palopegteriparatide
Yorvipath
Pharmaceutical company: Ascendis Pharma
Pharmacologic classification: Parathyroid hormone analog
Therapeutic classification: Endocrine & metabolic agent
AVAILABLE FORMS
Injection (prefilled pens): 168 mcg/0.56 mL delivering doses of 6, 9, or 12 mcg; 294 mcg/0.98 mL delivering doses of 15, 18, or 21 mcg; 420 mcg/1.4 mL delivering doses of 24, 27, or 30 mcg
INDICATIONS AND DOSAGES
Hypoparathyroidism
Adults: Initially, 18 mcg subcut once daily. Adjust in 3-mcg increments or decrements, to maintain serum calcium within normal range without the need for active vitamin D or therapeutic calcium doses. Don't increase dosage more often than every 7 days or decrease dosage more often than every 3 days. The recommended dosage range is 6 to 30 mcg once daily. Maximum, 30 mcg daily.
Adjust-a-dose: Adjust palopegteriparatide, active vitamin D, and calcium supplements based on albumin-corrected serum calcium and vitamin D level, according to the manufacturer's instructions. If albumin-corrected serum calcium is 12 mg/dL or greater, withhold palopegteriparatide for 2 to 3 days and then recheck serum calcium. If adequate response is not achieved with a maximum dosage of 30 mcg, consider adding or restarting calcium or active vitamin D therapy, or seek other treatment options.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in those with severe hypersensitivity to the drug or its excipients.
- Due to the risk of osteosarcoma, this drug isn't recommended in patients with open epiphyses, unexplained elevations of alkaline phosphatase, bone metastases or a history of skeletal malignancies, history of external beam or implant radiation therapy involving the skeleton, hereditary disorders predisposing to osteosarcoma, or metabolic bone diseases other than hypoparathyroidism, including Paget disease of bone.
- This drug isn't approved for acute postsurgical hypoparathyroidism.
- Serious hypercalcemia requiring hospitalization has occurred with palopegteriparatide. The risk is highest after starting or increasing the dose of this drug but may occur at any time.
- Serious hypocalcemia has occurred with palopegteriparatide. The risk is highest when the drug is abruptly discontinued but may occur at any time.
- Safety and effectiveness in children haven't been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- There are no adequate studies in pregnant patients. Hypocalcemia may cause an increased rate of spontaneous abortion, premature and dysfunctional labor, possibly fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica, and neonatal seizures.
- If the patient is or becomes pregnant while on this drug, health care providers should report exposure by calling 1-844-442-7236.
- Infants born to mothers with hypocalcemia should be monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability (myotonic jerks, seizures), apnea, cyanosis, and cardiac arrhythmias.
- There are no adequate studies of the use of this drug during breastfeeding, so use cautiously. Infants should be monitored for hypercalcemia or hypocalcemia.
INTERACTIONS
Drug-drug. Digoxin: May predispose patients who develop hypercalcemia to digitalis toxicity or may reduce digoxin efficacy if hypocalcemia is present. Use together cautiously. Measure digoxin levels, serum calcium, and monitor for digitalis toxicity. Adjust digoxin or palopegteriparatide dose as needed.
Drugs that affect serum calcium (lithium, thiazide diuretics, estrogens): May alter palopegteriparatide efficacy. Measure serum calcium more frequently and adjust dose as needed, especially after these drugs are initiated, discontinued, or dose-adjusted.
ADVERSE REACTIONS
CNS: headache, dizziness, presyncope, syncope, vertigo.
CV: orthostatic hypotension, palpitations, postural orthostatic tachycardiac syndrome.
EENT: oropharyngeal pain.
GI: diarrhea.
Metabolic: hypercalcemia.
Musculoskeletal: back, flank, or spinal pain.
Skin: injection site reactions.
Reactions in bold italics are life-threatening.
