Consumer medicine information

Cinacalcet Viatris

Cinacalcet

BRAND INFORMATION

Brand name

Cinacalcet Viatris

Active ingredient

Cinacalcet

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cinacalcet Viatris.

SUMMARY CMI

CINACALCET VIATRIS

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CINACALCET VIATRIS?

CINACALCET VIATRIS contains the active ingredient cinacalcet. CINACALCET VIATRIS is used to treat secondary hyperparathyroidism, primary hyperparathyroidism and high blood calcium levels in people with cancer of the parathyroid gland.

For more information, see Section 1. Why am I using CINACALCET VIATRIS? in the full CMI.

2. What should I know before I use CINACALCET VIATRIS?

Do not use if you have ever had an allergic reaction to cinacalcet or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CINACALCET VIATRIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CINACALCET VIATRIS and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CINACALCET VIATRIS?

  • Secondary hyperparathyroidism: the usual starting dose for this medicine is 30 mg (one tablet) once per day.
  • Primary hyperparathyroidism/cancer of the parathyroid gland: the usual starting dose for this medicine is 30 mg (one tablet) twice per day.
  • Should be taken orally either with, or shortly after food.

More instructions can be found in Section 4. How do I use CINACALCET VIATRIS? in the full CMI.

5. What should I know while using CINACALCET VIATRIS?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using CINACALCET VIATRIS.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
  • If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Things you should not do
  • Do not take CINACALCET VIATRIS to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how CINACALCET VIATRIS affects you. CINACALCET VIATRIS may cause dizziness in some people.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
Looking after your medicine
  • Keep your tablets in a cool dry place where the temperature stays below 25°C.
  • Keep it where young children cannot reach it.

For more information, see Section 5. What should I know while using CINACALCET VIATRIS? in the full CMI.

6. Are there any side effects?

Speak to your doctor if you have any of these less serious side effects and they worry you: nausea and vomiting, dizziness or light headedness or worsening of a heart condition, rash.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects: lower calcium level, seizure, bleeding from the stomach or intestines, allergic reaction, skin rash over a large area of the body, swelling of the face, lips, mouth, tongue or throat, shortness of breath, wheezing, faintness, rapid pulse, etc.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

CINACALCET VIATRIS

Active ingredient(s): cinacalcet hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using CINACALCET VIATRIS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CINACALCET VIATRIS.

Where to find information in this leaflet:

1. Why am I using CINACALCET VIATRIS?
2. What should I know before I use CINACALCET VIATRIS?
3. What if I am taking other medicines?
4. How do I use CINACALCET VIATRIS?
5. What should I know while using CINACALCET VIATRIS?
6. Are there any side effects?
7. Product details

1. Why am I using CINACALCET VIATRIS?

CINACALCET VIATRIS contains the active ingredient cinacalcet hydrochloride.

CINACALCET VIATRIS is used to treat:

  • a condition called secondary hyperparathyroidism (high-perpara-THIGH-royd-izm) in people with kidney disease who require dialysis treatment.
  • a condition called primary hyperparathyroidism when surgical removal of the parathyroid gland is not a treatment option.
  • high blood calcium levels in people with cancer of the parathyroid gland.

Secondary hyperparathyroidism

Kidney disease can cause a condition called secondary hyperparathyroidism, which can have a big impact on your health. Four small glands located behind the thyroid gland in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). Normally, PTH makes sure you have just enough calcium and phosphorus in your blood to keep your bones, heart, muscles, nerves and blood vessels working well. When your kidneys are working properly, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosphorus in and out of your bones.

When your kidneys aren't working properly, the calcium and phosphorus balance in your body is upset, and your parathyroid glands send out too much PTH to your body. This condition is called secondary hyperparathyroidism, and it can cause bone disease and also may be a risk factor for heart disease and abnormal calcium deposits in blood vessels and other parts of the body. This medicine lowers PTH by telling your parathyroid glands to stop releasing too much PTH into your blood. It also lowers your calcium and phosphorus levels.

Primary hyperparathyroidism/ Cancer of the parathyroid gland

An overactive parathyroid gland results in a condition called primary hyperparathyroidism, which can impact your health. Four small glands located behind the thyroid gland in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). When your parathyroid glands are working normally, PTH keeps your calcium levels normal by moving the right amounts of calcium in and out of your bones.

Primary hyperparathyroidism is caused by an enlargement of one or more of the parathyroid glands occasionally due to cancer of the parathyroid gland. In primary hyperparathyroidism, your parathyroid glands send out too much PTH to your body and your blood level of calcium becomes high. This medicine lowers PTH by telling your parathyroid glands to stop releasing too much PTH into your blood. It also lowers your calcium and phosphorus levels.

Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use CINACALCET VIATRIS?

Warnings

Do not use CINACALCET VIATRIS if:

  • you are allergic to cinacalcet, or any of the ingredients listed at the end of this leaflet.
    Some of the symptoms of an allergic reaction may include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue or other parts of the body
    - rash, itching or hives on the skin
  • Always check the ingredients to make sure you can use this medicine.
  • Do not give this medicine to a child.
  • Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
    If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives or dyes.
  • take any medicines for any other condition.
  • have or have had any of the following medical conditions:
    - seizures (sometimes called fits or convulsions, see 'Side effects' section)
    - heart failure (or a heart condition, see 'Side effects' section)
    - intolerance to sugars (sometimes called lactose intolerance, see 'Ingredients' section)
    - ulcers (stomach or intestinal), serious vomiting, inflammation of the stomach and swallowing tube

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor if you are taking any of the following medicines:

  • ketoconazole,
  • erythromycin,
  • itraconazole,
  • rifampicin,
  • phenytoin,
  • amitriptyline,
  • flecainide,
  • vinblastine,
  • thioridazine, or
  • medicines known as tricyclic antidepressants

Some of these medicines can affect how this medicine works, while others are affected by this medicine.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CINACALCET VIATRIS.

4. How do I use CINACALCET VIATRIS?

How much to take

  • If you are being treated for secondary hyperparathyroidism
    The usual starting dose for this medicine is 30 mg (one tablet) once per day.
    Your doctor will take regular blood samples to measure how you are responding to this medicine and will adjust your dose as necessary in order to control your parathyroid hormone, calcium and phosphate levels.
    Once your condition is under control, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your parathyroid hormone, calcium and phosphate levels.
  • If you are being treated for primary hyperparathyroidism/cancer of the parathyroid gland
    The usual starting dose for this medicine is 30 mg (one tablet) twice per day.
    Your doctor will take regular blood samples to measure how you are responding to this medicine and will adjust your dose as necessary in order to control your calcium levels.
    Once your condition is under control, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your calcium levels.
  • Follow the instructions provided and use CINACALCET VIATRIS until your doctor tells you to stop.

When to take CINACALCET VIATRIS

  • CINACALCET VIATRIS should be taken orally either with, or shortly after food.

How to take CINACALCET VIATRIS

  • The tablets must be taken whole and are not to be divided.
  • Follow all directions given to you by your doctor, nurse and pharmacist carefully.

They may differ from the information in this leaflet.

If you do not understand the instructions below, ask your doctor, nurse or pharmacist for help.

If you forget to take CINACALCET VIATRIS

CINACALCET VIATRIS should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much CINACALCET VIATRIS

If you think that you have used too much CINACALCET VIATRIS, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

5. What should I know while using CINACALCET VIATRIS?

Things you should do

  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
  • Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
    It may affect other medicines used during surgery.
  • If you are about to have any blood tests, tell your doctor that you are taking this medicine.
    It may interfere with the results of some tests.
  • Keep all of your doctor's appointments so that your progress can be checked.

Call your doctor straight away if you:

  • become pregnant while taking this medicine.

Things you should not do

  • Do not take CINACALCET VIATRIS to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CINACALCET VIATRIS affects you.

