Sensipar

DRUG DESCRIPTION

Sensipar (cinacalcet) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Sensipar (cinacalcet) tablets contain the hydrochloride salt of cinacalcet. Its empirical formula is C22H22F3N•HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity.

The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water.

Sensipar (cinacalcet) tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively).

The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:

Sensipar® (cinacalcet) Structural Formula Illustration
Inactive Ingredients

The following are the inactive ingredients in Sensipar (cinacalcet) tablets: pre-gelatinized starch, microcrystalline cellulose, povidone, crospovidone, colloidal silicon dioxide and magnesium stearate. Tablets are coated with color (Opadry® II green), clear film coat (Opadry® clear), and carnauba wax.

What are the possible side effects of cinacalcet (Sensipar)?

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...

Read All Potential Side Effects and See Pictures of Sensipar »

What are the precautions when taking cinacalcet (Sensipar)?

Before taking cinacalcet, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low levels of calcium in the blood (hypocalcemia), seizures.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult...

Read All Potential Precautions of Sensipar »


Sensipar Consumer (continued)

SIDE EFFECTS: Nausea or vomiting 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numb/tingling skin, severe muscle spasms, seizures, unusual tiredness, irregular 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.

PRECAUTIONS: Before taking cinacalcet, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low levels of calcium in the blood (hypocalcemia), seizures.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Sensipar Patient Information Including Side Effects

Brand Names: Sensipar

Generic Name: cinacalcet (Pronunciation: sin ah CAL set)

  • What is cinacalcet (Sensipar)?
  • What are the possible side effects of cinacalcet (Sensipar)?
  • What is the most important information I should know about cinacalcet (Sensipar)?
  • What should I discuss with my healthcare provider before taking cinacalcet (Sensipar)?
  • How should I take cinacalcet (Sensipar)?
  • What happens if I miss a dose (Sensipar)?
  • What happens if I overdose (Sensipar)?
  • What should I avoid while taking cinacalcet (Sensipar)?
  • What other drugs will affect cinacalcet (Sensipar)?
  • Where can I get more information?

What is cinacalcet (Sensipar)?

Cinacalcet decreases levels of parathyroid hormone (PTH), calcium, and phosphorous in the body.

Cinacalcet is used to treat hypoparathyroidism (decreased functioning of the parathyroid glands) in people who are on long-term dialysis for kidney disease.

Cinacalcet is also used to lower calcium levels in people with cancer of the parathyroid gland.

Cinacalcet may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cinacalcet (Sensipar)?

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.

What is the most important information I should know about cinacalcet (Sensipar)?

You should not take this medication if you are allergic to cinacalcet.

Before you take cinacalcet, tell your doctor if you have high blood pressure, heart disease, heart failure, a heart rhythm disorder, liver disease, or a history of seizures.

There are many other medicines that can interact with cinacalcet. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Cinacalcet works best if you take it with food or shortly after eating a meal.

Do not crush or break a cinacalcet tablet. Swallow the pill whole.

Your blood will need to be tested on a regular basis while you are taking cinacalcet. Do not miss any follow-up visits to your doctor.

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, feeling short of breath, swelling, rapid weight gain, or feeling like you might pass out.

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