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Diabetes
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Diabetes
 * Diabetes Home
 * Product Information
   
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Prescribing Information  |  Important Safety Information

Ozempic® (semaglutide) injection 0.5 mg or 1 mg

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg

Victoza® (liraglutide) injection 1.2 mg or 1.8 mg

Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 U/mL and 3.6
mg/mL

Fiasp® (insulin aspart injection) 100 U/mL

GlucaGen® HypoKit® (glucagon) for injection 1 mg/mL

Levemir® (insulin detemir injection) 100 U/mL

NovoLog® (insulin aspart) injection 100 U/mL

NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart) injectable
suspension 100 U/mL

Tresiba® (insulin degludec injection) 100 U/mL, 200 U/mL




Product sample ordering is now processed through our new Sample Portal, which
accommodates digital signatures. Please use your current novoMEDLINK™ account to
sign in and place your order.

Product sample ordering is now processed through our new Sample Portal, which
accommodates digital signatures.
Please use your current novoMEDLINK™ account to sign in and place your order.


REQUEST PRODUCT SAMPLES

Novo Nordisk provides access to complimentary prescription medicine samples to
eligible practitioners for appropriate patients. You may place your order
through the Novo Nordisk Sample Portal

Launch Sample Portal


(Requires a novoMEDLINK™ account)

How to order


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Samples are available for these productsa

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state to request Novo Nordisk samples.

You may submit a sample request every 30 days.

aSamples for other therapeutic areas may also be available.

RYBELSUS® (semaglutide) tablets 3 mg

Pen shown delivers 0.25 mg per injection



Ozempic® (semaglutide) injection 0.25 mg or 0.5 mg Pen

Tresiba® FlexTouch® (insulin degludec injection) 100 U/mL

Tresiba® FlexTouch® (insulin degludec injection) 200 U/mL

Tresiba® (insulin degludec injection) 100 U/mL Vial

Fiasp® FlexTouch® (insulin aspart injection) 100 U/mL

Fiasp® (insulin aspart injection) 100 U/mL Vial


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IMPORTANT SAFETY INFORMATION FOR OZEMPIC® (SEMAGLUTIDE) INJECTION 0.5 MG OR 1 MG

WARNING: RISK OF THYROID C-CELL TUMORS

 * In rodents, semaglutide causes dose-dependent and
   treatment-duration-dependent thyroid C-cell tumors at clinically relevant
   exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors,
   including medullary thyroid carcinoma (MTC), in humans as human relevance of
   semaglutide-induced rodent thyroid C-cell tumors has not been determined.
   
 * Ozempic® is contraindicated in patients with a personal or family history of
   MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN
   2). Counsel patients regarding the potential risk for MTC with the use of
   Ozempic® and inform them of symptoms of thyroid tumors (eg, a mass in the
   neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum
   calcitonin or using thyroid ultrasound is of uncertain value for early
   detection of MTC in patients treated with Ozempic®.


INDICATIONS AND LIMITATIONS OF USE

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is indicated as an adjunct to
diet and exercise to improve glycemic control in adults with type 2 diabetes
mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV
death, nonfatal myocardial infarction or nonfatal stroke) in adults with type 2
diabetes mellitus and established CV disease.

 * Ozempic® has not been studied in patients with a history of pancreatitis.
   Consider other antidiabetic therapies in patients with a history of
   pancreatitis.
 * Ozempic® is not a substitute for insulin. Ozempic® is not indicated for use
   in patients with type 1 diabetes mellitus or for the treatment of patients
   with diabetic ketoacidosis.


IMPORTANT SAFETY INFORMATION CONT.


CONTRAINDICATIONS

 * Ozempic® is contraindicated in patients with a personal or family history of
   MTC or in patients with MEN 2, and in patients with known hypersensitivity to
   semaglutide or to any of the product components.


