Side effects of sensipar

Sensipar

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of labeling:

  • Hypocalcemia
  • Upper Gastrointestinal Bleeding
  • Adynamic Bone Disease
  • Hepatic Impairment

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease On Dialysis

In three double-blind, placebo-controlled clinical trials, 1126 patients with CKD on dialysis received study drug (656 Sensipar, 470 placebo) for up to 6 months. The most frequently reported adverse reactions are listed in Table 1.

Table 1. Adverse Reactions with Frequency ≥ 5% in Patients on Dialysis in Short-Term Studies for up to 6 Months

Placebo
(n = 470)
Sensipar
(n = 656)
Event*: (%) (%)
Nausea 19 31
Vomiting 15 27
Diarrhea 20 21
Myalgia 14 15
Dizziness 8 10
Hypertension 5 7
Asthenia 4 7
Anorexia 4 6
Pain Chest, Non-Cardiac 4 6
Dialysis Access Site Infection 4 5
*Included are events that were reported at a greater incidence in the Sensipar group than in the placebo group.

In a randomized, double-blind placebo-controlled study of 3883 patients with secondary HPT and CKD receiving dialysis in which patients were treated for up to 64 months (mean duration of treatment was 21 months in the Sensipar group), the most frequently reported adverse reactions (incidence of ≥ 5% in the Sensipar group and a difference ≥ 1% compared to placebo) are listed in Table 2.

Table 2. Frequency of Adverse Reactions in Dialysis Patients Treated for up to 64 Months in a Long-Term Study1

Placebo (n = 1923) Sensipar (n = 1938)
3699 subject-years 4044 subject-years
Percent of subjects reporting Adverse Reactions (%) 90.9 93.2
Nausea 15.5 29.1
Vomiting 13.7 25.6
Diarrhea 18.7 20.5
Dyspnea 11.5 13.4
Cough 9.8 11.7
Hypotension 10.5 11.6
Headache 9.6 11.5
Hypocalcemia 1.4 11.2
Muscle spasms 9.2 11.1
Abdominal pain 9.6 10.9
Abdominal pain upper 6.3 8.2
Hyperkalemia 6.1 8.1
Upper respiratory tract infection 6.3 7.6
Dyspepsia 4.6 7.4
Dizziness 4.7 7.3
Decreased appetite 3.5 5.9
Asthenia 3.8 5.4
Constipation 3.8 5.0
1 Adverse reactions that occurred in ≥ 5% Frequency in the Sensipar group and a difference ≥ 1% compared to the placebo group (Safety Analysis Set)
Crude incidence rate = 100 * Total number of subjects with event/N
n = Number of subjects receiving at least one dose of study drug

Parathyroid Carcinoma And Primary Hyperparathyroidism

The safety profile of Sensipar in these patient populations is generally consistent with that seen in patients with CKD on dialysis. Forty-six patients were treated with Sensipar in a single-arm study, 29 with Parathyroid Carcinoma and 17 with intractable pHPT. Nine (20%) of the patients withdrew from the study due to adverse events. The most frequent adverse reactions and the most frequent cause of withdrawal in these patient populations were nausea and vomiting. Severe or prolonged cases of nausea and vomiting can lead to dehydration and worsening hypercalcemia so careful monitoring of electrolytes is recommended in patients with these symptoms.

Eight patients died during treatment with Sensipar in this study, 7 with Parathyroid Carcinoma (24%) and 1 (6%) with intractable pHPT. Causes of death were cardiovascular (5 patients), multi-organ failure (1 patient), gastrointestinal hemorrhage (1 patient) and metastatic carcinoma (1 patient). Adverse events of hypocalcemia were reported in three patients (7%).

Table 3. Adverse Reactions with Frequency ≥ 10% in a Single-Arm, Open-Label Study in Patients with Primary Hyperparathyroidism or Parathyroid Carcinoma

In a randomized double-blind, placebo-controlled study of 67 patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery, the most common adverse reactions are listed in Table 4.

