Colesevelam

Colesevelam may decrease exposure of cyclosporine. In vivo studies showed decreased cyclosporine exposure when coadministered with colesevelam.

7.6Bile Acid Sequestrants Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with deferasirox due to a possible decrease in deferasirox concentration.

Colesevelam may decrease exposure of levothyroxine. In vivo studies showed decreased levothyroxine exposure; postmarketing reports of elevated TSH.

Bile acid sequestrant that significantly decreases the AUC of ethinyl estradiol, potentially diminishing contraceptive effectiveness.

Colesevelam may decrease phenytoin levels. Postmarketing reports of increased seizure activity in patients receiving phenytoin with colesevelam.

Colesevelam may decrease warfarin exposure and INR. Monitor INR frequently during initiation and periodically thereafter.

Bile acid binding resin that adsorbs and reduces bile acid absorption, potentially reducing CHOLBAM efficacy. Take CHOLBAM at least 1 hour before or 4-6 hours after.

Bile acid sequestrant that significantly decreases the AUC of ethinyl estradiol, potentially diminishing contraceptive effectiveness.

Colesevelam may decrease exposure of oral contraceptives containing ethinyl estradiol and norethindrone.

Reduces glyburide AUC by 32% and Cmax by 47% when coadministered; effect depends on timing of administration.

Coadministration may reduce glimepiride absorption. Glimepiride should be administered at least 4 hours prior to colesevelam.

Colesevelam reduces glipizide ER AUC and Cmax by 12-13% when coadministered. Glipizide should be administered at least 4 hours prior to colesevelam.

Colesevelam reduces glipizide ER AUC by 12% and Cmax by 13% when coadministered, but not when glipizide ER is given 4 hours prior.

May reduce glyburide absorption by 32-47%; administer glyburide and metformin at least 4 hours prior to colesevelam.

Reduces glyburide absorption by 32% (AUC) and 47% (Cmax). Separate dosing by 4 hours.

Colesevelam significantly decreases the AUC of ethinyl estradiol. Taking colesevelam 4 hours apart from the COC may decrease this interaction.

Bile acid sequestrant significantly decreases AUC of ethinyl estradiol; effect reduced when given 4 hours apart.

Significantly decreases systemic exposure of ethinyl estradiol, potentially reducing contraceptive efficacy or increasing breakthrough bleeding.

Bile acid sequestrant known to decrease levothyroxine absorption, potentially resulting in hypothyroidism.

Bile acid sequestrant that may decrease T3 absorption by binding and delaying or preventing absorption, potentially resulting in hypothyroidism. Administer liothyronine sodium at least 4 hours prior.

Bile acid binding resin may bind to maralixibat in the gut. Administer LIVMARLI at least 4 hours before or after colesevelam.

Colesevelam may increase exposure of metformin extended release. Monitor patients' glycemic control.

Colesevelam may decrease exposure of oral contraceptives containing ethinyl estradiol and norethindrone.

Bile acid sequestrant that significantly decreases AUC of ethinyl estradiol; separation of dosing by 4 hours may mitigate interaction.

Significantly decreases AUC of ethinyl estradiol; effect reduced when given 4 hours apart.

Bile acid binding resins may bind odevixibat in the gut, reducing BYLVAY efficacy. Administer at least 4 hours before or after odevixibat.

Colesevelam may decrease exposure of olmesartan medoxomil. Administer at least 4 hours prior to colesevelam.

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects; increased risk of renal toxicity ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide with other drugs that raise serum potassium levels may result in hyperkalemia. 7.5 Colesevelam Hydrochloride Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects; increased risk of renal toxicity ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide with other drugs that raise serum potassium levels may result in hyperkalemia. 7.5 Colesevelam H ydrochloride Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.

May reduce glimepiride absorption. Pioglitazone and glimepiride should be administered at least 4 hours prior to colesevelam.

Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.

7 DRUG INTERACTIONS Concomitant use with colesevelam hydrochloride may decrease the exposure of the following drugs: Drugs with a narrow therapeutic index (e.g., cyclosporine), phenytoin, thyroid hormone replacement therapy, warfarin, oral contraceptives containing ethinyl estradiol and norethindrone, olmesartan medoxomil, and sulfonylureas (glimepiride, glipizide, glyburide). Administer these drugs 4 hours prior to colesevelam hydrochloride. Concomitant use with colesevelam hydrochloride may increase the exposure of the following drugs: Metformin extended release.

7 DRUG INTERACTIONS Concomitant use with colesevelam hydrochloride may decrease the exposure of the following drugs: Drugs with a narrow therapeutic index (e.g., cyclosporine), phenytoin, thyroid hormone replacement therapy, warfarin, oral contraceptives containing ethinyl estradiol and norethindrone, olmesartan medoxomil, and sulfonylureas (glimepiride, glipizide, glyburide). Olmesartan Medoxomil Clinical Impact In vivo drug interactions studies showed a decrease in olmesartan medoxomil when coadministered with colesevelam hydrochloride [see Clinical Pharmacology ( 12.3 )] . Intervention Administer olmesartan medoxomil 4 hours prior to colesevelam hydrochloride.

Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.

• Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Use with Colesevelam Hydrochloride Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.