WARNINGS AND PRECAUTIONS

 * Risk of Thyroid C-Cell Tumors: Patients should be referred to an
   endocrinologist for further evaluation if serum calcitonin is measured and
   found to be elevated or thyroid nodules are noted on physical examination or
   neck imaging.
 * Pancreatitis: Acute and chronic pancreatitis have been reported in clinical
   studies. Observe patients carefully for signs and symptoms of pancreatitis
   (persistent severe abdominal pain, sometimes radiating to the back with or
   without vomiting). If pancreatitis is suspected, discontinue Ozempic®
   promptly, and if pancreatitis is confirmed, do not restart.
 * Diabetic Retinopathy Complications: In a 2-year trial involving patients with
   type 2 diabetes and high cardiovascular risk, more events of diabetic
   retinopathy complications occurred in patients treated with Ozempic® (3.0%)
   compared with placebo (1.8%). The absolute risk increase for diabetic
   retinopathy complications was larger among patients with a history of
   diabetic retinopathy at baseline than among patients without a known history
   of diabetic retinopathy.
   Rapid improvement in glucose control has been associated with a temporary
   worsening of diabetic retinopathy. The effect of long-term glycemic control
   with semaglutide on diabetic retinopathy complications has not been studied.
   Patients with a history of diabetic retinopathy should be monitored for
   progression of diabetic retinopathy.
 * Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be
   shared between patients, even if the needle is changed. Pen-sharing poses a
   risk for transmission of blood-borne pathogens.
 * Hypoglycemia: The risk of hypoglycemia is increased when Ozempic® is used in
   combination with insulin secretagogues (eg, sulfonylureas) or insulin.
 * Acute Kidney Injury: There have been postmarketing reports of acute kidney
   injury and worsening of chronic renal failure, which may sometimes require
   hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these
   events have been reported in patients without known underlying renal disease.
   A majority of the reported events occurred in patients who had experienced
   nausea, vomiting, diarrhea, or dehydration. Monitor renal function when
   initiating or escalating doses of Ozempic® in patients reporting severe
   adverse gastrointestinal reactions.
 * Hypersensitivity: Serious hypersensitivity reactions (eg, anaphylaxis,
   angioedema) have been reported with GLP-1 receptor agonists. If
   hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly
   per standard of care, and monitor until signs and symptoms resolve. Use
   caution in a patient with a history of angioedema or anaphylaxis with another
   GLP-1 receptor agonist.


ADVERSE REACTIONS

 * The most common adverse reactions, reported in ≥5% of patients treated with
   Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.


DRUG INTERACTIONS

 * The risk of hypoglycemia may be lowered by a reduction in the dose of the
   secretagogue or insulin.
 * Ozempic® causes a delay of gastric emptying and has the potential to impact
   the absorption of concomitantly administered oral medications, so caution
   should be exercised.


USE IN SPECIFIC POPULATIONS

 * There are limited data with semaglutide use in pregnant women to inform a
   drug-associated risk for adverse developmental outcomes. Discontinue Ozempic®
   in women at least 2 months before a planned pregnancy due to the long washout
   period for semaglutide.

Please click here for Ozempic® Prescribing Information, including Boxed Warning.


IMPORTANT SAFETY INFORMATION FOR RYBELSUS® (SEMAGLUTIDE) TABLETS 7 MG OR 14 MG

WARNING: RISK OF THYROID C-CELL TUMORS

 * In rodents, semaglutide causes dose-dependent and
   treatment-duration-dependent thyroid C-cell tumors at clinically relevant
   exposures. It is unknown whether RYBELSUS® causes thyroid C-cell tumors,
   including medullary thyroid carcinoma (MTC), in humans as human relevance of
   semaglutide-induced rodent thyroid C-cell tumors has not been determined
 * RYBELSUS® is contraindicated in patients with a personal or family history of
   MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN
   2). Counsel patients regarding the potential risk for MTC with the use of
   RYBELSUS® and inform them of symptoms of thyroid tumors (e.g. a mass in the
   neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum
   calcitonin or using thyroid ultrasound is of uncertain value for early
   detection of MTC in patients treated with RYBELSUS®


INDICATIONS AND USAGE

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is indicated as an adjunct to diet
and exercise to improve glycemic control in adults with type 2 diabetes.


LIMITATIONS OF USE

 * RYBELSUS® is not recommended as a first-line therapy for patients who have
   inadequate glycemic control on diet and exercise because of the uncertain
   relevance of rodent C-cell tumor findings to humans
 * RYBELSUS® has not been studied in patients with a history of pancreatitis.
   Consider other antidiabetic therapies in patients with a history of
   pancreatitis
 * RYBELSUS® is not indicated for use in patients with type 1 diabetes


IMPORTANT SAFETY INFORMATION CONT.


CONTRAINDICATIONS

 * RYBELSUS® is contraindicated in patients with a personal or family history of
   medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine
   Neoplasia syndrome type 2 (MEN 2), and in patients with a prior serious
   hypersensitivity reaction to semaglutide or to any of the excipients in
   RYBELSUS®. Serious hypersensitivity reactions including anaphylaxis and
   angioedema have been reported with RYBELSUS®