CINACALCET VIATRIS may cause dizziness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep your tablets in a cool dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CINACALCET VIATRIS.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • Nausea and vomiting
    People taking this medicine may have a greater chance of developing nausea and/or vomiting.
  • Dizziness or light headedness, or worsening of a heart condition
    This medicine may cause low blood pressure or affect the heart's function in people who have a heart condition (heart failure).
  • Rash
    Pinkish, itchy swellings on the skin, also called hives or nettle rash. Itchy rash.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • CINACALCET VIATRIS lowers your calcium level. If calcium levels become too low, you might get hypocalcaemia.
    Signs of hypocalcaemia include numbness or tingling around the mouth, muscle aches or cramps and seizures. If you have any of these symptoms, you should tell your doctor straight away. People with kidney disease not requiring dialysis are at increased risk of developing hypocalcaemia.
  • Seizure (also known as a fit or convulsion)
    The risk of having seizures is greater in people who have had seizures before. Lowering the calcium level too much may also increase the risk of having a seizure.
  • Bleeding from the stomach or intestines
    Bleeding from the stomach or intestines may occur in some patients. You may experience severe pain or tenderness in the stomach, vomit blood or material that looks like coffee grounds, or have black or tar-like stools.
  • Allergic reaction
  • Skin rash over a large area of the body
  • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • Shortness of breath
  • Wheezing
  • Faintness, rapid pulse or sweating
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems

By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CINACALCET VIATRIS contains

Active ingredient
(main ingredient)		cinacalcet hydrochloride
Other ingredients
(inactive ingredients)		microcrystalline cellulose
colloidal anhydrous silica
crospovidone
povidone
magnesium stearate
OPADRY complete film coating system 03K51674 GREEN (ARTG PI No: 109807).
Potential allergenssulfites

Do not take this medicine if you are allergic to any of these ingredients.

What CINACALCET VIATRIS looks like

CINACALCET VIATRIS 30 mg: green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI30 on the other side. (AUST R 289379).

CINACALCET VIATRIS 60 mg: green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI60 on the other side. (AUST R 289380).

CINACALCET VIATRIS 90 mg: green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI90 on the other side. (AUST R 289381).

Who distributes CINACALCET VIATRIS

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in June 2023.

CINACALCET VIATRIS_cmi\Jun23/00

Published by MIMS August 2023

BRAND INFORMATION

Brand name

Cinacalcet Viatris

Active ingredient

Cinacalcet

Schedule

S4

 

1 Name of Medicine

Cinacalcet hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet of Cinacalcet Viatris contains either 30 mg, 60 mg or 90 mg of cinacalcet as the free base equivalent (corresponding to 33 mg, 66 mg and 99 mg as the hydrochloride salt, respectively).

Excipients with known effect.

Sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cinacalcet Viatris 30 mg film-coated tablet.

Green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI30 on the other side.

Cinacalcet Viatris 60 mg film-coated tablet.

Green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI60 on the other side.

Cinacalcet Viatris 90 mg film-coated tablet.

Green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI90 on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Cinacalcet Viatris may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see Section 5.1 Pharmacodynamic Properties, Clinical trials). Cinacalcet Viatris should be used as adjunctive therapy.
Cinacalcet Viatris is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.
Cinacalcet Viatris may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

4.2 Dose and Method of Administration

Dosage.

Patients with end stage renal disease receiving dialysis.

Cinacalcet Viatris reduces parathyroid hormone (PTH) while simultaneously lowering Ca x P, calcium and phosphorus levels in patients receiving dialysis.
The recommended starting dose for adults is 30 mg once per day.
Cinacalcet Viatris should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target PTH between 1.5 to 5 times the upper limit of normal.
In chronic kidney disease (CKD) patients, PTH levels should be assessed at least 12 hours after dosing with cinacalcet.
During dose titration, serum calcium levels should be monitored frequently and if serum calcium levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels (see Section 4.4 Special Warnings and Precautions for Use).

Parathyroid carcinoma and primary HPT for whom parathyroidectomy is not a treatment option.

The recommended starting dose of Cinacalcet Viatris for adults is 30 mg twice daily.
The dosage of Cinacalcet Viatris should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalise serum calcium.

Special populations.

Geriatric patients.

Age does not alter the pharmacokinetics of cinacalcet; no dosage adjustment is required for geriatric patients.

Patients with renal impairment.

Renal impairment does not alter the pharmacokinetics of cinacalcet; no dosage adjustment is necessary for renal impairment.

Patients with hepatic impairment.

Moderate to severe hepatic impairment (Child-Pugh classification) increases cinacalcet drug concentrations by approximately 2 to 4 fold. In patients with moderate-severe hepatic impairment, PTH and serum calcium concentrations should be closely monitored during dose titration of cinacalcet.

