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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 11.05.2022
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Trajentamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Trajentamet and Metformin (Trajentamet) is appropriate, in patients inadequately controlled on Metformin (Trajentamet) alone or those already being treated and well controlled with the free combination of Trajentamet and Metformin (Trajentamet).
Trajentamet is indicated in combination with a sulphonylurea (ie, triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of Metformin (Trajentamet) and a sulphonylurea.
Trajentamet is indicated as add-on to insulin (ie, triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and Metformin (Trajentamet) alone do not provide adequate glycaemic control.
Limitation of Use: Trajentamet must not be used in patients with type 1 diabetes or ketoacidosis due to no clinical effects.
Clinical experience of the use of Trajentamet in patients with pancreatitis history is limited. There is no information if patients-risk from pancretitis will be increased by the drug. Therefore, Trajentamet should be used in these patients only when necessary and pancreatitis monitoring is required.
Trajentamet and Metformin (Trajentamet) combination is used to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.
Many people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of Trajentamet and Metformin (Trajentamet) combination you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.
Trajentamet and Metformin (Trajentamet) combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood glucose is best controlled by insulin injections.
Trajentamet and Metformin (Trajentamet) is available only with your doctor's prescription.
Recommended Dosing
The dosage of Trajentamet should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Trajentamet 5 mg and Metformin (Trajentamet) hydrochloride 2000 mg. Trajentamet should be given once daily with a meal. For available dosage forms and strengths see [Dosage Forms and Strengths (3)].
Recommended starting dose:
- In patients currently not treated with Metformin (Trajentamet), initiate Trajentamet treatment with 5 mg Trajentamet/1000 mg Metformin (Trajentamet) hydrochloride extended-release once daily with a meal.
- In patients already treated with Metformin (Trajentamet), start Trajentamet with 5 mg of Trajentamet total daily dose and a similar total daily dose of Metformin (Trajentamet) once daily with a meal.
- In patients already treated with Trajentamet and Metformin (Trajentamet) or Trajentamet, switch to Trajentamet containing 5 mg of Trajentamet total daily dose and a similar total daily dose of Metformin (Trajentamet) once daily with a meal.
Trajentamet should be swallowed whole. The tablets must not be split, crushed, dissolved, or chewed before swallowing. There have been reports of incompletely dissolved tablets being eliminated in the feces for other tablets containing Metformin (Trajentamet) extended-release. If a patient reports seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.
Trajentamet 5 mg Trajentamet/1000 mg Metformin (Trajentamet) hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Trajentamet/1000 mg Metformin (Trajentamet) extended-release tablets should take two tablets together once daily.
No studies have been performed specifically examining the safety and efficacy of Trajentamet in patients previously treated with other oral antihyperglycemic agents and switched to Trajentamet. Any change in therapy of type 2 diabetes mellitus should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Recommended Dosing in Renal Impairment
Assess renal function prior to initiation of Trajentamet and periodically thereafter.
Trajentamet is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.
Initiation of Trajentamet in patients with an eGFR between 30-45 mL/min/1.73 m2 is not recommended.
In patients taking Trajentamet whose eGFR later falls below 45 mL/min/1.73 m2, assess benefit risk of continuing therapy.
Discontinue Trajentamet if the patient’s eGFR later falls below 30 mL/min/1.73 m2.
Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue Trajentamet at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Trajentamet if renal function is stable.
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What is the most important information I should know about Trajentamet?
Trajentamet 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 Trajentamet, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity
- Hypersensitivity to Metformin (Trajentamet)
Use Trajentamet as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Trajentamet comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Trajentamet refilled.
- Take Trajentamet by mouth with meals as directed by your doctor.
- Take Trajentamet on a regular schedule to get the most benefit from it.
- Continue to take Trajentamet even if you feel well. Do not miss any doses.
- If you miss a dose of Trajentamet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Trajentamet.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Diabetes mellitus type 2: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Trajentamet and Metformin (Trajentamet) is appropriate.
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What other drugs will affect Trajentamet?
Drug Interactions With Metformin (Trajentamet)
Carbonic Anhydrase Inhibitors
Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with Trajentamet, may increase the risk of lactic acidosis. Consider more frequent monitoring of these patients.
Drugs That Reduce Metformin (Trajentamet) Clearance
Drugs that are eliminated by renal tubular secretion (e.g., cationic drugs such as cimetidine) have the potential for interaction with Metformin (Trajentamet) by competing for common renal tubular transport systems, and may increase the accumulation of Metformin (Trajentamet) and the risk for lactic acidosis. Consider more frequent monitoring of these patients.