WARNINGS AND PRECAUTIONS

 * Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum
   calcitonin is measured and found to be elevated or thyroid nodules are noted
   on physical examination or neck imaging
 * Pancreatitis: Has been reported in clinical trials. Observe patients
   carefully for signs and symptoms of pancreatitis (including persistent severe
   abdominal pain, sometimes radiating to the back and which may or may not be
   accompanied by vomiting). If pancreatitis is suspected, discontinue
   RYBELSUS® and initiate appropriate management; if confirmed, do not restart
   RYBELSUS® 
 * Diabetic Retinopathy Complications: In a pooled analysis of glycemic control
   trials with RYBELSUS®, patients reported diabetic retinopathy related adverse
   reactions during the trial (4.2% with RYBELSUS® and 3.8% with comparator). In
   a 2-year trial with semaglutide injection involving patients with type 2
   diabetes and high cardiovascular risk, more events of diabetic retinopathy
   complications occurred in patients treated with semaglutide injection (3.0%)
   compared to placebo (1.8%). The absolute risk increase for diabetic
   retinopathy complications was larger among patients with a history of
   diabetic retinopathy at baseline than among patients without a known history
   of diabetic retinopathy.
   Rapid improvement in glucose control has been associated with a temporary
   worsening of diabetic retinopathy. Patients with a history of diabetic
   retinopathy should be monitored for progression of diabetic retinopathy
 * Hypoglycemia: Patients receiving RYBELSUS® in combination with an insulin
   secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of
   hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be
   lowered by a reduction in the dose of sulfonylurea (or other concomitantly
   administered insulin secretagogue) or insulin. Inform patients using these
   concomitant medications of the risk of hypoglycemia and educate them on the
   signs and symptoms of hypoglycemia
 * Acute Kidney Injury: There have been postmarketing reports of acute kidney
   injury and worsening of chronic renal failure, which may sometimes require
   hemodialysis, in patients treated with GLP-1 receptor agonists, including
   semaglutide. Some of these events have been reported in patients without
   known underlying renal disease. A majority of the reported events occurred in
   patients who had experienced nausea, vomiting, diarrhea, or dehydration.
   Monitor renal function when initiating or escalating doses of RYBELSUS® in
   patients reporting severe adverse gastrointestinal reactions
 * Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis,
   angioedema) have been reported in patients treated with RYBELSUS®. If
   hypersensitivity reactions occur, discontinue use of RYBELSUS®, treat
   promptly per standard of care, and monitor until signs and symptoms resolve.
   Use caution in a patient with a history of angioedema or anaphylaxis with
   another GLP-1 receptor agonist


ADVERSE REACTIONS

 * The most common adverse reactions, reported in ≥5% of patients treated with
   RYBELSUS® are nausea, abdominal pain, diarrhea, decreased appetite, vomiting
   and constipation


DRUG INTERACTIONS

 * When initiating RYBELSUS®, consider reducing the dose of concomitantly
   administered insulin secretagogue (such as sufonylureas) or insulin to reduce
   the risk of hypoglycemia
 * RYBELSUS® delays gastric emptying and has the potential to impact the
   absorption of other oral medications. Closely follow RYBELSUS® administration
   instructions when coadministering with other oral medications and consider
   increased monitoring for medications with a narrow therapeutic index, such as
   levothyroxine


USE IN SPECIFIC POPULATIONS

 * Pregnancy: Available data with RYBELSUS® are not sufficient to determine a
   drug-associated risk for major birth defects, miscarriage, or other adverse
   maternal or fetal outcomes. Based on animal reproduction studies, there may
   be risks to the fetus from exposure to RYBELSUS®. Use only if the potential
   benefit justifies the potential risk to the fetus
 * Lactation: There are no data on the presence of semaglutide in human milk,
   the effects on the breastfed infant, or the effects on milk production.
   Because of the unknown potential for serious adverse reactions in the
   breastfed infant due to the possible accumulation of salcaprozate sodium
   (SNAC), an absorption enhancer in RYBELSUS®, from breastfeeding and because
   there are alternative formulations of semaglutide that can be used during
   lactation, advise patients that breastfeeding is not recommended during
   treatment with RYBELSUS®
 * Discontinue RYBELSUS® in women at least 2 months before a planned pregnancy
   due to the long washout period for semaglutide
 * Pediatric Use: Safety and efficacy of RYBELSUS® have not been established in
   pediatric patients (younger than 18 years)

Please click here for RYBELSUS® Prescribing Information, including Boxed
Warning.


INDICATIONS AND USAGE FOR FIASP® (INSULIN ASPART INJECTION) 100 U/ML

Fiasp® (insulin aspart injection) 100 U/mL is a rapid-acting insulin analog
indicated to improve glycemic control in adult and pediatric patients with
diabetes mellitus.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

 * Fiasp® is contraindicated during episodes of hypoglycemia and in patients
   hypersensitive to Fiasp® or one of its excipients.


