Kazano Generic Name: alogliptin and metformin hcl tablets Brand Name: Kazano Kazano (Alogliptin and Metformin HCl Tablets) side effects drug center Related Drugs GlucaGen Glucophage Glucotrol Glucotrol XL Glucovance Glumetza Glynase Prestab Glyset Humulin R U-500 Kwikpen Lyumjev Precose Qternmet XR Semglee Trijardy XR Zegalogue Health Resources Diabetes (Type 1 and Type 2) Complete Blood Count (CBC): Test, Types, Ranges, and Chart New Diabetes Medications List PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Kazano Side Effects Center What Is Kazano? Kazano (alogliptin and metformin HCl) is an antidiabetic medication used to treat type 2 diabetes mellitus, along with diet and exercise. What Are Side Effects of Kazano? Common side effects of Kazano include: upper respiratory tract infection, diarrhea, high blood pressure, headache, back pain, urinary tract infection, and cold symptoms (stuffy nose, sinus pain, sore throat). Patients with impaired kidneys, acute or chronic metabolic acidosis, including diabetic ketoacidosis should not take Kazano. Kazano is not recommended in patients with a history of hypersensitivity reaction to alogliptin or metformin, which are components of Kazano. Dosage for Kazano Kazano is available in doses of 12.5 mg alogliptin and 500 mg metformin HCl; and 12.5 mg alogliptin and 1000 mg metformin HCl. Kazano should be taken twice a day with a meal. Lactic acidosis is a rare, but serious complication. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. What Drugs, Substances, or Supplements Interact with Kazano? Kazano may interact with cimetidine, morphine, quinine, ranitidine, topiramate, trimethoprim, vancomycin, zonisamide, acetazolamide, methazolamide, triamterene, heart or blood pressure medications, isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicines, birth control pills and other hormones, seizure medicines, diet pills, and medicines to treat asthma, colds or allergies. Tell your doctor all medications and supplements you use. Kazano During Pregnancy or Breastfeeding Tell your doctor if you are pregnant or plan to become pregnant during treatment with Kazano; it is not expected to be harmful to a fetus. It is unknown if Kazano passes into breast milk. Consult your doctor before breastfeeding. Additional Information Our Kazano (alogliptin and metformin HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when using this device. Kazano Consumer Information Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). 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 using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as: unusual muscle pain; feeling cold; trouble breathing; feeling dizzy, light-headed, tired, or very weak; stomach pain, vomiting; or slow or irregular heart rate. Call your doctor at once if you have: severe or ongoing pain in your joints; pain or burning when you urinate; liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain. Common side effects may include: diarrhea, upset stomach; increased blood pressure (severe headache, blurred vision, pounding in your neck or ears); back pain, headache; or cold symptoms such as stuffy nose, sinus pain, sore throat. 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. Read the entire detailed patient monograph for Kazano (Alogliptin and Metformin HCl Tablets) Kazano Professional Information SIDE EFFECTS The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see WARNINGS AND PRECAUTIONS] Heart Failure [see WARNINGS AND PRECAUTIONS] Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS] Hepatic Effects [see WARNINGS AND PRECAUTIONS] Severe and Disabling Arthralgia [see WARNINGS AND PRECAUTIONS] Bullous Pemphigoid [see WARNINGS AND PRECAUTIONS] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Alogliptin And Metformin Hydrochloride Over 2700 patients with type 2 diabetes have received alogliptin coadministered with metformin in four large, randomized, double-blind controlled clinical trials. The mean exposure to KAZANO was 58 weeks, with more than 1400 subjects treated for more than one year. These included two 26 week placebo-controlled studies, one 52 week active control study and an interim analysis of a 104 week active-controlled study. In the KAZANO arm, the mean duration of diabetes was approximately six years, the mean body mass index (BMI) was 31 kg/m² (56% of patients had a BMI ≥30 kg/m²) and the mean age was 55 years (18% of patients ≥65 years of age). In a pooled analysis of these four controlled clinical studies, the overall incidence of adverse reactions was 74% in patients treated with KAZANO compared to 75% treated with placebo. Overall discontinuation of therapy due to adverse reactions was 6.2% with KAZANO compared to 1.9% in placebo, 6.4% in metformin and 5.0% in alogliptin. Adverse reactions reported in ≥4% of patients treated with KAZANO and more frequently than in patients who received alogliptin, metformin or placebo are summarized in Table 1. Table 1: Adverse Reactions Reported in ≥4% of Patients Treated with KAZANO and More Frequently Than in Patients Receiving Either Alogliptin, Metformin or Placebo Number of Patients (%) KAZANO* N=2794 Alogliptin† N=222 Metformin‡ N=1592 Placebo N=106 Upper respiratory tract infection 224 (8.0) 6 (2.7) 105 (6.6) 3 (2.8) Nasopharyngitis 191 (6.8) 7 (3.2) 93 (5.8) 2 (1.9) Diarrhea 155 (5.5) 4 (1.8) 105 (6.6) 3 (2.8) Hypertension 154 (5.5) 5 (2.3) 96 (6.0) 6 (5.7) Headache 149 (5.3) 11 (5.0) 74 (4.6) 3 (2.8) Back pain 119 (4.3) 1 (0.5) 72 (4.5) 1 (0.9) Urinary tract infection 116 (4.2) 4 (1.8) 59 (3.7) 2 (1.9) *KAZANO - includes