Method of administration.

Cinacalcet Viatris is administered orally. It is recommended that Cinacalcet Viatris be taken with food or shortly after a meal. Tablets should be taken whole and should not be divided.

4.3 Contraindications

Cinacalcet Viatris is contraindicated in patients with hypersensitivity to any component(s) of this product.

Hypocalcaemia.

Cinacalcet Viatris treatment should not be initiated if serum calcium is less than the lower limit of the normal range (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Serum calcium.

Cinacalcet treatment should not be initiated in patients with CKD receiving dialysis if serum calcium is less than 8.4 mg/dL [2.1 mmol/L]. Since cinacalcet lowers serum calcium, patients should be monitored for the occurrence of hypocalcaemia.
Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in patients treated with cinacalcet including in paediatric patients. Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been reported in patients treated with cinacalcet. Manifestations of hypocalcaemia may also include paresthesias, myalgias, cramping, tetany, and seizures.
Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet. Once the maintenance dose has been established, serum calcium should be measured approximately monthly. If serum calcium falls below 8.4 mg/dL [2.1 mmol/L] but remains above 7.5 mg/dL [1.88 mmol/L], or if symptoms of hypocalcaemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium. If hypocalcaemia persists, reduce the dose or discontinue administration of cinacalcet. If serum calcium falls below 7.5 mg/dL [1.88 mmol/L], or if symptoms of hypocalcaemia persist and the dose of vitamin D cannot be increased, withhold administration of cinacalcet until serum calcium levels reach 8.0 mg/dL [2.0 mmol/L] and/or symptoms of hypocalcaemia have resolved. Treatment should be reinitiated using the next lowest dose of cinacalcet (see Section 4.2 Dose and Method of Administration).
In the 6-month registrational trials of patients with CKD on dialysis, 66% of patients receiving cinacalcet compared with 25% of patients receiving placebo developed at least one serum calcium value < 8.4 mg/dL [2.1 mmol/L]. In CKD patients receiving dialysis who were administered cinacalcet, 29% of patients in the 6-month registrational trials and 21% and 33% of patients (within the first 6 months and overall, respectively) in the EVOLVE clinical trial, had at least one serum calcium value less than 7.5 mg/dL [1.88 mmol/L]. In the EVOLVE clinical trial, 1.1% of patients in the cinacalcet group and 0.1% in the placebo group permanently discontinued study drug due to hypocalcaemia.
Cinacalcet is not indicated for CKD patients not receiving dialysis. Investigational studies have shown that CKD patients not receiving dialysis treated with cinacalcet have an increased risk of hypocalcaemia (serum calcium levels less than 8.4 mg/dL [2.1 mmol/L]) compared with cinacalcet-treated CKD patients receiving dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.

Seizures.

In clinical studies, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (43/3049) of cinacalcet-treated patients and 0.7% (5/687) of placebo-treated patients. While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels.

Hypotension and/or worsening heart failure.

In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels. Clinical trial data showed hypotension occurred in 7% of cinacalcet-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving cinacalcet or placebo.

Upper gastrointestinal bleeding.

Cases of gastrointestinal bleeding, mostly upper gastrointestinal bleeding, have occurred in patients using calcimimetics, including cinacalcet, from post marketing and clinical trial sources. The exact cause of GI bleeding in these patients is unknown.
Patients with risk factors for upper GI bleeding (such as known gastritis, esophagitis, ulcers or severe vomiting) may be at increased risk for GI bleeding when receiving cinacalcet treatment. Monitor patients for worsening of common GI adverse reactions of nausea and vomiting associated with cinacalcet (see Section 4.8 Adverse Effects (Undesirable Effects)) and for signs and symptoms of GI bleeding and ulcerations during cinacalcet therapy. Promptly evaluate and treat any suspected GI bleeding.

Adynamic bone.

In CKD patients receiving dialysis adynamic bone may develop if PTH levels are suppressed below 100 picogram/mL (10.6 picomol/L). If PTH levels decrease below the recommended target range in patients treated with cinacalcet, the dose of vitamin D sterols and/or cinacalcet should be reduced or therapy discontinued.

Testosterone levels.

