[Posted 02/26/2013]ISSUE:FDA has stopped all pediatric clinical trials of cinacalcet hydrochloride (Sensipar) after the recent death of a 14-year-old patient in a trial. Posting this information does not mean that FDA has concluded whether or not cinacalcet had a role in the patient's death. This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete.
BACKGROUND:Cinacalcet is a calcium-sensing receptor agonist indicated in adults for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid cancer and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. FDA has approved cinacalcet for use in adults but not in children (less than 18 years of age), and the clinical trials were underway to determine if the drug is effective and can be used safely in children.
RECOMMENDATION:At this time, FDA would like to remind health care professionals of the following: Patients should be monitored for the development of low serum calcium levels (hypocalcemia) since cinacalcet lowers calcium levels in the blood.The potential signs of low serum calcium levels include muscular problems such as muscle cramping, tetany, convulsions, paresthesias, and myalgias.If serum calcium levels decrease below the normal range, appropriate steps should be taken to increase calcium levels, such as by providing supplemental calcium, initiating or increasing the dose of a calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with cinacalcetSerum calcium levels should be measured within 1 week after initiation or dose adjustment of cinacalcet. Once a maintenance dose has been established, serum calcium should be measured monthly.
For more information visit the FDA website at: Web Siteand Web Site.
Cinacalcet is used alone or with other medications to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [a natural substance needed to control the amount of calcium in the blood] which can cause serious problems with the bones, heart, blood vessels, and lungs) in patients with chronic kidney disease (condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly). Cinacalcet is also used to treat high levels of calcium in the blood of patients who have parathyroid cancer (cancer of the glands in the neck that make parathyroid hormone). Cinacalcet is in a class of medications called calcimimetics. It works by signaling the body to produce less parathyroid hormone in order to decrease the amount of calcium in the blood.
Cinacalcet comes as a tablet to take by mouth. It is usually taken once a day with food or shortly after a meal. To help you remember to take cinacalcet, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cinacalcet exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Your doctor will probably start you on a low dose of cinacalcet and gradually increase your dose, not more than once every 2-4 weeks.
Cinacalcet may help control your condition but will not cure it. Continue to take cinacalcet even if you feel well. Do not stop taking cinacalcet without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking cinacalcet, tell your doctor and pharmacist if you are allergic to cinacalcet or any other medications.tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antidepressants (mood elevators) such as amitriptyline (Elavil), clomipramine (Anafranil), desipramine (Norpramin), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), nefazodone, nortriptyline (Aventyl, Pamelor), paroxetine (Paxil), protriptyline (Vivactil) and trimipramine (Surmontil); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); flecainide (Tambocor); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); isoniazid (INH, Nydrazid); metronidazole (Flagyl); oral contraceptives (birth control pills); thioridazine (Mellaril); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); vinblastine (Velban); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.tell your doctor if you have or have ever had seizures or liver disease.tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cinacalcet, call your doctor.
Talk to your doctor about drinking grapefruit juice while taking this medication.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Cinacalcet may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: upset stomachvomitingdiarrheadizzinessweaknesschest pain
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: burning, tingling, or unusual feelings of the lips, tongue, fingers, or feetmuscle aches or crampssudden tightening of the muscles in the hands, feet, face, or throatseizuresinfection of dialysis access (surgically created blood vessel where blood leaves and enters the body during dialysis)
Cinacalcet may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include: burning, tingling, or unusual feelings of the lips, tongue, fingers, or feetmuscle aches or crampssudden tightening of the muscles in the hands, feet, face, or throatseizures
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cinacalcet.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: March 15, 2013.