WARNINGS AND PRECAUTIONS

 * Never share a Fiasp® FlexTouch® Pen, PenFill® cartridge or PenFill® cartridge
   device between patients, even if the needle is changed. Patients using
   Fiasp® vials must never share needles or syringes with another person.
   Sharing poses a risk for transmission of blood-borne pathogens.
 * Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an
   insulin regimen (e.g., insulin strength, manufacturer, type, injection site
   or method of administration) may affect glycemic control and predispose to
   hypoglycemia or hyperglycemia. Repeated insulin injections into areas of
   lipodystrophy or localized cutaneous amyloidosis have been reported to result
   in hyperglycemia; and a sudden change in the injection site (to an unaffected
   area) has been reported to result in hypoglycemia. Make any changes to a
   patient’s insulin regimen under close medical supervision with increased
   frequency of blood glucose monitoring. Advise patients who have repeatedly
   injected into areas of lipodystrophy or localized cutaneous amyloidosis to
   change the injection site to unaffected areas and closely monitor for
   hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be
   needed.
 * Hypoglycemia is the most common adverse reaction of insulin, including
   Fiasp®, and may be life-threatening. Increase glucose monitoring with changes
   to: insulin dosage, co-administered glucose lowering medications, meal
   pattern, physical activity; and in patients with renal impairment or hepatic
   impairment or hypoglycemia unawareness.
 * To avoid medication errors and accidental mix-ups between Fiasp® and other
   insulin products, instruct patients to always check the insulin label before
   injection.
 * As with all insulins, Fiasp® use can lead to life-threatening hypokalemia,
   which then may cause respiratory paralysis, ventricular arrhythmia, and
   death. Monitor potassium levels in patients at risk for hypokalemia and treat
   if indicated.
 * Severe, life-threatening, generalized allergy, including anaphylaxis, may
   occur with insulin products, including Fiasp®.
 * Fluid retention and heart failure can occur with concomitant use of
   thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin,
   including Fiasp®. Patients should be observed for signs and symptoms of heart
   failure. If heart failure occurs, dosage reduction or discontinuation of the
   TZD must be considered.
 * Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia
   and ketoacidosis. Prompt identification and correction of the cause of
   hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous
   injection of Fiasp® may be required. Patients using continuous subcutaneous
   insulin infusion pump therapy must be trained to administer insulin by
   injection and have alternate insulin therapy available in case of pump
   failure.


ADVERSE REACTIONS

 * Adverse reactions observed with Fiasp® include hypoglycemia, allergic
   reactions, hypersensitivity, injection site reactions, lipodystrophy, and
   weight gain.


USE IN SPECIFIC POPULATIONS

 * Pediatric patients with type 1 diabetes treated with mealtime and postmeal
   Fiasp® reported a higher rate of blood glucose confirmed hypoglycemic
   episodes compared to patients treated with NovoLog® (insulin aspart
   injection); the imbalance was greater during the nocturnal period. Monitor
   blood glucose levels closely in pediatric patients.
 * Like all insulins, Fiasp® requirements may be reduced in patients with renal
   impairment or hepatic impairment. These patients may require more frequent
   blood glucose monitoring and dose adjustments.

Please click here for Fiasp® Prescribing Information.


INDICATIONS AND USAGE FOR TRESIBA® (INSULIN DEGLUDEC INJECTION) 100 U/ML, 200
U/ML

Tresiba® (insulin degludec injection) is indicated to improve glycemic control
in patients 1 year of age and older with diabetes mellitus.


LIMITATIONS OF USE

Tresiba® is not recommended for treating diabetic ketoacidosis.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

 * Tresiba® is contraindicated during episodes of hypoglycemia and in patients
   with hypersensitivity to Tresiba® or one of its excipients


WARNINGS AND PRECAUTIONS

 * Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients,
   even if the needle is changed. Patients using Tresiba® vials should never
   share needles or syringes with another person. Sharing poses a risk for
   transmission of blood-borne pathogens
 * Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an
   insulin regimen (e.g., insulin strength, manufacturer, type, or injection
   site or method of administration) may affect glycemic control and predispose
   to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of
   lipodystrophy or localized cutaneous amyloidosis have been reported to result
   in hyperglycemia; and a sudden change in the injection site (to an unaffected
   area) has been reported to result in hypoglycemia. Make any changes to a
   patient’s insulin regimen under close medical supervision with increased
   frequency of blood glucose monitoring. Advise patients who have repeatedly
   injected into areas of lipodystrophy or localized cutaneous amyloidosis to
   change the injection site to unaffected areas and closely monitor for
   hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be
   needed.
 * Hypoglycemia is the most common adverse reaction of insulin, including
   Tresiba®, and may be life-threatening. Increase monitoring with changes to:
   insulin dose, co-administered glucose lowering medications, meal pattern,
   physical activity; and in patients with hypoglycemia unawareness or renal or
   hepatic impairment
 * Accidental mix-ups between basal insulin products and other insulins,
   particularly rapid-acting insulins, have been reported. To avoid medication
   errors, always instruct patients to check the insulin label before each
   injection
 * Severe, life-threatening, generalized allergy, including anaphylaxis, can
   occur with insulin products, including Tresiba® 
   
 * As with all insulins, Tresiba® use can lead to life-threatening hypokalemia,
   which then may cause respiratory paralysis, ventricular arrhythmia, and
   death. Closely monitor potassium levels in patients at risk of hypokalemia
   and treat if indicated
 * Fluid retention and heart failure can occur with concomitant use of
   thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin,
   including Tresiba®. Patients should be observed for signs and symptoms of
   heart failure. If heart failure occurs, dosage reduction or discontinuation
   of the TZD must be considered


ADVERSE REACTIONS

 * Adverse reactions commonly associated with Tresiba® are hypoglycemia,
   allergic reactions, injection site reactions, lipodystrophy, pruritus, rash,
   edema, and weight gain


DRUG INTERACTIONS

 * There are certain drugs that may cause clinically significant drug
   interactions with Tresiba®.
   
   * Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE
     inhibitors, angiotensin II receptor blocking agents, disopyramide,
     fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline,
     pramlintide, salicylates, somatostatin analog (e.g., octreotide),
     sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and
     SGLT-2 inhibitors
   * Drugs that may decrease the blood glucose lowering effect: atypical
     antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol,
     diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives,
     phenothiazines, progestogens (e.g., in oral contraceptives), protease
     inhibitors, somatropin, sympathomimetic agents (e.g., albuterol,
     epinephrine, terbutaline), and thyroid hormones
   * Drugs that may increase or decrease the blood glucose lowering effect:
     alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
   * Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers,
     clonidine, guanethidine, and reserpine

Please click here for Tresiba® Prescribing Information.



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IMPORTANT SAFETY INFORMATION FOR OZEMPIC® (SEMAGLUTIDE) INJECTION 0.5 MG OR 1 MG

WARNING: RISK OF THYROID C-CELL TUMORS

 * In rodents, semaglutide causes dose-dependent and
   treatment-duration-dependent thyroid C-cell tumors at clinically relevant
   exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors,
   including medullary thyroid carcinoma (MTC), in humans as human relevance of
   semaglutide-induced rodent thyroid C-cell tumors has not been determined.
   
 * Ozempic® is contraindicated in patients with a personal or family history of
   MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN
   2). Counsel patients regarding the potential risk for MTC with the use of
   Ozempic® and inform them of symptoms of thyroid tumors (eg, a mass in the
   neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum
   calcitonin or using thyroid ultrasound is of uncertain value for early
   detection of MTC in patients treated with Ozempic®.


INDICATIONS AND LIMITATIONS OF USE

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is indicated as an adjunct to
diet and exercise to improve glycemic control in adults with type 2 diabetes
mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV
death, nonfatal myocardial infarction or nonfatal stroke) in adults with type 2
diabetes mellitus and established CV disease.

 * Ozempic® has not been studied in patients with a history of pancreatitis.
   Consider other antidiabetic therapies in patients with a history of
   pancreatitis.
 * Ozempic® is not a substitute for insulin. Ozempic® is not indicated for use
   in patients with type 1 diabetes mellitus or for the treatment of patients
   with diabetic ketoacidosis.


IMPORTANT SAFETY INFORMATION CONT.


CONTRAINDICATIONS

 * Ozempic® is contraindicated in patients with a personal or family history of
   MTC or in patients with MEN 2, and in patients with known hypersensitivity to
   semaglutide or to any of the product components.


WARNINGS AND PRECAUTIONS

 * Risk of Thyroid C-Cell Tumors: Patients should be referred to an
   endocrinologist for further evaluation if serum calcitonin is measured and
   found to be elevated or thyroid nodules are noted on physical examination or
   neck imaging.
 * Pancreatitis: Acute and chronic pancreatitis have been reported in clinical
   studies. Observe patients carefully for signs and symptoms of pancreatitis
   (persistent severe abdominal pain, sometimes radiating to the back with or
   without vomiting). If pancreatitis is suspected, discontinue Ozempic®
   promptly, and if pancreatitis is confirmed, do not restart.
 * Diabetic Retinopathy Complications: In a 2-year trial involving patients with
   type 2 diabetes and high cardiovascular risk, more events of diabetic
   retinopathy complications occurred in patients treated with Ozempic® (3.0%)
   compared with placebo (1.8%). The absolute risk increase for diabetic
   retinopathy complications was larger among patients with a history of
   diabetic retinopathy at baseline than among patients without a known history
   of diabetic retinopathy.
   Rapid improvement in glucose control has been associated with a temporary
   worsening of diabetic retinopathy. The effect of long-term glycemic control
   with semaglutide on diabetic retinopathy complications has not been studied.
   Patients with a history of diabetic retinopathy should be monitored for
   progression of diabetic retinopathy.
 * Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be
   shared between patients, even if the needle is changed. Pen-sharing poses a
   risk for transmission of blood-borne pathogens.
 * Hypoglycemia: The risk of hypoglycemia is increased when Ozempic® is used in
   combination with insulin secretagogues (eg, sulfonylureas) or insulin.
 * Acute Kidney Injury: There have been postmarketing reports of acute kidney
   injury and worsening of chronic renal failure, which may sometimes require
   hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these
   events have been reported in patients without known underlying renal disease.
   A majority of the reported events occurred in patients who had experienced
   nausea, vomiting, diarrhea, or dehydration. Monitor renal function when
   initiating or escalating doses of Ozempic® in patients reporting severe
   adverse gastrointestinal reactions.
 * Hypersensitivity: Serious hypersensitivity reactions (eg, anaphylaxis,
   angioedema) have been reported with GLP-1 receptor agonists. If
   hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly
   per standard of care, and monitor until signs and symptoms resolve. Use
   caution in a patient with a history of angioedema or anaphylaxis with another
   GLP-1 receptor agonist.


