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Yorvipath
palopegteriparatide
Adult Dosing .
Dosage forms: INJ (pen): 168 mcg per 0.56 mL, 294 mcg per 0.98 mL, 420 mcg per 1.4 mL
Special Note
- [strength clarification]
- Info: 168 mcg per 0.56 mL pen delivers 6 mcg, 9 mcg, 12 mcg doses; 294 mcg per 0.98 mL pen delivers 15 mcg, 18 mcg, 21 mcg doses; 420 mcg per 1.4 mL pen delivers 24 mcg, 27 mcg, 30 mcg doses
hypoparathyroidism
- [6-30 mcg SC qd]
- Start: 18 mcg SC qd, may incr. by 3 mcg/dose no more frequently than q7 days or may decr. by 3 mcg/dose no more frequently than q3 days based on corrected Ca levels; Max: 30 mcg/day; Info: for patients with corrected Ca level >7.8 mg/dL; see pkg insert for dose adjustments based on corrected Ca level, Ca supplements, and active vitamin D intake
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- abrupt withdrawal
- Paget bone disease
- epiphysis, open
- bone XRT history
- skeletal malignancy history
- bone metastases
- metabolic bone disease
- hereditary disorder with osteosarcoma risk
- alk phos elevated, unexplained
- baseline corrected Ca <7.8 mg/dL
- corrected Ca >12 mg/dL
- caution: corrected Ca 7.8-11.9 mg/dL
Drug Interactions .
Overview
palopegteriparatide
parathyroid hormone analog
- hypercalcemia
- hypocalcemia
- hypotensive effects
Avoid/Use Alternative
- aldesleukin
- lofexidine
Monitor/Modify Tx
- abaloparatide
- acebutolol
- alendronate
- alfentanil
- alfuzosin
- aliskiren
- alprostadil intracavernous
- amantadine
- amifostine
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- apomorphine
- apraclonidine ophthalmic
- aprocitentan
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- articaine
- asenapine
- atenolol
- avanafil
- azilsartan medoxomil
- benazepril
- berberine
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bexagliflozin
- bisoprolol
- bortezomib
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- bumetanide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- burosumab
- butorphanol
- cabergoline
- cabozantinib
- calcipotriene topical
- calcitonin-salmon
- calcitriol
- calcitriol topical
- calcium acetate
- calcium carbonate
- calcium chloride
- calcium citrate
- calcium gluconate
- canagliflozin
- candesartan cilexetil
- cannabis
- captopril
- cariprazine
- carteolol ophthalmic
- carvedilol
- cetuximab
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cholecalciferol (vitamin D3)
- cilostazol
- cinacalcet
- cisplatin
- clevidipine
- clofarabine
- clomipramine
- clonidine
- clozapine
- codeine
- coenzyme Q-10
- dapagliflozin
- denileukin diftitox
- denosumab
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- digoxin
- dihydrocodeine
- diltiazem
- dinutuximab
- dipyridamole
- doxazosin
- doxepin
- doxercalciferol
- dronabinol
- duloxetine
- empagliflozin
- enalapril
- enalaprilat
- entacapone
- entrectinib
- eplerenone
- epoprostenol
- ergocalciferol (vitamin D2)
- ertugliflozin
- esmolol
- etelcalcetide
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethanol injection
- etripamil nasal
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- flaxseed
- flibanserin
- fluphenazine
- foscarnet
- fosfomycin injection
- fosinopril
- foslevodopa
- furosemide
- garlic
- gentamicin
- gilteritinib
- guanfacine
- haloperidol
- hydralazine
- hydrochlorothiazide
- hydrocodone
- hydromorphone
- ibandronate
- iloperidone
- iloprost
- imipramine
- indapamide
- irbesartan
- iron sucrose
- isocarboxazid
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- labetalol
- landiolol
- lenalidomide
- lenvatinib
- leucovorin
- levobunolol ophthalmic
- levodopa
- levorphanol
- lidocaine
- lisinopril
- losartan
- loxapine
- lubiprostone
- lumateperone
- lurasidone
- magnesium sulfate
- maraviroc
- meperidine
- mepivacaine
- methadone
- methohexital
- methyldopa
- methylene blue injection
- methyltestosterone
- metolazone
- metoprolol
- midazolam
- milrinone
- milsaperidone
- minoxidil
- mirtazapine
- moexipril
- molindone
- morphine
- nadolol
- nalbuphine
- nattokinase
- naxitamab
- nebivolol
- necitumumab
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- obinutuzumab
- olanzapine
- oliceridine
- olmesartan medoxomil
- opicapone
- opium
- oxazepam
- oxycodone
- oxymorphone
- paliperidone
- pamidronate
- panitumumab
- paricalcitol
- pentamidine
- pentazocine
- pentobarbital
- perindopril
- perphenazine
- phenelzine
- phenobarbital
- phenoxybenzamine
- phentolamine
- pindolol
- pralsetinib
- pramipexole
- prazosin
- procarbazine
- prochlorperazine
- promethazine
- propafenone
- propofol
- propranolol
- protriptyline
- quetiapine
- quinapril
- ramipril
- rasagiline
- remifentanil
- remimazolam
- riociguat
- risedronate
- risperidone
- romidepsin
- romosozumab
- ropinirole
- ropivacaine
- rotigotine transdermal
- sacubitril
- safinamide
- selegiline
- selegiline transdermal
- sevoflurane
- sildenafil
- silodosin
- sodium ferric gluconate complex
- sodium polystyrene sulfonate
- sotagliflozin
- sotalol
- sparsentan
- spironolactone
- sufentanil
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- telmisartan
- terazosin
- teriparatide
- testosterone
- thalidomide
- thioridazine
- thiothixene
- timolol
- timolol ophthalmic
- tizanidine
- tobramycin
- tolcapone
- torsemide
- tramadol
- trandolapril
- tranylcypromine
- trazodone
- treprostinil
- triamterene
- trifluoperazine
- trimipramine
- valsartan
- vardenafil
- verapamil
- vosoritide
- yohimbe
- ziprasidone
- zoledronic acid
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- angioedema
- osteosarcoma
- hypercalcemia
- hypocalcemia
- hypotension, orthostatic
- syncope
Common Reactions
- injection site reaction
- vasodilatory symptoms
- headache
- diarrhea
- back pain
- hypercalcemia
- oropharyngeal pain
Safety/Monitoring .
Monitoring Parameters
vitamin D at baseline if none within 2wk of tx start; Ca at baseline if none within 2 wk of tx start, then 7-10 days after tx start, dose adjustment, or tx interruption >3 days, then q4-6wk after maintenance dose achieved or more frequently if clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at 13x and 16x MRHD
Pregnancy Reporting
report any suspected fetal exposure to Ascendis Pharma pregnancy safety study at 1-844-442-7236
Lactation
weigh risk/benefit while breastfeeding; consider monitoring infant Ca levels while breastfeeding; no human data available, though theoretical risk of infant hypercalcemia or hypocalcemia based on drug's mechanism of action; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for palopegteriparatide: unknown; CYP450: unknown
Excretion: for palopegteriparatide: unknown; Half-life: 60h
Subclass: Calcium Disorders ; Parathyroid Disorders: Hypoparathyroidism
Mechanism of Action
for palopegteriparatide: prodrug converted to teriparatide, which binds to parathyroid hormone type 1 receptors and stimulates renal Ca reabsorption, intestinal Ca absorption, and bone turnover, increasing serum Ca levels (parathyroid hormone analog)
Formulary .
No Formulary Selected
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