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Interactions between Insulin glulisine and Ledipasvir / sofosbuvir

2 drug interactions and 15 additional warnings found for the following 2 drugs:

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Drug interactions

Moderate drug interactions

Moderate:

insulin glulisine sofosbuvir

Applies to: insulin glulisine and ledipasvir / sofosbuvir
Monitor

Clearance of hepatitis C virus (HCV) infection with direct acting antiviral agents (DAAs) may lead to changes in hepatic function which may result in altered blood glucose control. Serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. These cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.

Management

Blood glucose should be closely monitored during treatment of HCV with DAAs, particularly during the first 3 months, and appropriate changes made to the antidiabetic drug regimen as needed. The patient as well as the healthcare providers in charge of diabetic care should be apprised of the risk of hypoglycemia. Patients should be aware of the potential signs and symptoms of hypoglycemia such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, palpitation, and tachycardia. For antidiabetic medications that are not glucose-dependent, reduction in the dosage should be considered to mitigate the risk of hypoglycemia.

References (12)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences
  4. (2014) "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences
  5. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC
  6. (2015) "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb
  7. Cerner Multum, Inc (2015) "Malaysia product information."
  8. (2016) "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc
  9. (2016) "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences
  10. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences
  11. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical
  12. Drazilova S, Gazda J, Janicko M, Jarcuska P (2018) "Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy" Can J Gastroenterol Hepatol, 1, p. 1-11
Moderate:

insulin glulisine ledipasvir

Applies to: insulin glulisine and ledipasvir / sofosbuvir
Monitor

Clearance of hepatitis C virus (HCV) infection with direct acting antiviral agents (DAAs) may lead to changes in hepatic function which may result in altered blood glucose control. Serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. These cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.

Management

Blood glucose should be closely monitored during treatment of HCV with DAAs, particularly during the first 3 months, and appropriate changes made to the antidiabetic drug regimen as needed. The patient as well as the healthcare providers in charge of diabetic care should be apprised of the risk of hypoglycemia. Patients should be aware of the potential signs and symptoms of hypoglycemia such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, palpitation, and tachycardia. For antidiabetic medications that are not glucose-dependent, reduction in the dosage should be considered to mitigate the risk of hypoglycemia.

References (12)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences
  4. (2014) "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences
  5. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC
  6. (2015) "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb
  7. Cerner Multum, Inc (2015) "Malaysia product information."
  8. (2016) "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc
  9. (2016) "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences
  10. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences
  11. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical
  12. Drazilova S, Gazda J, Janicko M, Jarcuska P (2018) "Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy" Can J Gastroenterol Hepatol, 1, p. 1-11

Food/lifestyle interactions

Moderate food/lifestyle interactions

Moderate:

insulin glulisine Food/Lifestyle

Applies to: insulin glulisine
Generally avoid

Alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes. Hypoglycemia most frequently occurs during acute consumption of alcohol. Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise. The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia. Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion. By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia. Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes. A disulfiram-like reaction (e.g., flushing, headache, and nausea) to alcohol has been reported frequently with the use of chlorpropamide and very rarely with other sulfonylureas.

Management

Patients with diabetes should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis. Patients with well controlled diabetes should limit their alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with their normal meal plan. Alcohol should not be consumed on an empty stomach or following exercise.

References (11)
  1. Jerntorp P, Almer LO (1981) "Chlorpropamide-alcohol flushing in relation to macroangiopathy and peripheral neuropathy in non-insulin dependent diabetes." Acta Med Scand, 656, p. 33-6
  2. Jerntorp P, Almer LO, Holin H, et al. (1983) "Plasma chlorpropamide: a critical factor in chlorpropamide-alcohol flush." Eur J Clin Pharmacol, 24, p. 237-42
  3. Barnett AH, Spiliopoulos AJ, Pyke DA, et al. (1983) "Metabolic studies in chlorpropamide-alcohol flush positive and negative type 2 (non-insulin dependent) diabetic patients with and without retinopathy." Diabetologia, 24, p. 213-5
  4. Hartling SG, Faber OK, Wegmann ML, Wahlin-Boll E, Melander A (1987) "Interaction of ethanol and glipizide in humans." Diabetes Care, 10, p. 683-6
  5. (2002) "Product Information. Diabinese (chlorpropamide)." Pfizer U.S. Pharmaceuticals
  6. (2002) "Product Information. Glucotrol (glipizide)." Pfizer U.S. Pharmaceuticals
  7. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  8. Skillman TG, Feldman JM (1981) "The pharmacology of sulfonylureas." Am J Med, 70, p. 361-72
  9. (2002) "Position Statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes related complications. American Diabetes Association." Diabetes Care, 25(Suppl 1), S50-S60
  10. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  11. (2026) "Product Information. Awiqli FlexTouch (insulin icodec)." Novo Nordisk Pharmaceuticals Inc

Disease interactions

14 potential interactions Applies to: 11 conditions, including Hypokalemia, Adrenal Insufficiency, Liver Disease, Cirrhosis, and Immunodeficiency.