ADVERSE REACTIONS

 * The most common adverse reactions, reported in ≥5% of patients treated with
   Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.


DRUG INTERACTIONS

 * The risk of hypoglycemia may be lowered by a reduction in the dose of the
   secretagogue or insulin.
 * Ozempic® causes a delay of gastric emptying and has the potential to impact
   the absorption of concomitantly administered oral medications, so caution
   should be exercised.


USE IN SPECIFIC POPULATIONS

 * There are limited data with semaglutide use in pregnant women to inform a
   drug-associated risk for adverse developmental outcomes. Discontinue Ozempic®
   in women at least 2 months before a planned pregnancy due to the long washout
   period for semaglutide.

Please click here for Ozempic® Prescribing Information, including Boxed Warning.


IMPORTANT SAFETY INFORMATION FOR RYBELSUS® (SEMAGLUTIDE) TABLETS 7 MG OR 14 MG

WARNING: RISK OF THYROID C-CELL TUMORS

 * In rodents, semaglutide causes dose-dependent and
   treatment-duration-dependent thyroid C-cell tumors at clinically relevant
   exposures. It is unknown whether RYBELSUS® causes thyroid C-cell tumors,
   including medullary thyroid carcinoma (MTC), in humans as human relevance of
   semaglutide-induced rodent thyroid C-cell tumors has not been determined
 * RYBELSUS® is contraindicated in patients with a personal or family history of
   MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN
   2). Counsel patients regarding the potential risk for MTC with the use of
   RYBELSUS® and inform them of symptoms of thyroid tumors (e.g. a mass in the
   neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum
   calcitonin or using thyroid ultrasound is of uncertain value for early
   detection of MTC in patients treated with RYBELSUS®


INDICATIONS AND USAGE

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is indicated as an adjunct to diet
and exercise to improve glycemic control in adults with type 2 diabetes.


LIMITATIONS OF USE

 * RYBELSUS® is not recommended as a first-line therapy for patients who have
   inadequate glycemic control on diet and exercise because of the uncertain
   relevance of rodent C-cell tumor findings to humans
 * RYBELSUS® has not been studied in patients with a history of pancreatitis.
   Consider other antidiabetic therapies in patients with a history of
   pancreatitis
 * RYBELSUS® is not indicated for use in patients with type 1 diabetes


IMPORTANT SAFETY INFORMATION CONT.


CONTRAINDICATIONS

 * RYBELSUS® is contraindicated in patients with a personal or family history of
   medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine
   Neoplasia syndrome type 2 (MEN 2), and in patients with a prior serious
   hypersensitivity reaction to semaglutide or to any of the excipients in
   RYBELSUS®. Serious hypersensitivity reactions including anaphylaxis and
   angioedema have been reported with RYBELSUS®


WARNINGS AND PRECAUTIONS

 * Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum
   calcitonin is measured and found to be elevated or thyroid nodules are noted
   on physical examination or neck imaging
 * Pancreatitis: Has been reported in clinical trials. Observe patients
   carefully for signs and symptoms of pancreatitis (including persistent severe
   abdominal pain, sometimes radiating to the back and which may or may not be
   accompanied by vomiting). If pancreatitis is suspected, discontinue
   RYBELSUS® and initiate appropriate management; if confirmed, do not restart
   RYBELSUS® 
 * Diabetic Retinopathy Complications: In a pooled analysis of glycemic control
   trials with RYBELSUS®, patients reported diabetic retinopathy related adverse
   reactions during the trial (4.2% with RYBELSUS® and 3.8% with comparator). In
   a 2-year trial with semaglutide injection involving patients with type 2
   diabetes and high cardiovascular risk, more events of diabetic retinopathy
   complications occurred in patients treated with semaglutide injection (3.0%)
   compared to placebo (1.8%). The absolute risk increase for diabetic
   retinopathy complications was larger among patients with a history of
   diabetic retinopathy at baseline than among patients without a known history
   of diabetic retinopathy.
   Rapid improvement in glucose control has been associated with a temporary
   worsening of diabetic retinopathy. Patients with a history of diabetic
   retinopathy should be monitored for progression of diabetic retinopathy
 * Hypoglycemia: Patients receiving RYBELSUS® in combination with an insulin
   secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of
   hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be
   lowered by a reduction in the dose of sulfonylurea (or other concomitantly
   administered insulin secretagogue) or insulin. Inform patients using these
   concomitant medications of the risk of hypoglycemia and educate them on the
   signs and symptoms of hypoglycemia
 * Acute Kidney Injury: There have been postmarketing reports of acute kidney
   injury and worsening of chronic renal failure, which may sometimes require
   hemodialysis, in patients treated with GLP-1 receptor agonists, including
   semaglutide. Some of these events have been reported in patients without
   known underlying renal disease. A majority of the reported events occurred in
   patients who had experienced nausea, vomiting, diarrhea, or dehydration.
   Monitor renal function when initiating or escalating doses of RYBELSUS® in
   patients reporting severe adverse gastrointestinal reactions
 * Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis,
   angioedema) have been reported in patients treated with RYBELSUS®. If
   hypersensitivity reactions occur, discontinue use of RYBELSUS®, treat
   promptly per standard of care, and monitor until signs and symptoms resolve.
   Use caution in a patient with a history of angioedema or anaphylaxis with
   another GLP-1 receptor agonist