Table 4. Adverse Reactions Occurring in ≥ 10% of Subjects in a Double-Blind, Placebo-Controlled Study in Patients with Primary Hyperparathyroidism

Hypocalcemia

In 26-week studies of patients with secondary HPT and CKD on dialysis 66% of patients receiving Sensipar compared with 25% of patients receiving placebo developed at least one serum calcium value less than 8.4 mg/dL, whereas, 29% of patients receiving Sensipar compared with 11% of patients receiving placebo developed at least one serum calcium value less than 7.5 mg/dL. Less than 1% of patients in each group permanently discontinued study drug due to hypocalcemia.

In a randomized, double-blind, placebo-controlled study in patients with secondary HPT and CKD receiving dialysis in which patients were treated for up to 64 months (mean duration of treatment was 21 months in the cinacalcet group), 75% of patients receiving Sensipar compared with 29% of patients receiving placebo developed at least one serum calcium value less than 8.4 mg/dL and 33% of cinacalcet patients compared with 12% of patients receiving placebo had at least one serum calcium value less than 7.5 mg/dL. Most of the cases of severe hypocalcemia less than 7.5 mg/dL (21/33=64%) occurred during the first 6 months. In this trial, 1.1% of patients receiving Sensipar and 0.1% of patients receiving placebo permanently discontinued study drug due to hypocalcemia.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Sensipar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Rash and hypersensitivity reactions (including angioedema and urticaria), and myalgia
  • Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function
  • Gastrointestinal bleeding

Read the entire FDA prescribing information for Sensipar (Cinacalcet)

Generic Name: cinacalcet (sin ah CAL set)
Brand Names: Sensipar

Medically reviewed by Sophia Entringer, PharmD Last updated on Apr 21, 2019.

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What is Sensipar?

Sensipar (cinacalcet) decreases levels of parathyroid hormone (PTH), calcium, and phosphorous in the body.

Sensipar is used to treat hyperparathyroidism (overactive functioning of the parathyroid glands) in people who are on long-term dialysis for kidney disease.

Sensipar is also used to treat hypercalcemia (high levels of calcium in the blood) in people with cancer of the parathyroid gland, and in people with overactive parathyroid glands that cannot be treated surgically.

Important information

You should not take Sensipar if you have low levels of calcium in your blood (hypocalcemia).

Before you take Sensipar, tell your doctor if you have high blood pressure, heart disease, heart failure, a heart rhythm disorder, liver disease, or a history of seizures.

Sensipar works best if you take it with food or shortly after eating a meal. Do not crush or break a tablet. Swallow the pill whole.

Call your doctor at once if you have a serious side effect such as numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes, seizure, feeling short of breath, swelling, rapid weight gain, or feeling like you might pass out.

To be sure Sensipar is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Before taking this medicine

You should not use Sensipar if you are allergic to cinacalcet, or if you have:

  • low levels of calcium in your blood (hypocalcemia).

To make sure Sensipar is safe for you, tell your doctor if you have ever had:

  • high or low blood pressure;

  • heart disease, heart failure, heart rhythm disorder;

  • personal or family history of long QT syndrome;

  • a stomach ulcer or severe vomiting;

  • liver disease;

  • seizures; or

  • if you have kidney disease and you are not on dialysis.

It is not known whether Sensipar will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether cinacalcet passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking this medicine.

Sensipar is not FDA-approved for use by anyone younger than 18 years old.

How should I take Sensipar?

Take Sensipar exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Sensipar works best if you take it with food or shortly after eating a meal.

Do not crush or break a tablet. Swallow the pill whole.

To be sure your calcium and phosphorous levels do not get too low, your blood will need to be tested 1 week after you start taking Sensipar or whenever your dose is changed. You may also need blood tests on a regular basis during treatment.

Store at room temperature away from moisture, light, and heat.

