Saxagliptin

Saxagliptin is a prescription used for the treatment of type 2 diabetes mellitus.

• Saxagliptin is available under the following different brand names: Onglyza

Adult dosage

Tablet

• 2.5mg
• 5mg

Diabetes Mellitus Type 2

Adult dosage

• 2.5-5 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Saxagliptin include:

• painful urination;
• headache;
• runny or stuffy nose, sore throat, cough; or
• swelling in the hands or feet.

Serious side effects of the Saxagliptin include:

• hives, 
• a purple or red skin rash that spreads and causes blistering and peeling; 
• difficulty breathing;
• swelling of the face, lips, tongue, or throat.
• severe or ongoing pain in the joints;
• pain or burning while urinating; or
• heart problems--shortness of breath (even while lying down), feeling weak or tired, rapid weight gain, swelling especially in the feet, legs, or midsection.
• severe pain in the upper stomach spreading to the back, 
• nausea and vomiting,
• loss of appetite, or 
• fast heartbeats.

Rare side effects of the Saxagliptin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Saxagliptin has severe interactions with no other drugs.
• Saxagliptin has serious interactions with the following drug:
  • abametapir
  • apalutamide
  • chloramphenicol
  • cobicistat
  • erdafitinib
  • ethanol
  • fexinidazole
  • idelalisib
  • ivosidenib
  • lasmiditan
  • lonafarnib
  • sotorasib
  • tepotinib
  • tucatinib
  • voxelotor
• Saxagliptin has moderate interactions with at least 107 other drugs.
• Saxagliptin has minor interactions with at least 109 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Saxagliptin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Saxagliptin?”

Cautions

• Renal impairment
• Decrease dose with strong CYP450 3A4/5 inhibitors
• Coadministration with thiazolidinediones (eg, rosiglitazone, pioglitazone) increases the risk for peripheral edema
• Pancreatitis reported with saxagliptin; monitor for signs and symptoms and discontinue if pancreatitis suspected
• Serious hypersensitivity reactions with saxagliptin were reported (typically within the first 3 months of therapy)
• History of angioedema
• Coadministration with a sulfonylurea or with insulin may increase hypoglycemia; monitor closely and adjust sulfonylurea and/or insulin dose accordingly
• Postmarketing cases of bullous pemphigoid requiring hospitalization reported with DPP-4 inhibitor use; patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor; inform patients to report the development of blisters or erosions while on treatment; if bullous pemphigoid is suspected, discontinue therapy and refer the patient to a dermatologist for diagnosis and appropriate treatment
• Severe and disabling arthralgia was reported in patients taking DPP-4 inhibitors; considered a1s a possible cause of severe joint pain and discontinue the drug if appropriate
• There are no clinical studies establishing conclusive evidence of macrovascular risk reduction with this therapy
• Congestive heart failure (CHF) risks
  • In the SAVOR-TIMI 53 trial (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) 16,492 patients with type 2 diabetes mellitus and a history of, or at risk of, cardiovascular events were randomized to saxagliptin or placebo
  • A higher incidence of hospitalization for CHF was observed in patients treated with saxagliptin compared with those treated with placebo (3.5% vs 2.8%; P=0.007); this increased risk was highest among patients with elevated levels of natriuretic peptides, previous heart failure, or chronic kidney disease
  • Observe patients for signs and symptoms of heart failure during therapy; inform patients of characteristic symptoms of heart failure and advise patients to immediately report them; if heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of therapy

Pregnancy and Lactation

• Limited available data on pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage; published studies on metformin use during pregnancy have not reported a clear association between metformin and major birth defect or miscarriage risk
• No adverse developmental effects independent of maternal toxicity were observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during the period of organogenesis
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. also increases the fetal risk for major malformations and macrosomia related morbidity
• Lactation
  • There is no information regarding the presence of metformin or alogliptin in human milk, effects on the breastfed infant, or effects on milk production; limited published studies report that metformin is present in human milk; however, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on effects of metformin on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition