Teduglutide

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if teduglutide passes into your breast milk. You and your healthcare provider should decide if you will use teduglutide or breastfeed. You should not do both.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Usual Adult Dose for Short Bowel Syndrome:

0.05 mg/kg administered by subcutaneous injection once a day.

Use: Treatment of patients with Short Bowel Syndrome who are dependent on parenteral support.

General

Restricted Distribution Program

• Teduglutide can be obtained only through a network of designated specialty home infusion providers.19 20

• Clinician and patient must complete a referral form (available at ) that serves as the teduglutide prescription and also registers patient and clinician's office with NPS Advantage, a manufacturer-sponsored program that provides reimbursement assistance and clinical support services for patients and clinicians.19 20 21

• Additional information available at or at 855-832-6677.20 21

Patient Monitoring

• Determine urine output (ideally 1–2 L per day) prior to initiation of therapy.3

• Reassess urine output 2–4 weeks following initiation of therapy; reduce parenteral support volume by 10–30% if urine output has increased from pretreatment levels by ≥10%.3 (See Fluid Overload under Cautions.) Assess patient's tolerance of parenteral volume adjustments 1–2 weeks after implementation.3

• Monitor urine output regularly and adjust parenteral support volume accordingly, with the goal of reducing or eliminating need for parenteral support while maintaining patient's nutritional status.3

• Carefully monitor fluid and electrolyte status if drug is discontinued, since fluid and electrolyte imbalance may occur.1

Administration

Administer by sub-Q injection; do not administer IV or IM.1

Patient may self-administer drug after receiving training from healthcare provider.1

Sub-Q Administration

Administer once daily.1

Inject sub-Q into abdomen, thighs, or upper arms; rotate sites.1

If dose is missed, administer missed dose as soon as possible; do not administer 2 doses on same day.1

Use strict aseptic technique since drug product contains no preservative.1 Vials are for single use only.1

Slowly inject contents of manufacturer-supplied prefilled diluent syringe (0.5 mL of sterile water for injection) into vial containing 5 mg of teduglutide to provide a solution containing 10 mg/mL.1 Reconstituted vial can deliver maximum volume of 0.38 mL (3.8 mg).1

Allow vial to stand for 30 seconds, then roll gently between palms for 15 seconds to dissolve.1 Do not shake vial.1

Allow vial to stand again for about 2 minutes.1 If powder not fully dissolved, attempt to dissolve by rolling between the palms once again.1 Thereafter, discard the vial if any undissolved material remains.1

Use manufacturer-supplied dosing syringe and needle to withdraw desired dose.1

Dosage

Adults

0.05 mg/kg once daily.1

Special Populations

Hepatic Impairment

No dosage adjustment necessary in patients with mild or moderate hepatic impairment.1 (See Hepatic Impairment under Cautions.)

Not studied in patients with severe hepatic impairment.1

Renal Impairment

In patients with Clcr <50 mL/minute, reduce dosage by 50% (i.e., to 0.025 mg/kg once daily).1 14 (See Special Populations under Pharmacokinetics.)

Geriatric Patients

No dosage adjustment necessary in geriatric patients >65 years of age.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of teduglutide is restricted.19 20 (See Restricted Distribution Program under Dosage and Administration.)

(te due GLOO tide)

Teduglutide exposure is decreased in patients with moderate hepatic impairment.

Short bowel syndrome: Treatment of short bowel syndrome in adults who are dependent on parenteral support.

Mild-to-moderate impairment (Child-Pugh class B): No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Reconstitute each vial with 0.5 mL of preservative-free SWFI (provided in syringe); let stand for 30 seconds and then roll vial between palms for 15 seconds. Do not shake. Allow vial to stand for an additional ~2 minutes; if undissolved material remains, roll between palms again. If particles are not dissolved after second attempt, discard vial. Once reconstituted, each vial provides 3.8 mg/0.38 mL (concentration is 10 mg/mL).

SubQ: Rotate injection site between thighs, upper arms, and quadrants of the abdomen. Do not administer IM or IV

Prior to dispensing, store intact vials refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. The carton of ancillary supplies should be stored at 25°C (77°F). After dispensing, store vials at 25°C (77°F); once dispensed, vials must be used within 90 days. Once reconstituted, store at <25°C (77°F); do not shake or freeze; use within 3 hours. Discard any unused portion.

Benzodiazepines: Teduglutide may increase the serum concentration of Benzodiazepines. Monitor therapy

Concerns related to adverse effects:

• Colorectal polyps: Short bowel syndrome: Development of colorectal polyps has occurred. Preform a baseline colonoscopy of the entire colon with polyp removal ≤6 months prior to initiation of therapy. Follow-up colonoscopy (or alternative imaging) should be performed at 1 year and at least every 5 years, thereafter. Discontinue teduglutide in patients who develop colorectal cancer.

• Fluid overload: Increased fluid absorption and subsequent fluid overload/congestive heart failure has been reported; consider modification of parenteral support in patients who develop fluid overload, especially in patients with underlying cardiovascular disease. If significant cardiac deterioration develops, reassess the need for continued teduglutide treatment.

• Gallbladder/biliary tract disease: Cholecystitis, cholangitis, and cholelithiasis have been reported; monitor serum bilirubin and alkaline phosphatase ≤6 month prior to initiation of therapy and at least every 6 months for duration of therapy. If clinically meaningful changes are detected, perform gallbladder/biliary tract imaging and reassess the need for continued teduglutide treatment.

• Intestinal obstruction: Temporarily discontinue treatment in patients that develop intestinal or stomal obstruction; teduglutide may be resumed (if clinically indicated) once the obstruction is resolved.

• Malignancy: Teduglutide may increase the risk of hyperplastic changes, including neoplasia. In patients at increased risk for malignancy, consider treatment only if benefits outweigh the risks. Discontinue treatment in patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic); evaluate risk versus benefit in patients with active non-GI malignancy. Monitor for small bowel neoplasia; remove any benign neoplasm. Discontinue in patients who develop small bowel cancer.

• Pancreatitis: Pancreatitis has been reported; monitor serum lipase and amylase ≤6 months prior to initiation of therapy and at least every 6 months for duration of therapy. If clinically meaningful changes are detected, evaluate for pancreatitis and reassess the need for continued teduglutide treatment.

Concurrent drug therapy issues:

• Oral medications: Teduglutide may increase absorption of oral medications; monitor therapy of medications with a narrow therapeutic index.

Special populations:

• Renal function impairment: Use with caution; reduced doses required in moderate to severe renal impairment and end-stage renal disease (ESRD).

Other warnings/precautions:

• Discontinuation: Treatment discontinuation may result in fluid and electrolyte imbalance. Carefully monitor fluid/electrolyte status.