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Sensipar

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Sensipar

Sensipar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sensipar (cinacalcet) is used to treat hyperparathyroidism (overactive parathyroid glands) in people who are on long-term dialysis for kidney disease. It is also used to lower calcium levels in people with cancer of the parathyroid gland. Sensipar is a calcimimetic agent that decreases levels of parathyroid hormone (PTH), calcium, and phosphorous in the body. Common side effects include nausea or vomiting.

The recommended starting oral dose of Sensipar is 30 mg once daily. Sensipar may interact with chloroquine, conivaptan, diclofenac, imatinib, isoniazid, bladder medications, antibiotics, antidepressants, antifungal medications, ADHD medications, cancer medicines, cough medicine, heart or blood pressure medications, HIV/AIDS medicines, medicine to treat psychiatric disorders, or narcotic pain medications. Tell your doctor all medications you are taking. During pregnancy, Sensipar should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Sensipar (cinacalcet) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sensipar in Detail - Patient Information: Side Effects

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

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 (convulsions);
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • feeling like you might pass out.

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • loss of appetite;
  • muscle pain, mild chest pain;
  • dizziness; or
  • weakness;

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.

Read the entire detailed patient monograph for Sensipar (Cinacalcet) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sensipar Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, or unusual tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Cinacalcet can cause low calcium blood levels. Your doctor will check your calcium blood levels while your are taking this medication. Tell your doctor right away if you have any of the following symptoms of low calcium levels: numb/tingling skin, severe muscle spasms, seizures, unusual tiredness, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sensipar (Cinacalcet)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sensipar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

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

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

Event*: Placebo
(n = 470) (%)
Sensipar
(n = 656) (%)
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 3,883 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

Adverse Reactio 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
Hypocalcaemia 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
1Adverse 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

Additional adverse reaction rates from the long-term, randomized, double-blind placebo controlled study for Sensipar versus placebo are as follows: seizure (2.5%, 1.6%), rash (2.2%, 1.9%), hypersensitivity reactions (9.4%, 8.3%).

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%).

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

  Sensipar
Parathyroid Carcinoma
(N=29)
n (%)
Intractable pHPT
(N=17)
n (%)
Total
(N=46)
n (%)
Number of Subjects Reporting Adverse Reactions 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)
N=Number of subjects receiving at least one dose of study drug.
pHPT=primary hyperparathyroidism

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

Adverse Reaction Placebo
(N = 34)
n (%)
Cinacalcet
(N = 33)
n (%)
Nausea 6 (18) 10 (30)
Muscle spasms 0 (0) 6 (18)
Headache 2 (6) 4 (12)
Back pain 2 (6) 4 (12)
N=Number of subjects receiving at least one dose of study drug Coded using MedDRA version 16.0

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 7.5mg/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.

During a placebo-controlled part of a 52-week study in patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium ( > 11.3 mg/dl [2.82 mmol/L] and ≤ 12.5 mg/dl [3.12 mmol/L]), serum calcium less than 8.4 mg/dL was observed in 6.1% (2/33) of Sensipar treated patients and 0% (0/34) of placebo treated patients.

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 and hypersensitivity reactions (including angioedema, and urticaria), and myalgia have been identified as adverse reactions during post approval 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 [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Sensipar (Cinacalcet) »

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Sensipar - User Reviews

Sensipar User Reviews

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