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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 (cinacalcet) , 470 placebo) for up to 6 months. The most frequently reported adverse reactions (incidence of at least 5% in the Sensipar (cinacalcet) group and greater than placebo) are provided in Table 1. The most frequently reported adverse reactions in the Sensipar (cinacalcet) group were nausea, vomiting, and diarrhea.

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

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

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

12-Month Experience with Sensipar (cinacalcet) 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 (cinacalcet) 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 (cinacalcet) 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%).

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

Preferred Term Cinacalcet
Parathyroid Carcinoma
(N=29)
Intractablep HPT
(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)
N=Number of subjects receiving at least one dose of study drug.

Postmarketing Experience with Sensipar (cinacalcet)

The following adverse reactions have been identified during postapproval use of Sensipar (cinacalcet) . 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 (cinacalcet) . Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in Sensipar (cinacalcet) -treated patients with impaired cardiac function in postmarketing safety surveillance.

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

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Sensipar - User Reviews

Sensipar User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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