ADVERSE REACTIONS

 * The most common adverse reactions, reported in ≥5% of patients treated with
   RYBELSUS® are nausea, abdominal pain, diarrhea, decreased appetite, vomiting
   and constipation


DRUG INTERACTIONS

 * When initiating RYBELSUS®, consider reducing the dose of concomitantly
   administered insulin secretagogue (such as sufonylureas) or insulin to reduce
   the risk of hypoglycemia
 * RYBELSUS® delays gastric emptying and has the potential to impact the
   absorption of other oral medications. Closely follow RYBELSUS® administration
   instructions when coadministering with other oral medications and consider
   increased monitoring for medications with a narrow therapeutic index, such as
   levothyroxine


USE IN SPECIFIC POPULATIONS

 * Pregnancy: Available data with RYBELSUS® are not sufficient to determine a
   drug-associated risk for major birth defects, miscarriage, or other adverse
   maternal or fetal outcomes. Based on animal reproduction studies, there may
   be risks to the fetus from exposure to RYBELSUS®. Use only if the potential
   benefit justifies the potential risk to the fetus
 * Lactation: There are no data on the presence of semaglutide in human milk,
   the effects on the breastfed infant, or the effects on milk production.
   Because of the unknown potential for serious adverse reactions in the
   breastfed infant due to the possible accumulation of salcaprozate sodium
   (SNAC), an absorption enhancer in RYBELSUS®, from breastfeeding and because
   there are alternative formulations of semaglutide that can be used during
   lactation, advise patients that breastfeeding is not recommended during
   treatment with RYBELSUS®
 * Discontinue RYBELSUS® in women at least 2 months before a planned pregnancy
   due to the long washout period for semaglutide
 * Pediatric Use: Safety and efficacy of RYBELSUS® have not been established in
   pediatric patients (younger than 18 years)

Please click here for RYBELSUS® Prescribing Information, including Boxed
Warning.


INDICATIONS AND USAGE FOR FIASP® (INSULIN ASPART INJECTION) 100 U/ML

Fiasp® (insulin aspart injection) 100 U/mL is a rapid-acting insulin analog
indicated to improve glycemic control in adult and pediatric patients with
diabetes mellitus.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

 * Fiasp® is contraindicated during episodes of hypoglycemia and in patients
   hypersensitive to Fiasp® or one of its excipients.


WARNINGS AND PRECAUTIONS

 * Never share a Fiasp® FlexTouch® Pen, PenFill® cartridge or PenFill® cartridge
   device between patients, even if the needle is changed. Patients using
   Fiasp® vials must never share needles or syringes with another person.
   Sharing poses a risk for transmission of blood-borne pathogens.
 * Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an
   insulin regimen (e.g., insulin strength, manufacturer, type, injection site
   or method of administration) may affect glycemic control and predispose to
   hypoglycemia or hyperglycemia. Repeated insulin injections into areas of
   lipodystrophy or localized cutaneous amyloidosis have been reported to result
   in hyperglycemia; and a sudden change in the injection site (to an unaffected
   area) has been reported to result in hypoglycemia. Make any changes to a
   patient’s insulin regimen under close medical supervision with increased
   frequency of blood glucose monitoring. Advise patients who have repeatedly
   injected into areas of lipodystrophy or localized cutaneous amyloidosis to
   change the injection site to unaffected areas and closely monitor for
   hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be
   needed.
 * Hypoglycemia is the most common adverse reaction of insulin, including
   Fiasp®, and may be life-threatening. Increase glucose monitoring with changes
   to: insulin dosage, co-administered glucose lowering medications, meal
   pattern, physical activity; and in patients with renal impairment or hepatic
   impairment or hypoglycemia unawareness.
 * To avoid medication errors and accidental mix-ups between Fiasp® and other
   insulin products, instruct patients to always check the insulin label before
   injection.
 * As with all insulins, Fiasp® use can lead to life-threatening hypokalemia,
   which then may cause respiratory paralysis, ventricular arrhythmia, and
   death. Monitor potassium levels in patients at risk for hypokalemia and treat
   if indicated.
 * Severe, life-threatening, generalized allergy, including anaphylaxis, may
   occur with insulin products, including Fiasp®.
 * Fluid retention and heart failure can occur with concomitant use of
   thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin,
   including Fiasp®. Patients should be observed for signs and symptoms of heart
   failure. If heart failure occurs, dosage reduction or discontinuation of the
   TZD must be considered.
 * Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia
   and ketoacidosis. Prompt identification and correction of the cause of
   hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous
   injection of Fiasp® may be required. Patients using continuous subcutaneous
   insulin infusion pump therapy must be trained to administer insulin by
   injection and have alternate insulin therapy available in case of pump
   failure.


