Cinacalcet Hydrochloride, Oral

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KEY POINTS

• This medicine is taken by mouth to treat high levels of parathyroid hormone in people on dialysis. It is also used to treat high levels of calcium caused by parathyroid cancer or an overactive parathyroid gland. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: calcimimetic

Generic and brand names: cinacalcet hydrochloride, oral; Sensipar

What is this medicine used for?

This medicine is taken by mouth to treat:

• High levels of parathyroid hormone in people who have kidney problems and need dialysis
• High levels of calcium in people with an overactive parathyroid gland
• High levels of calcium in people with parathyroid cancer

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An irregular heartbeat or heart disease such as heart failure
• Liver disease
• Low or high blood pressure
• Problems with low calcium levels in your blood
• Seizures

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine with food or shortly after a meal. Do not break, crush, or chew the tablets. Swallow them whole.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: seizures, muscle pain, numbness, tingling, twitching.

What should I watch out for?

During treatment, you need to have blood tests often to check the levels of calcium, phosphorus, and parathyroid hormone in your blood. Keep all appointments for these tests.

You will need to follow a diet in which you get the right amount of calcium. Follow your healthcare provider's directions exactly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures; chest pain; severe muscle pain or muscle twitches; severe joint pain; numbness, tingling, or burning sensations; confusion; unusual mood or behavior changes; severe headache; severe dizziness or fainting; hallucinations; severe stomach pain; irregular heartbeat; shortness of breath; unexplained swelling; unusual weakness or tiredness.

Other: Nausea, vomiting, diarrhea, constipation, mild dizziness, loss of appetite, rash, itching.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), pimozide (Orap), and thioridazine
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Atomoxetine (Strattera)
• Beta blockers such as carvedilol (Coreg) and metoprolol (Lopressor, Toprol)
• Cancer medicines such as ceritinib (Zykadia), idelalisib (Zydelig), imatinib (Gleevec), nilotinib (Tasigna), tamoxifen, and vinblastine
• Conivaptan (Vaprisol)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Malaria medicines such as chloroquine and primaquine
• Nausea medicines such as aprepitant (Emend), netupitant/palonosetron (Akynzeo), and promethazine
• Pain medicines such as codeine, hydrocodone (Hysingla, Zohydro), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Tetrabenazine (Xenazine)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.