Alcohol
Alcohol is known to potentiate the effect of Metformin (Trajentamet) on lactate metabolism. Warn patients against excessive alcohol intake while receiving Trajentamet.
Drug Interactions With Trajentamet
Inducers Of P-glycoprotein And CYP3A4 Enzymes
Rifampin decreased Trajentamet exposure, suggesting that the efficacy of Trajentamet may be reduced when administered in combination with a strong P-gp inducer or CYP 3A4 inducer. As Trajentamet is a fixed-dose combination of Trajentamet and Metformin (Trajentamet), use of alternative treatments (not containing Trajentamet) is strongly recommended when concomitant treatment with a strong P-gp or CYP 3A4 inducer is necessary.
Insulin Secretagogues Or Insulin
Coadministration of Trajentamet with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Drugs Affecting Glycemic Control
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Trajentamet, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Trajentamet, the patient should be observed closely for hypoglycemia.
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What are the possible side effects of Trajentamet?
Summary of the Safety Profile: Fixed Dose Combination: The most frequently reported adverse reaction for Trajentamet plus Metformin (Trajentamet) was diarrhoea (0.9%) with a comparable rate on Metformin (Trajentamet) plus placebo (1.2%).
Hypoglycaemia may occur when Trajentamet is administered together with sulphonylurea (≥1 case per 10 patients).
The safety of Trajentamet 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with Metformin (Trajentamet) 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 Trajentamet twice daily (or its bioequivalent of 5 mg Trajentamet once daily) in combination with Metformin (Trajentamet) 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 (Trajentamet) was comparable to that seen with Trajentamet 2.5 mg and Metformin (Trajentamet) (50.6 and 47.8%). Discontinuation of therapy due to adverse reactions was comparable in patients who received placebo and Metformin (Trajentamet) to patients treated with Trajentamet and Metformin (Trajentamet) (2.6% and 2.3%).
Adverse Reactions Reported When Trajentamet and Metformin (Trajentamet) were Combined with Sulphonylurea: In one study Trajentamet was given as add-on to Metformin (Trajentamet) plus sulphonylurea. When Trajentamet and Metformin (Trajentamet) were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse reaction (Trajentamet plus Metformin (Trajentamet) plus sulphonylurea 22.9% versus 14.8% in placebo plus Metformin (Trajentamet) plus sulphonylurea).
Adverse Reactions Reported When Trajentamet and Metformin (Trajentamet) were Combined with Insulin: When Trajentamet and Metformin (Trajentamet) were administrated in combination with insulin, hypoglycaemia was the most frequently reported adverse reactions, but occurred at comparable rate when placebo and Metformin (Trajentamet) were combined with insulin (Trajentamet plus Metformin (Trajentamet) plus insulin 29.5% versus 30.9% in the placebo plus Metformin (Trajentamet) 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 Trajentamet 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 Trajentamet, 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 Trajentamet and Metformin (Trajentamet) were Combined with Sulphonylurea: When Trajentamet and Metformin (Trajentamet) 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 Trajentamet and Metformin (Trajentamet) were Combined with Insulin: When Trajentamet and Metformin (Trajentamet) were administered in combination with insulin, constipation was identified as an additional adverse reaction under these conditions. The combination of Trajentamet and Metformin (Trajentamet) 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 Trajentamet, even if not observed in clinical trials with this medicinal product.Trajentamet: All identified adverse reactions of Trajentamet monotherapy are also described for Trajentamet in Table 2.
Metformin (Trajentamet): Known adverse reactions for Metformin (Trajentamet), that were not reported in patients who received Trajentamet 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 Trajentamet or Metformin (Trajentamet) hydrochloride and resolve spontaneously in most cases. For prevention, it is recommended that Trajentamet 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 (Trajentamet) 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).
Each tablet contains 2.5 mg of Trajentamet and 500 mg, 850 mg or 1000 mg of Metformin (Trajentamet) hydrochloride.
Excipients/Inactive Ingredients: Tablet Core: Arginine, copovidone, magnesium stearate, maize starch, silica, colloidal anhydrous.
Film Coating: Hypromellose, titanium dioxide (E171), talc, propylene glycol.
Trajentamet 2.5mg/500mg: Iron oxide, yellow (E172).
Trajentamet 2.5mg/850mg: Iron oxide, yellow (E172), iron oxide, red (E172).
Trajentamet 2.5mg/1000mg: Iron oxide, red (E172).