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Kazano Side Effects

Generic name: alogliptin / metformin

Medically reviewed by Drugs.com. Last updated on May 2, 2023.

Note: This document contains side effect information about alogliptin / metformin. Some dosage forms listed on this page may not apply to the brand name Kazano.

Applies to alogliptin / metformin: oral tablet.

Warning

Oral route (Tablet)

Lactic AcidosisPostmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL.Risk factors include renal impairment, concomitant use of certain drugs, age greater than or equal to 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information.If lactic acidosis is suspected, discontinue alogliptin/metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Serious side effects of Kazano

Along with its needed effects, alogliptin / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alogliptin / metformin:

More common

Less common

Rare

Incidence not known

Other side effects of Kazano

Some side effects of alogliptin / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to alogliptin / metformin: oral tablet.

General

The most common adverse reactions reported include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, and urinary tract infection.[Ref]

Gastrointestinal

Alogliptin-Metformin:

Common (1% to 10%): Diarrhea, gastroenteritis, abdominal pain, vomiting, gastritis, gastroesophageal reflux disease

Alogliptin:

Common (1% to 10%): Diarrhea, abdominal pain, gastroesophageal reflux disease

Uncommon (0.1% to 1%): Pancreatitis

Postmarketing reports: Acute pancreatitis

Metformin:

Very common (10% or more): Diarrhea (up to 53.2%), Nausea/vomiting (25.5%), flatulence (12.1%)

Common (1% to 10%): Indigestion, abdominal discomfort[Ref]

Acute pancreatitis has been associated with DPP-4 inhibitors. In a pooled analysis of 13 studies, the overall rate of pancreatitis reported with alogliptin 25 mg, 12.5 mg, active control, or placebo was 2, 1, 1, or 0, events per 1000 patient years, respectively.[Ref]

Hepatic

Alogliptin:

Postmarketing reports: Hepatic enzyme elevations, fulminant hepatic failure

Metformin:

Very rare (less than 0.01%): Hepatitis, liver function test abnormalities[Ref]

Cases of hepatic dysfunction including hepatic failure have been received in the postmarketing period with alogliptin-treated patients; causality has not been established.[Ref]

Metabolic

In metformin-treated patients, lactic acidosis has been reported in approximately 0.03 cases per 1000 patient-years with approximately half these cases resulting in fatalities. In more than 20,000 patient-years exposure in clinical trials, there were no cases of lactic acidosis. Reported cases have occurred primarily in patients with significant renal insufficiency, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications.

In an alogliptin monotherapy study, the incidence of hypoglycemia was 1.5% (compared with 1.6% in placebo). Adding alogliptin to glyburide or insulin did not increase the incidence of hypoglycemia compared with placebo. In elderly patients, the incidence of hypoglycemia was 5.4% with alogliptin compared with 26% for glipizide. In a 26-week, placebo-controlled study of alogliptin once daily as add-on to a metformin regimen, hypoglycemic events were reported in 0.9% of patients in the alogliptin-metformin group compared with 2.9% in the placebo group.[Ref]

Alogliptin-Metformin:

Common (1% to 10%): Hypoglycemia

Alogliptin:

Common (1% to 10%): Hypoglycemia

Metformin:

Common (1% to 10%): Hypoglycemia, loss of appetite

Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency[Ref]

Hypersensitivity

Alogliptin:

Uncommon (0.1% to 1%): Hypersensitivity reactions (0.6%)

Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria, severe cutaneous adverse reactions (Stevens-Johnson syndrome), erythema multiforme[Ref]

Dermatologic

Postmarketing reports of bullous pemphigoid requiring hospitalization have been reported with dipeptidyl peptidase-4 (DPP-4) inhibitors use. These case typically recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor.[Ref]

Alogliptin-metformin:

Common (1% to 10%): Pruritus, rash

Alogliptin:

Common (1% to 10%): Pruritus, rash

Postmarketing reports: Exfoliative skin conditions including Stevens-Johnson syndrome, angioedema, urticaria

Metformin:

Very rare (less than 0.01%): Erythema, pruritus, urticaria

Dipeptidyl peptidase-4 inhibitors:

Postmarketing reports: Bullous pemphigoid[Ref]

Respiratory

Alogliptin-Metformin:

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis

Alogliptin:

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection

Metformin:

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis[Ref]

Nervous system

Alogliptin-Metformin:

Common (1% to 10%): Headache

Alogliptin:

Common (1% to 10%): Headache

Metformin:

Common (1% to 10%): Headache, metallic taste[Ref]

Cardiovascular

In a clinical trial in patients with recent acute coronary syndrome, a greater proportion of patients receiving this drug were hospitalized for congestive heart failure compared with placebo (3.9% [n=106] vs 3.3% [n=89]),[Ref]

Alogliptin-Metformin:

Common (1% to 10%): Hypertension

Alogliptin:

Common (1% to 10%): Hypertension

Frequency not reported: Heart failure

Metformin:

Common (1% to 10%): Hypertension[Ref]

Genitourinary

Alogliptin-Metformin:

Common (1% to 10%): Urinary tract infection

Alogliptin:

Common (1% to 10%): Urinary tract infection

Metformin:

Common (1% to 10%): Urinary tract infection[Ref]

Musculoskeletal

Alogliptin-Metformin:

Common (1% to 10%): Back pain

Alogliptin:

Uncommon (0.1% to 1%): Back pain

Frequency not reported: Arthralgia

Metformin:

Common (1% to 10%): Back pain[Ref]

Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]

Other

Metformin:

Common (1% to 10%): Asthenia[Ref]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Kazano (alogliptin-metformin). Takeda Pharmaceuticals America. 2013.

4. US Food and Drug Administration. FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin. http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm?source=govdelivery&utm_medium=email&utm_source=govde 2016.

5. US Food and Drug Administration. FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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