Adrenal Insufficiency

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Adrenal Insufficiency.

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

Anorexia/Feeding Problems

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Anorexia/Feeding Problems.

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

Autonomic Neuropathy

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Autonomic Neuropathy.

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

Cirrhosis

Moderate:

ledipasvir / sofosbuvir

The sofosbuvir in ledipasvir / sofosbuvir has a moderate potential interaction with Cirrhosis.

Sofosbuvir is extensively metabolized in the liver. The safety and efficacy of sofosbuvir as a single agent have not been established in patients with decompensated cirrhosis. No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C).

Hypokalemia

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Hypokalemia.

Hypokalemia may commonly occur during treatment with insulin. Use with caution in patients who may be particularly at risk of developing hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

Immunodeficiency

Major:

ledipasvir / sofosbuvir

The sofosbuvir in ledipasvir / sofosbuvir has a major potential interaction with Immunodeficiency.

HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in hepatitis B surface antigen (HBsAg)-positive patients and patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and hepatitis B core antibody [anti-HBc] positive). HBV reactivation has also been reported in patients using certain immunosuppressant or chemotherapeutic agents; risk of HBV reactivation associated with HCV direct-acting antiviral therapy may be increased in these patients. All patients should be tested for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before starting HCV direct-acting antiviral therapy. Patients with serologic evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

Infectious Hepatitis

Major:

ledipasvir / sofosbuvir

The sofosbuvir in ledipasvir / sofosbuvir has a major potential interaction with Infectious Hepatitis.

HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in hepatitis B surface antigen (HBsAg)-positive patients and patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and hepatitis B core antibody [anti-HBc] positive). HBV reactivation has also been reported in patients using certain immunosuppressant or chemotherapeutic agents; risk of HBV reactivation associated with HCV direct-acting antiviral therapy may be increased in these patients. All patients should be tested for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before starting HCV direct-acting antiviral therapy. Patients with serologic evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

Liver Disease

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Liver Disease.

Insulin requirements may be diminished in patients with renal or hepatic impairment due to reduced insulin metabolism and, in the latter case, also to reduced capacity for gluconeogenesis. Lower initial dosages may be appropriate, with careful monitoring of plasma glucose levels and dosing adjustments.

Moderate:

ledipasvir / sofosbuvir

The sofosbuvir in ledipasvir / sofosbuvir has a moderate potential interaction with Liver Disease.

Sofosbuvir is extensively metabolized in the liver. The safety and efficacy of sofosbuvir as a single agent have not been established in patients with decompensated cirrhosis. No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C).

Malnourishment

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Malnourishment.

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

Panhypopituitarism

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Panhypopituitarism.

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

Renal Dysfunction

Moderate:

insulin glulisine

Insulin glulisine has a moderate potential interaction with Renal Dysfunction.

Insulin requirements may be diminished in patients with renal or hepatic impairment due to reduced insulin metabolism and, in the latter case, also to reduced capacity for gluconeogenesis. Lower initial dosages may be appropriate, with careful monitoring of plasma glucose levels and dosing adjustments.

Moderate:

ledipasvir / sofosbuvir

The sofosbuvir in ledipasvir / sofosbuvir has a moderate potential interaction with Renal Dysfunction.

The safety and efficacy of sofosbuvir as a single agent have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73m2) or ESRD requiring hemodialysis. No dosage recommendation can be given for patients with severe renal impairment or ESRD. No dosage adjustment is necessary for patients with mild or moderate renal impairment.

Moderate:

ledipasvir / sofosbuvir

The ledipasvir in ledipasvir / sofosbuvir has a moderate potential interaction with Renal Dysfunction.

The use of products containing ledipasvir and sofosbuvir in patients with mild or moderate renal impairment does not require dosage adjustment. Exercise care when using in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or ESRD requiring hemodialysis as the safety and efficacy has not been established, and no dosage recommendation can be given for these patients.

More resources

insulin glulisine

A total of 458 drugs are known to interact with insulin glulisine.

ledipasvir / sofosbuvir

A total of 187 drugs are known to interact with ledipasvir / sofosbuvir.

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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