TEP-roe-TOOM-ue-mab

Therapeutic Classification: n/a

Pharmacologic Classification: monoclonal antibodies

• Thyroid eye disease.

• Exact mechanism in thyroid eye disease not fully characterized. Inhibits insulin-like growth factor-1 receptors.

• Reduction in proptosis (eyeball protrusion)

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to extravascular tissues.

Metabolism/Excretion: Metabolized via proteolytic degradation. Excretion pathway not characterized.

Half-life: 20 days.

(plasma concentrations)

Contraindicated in:

• OB: Pregnancy.

Use Cautiously in:

• Inflammatory bowel disease (may cause exacerbation)
• Diabetes
• Lactation: Safety not established in breastfeeding
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

Derm: alopecia, dry skin.

EENT: hearing impairment.

Endo: hyperglycemia.

GI: diarrhea, nausea.

MS: muscle spasms.

Neuro: dysgeusia, headache.

Misc: fatigue, infusion reactions.

Drug-Drug:

• None reported.

• IV (Adults): 10 mg/kg initially, then 20 mg/kg every 3 wk for 7 additional doses.

• Lyophilized powder for injection: 500 mg/vial;

• Monitor for signs and symptoms of infusion reaction (transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, muscular pain) during or within 90 min of infusion. Reactions are usually mild to moderate and can be managed with corticosteroids and antihistamines. If infusion reaction occurs, consider pre-medicating with an antihistamine, antipyretic, corticosteroid and/or administering all subsequent infusions at a slower rate.
• Monitor patients with inflammatory bowel disease (IBD) for flare of disease. If IBD exacerbation is suspected, consider discontinuation of therapy.

• Assess for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor during therapy. Ensure patients with hyperglycemia or preexisting diabetes are under glycemic control before and during therapy.

IV Administration:

• Intermittent Infusion: Reconstitution: Reconstitute each vial with 10 mL of Sterile Water for Injection. Powder has a cake-like appearance. Ensure stream of diluent is not directed onto the powder. Do not shake; gently swirl solution by rotating vial until powder is dissolved. Concentration: Final concentration is 47.6 mg/mL.
  Diluent: Further dilute in 0.9% NaCl. To maintain a constant volume in infusion bag, use a sterile syringe and needle to remove volume equivalent to amount of reconstituted solution to be placed into infusion bag. Withdraw required volume from reconstituted vial(s) based on the patient’s weight (in kg) and transfer into an IV bag containing 0.9% NaCl for a total volume of 100 mL (for <1800 mg dose) or 250 mL (for 1800 mg and greater dose). Mix diluted solution by gentle inversion. Do not shake. Diluted solution is stable for 4 hrs at room temperature or up to 48 hrs if refrigerated; protected from light. If refrigerated prior to administration, allow diluted solution to reach room temperature prior to infusion. Solution is colorless or slightly brown, clear to opalescent; do not administer solutions that are cloudy, discolored, or contain particulate matter.
• Infuse over 90 min for first two infusions. If well tolerated, may reduce subsequent infusions to 60 min. If not well tolerated, continue at 90 min. Do not administer as IV push or bolus.
• Y-Site Incompatibility: Do not infuse concomitantly with other agents.
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• Explain purpose of teprotumumab to patient.
• Advise patient to notify health care professional if symptoms of infusion reaction occur.
• Inform patient of risk of IBD. Instruct patient to notify health care professional immediately if diarrhea, with or without blood or rectal bleeding, associated with abdominal pain or cramping/colic, urgency, tenesmus or incontinence occurs.
• May cause hyperglycemia. If diabetic, Advise patient to discuss with health care professional need to adjust glycemic control measures including medications as appropriate. Encourage compliance with glycemic control.
• Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional immediately if pregnancy is planned or suspected; discontinue teprotumumab if pregnancy occurs. Advise females of reproductive potential to use effective contraception during therapy and for 6 mo following last dose.

• Reduction in proptosis (eyeball protrusion)

Tepezza