ADVERSE REACTIONS

 * Adverse reactions observed with Fiasp® include hypoglycemia, allergic
   reactions, hypersensitivity, injection site reactions, lipodystrophy, and
   weight gain.


USE IN SPECIFIC POPULATIONS

 * Pediatric patients with type 1 diabetes treated with mealtime and postmeal
   Fiasp® reported a higher rate of blood glucose confirmed hypoglycemic
   episodes compared to patients treated with NovoLog® (insulin aspart
   injection); the imbalance was greater during the nocturnal period. Monitor
   blood glucose levels closely in pediatric patients.
 * Like all insulins, Fiasp® requirements may be reduced in patients with renal
   impairment or hepatic impairment. These patients may require more frequent
   blood glucose monitoring and dose adjustments.

Please click here for Fiasp® Prescribing Information.


INDICATIONS AND USAGE FOR TRESIBA® (INSULIN DEGLUDEC INJECTION) 100 U/ML, 200
U/ML

Tresiba® (insulin degludec injection) is indicated to improve glycemic control
in patients 1 year of age and older with diabetes mellitus.


LIMITATIONS OF USE

Tresiba® is not recommended for treating diabetic ketoacidosis.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

 * Tresiba® is contraindicated during episodes of hypoglycemia and in patients
   with hypersensitivity to Tresiba® or one of its excipients


WARNINGS AND PRECAUTIONS

 * Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients,
   even if the needle is changed. Patients using Tresiba® vials should never
   share needles or syringes with another person. Sharing poses a risk for
   transmission of blood-borne pathogens
 * Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an
   insulin regimen (e.g., insulin strength, manufacturer, type, or injection
   site or method of administration) may affect glycemic control and predispose
   to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of
   lipodystrophy or localized cutaneous amyloidosis have been reported to result
   in hyperglycemia; and a sudden change in the injection site (to an unaffected
   area) has been reported to result in hypoglycemia. Make any changes to a
   patient’s insulin regimen under close medical supervision with increased
   frequency of blood glucose monitoring. Advise patients who have repeatedly
   injected into areas of lipodystrophy or localized cutaneous amyloidosis to
   change the injection site to unaffected areas and closely monitor for
   hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be
   needed.
 * Hypoglycemia is the most common adverse reaction of insulin, including
   Tresiba®, and may be life-threatening. Increase monitoring with changes to:
   insulin dose, co-administered glucose lowering medications, meal pattern,
   physical activity; and in patients with hypoglycemia unawareness or renal or
   hepatic impairment
 * Accidental mix-ups between basal insulin products and other insulins,
   particularly rapid-acting insulins, have been reported. To avoid medication
   errors, always instruct patients to check the insulin label before each
   injection
 * Severe, life-threatening, generalized allergy, including anaphylaxis, can
   occur with insulin products, including Tresiba® 
   
 * As with all insulins, Tresiba® use can lead to life-threatening hypokalemia,
   which then may cause respiratory paralysis, ventricular arrhythmia, and
   death. Closely monitor potassium levels in patients at risk of hypokalemia
   and treat if indicated
 * Fluid retention and heart failure can occur with concomitant use of
   thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin,
   including Tresiba®. Patients should be observed for signs and symptoms of
   heart failure. If heart failure occurs, dosage reduction or discontinuation
   of the TZD must be considered


ADVERSE REACTIONS

 * Adverse reactions commonly associated with Tresiba® are hypoglycemia,
   allergic reactions, injection site reactions, lipodystrophy, pruritus, rash,
   edema, and weight gain


DRUG INTERACTIONS

 * There are certain drugs that may cause clinically significant drug
   interactions with Tresiba®.
   
   * Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE
     inhibitors, angiotensin II receptor blocking agents, disopyramide,
     fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline,
     pramlintide, salicylates, somatostatin analog (e.g., octreotide),
     sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and
     SGLT-2 inhibitors
   * Drugs that may decrease the blood glucose lowering effect: atypical
     antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol,
     diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives,
     phenothiazines, progestogens (e.g., in oral contraceptives), protease
     inhibitors, somatropin, sympathomimetic agents (e.g., albuterol,
     epinephrine, terbutaline), and thyroid hormones
   * Drugs that may increase or decrease the blood glucose lowering effect:
     alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
   * Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers,
     clonidine, guanethidine, and reserpine

Please click here for Tresiba® Prescribing Information.



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