Sensipar dosing information

Usual Adult Dose for Secondary Hyperparathyroidism:

Initial dose: 30 mg orally once a day (cinacalcet should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg orally once daily).
Maintenance dose: 30 to 180 mg orally once a day
Maximum dose: 180 mg once a day
Approved indication: Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis

Usual Adult Dose for Hypercalcemia of Malignancy:

Initial dose: 30 mg orally twice a day (Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg 3 or 4 times daily).
Maintenance dose: 60 mg to 360 mg orally per day
Maximum dose: 90 mg four times a day
Approved indication: Parathyroid carcinoma and primary hyperparathyroidism who are unable to undergo parathyroidectomy

Usual Adult Dose for Primary Hyperparathyroidism:

Initial dose: 30 mg orally twice a day (Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg 3 or 4 times daily).
Maintenance dose: 60 mg to 360 mg orally per day
Maximum dose: 90 mg four times a day
Approved indication: Parathyroid carcinoma and primary hyperparathyroidism who are unable to undergo parathyroidectomy

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Sensipar?

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

Sensipar side effects

Get emergency medical help if you have signs of an allergic reaction to Sensipar : hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • numbness or tingly feeling around your mouth;

  • muscle pain, tightness, or contraction;

  • a seizure (convulsions);

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

  • low levels of calcium in your blood – numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes.

Common Sensipar side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sensipar?

Many drugs can interact with cinacalcet. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sensipar. Give a list of all your medicines to any healthcare provider who treats you.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Sensipar (cinacalcet) should not be used for high blood calcium caused by primary hyperparathyroidism.

Sensipar is a drug that can be problematic (dangerous?) when given to patients with PRIMARY hyperparathyroidism. Sensipar (Cinacalcet) is NOT approved by the FDA for treating patients with primary hyperparathyroidism. If your doctor prescribed this drug for you, you should print this page of parathyroid.com and take it to him/her. Sensipar is likely to make you feel sick, and new evidence suggests that Sensipar can make your osteoporosis worse if you take it. Many patients actually get worsening kidney function taking Sensipar. Most insurance companies will not pay for this drug for treating primary hyperparathyroidism… and they shouldn’t. There is good evidence that taking Sensipar is worse for you than if you took nothing and simply ignored the parathyroid tumor in your neck. The pros and cons of taking Sensipar for primary hyperparathyroidism are discussed on this page. In our opinion, there is almost never a case where a patient with primary hyperparathyroidism should be on this drug! DANGER! Again, this drug may make you significantly worse and is not approved for patients with primary hyperparathyroidism!

Update February 2013 from Dr Norman: Death due to Sensipar. We have said Sensipar is dangerous for many years and have seen many people made sick by Sensipar (Cinicalcet). Yet Amgen (and the biased endocrinologists who are on their payroll to do Sensipar research) keep trying to find ways to sell this drug. This month (February 2013) the FDA told Amgen to stop Sensipar research immediately after a 14 year old was killed by this drug. I could have operated on that 14 year old and removed the parathyroid tumor and cured the patient forever with an operation that took 15-20 minutes. But instead, Amgen wants to get rich by giving an expensive drug (for 50 years??) to a teenager. These people don’t need Sensipar to make them sick and kill them, they need a talented surgeon to remove their tumor and send them home for lunch. Read about the death here.

If you are on this page of parathyroid.com because you have hyperparathyroidism and your doctor gave you a prescription for Sensipar and you came home and typed “Sensipar” into Google… then you are on the right web site… However, you may want to read about hyperparathyroidism and parathyroid disease at the beginning of this website and then come back here later. Make sure you understand that taking a pill will not make the tumor in your neck go away. Also, be careful, this is an advanced page and we will confuse you if you haven’t read more about parathyroid disease on our other pages first.

Sensipar is a drug manufactured by Amgen. Sensipar is the trade name, the generic name for this drug is “Cinacalcet”. Sensipar comes as a small pill in three strengths (30mg, 60mg, and 90mg). This drug was designed for the treatment of SECONDARY hyperparathyroidism. Secondary hyperparathyroidism is a disease that occurs in patients with kidney failure that are on dialysis. These patients do NOT get parathyroid tumors like patients with PRIMARY hyperparathyroidism. Patients with SECONDARY hyperparathyroidism are usually treated with a combination of medications along with dialysis to control all of the problems they have with the chemical balance of their blood (due to the lack of kidney function).

Patients with PRIMARY hyperparathyroidism do NOT have kidney failure, and are NOT on dialysis. This entire website (parathyroid.com) is dedicated to the treatment of PRIMARY hyperparathyroidism. People with PRIMARY hyperparathyroidism have high calcium levels, high PTH levels and other issues (like kidney stones and osteoporosis) which are discussed on this website extensively. We cannot confuse primary and secondary hyperparathyroidism. Let us make this simple…if you have a parathyroid problem, and you are not on kidney dialysis, then you have PRIMARY hyperparathyroidism.

Sensipar was approved by the FDA for the treatment of SECONDARY hyperparathyroidism in March 2004. This drug works well in many patients who are on dialysis, and many thousands of patients with kidney failure are on this drug. (Editorial note: truth be told, it is not a great drug for patients with secondary hyperparathyroidism–not near the “wonder drug” it was thought). IMPORTANT..Sensipar is NOT approved (nor does Amgen support its use) for patients who are not on kidney dialysis. Sensipar is NOT FDA approved for the treatment of PRIMARY hyperparathyroidism. This is why your insurance won’t pay for it. They shouldn’t! Amgen–the maker of this drug, does not say this drug can be used for primary hyperparathyroidism… and they know why — It can make things worse!

Several studies of Sensipar were conducted in patients with PRIMARY hyperparathyroidism in the past few years (mid 2000’s). Patients with primary hyperparathyroidism were given Sensipar and the doctors measured their calcium levels and PTH levels. The biggest study had a total of 40 (forty) patients getting Sensipar, while 38 got placebo (not a very big study, was it?). The trial was to last 1 year. Only 28 of the 40 patients taking Sensipar (70%) were able to stay on the drug for one year–the rest got sick and were not able to take it. Of the 28 patients that took the drug for one year, 73% had a decrease in their blood calcium levels. Only 7% of patients had a decrease in their PTH values. All the patients still had the parathyroid tumor still in their neck, and even in patients who had lower calcium levels, when the drug was stopped, their calcium and PTH levels went back up–some even higher than before. The researchers did uncover a potential problem, however, that the bones of these people may not be any better, and they may be worse. This paper can be read here: Peacock M, Bilezikian JP, et al. Cinicalcet maintains long-term normocalcemia in patients with primary hyperparathyroidism. J Clin Endocrinol Metab. 2005;90:135-141.

This was a well conducted study (and paid for by Amgen of course), and like other smaller studies (yep, even fewer patients also paid for by Amgen), it shows that Sensipar will decrease the blood calcium in about 3/4 of patients. However, since the PTH doesn’t go down in most people, it seems that the patient’s bones are still exposed to excess PTH. The evidence is that even though the calcium goes down, it often CAUSES kidney failure and often makes osteoporosis WORSE. What is most important, is that at least 40% of people can’t even take this drug because it makes them feel very sick (nauseated). See our publication below: Sensipar makes people worse, not better!

Our Experience With Sensipar and Primary Hyperparathyroidism.

We consult on nearly 3500 patients with PRIMARY hyperparathyroidism annually (we do not see patients with secondary hyperparathyroidism who are on dialysis). We have tried Sensipar quite a few times in the past for patients who were operated on somewhere else who we could not operate on, in order to see if the drug would make them feel better. We have also seen hundreds of people referred to us over the years who have been put on this drug because their doctor said that “surgery was too dangerous”, or because the local surgeon tried to operate and couldn’t find the tumor.

Now, in 2013 our opinion is clear: Sensipar is a drug that hurts people, makes them feel bad, and has no role in patients with primary hyperparathyroidism. We call Sensipar “the devil’s drug”, as it does nothing, makes people sick, decreases kidney function, and causes osteoporosis to become worse. All this for $650 per month!