data pooled for patients receiving alogliptin 25 and 12.5 mg combined with various dose of metformin †Alogliptin - includes data pooled for patients receiving alogliptin 25 and 12.5 mg ‡Metformin - includes data pooled for patients receiving various doses of metformin Hypoglycemia In a 26 week, double-blind, placebo-controlled study of alogliptin in combination with metformin, the number of patients reporting hypoglycemia was 1.9% in the alogliptin 12.5 mg with metformin HCl 500 mg, 5.3% in the alogliptin 12.5 mg with metformin HCl 1000 mg, 1.8% in the metformin HCl 500 mg and 6.3% in the metformin HCl 1000 mg treatment groups. In a 26 week placebo-controlled study of alogliptin 25 mg administered once daily as add-on to metformin regimen, the number of patients reporting hypoglycemic events was 0% in the alogliptin with metformin and 2.9% in the placebo treatment groups. In a 52 week, active-controlled, double-blind study of alogliptin once daily as add-on therapy to the combination of pioglitazone 30 mg and metformin compared to the titration of pioglitazone 30 mg to 45 mg and metformin, the number of patients reporting hypoglycemia was 4.5% in the alogliptin 25 mg with pioglitazone 30 mg and metformin group versus 1.5% in the pioglitazone 45 mg with metformin group. In an interim analysis conducted in a 104-week, double-blind, active-controlled study of alogliptin 25 mg in combination with metformin, the number of patients reporting hypoglycemia was 1.4% in the alogliptin 25 mg with metformin group versus 23.8% in the glipizide with metformin group. Alogliptin A total of 14,778 patients with type 2 diabetes participated in 14 randomized, double-blind, controlled clinical trials of whom 9052 subjects were treated with alogliptin, 3469 subjects were treated with placebo and 2257 were treated with an active comparator. The mean duration of diabetes was seven years, the mean body mass index (BMI) was 31 kg/m² (49% of patients had a BMI ≥30 kg/m²), and the mean age was 58 years (26% of patients ≥65 years of age). The mean exposure to alogliptin was 49 weeks with 3348 subjects treated for more than one year. In a pooled analysis of these 14 controlled clinical trials, the overall incidence of adverse reactions was 73% in patients treated with alogliptin 25 mg compared to 75% with placebo and 70% with active comparator. Overall discontinuation of therapy due to adverse reactions was 6.8% with alogliptin 25 mg compared to 8.4% with placebo or 6.2% with active comparator. Adverse reactions reported in ≥4% of patients treated with alogliptin 25 mg and more frequently than in patients who received placebo are summarized in Table 2. Table 2: Adverse Reactions Reported in ≥4% Patients Treated with Alogliptin 25 mg and More Frequently Than in Patients Given Placebo in Pooled Studies Number of Patients (%) Alogliptin 25 mg N=6447 Placebo N=3469 Active Comparator N=2257 Nasopharyngitis 309 (4.8) 152 (4.4) 113 (5.0) Upper Respiratory Tract Infection 287 (4.5) 121 (3.5) 113 (5.0) Headache 278 (4.3) 101 (2.9) 121 (5.4) Hypoglycemia Hypoglycemic events were documented based upon a blood glucose value and/or clinical signs and symptoms of hypoglycemia. In the monotherapy study, the incidence of hypoglycemia was 1.5% in patients treated with alogliptin compared to 1.6% with placebo. The use of alogliptin as add-on therapy to glyburide or insulin did not increase the incidence of hypoglycemia compared to placebo. In a monotherapy study comparing alogliptin to a sulfonylurea in elderly patients, the incidence of hypoglycemia was 5.4% with alogliptin compared to 26% with glipizide. In the EXAMINE trial, the incidence of investigator reported hypoglycemia was 6.7% in patients receiving alogliptin and 6.5% in patients receiving placebo. Serious adverse reactions of hypoglycemia were reported in 0.8% of patients treated with alogliptin and in 0.6% of patients treated with placebo. Metformin Hydrochloride Table 3: Most Common Adverse Reactions (≥5%) in a Placebo-Controlled Clinical Study of Metformin Monotherapy* Adverse Reaction Metformin Monotherapy (n=141) Placebo (n=145) % of Patients Diarrhea 53.2 11.7 Nausea/vomiting 25.5 8.3 Flatulence 12.1 5.5 Asthenia 9.2 5.5 Indigestion 7.1 4.1 Abdominal discomfort 6.4 4.8 Headache 5.7 4.8 *Reactions that were more common in metformin than placebo-treated patients Laboratory Abnormalities Alogliptin And Metformin Hydrochloride No clinically meaningful differences were observed among treatment groups regarding hematology, serum chemistry or urinalysis results. Metformin Hydrochloride Metformin may lower serum vitamin B12 concentrations. Measurement of hematologic parameters on an annual basis is advised in patients on KAZANO, and any apparent abnormalities should be appropriately investigated and managed [see WARNINGS AND PRECAUTIONS]. Postmarketing Experience The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Alogliptin Acute pancreatitis, hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria and severe cutaneous adverse reactions, including Stevens-Johnson syndrome, hepatic enzyme elevations, fulminant hepatic failure, severe and disabling arthralgia and bullous pemphigoid, rhabdomyolysis, diarrhea, constipation, nausea, and ileus [see WARNINGS AND PRECAUTIONS.] Metformin Cholestatic, hepatocellular, and mixed hepatocellular liver injury. Read the entire FDA prescribing information for Kazano (Alogliptin and Metformin HCl Tablets) &Copy; Kazano Patient Information is supplied by Cerner Multum, Inc. and Kazano Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