Testosterone levels are often below the normal range in patients with end-stage renal disease. In a clinical study of CKD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the cinacalcet treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment. The clinical significance of these reductions in serum testosterone is unknown. An open label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in cinacalcet-treated patients.

Neoplastic events.

In EVOLVE, a randomised, double-blind, placebo-controlled clinical study of 3,883 dialysis patients, neoplastic events were reported in 2.9 and 2.5 patients per 100 patient-years in cinacalcet and placebo-treatment groups, respectively. A causal relationship to cinacalcet has not been established.

Patients with CKD and secondary hyperparathyroidism.

Serum calcium should be measured within 1 week and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. Once the maintenance dose has been established, serum calcium should be measured approximately monthly, and PTH every 1 to 3 months (see Section 4.2 Dose and Method of Administration). Either the intact PTH (iPTH) or bio-intact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter the relationship between iPTH and biPTH.

Patients with parathyroid carcinoma and patients with primary hyperparathyroidism for whom parathyroidectomy is not a treatment option.

Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet. Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months (see Section 4.2 Dose and Method of Administration).

Co-administration with other products.

Administer cinacalcet with caution in patients receiving any other medications known to lower serum calcium. Closely monitor serum calcium levels in patients receiving other medications known to lower serum calcium.

Use in hepatic impairment.

Due to the potential for 2 to 4 times higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment, physicians should closely monitor these patients when initiating cinacalcet (see Section 5.2 Pharmacokinetic Properties).

Use in the elderly.

Of the 1136 patients enrolled in the cinacalcet phase 3 clinical programme, 26% were over 65 years old, and 9% were over 75 years old. No differences in the safety and efficacy of cinacalcet were observed in patients greater or less than 65 years of age (see Section 4.2 Dose and Method of Administration, Geriatric patients).

Paediatric use.

The safety and efficacy of cinacalcet in paediatric patients have not been established. Cinacalcet is not indicated for use in paediatric patients. A fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see Section 5.2 Pharmacokinetic Properties, Paediatric patients; Section 4.4 Special Warnings and Precautions for Use, Serum calcium).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Effect of cinacalcet on other drugs.

Drugs metabolised by the enzyme cytochrome P450 2D6 (CYP2D6). Cinacalcet is an inhibitor of CYP2D6. Therefore, dose adjustments of concomitant medications may be required when cinacalcet is administered with medications that are predominantly metabolised by this enzyme (e.g. metoprolol) and particularly those with a narrow therapeutic index (e.g. flecainide, vinblastine, thioridazine and most tricyclic antidepressants).

Desipramine.

Concurrent administration of 90 mg cinacalcet with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, increased desipramine exposure approximately 3.6 times in CYP2D6 extensive metabolisers.

Amitriptyline.

Co-administration of 25 mg or 100 mg cinacalcet with 50 mg amitriptyline, a tricyclic antidepressant metabolised in part by CYP2D6, increased exposure to amitriptyline and its active metabolite nortriptyline by approximately 20% in extensive metabolisers of CYP2D6 enzymes. Dose reductions of amitriptyline may be required in some subjects receiving cinacalcet concurrently.
Drugs metabolised by other cytochrome P450 (CYP) enzymes. Based on in vitro data, cinacalcet is not an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C9, CYP2C19, and CYP3A4.

Warfarin.

Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and the clotting factor VII) of warfarin.
The lack of effect of cinacalcet on the pharmacokinetics of R- and S-warfarin and the absence of auto-induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.

Midazolam.

Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam. These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of drugs that are metabolised by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporin and tacrolimus.

Effect of other drugs on cinacalcet.

Cinacalcet is metabolised by multiple cytochrome P450 enzymes, primarily CYP3A4, CYP1A2 and CYP2D6, which limit the potential for other drugs to increase cinacalcet concentrations.

Ketoconazole.

Cinacalcet is metabolised in part by the enzyme CYP3A4. Co-administration of ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet exposure. Dose adjustment of cinacalcet may be required if a patient receiving cinacalcet initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g. ketoconazole, erythromycin, itraconazole) or inducer (e.g. rifampicin, phenytoin, St. John's Wort) of this enzyme.

Calcium carbonate.

