta Duo) twice daily (or its bioequivalent of 5 mg Linagliptin (Trayenta Duo) once daily) in combination with Metformin (Trayenta Duo) for ≥12/24 weeks.

In the pooled analysis of the four placebo-controlled trials, the overall incidence of adverse reactions in patients treated with placebo and Metformin (Trayenta Duo) was comparable to that seen with Linagliptin (Trayenta Duo) 2.5 mg and Metformin (Trayenta Duo) (50.6 and 47.8%). Discontinuation of therapy due to adverse reactions was comparable in patients who received placebo and Metformin (Trayenta Duo) to patients treated with Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) (2.6% and 2.3%).

Adverse Reactions Reported When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were Combined with Sulphonylurea: In one study Linagliptin (Trayenta Duo) was given as add-on to Metformin (Trayenta Duo) plus sulphonylurea. When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse reaction (Linagliptin (Trayenta Duo) plus Metformin (Trayenta Duo) plus sulphonylurea 22.9% versus 14.8% in placebo plus Metformin (Trayenta Duo) plus sulphonylurea).

Adverse Reactions Reported When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were Combined with Insulin: When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were administrated in combination with insulin, hypoglycaemia was the most frequently reported adverse reactions, but occurred at comparable rate when placebo and Metformin (Trayenta Duo) were combined with insulin (Linagliptin (Trayenta Duo) plus Metformin (Trayenta Duo) plus insulin 29.5% versus 30.9% in the placebo plus Metformin (Trayenta Duo) plus insulin group) with a low rate of severe episodes (1.5% versus 0.9%).

Tabulated List of Adverse Reactions: Adverse Reactions Reported with the Fixed Dose Combination: Adverse reactions reported in all clinical trials with Trayenta Duo are shown as follows according to system organ class. Adverse reactions known to occur with each active substance given singly, but which have not been seen in clinical trials with Trayenta Duo, may occur during treatment with this medicinal product.

The adverse reactions are listed by system organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000) and not known (cannot be estimated from the available data)..

Adverse Reactions Reported When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were Combined with Sulphonylurea: When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were administered in combination with a sulphonylurea, hypoglycaemia was identified as an additional adverse reaction under these conditions..

None of the hypoglycaemias was classified as severe.

Adverse Reactions Reported When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were Combined with Insulin: When Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) were administered in combination with insulin, constipation was identified as an additional adverse reaction under these conditions. The combination of Linagliptin (Trayenta Duo) and Metformin (Trayenta Duo) when administered in combination with insulin may be associated with an increased risk of hepatic events..

Additional Information on Individual Components: Adverse reactions previously reported with one of the individual active substances may be potential adverse reactions with Trayenta Duo, even if not observed in clinical trials with this medicinal product.

Linagliptin (Trayenta Duo): All identified adverse reactions of Linagliptin (Trayenta Duo) monotherapy are also described for Trayenta Duo in Table 2.

Metformin (Trayenta Duo): Known adverse reactions for Metformin (Trayenta Duo), that were not reported in patients who received Trayenta Duo are listed in Table 5..

Description of Selected Adverse Reactions: Gastrointestinal disorders such as, nausea, vomiting, diarrhoea and decreased appetite (Table 2) and abdominal pain (Table 5) occur most frequently during initiation of therapy with Trayenta Duo or Metformin (Trayenta Duo) hydrochloride and resolve spontaneously in most cases. For prevention, it is recommended that Trayenta Duo be taken in 2 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Long-term treatment with Metformin (Trayenta Duo) has been associated with a decrease in vitamin B12 absorption (Table 5) which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).

What is the most important information I should know about Trayenta Duo?

• Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Trayenta Duo.
• Do not drink large amounts of alcohol while you use Trayenta Duo. Talk to your doctor or health care provider before you drink alcohol while you use Trayenta Duo.
• Do NOT take more than the recommended dose without checking with your doctor.
• Tell your doctor or dentist that you take Trayenta Duo before you receive any medical or dental care, emergency care, or surgery.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Trayenta Duo exactly as prescribed, tell your doctor.
• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
• Trayenta Duo usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Metformin (Trayenta Duo) may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at right away. This may be a sign of lactic acidosis.
• Severe and sometimes fatal inflammation of the pancreas (pancreatitis) has been reported in patients taking Trayenta Duo. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe or persistent stomach or back pain with or without nausea or vomiting.
• Lab tests, including kidney function, fasting blood glucose, hemoglobin A, and complete blood cell counts, may be performed while you use Trayenta Duo. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Trayenta Duo with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in elderly patients.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Trayenta Duo while you are pregnant. Trayenta Duo is found in breast milk. If you are or will be breast-feeding while you take Trayenta Duo, check with your doctor. Discuss any possible risks to your baby.

Trayenta Duo contraindications

Trayenta Duo is contraindicated in patients with:

• Renal impairment (e.g., serum creatinine ≥1.5 mg/dL for men, ≥1.4 mg/dL for women, or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin
• A history of hypersensitivity reaction to Linagliptin (Trayenta Duo), such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity
• Hypersensitivity to Metformin (Trayenta Duo)

References

1. DailyMed. "LINAGLIPTIN; METFORMIN HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Metformin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "Linagliptin". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology