Sensipar Side Effects

Please note - some side effects for Sensipar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sensipar - for the Consumer

Sensipar

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sensipar:

Constipation; diarrhea; dizziness; headache; loss of appetite; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Sensipar:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling of the skin; chest pain; confusion; decreased urination; depression; fainting; fast, slow, or irregular heartbeat; joint pain; muscle aches, cramps, pain, spasms, or weakness; seizures; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; swelling of the hands or feet; tremors; unusual bone pain; unusual thirst; unusual tiredness or weakness; very dry mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Sensipar Side Effects - for the Professional

Sensipar

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 (incidence of at least 5% in the Sensipar group and greater than placebo) are provided in Table 1. The most frequently reported adverse reactions in the Sensipar group were nausea, vomiting, and diarrhea.

Seizures were observed in 1.4% (13/910) of cinacalcet-treated patients and 0.7% (5/641) of placebo-treated patients across all completed placebo controlled trials.

Table 1. Adverse Reaction Incidence (≥ 5%) in Patients on Dialysis

* Included are events that were reported at a greater incidence in the Sensipar group than in the placebo group.
	Placebo	Sensipar
	(n = 470)	(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
Access Infection	4	5

The incidence of serious adverse reactions was similar in the Sensipar and placebo groups (29% vs. 31%, respectively).

12-Month Experience with Sensipar in Secondary Hyperparathyroidism

Two hundred sixty-six patients from two of the phase 3 studies in patients with CKD on dialysis continued to receive Sensipar or placebo treatment in a 6-month, double-blind extension study (12-month total treatment duration). The incidence and nature of adverse reactions in this long term extension study were comparable to those observed in the original phase 3 studies.

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 cinacalcet 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 while on 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%).

Seizures were observed in 0.7% (1/140) of cinacalcet-treated patients and 0.0% (0/46) of placebo-treated patients in all clinical studies.

Table 2. Adverse Reactions Occurring in ≥ 10% of Total Subjects

N=Number of subjects receiving at least one dose of study drug.
Preferred Term	Cinacalcet
	Parathyroid Carcinoma (N=29)	Intractable pHPT (N=17)	Total (N=46)
	n (%)	n (%)	n (%)
Number of Subjects Reporting Adverse Events	28 (97)	17 (100)	45 (98)
Nausea	19 (66)	10 (59)	29 (63)
Vomiting	15 (52)	6 (35)	21 (46)
Paresthesia	4 (14)	5 (29)	9 (20)
Fatigue	6 (21)	2 (12)	8 (17)
Fracture	6 (21)	2 (12)	8 (17)
Hypercalcemia	6 (21)	2 (12)	8 (17)
Anorexia	6 (21)	1 (6)	7 (15)
Asthenia	5 (17)	2 (12)	7 (15)
Dehydration	7 (24)	0 (0)	7 (15)
Anemia	5 (17)	1 (6)	6 (13)
Arthralgia	5 (17)	1 (6)	6 (13)
Constipation	3 (10)	3 (18)	6 (13)
Depression	3 (10)	3 (18)	6 (13)
Headache	6 (21)	0 (0)	6 (13)
Infection Upper Respiratory	3 (10)	2 (12)	5 (11)
Pain Limb	3 (10)	2 (12)	5 (11)

Postmarketing Experience with Sensipar

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, hypersensitivity reactions (including angioedema and urticaria), diarrhea, and myalgia have been identified as adverse reactions during postapproval use of Sensipar. Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in Sensipar-treated patients with impaired cardiac function in postmarketing safety surveillance.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included hypertension. Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function in postmarketing safety surveillance.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea and anorexia.

Musculoskeletal

Musculoskeletal side effects have included myalgia.

Nervous system

Nervous system side effects have included dizziness and asthenia.

General

General side effects have included noncardiac chest pain.

Hypersensitivity

Hypersensitivity side effects have included post-approval reports of rash and hypersensitivity. Additional postmarketing reports include angioedema and urticaria.

Local

Local side effects have included access site infection.

Dermatologic

Dermatologic side effects have included a case report of leukocytoclastic vasculitis with palpable purpura on both upper and lower extremities.

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