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Drug Interactions between sotagliflozin and Viekira Pak

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

ritonavir sotagliflozin

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir) and sotagliflozin

MONITOR: Coadministration with inducers of uridine diphosphate glucuronosyl transferase (UGT) enzymes may decrease the plasma concentrations of sotagliflozin, which is primarily metabolized by UGT1A9. When sotagliflozin (400 mg single dose) was coadministered with rifampin (multiple 600 mg doses), sotagliflozin peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 40% and 55%, respectively. Reduced efficacy of sotagliflozin may occur.

MANAGEMENT: Clinical and laboratory monitoring may be considered whenever a UGT inducer is added to or withdrawn from sotagliflozin therapy.

References

  1. (2023) "Product Information. Inpefa (sotagliflozin)." Lexicon Pharmaceuticals, Inc.

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Moderate

ombitasvir sotagliflozin

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir) and sotagliflozin

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

  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
View all 11 references

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Moderate

paritaprevir sotagliflozin

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir) and sotagliflozin

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

  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
View all 11 references

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Moderate

dasabuvir sotagliflozin

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir) and sotagliflozin

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

  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
View all 11 references

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Drug and food interactions

Moderate

ritonavir food

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Administration with food may modestly affect the bioavailability of ritonavir from the various available formulations. When the oral solution was given under nonfasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption decreased 7% relative to fasting conditions. Dilution of the oral solution (within one hour of dosing) with 240 mL of chocolate milk or a nutritional supplement (Advera or Ensure) did not significantly affect the extent and rate of ritonavir absorption. When a single 100 mg dose of the tablet was administered with a high-fat meal (907 kcal; 52% fat, 15% protein, 33% carbohydrates), approximately 20% decreases in mean peak concentration (Cmax) and systemic exposure (AUC) were observed relative to administration after fasting. Similar decreases in Cmax and AUC were reported when the tablet was administered with a moderate-fat meal. In contrast, the extent of absorption of ritonavir from the soft gelatin capsule formulation was 13% higher when administered with a meal (615 KCal; 14.5% fat, 9% protein, and 76% carbohydrate) relative to fasting.

MANAGEMENT: Ritonavir should be taken with meals to enhance gastrointestinal tolerability.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical

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Moderate

paritaprevir food

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ombitasvir, paritaprevir, ritonavir, and dasabuvir. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a moderate-fat meal (approximately 600 Kcal; 20% to 30% calories from fat) increased the mean systemic exposure (AUC) by 82%, 211%, 49%, and 30%, respectively. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a high-fat meal (approximately 900 Kcal; with 60% calories from fat) increased the mean AUC by 76%, 180%, 44%, and 22%, respectively.

MANAGEMENT: Ombitasvir/paritaprevir/ritonavir plus dasabuvir should always be administered with a meal. The fat or calorie content does not matter.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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Moderate

sotagliflozin food

Applies to: sotagliflozin

ADJUST DOSING INTERVAL: Coadministration with a high-caloric meal may increase the bioavailability of sotagliflozin. When coadministered with a high-caloric breakfast, sotagliflozin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 149% and 50%, respectively, compared to fasting conditions. Multiple sotagliflozin doses (400 mg) administered immediately before breakfast, 30 minutes before breakfast, and 1 hour before breakfast in healthy subjects showed a consistent effect on urine glucose excretion, insulin, and postprandial glucose across all dose schedules.

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.

MANAGEMENT: Sotagliflozin should be administered no more than 1 hour before the first meal of the day. 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

  1. (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
  2. (2023) "Product Information. Inpefa (sotagliflozin)." Lexicon Pharmaceuticals, Inc.

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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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.

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