We have NEVER seen this drug help a person with primary hyperparathyroidism. We have never seen this drug make somebody with primary hyperparathyroidism feel better. We have never seen this drug make somebody’s osteoporosis better. We have seen hundreds of people made sick, just so their doctor could show that the blood calcium level decreased. Look folks, we are supposed to treat people, not numbers.

We have parathyroid patients sent to us by about 600 different endocrinologists every year. We can tell you this, the best endocrinologists know Sensipar is a drug of the devil and would never give it to a patient with primary hyperparathyroidism. We rarely see the really good endocrinologists giving this terrible drug to patients.

In 2012 the FDA approved Sensipar for use in primary hyperparathyroidism for patients who were “too sick to undergo surgery”. Folks, we’ve done more than 20,000 parathyroid operations and have NEVER seen a patient that is too sick to have surgery. If they can eat breakfast, they are healthy enough to have a mini-parathyroid operation. Heck, once the tumor is out they are healthier almost immediately since their heart will beat better and stronger within hours of tumor removal. There is no such thing as a patient who is too sick for parathyroid surgery. Even if there were, giving a drug to make them feel bad is clearly NOT in their best interest. Nothing good will happen by taking Sensipar except that the calcium level will drop. The PTH level will remain high and the patients will become sicker, not better.

This is a big pharma company (Amgen) who wants to make money selling a drug that kills people and does not make them feel better. Our advice: spend 20 minutes with an expert parathyroid surgeon and get the damn tumor removed. There is no other disease that is so easy to cure!

Our experiences with this drug are very poor, and we have written the FDA and Amgen to make them aware of our findings… the abstract of our findings were presented at the biggest endocrine meeting in 2010: and then published in 2012:

Cinacalcet (Sensipar) provides no measurable clinical benefits for patients with primary hyperparathyroidism and may accelerate bone loss with prolonged use. Norman J, Lopez J, Politz D. Annals of Surgical Oncology May;19(5):1466-71

Presented at Endocrine Society 08. San Francisco, CA. June, 2010.

Cinacalcet (Sensipar) provides no measurable clinical benefits for patients with primary hyperparathyroidism and significantly accelerates bone loss with prolonged use.

James Norman, MD, FACS, FACE, and Doug Politz, MD, FACS.
Norman Parathyroid Center.

Introduction: Cinacalcet (Sensipar) has been shown to decrease calcium levels in patients with primary hyperparathyroidism (PHPT) in several small trials, however no other endpoints have been studied and long-term effects are not known.

Methods: 90 patients began Cinacalcet as an alternative to surgery for PHPT. Patients filled out a symptom questionnaire specific for PHPT. All had bone density DEXA scans before treatment and annually. All patients were followed as long as the drug was tolerated or until complications arose, at which time all underwent minimally invasive parathyroidectomy. Starting dose was 30mg/d and increased to 60 to 90mg/d as necessary. Serum calcium and PTH levels were studied at 3-4 month intervals. Symptom resolution was tracked.

Results: Women comprised 73% while 27% were men. The average age was 62 (range 19-90). Prior to treatment, serum calcium levels averaged 11.7 (range 11.0 – 15.1) and PTH averaged 126 (range 88-815). 93% had 2 or more classic parathyroid symptoms (average 5.3 symptoms, range 0-9). Cinacalcet had to be discontinued in 19 patients (21%) within 3 months because of nausea and vomiting. The remainder (n=71) were treated from 8 to 34 months. Calcium and/or PTH levels dropped in 98% of patients taking Cinacalcet, but this was intermittent in all patients, none had consistently normal calcium levels. Despite decreases in calcium, only 5 (7%) had any relief from their symptoms (p=0.08), and 11 (15.5%) said they actually felt worse (p<0.05). 23 patients had Cinacalcet for >1.5 years, all of which showed decreases in bone density. 19 of the 23 (83%) had significant reductions in bone density of 1.5 to 2.9 standard deviations below their starting point (p<0.01). Those on the drug longer had the most loss of bone density (R=0.83) losing density faster than 500 cohort PHPT patients with no therapy (p<0.05). All patients underwent mini, outpatient surgery and were cured. 96% had partial or complete resolution of symptoms within 2 months of surgery (p< 0.001).