Released: January 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer
xanomeline and trospium chloride
Cobenfy
Pharmaceutical company: Bristol Myers-Squibb
Pharmacologic classification: Anticholinergic and cholinergic agonists
Therapeutic classification: Antipsychotics
AVAILABLE FORMS
Capsules: 50 mg xanomeline and 20 mg trospium; 100 mg xanomeline and 20 mg trospium; 125 mg xanomeline and 30 mg trospium
INDICATIONS AND DOSAGES
Schizophrenia
Adults: Initially, 50 mg xanomeline and 20 mg trospium PO b.i.d. for at least 2 days, then increase to 100 mg xanomeline and 20 mg trospium b.i.d. for at least 5 days. May increase to a maximum dosage of 125 mg xanomeline and 30 mg trospium b.i.d. based on tolerance and response.
Adjust-a-dose: For older adults, consider a slower titration and maximum dosage of 100 mg xanomeline and 20 mg trospium b.i.d.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with a history of hypersensitivity to xanomeline or trospium chloride. Angioedema has been reported with trospium chloride.
- Contraindicated in patients with urinary retention, Child-Pugh class B or C liver impairment, gastric retention, or untreated narrow-angle glaucoma.
- Use cautiously in older adults, patients with significant bladder outlet obstruction or incomplete bladder emptying (BPH, diabetic cystopathy) as they may be at an increased risk for urinary retention.
- Not recommended in patients with Child-Pugh class A liver impairment, estimated GFR less than 60 mL/minute, or active biliary disease, such as symptomatic gallstones.
- This drug may decrease GI motility. Use cautiously in patients with GI obstructive disorders, ulcerative colitis, intestinal atony, or myasthenia gravis because of the risk of gastric retention.
- Use cautiously in patients with narrow-angle glaucoma as pupillary dilation may occur triggering an acute angle closure attack.
- Safety and effectiveness in children haven't been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during pregnancy are inadequate. Consider the risks of untreated schizophrenia to the patient (relapse, hospitalization, suicide, preterm birth) and the risk to the fetus. Maternal and fetal toxicity were seen in animal studies.
- Encourage patient enrollment in pregnancy exposure registry (1-866-961-2388 or https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/).
- No data are available on the presence of this drug in human milk, the effects on the breastfed infant, or on milk production. This drug is likely excreted in human milk. Consider the benefit of breastfeeding, the mother's clinical need for the drug, and potential adverse effects on the breastfed infant.
INTERACTIONS
Drug-drug. Antimuscarinic drugs (diphenhydramine, scopolamine): May increase the frequency or severity of adverse reactions. Monitor for anticholinergic adverse reactions.
Drugs eliminated by active tubular secretion (cephalosporins, quinolone antibiotics, diuretics, antidiabetic agents, antiviral agents, some chemotherapy agents): May increase levels of trospium and the other drug competing for this elimination pathway. Use cautiously together and monitor for adverse reactions of both drugs.
Oral sensitive CYP3A4 substrates (amiodarone, cyclosporine, warfarin) or P-gp substrates (digoxin, diltiazem, morphine, sirolimus): May increase level of substrates. Use cautiously together and monitor for adverse reactions of the substrates.
Orally administered drugs: May decrease GI motility and alter absorption of some other oral drugs. Adjust dose of concomitantly administered drugs, as clinically needed.
Strong inhibitors of CYP2D6 (paroxetine, bupropion): May increase xanomeline level. Use cautiously together and monitor for adverse reactions.
ADVERSE REACTIONS
CNS: dizziness, somnolence, extrapyramidal symptoms.
CV: hypertension, tachycardia, orthostatic hypotension.
EENT: dry mouth, blurred vision, salivary hypersecretion.
GI: nausea, dyspepsia, constipation, vomiting, abdominal pain, diarrhea, gastroesophageal reflux disease.
GU: urinary retention, UTI.
Hepatic: elevated liver enzymes.
Respiratory: cough.
Reactions in bold italics are life-threatening.
Released: January 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer