Names and pronunciation
(sin-a-kal′set) Sensipar
PDF page 280
Loading InternPractice…
Drug reference
(sin-a-kal′set) Sensipar
PDF page 280
Func. class.: Hyperparathyroidism agent, calcium receptor agonist
PDF page 280
Chem. class.: Polypeptide hormone
PDF page 280
ACTION: Directly lowers PTH levels by increasing sensitivity of calcium-sensing receptors to extracellular calcium
PDF page 280
USES: Hypercalcemia with parathyroid carcinoma, secondary hyperparathyroid- ism with chronic kidney disease for patient on dialysis, primary hyperparathyroidism
PDF page 280
CONTRAINDICATIONS: Hyper- sensitivity, hypocalcemia Precautions: Pregnancy, breastfeeding, children, seizure disorders, hepatic disease
PDF page 280
SIDE EFFECTS CNS: Dizziness, asthenia, seizures, pares- thesia, fatigue, headache CV: Dysrhythmia hypotension GI: Nausea, diarrhea, vomiting, anorexia, constipation MISC: Infection, dehydration, hypercal- cemia, anemia, hypocalcemia MS: Myalgia, bone fractures binding
PDF page 281
INTERACTIONS Increase: cinacalcet levels—CYP3A4 inhib- itors (ketoconazole, erythromycin, itracon- azole), dose may need to be reduced Increase: levels of CYP2D6 inhibitors (fle- cainide, vinBLAStine, thioridazine, tricyclics) Drug/Food Increase: action by high-fat meal
PDF page 281
DOSAGE AND ROUTES Parathyroid carcinoma • Adult: PO 30 mg bid, titrate q2-4wk, with sequential doses of 30 mg bid, 60 mg bid, 90 mg bid, 90 mg tid-qid to normalize calcium levels Secondary hyperparathyroidism • Adult: PO 30 mg/day, titrate no more frequently than q2-4wk with sequential doses of 30, 60, 90, 120, 180 mg/day Primary hyperparathyroidism • Adult: PO 30 mg bid, titrate q2-4wk to target calcium levels
PDF page 280
Available forms: Tablets 30, 60, 90 mg
PDF page 280
Administer: • Swallow tablets whole; do not break, crush, or chew; use with food or right after a meal • Can be used alone or in combination with vitamin D sterols, phosphate binders • Storage at <77°F (25°C) Chronic kidney disease: Titrate q2-4wk to target iPTH consistent with National Kidney Foundation–Kidney Disease Out- comes Quality Initiative (NKF-K/DOQI) for chronic kidney disease patient on dialysis of 150-300 pg/mL; if iPTH <150-300 pg/ mL, reduce dose of cinacalcet and/or vita- min D sterols or discontinue treatment
PDF pages 280, 281
Assess: • Hypocalcemia: cramping, seizures, tetany, myalgia, paresthesia; calcium, phosphorous within 1 wk and iPTH 1-4 wk after initiation or dosage adjustment when maintenance established; measure calcium, phosphorus monthly; iPTH q1- 3mo, target range 150-300 pg/mL for iPTH level; biochemical markers of bone formation/resorption; radiologic evi- dence of fracture; serum testosterone • Renal disease (without dialysis): these patients should not receive treat- ment with this product; high risk of hy- pocalcemia • Liver studies in those with liver disease • If calcium <8.4 mg/dL, do not start; if calcium is 7.5-8.4 mg/dL, give calcium- containing phosphate binders, vitamin D sterols to increase calcium; if calcium <7.5 mg/dL or if symptoms of hypocalce- mia continue and vitamin D cannot be in- creased, withhold until calcium reaches C 8.0 mg/dL, symptoms resolve, start prod- uct at next lowest dose • Pregnancy/breastfeeding: no well- controlled studies, use only if benefits outweigh fetal risk; those who are preg- nant should enroll in Amgen’s Pregnancy Surveillance Program (800-772-6436); discontinue breastfeeding or product, it is unknown if excreted in breast milk
PDF page 281
Evaluate: • Therapeutic response: calcium levels 9-10 mg/dL, decreasing symptoms of hy- percalcemia
PDF page 281
CLINICAL CONSIDERATIONS
PDF page 281
Patient and caregiver information: • To take with food or shortly after a meal; to take tablets whole, not to take any other meds, supplements without pre- scriber approval • Hypocalcemia: to report cramping, seizures, muscle pain, tingling, tetany im- mediately • To continue exams and lab work
PDF page 281
PHARMACOKINETICS 93%-97% plasma; proteins metabolized by CYP3A4, 2D6, 1A2; half-life 30-40 hr; renal excretion of metabolites (80% renal, 15% in feces)
PDF page 281
• Adult: PO 30 mg bid, titrate q2-4wk, with sequential doses of 30 mg bid, 60 mg bid, 90 mg bid, 90 mg tid-qid to normalize calcium levels Secondary hyperparathyroidism
PDF page 280
• Adult: PO 30 mg/day, titrate no more frequently than q2-4wk with sequential doses of 30, 60, 90, 120, 180 mg/day Primary hyperparathyroidism
PDF page 280
• Adult: PO 30 mg bid, titrate q2-4wk to target calcium levels
PDF page 280