Conclusion: Although Cinacalcet will cause intermittent reductions in serum calcium in patients with PHPT, this provides symptom relief in almost none. Prolonged use of Cinacalcet is associated with significant bone loss that is accelerated over bone loss seen in untreated PHPT patients. There appears to be no role for Cinacalcet in the treatment of PHPT; patients are better off with no treatment. Surgery remains the best choice for these patients.

Sensipar and Primary Hyperparathyroidism… What is the Bottom Line?

The bottom line is this: primary hyperparathyroidism is caused by a tumor of one (or two) parathyroid glands. Taking a pill every day will not remove the tumor. Taking a pill every day may actually accelerate the formation of osteoporosis–thus this drug does not appear to be a way to “avoid” parathyroid surgery. If your doctor thinks you can “avoid” parathyroid surgery, or “delay” parathyroid surgery by taking a pill every day… then print this and take it to him/her. There is no medical evidence ANYWHERE that suggests taking Sensipar will help you avoid surgery. In fact, all of the evidence is that 1/3 of you can’t tolerate the drug because it will make you sick, and most of you will get a dramatic worsening of your bones. And THEN, you will get surgery to get the tumor out.

This drug will cost you between $620 and $1250 per month in the US. Most insurances will not pay it… and they should not. It is in your best interest to find an excellent parathyroid surgeon and get the parathyroid tumor removed. It can be done in less than 20 minutes by some experts… then get on with your life.

Do not take this mediction if you are allergic to cinacalcet or any ingredients of the medication.

Why did my doctor prescribe Sensipar® (cinacalcet)?

References: 1. Sensipar® (cinacalcet) prescribing information, Amgen. 2. Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism. Am J Physiol Renal Physiol. 2005;288:F253–F264. 3. Moe SM. Disorders involving calcium, phosphorus, and magnesium. Prim Care. 2008;35:215–237, v-vi. 4. Uhlig K, Berns JS, Kestenbaum B, et al. KDOQI US commentary on the 2009 KDIGO clinical practice guideline for the diagnosis, evaluation, and treatment of CKD-mineral and bone disorder (CKD-MBD). Am J Kidney Dis. 2010;55:773–799. 5. Ureña-Torres P, Bridges I, Christiano C, et al. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013;28:1241–1254. 6. Bringhurst FR, Demay MB, Kronenberg HM. Hormones and disorders of mineral metabolism: basic biology of mineral metabolism. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR, eds. Williams Textbook of Endocrinology. 11th ed. Philadelphia, PA: Saunders Elsevier; 2008:1203-1223. 7. Pollak MR, Yu ASL, Taylor EN. Disorders of calcium, magnesium, and phosphate balance: disorders of phosphate homeostasis. In: Brenner BM, Levine SA, eds. Brenner & Rector’s The Kidney. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:602-604. 8. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148-157. 9. Lorenzo JA, Canalis E, Raisz LG. Metabolic bone disease. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR, eds. Williams Textbook of Endocrinology. 11th ed. Philadelphia, PA: Saunders Elsevier; 2008:1269-1310. 10. Goodman WG, Quarles LD. Vitamin D, calcimimetics, and phosphate-binders. In: Brenner BM, Levine SA, eds. Brenner & Rector’s The Kidney. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:1904–1927. 11. Moe SM, Drüeke TB. Management of secondary hyperparathyroidism: the importance and the challenge of controlling parathyroid hormone levels without elevating calcium, phosphorus, and calcium-phosphorus product. Am J Nephrol. 2003;23:369–379. 12. Data on file, Amgen; . 13. Centers for Medicare & Medicaid Services (CMS). Implementation of the transitional drug add-on payment adjustment. Transmittal R1889OTN. https://www.cms.gov/Regulations-and-Guidance/ Guidance/Transmittals/2017Downloads/R1889OTN.pdf. Accessed August 17, 2017. 14. Data on file, Amgen; .

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