Co-administration of calcium carbonate (1500 mg) did not alter the pharmacokinetics of cinacalcet.

Sevelamer HCl.

Co-administration of sevelamer HCl (2400 mg tid) did not alter the pharmacokinetics of cinacalcet.

Pantoprazole.

Co-administration of pantoprazole (80 mg qd) did not alter the pharmacokinetics of cinacalcet.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Cinacalcet did not impair mating or fertility in rats at oral doses up to 75 mg/kg/day, with systemic exposures up to 2 times human exposure at the maximum recommended clinical dose (MRCD), based on AUC.
Studies in monkeys showed that cinacalcet depressed serum testosterone concentrations by 70-90% at oral doses 5-100 mg/kg/day, corresponding to systemic exposures 0.1-1 times the clinical exposure, on an AUC basis, at the MRCD of 360 mg/day. The highest dose also resulted in a 42% reduction in testicular weights.
(Category B3)*
Cinacalcet crossed the placental barrier in rabbits; foetal plasma cinacalcet concentrations were about 10-13% of the maternal plasma concentrations. There was no evidence of teratogenicity in rats or rabbits. Fetal body weights were decreased in rats at 50 mg/kg/day PO (approximately 2 times the clinical exposure at the MRCD, based on AUC) and increased incidences of unossified sternebrae occurred in rats at exposures 0.1-2 times the clinical exposure, with maternal toxicity.
There are no adequate and well-controlled studies of cinacalcet in pregnant women. Because animal reproduction studies are not always predictive of human response, cinacalcet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
*Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
 It is not known whether cinacalcet is excreted in human milk. Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio. Oral administration of cinacalcet to female rats during gestation and lactation at doses of 25 mg/kg/day and above (exposures at and above 1.5 times the clinical exposure at the MRCD, based on AUC) was associated with increases in neonatal loss and reduced body weight gain of suckling rats.
Considering the rat study findings and because many drugs are excreted in breast milk, a decision should be made to discontinue nursing or discontinue cinacalcet, taking into account the importance of cinacalcet to the mother.

4.7 Effects on Ability to Drive and Use Machines

Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking cinacalcet (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

Studies were conducted in patients with CKD receiving dialysis, and in patients with parathyroid carcinoma or primary HPT for whom parathyroidectomy is not a treatment option. Cinacalcet was safe and generally well tolerated. However, nausea and vomiting are very common adverse reactions.

Secondary hyperparathyroidism in patients with chronic kidney disease.

In 3 double-blind placebo-controlled clinical trials, 1126 CKD patients on dialysis received study drug (656 cinacalcet, 470 placebo) for up to 6 months. Adverse events reported during the studies were typical for the dialysis patient population. The most frequently reported adverse events (incidence of at least 5% in the cinacalcet group) are provided in Table 1. The most frequently reported events in the cinacalcet group were nausea and vomiting which were generally mild to moderate in severity, brief in duration, and infrequently led to discontinuation of study drug. Rash and hypocalcaemia have been observed.
Seizures were observed in 1.4% (13/910) of cinacalcet-treated patients and 0.7% (5/641) of placebo-treated patients across all completed placebo controlled trials.
The incidence of serious adverse events (29% vs 31%) and deaths (2% vs 3%) was similar in the cinacalcet and placebo groups, respectively.

12-month experience with cinacalcet.

Two hundred and sixty-six patients from the 2 pivotal phase 3 studies continued to receive cinacalcet or placebo treatment in a 6-month double-blind extension study (12-month total treatment duration). The incidence and nature of adverse events in this study were similar in the 2 treatment groups, and comparable to those observed in the pivotal phase 3 studies.

Other clinical experience with cinacalcet in secondary hyperparathyroidism.

In EVOLVE, a randomised, 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, the most frequently reported adverse reactions (incidence of ≥ 5% in the cinacalcet group and ≥ 1% compared to placebo) were nausea, vomiting, diarrhoea, dyspnoea, cough, hypotension, headache, hypocalcaemia, muscle spasms, abdominal pain, abdominal pain-upper, hyperkalaemia, upper respiratory tract infection, dyspepsia, dizziness, decreased appetite, asthenia and constipation.
Additional adverse event rates for cinacalcet versus placebo are as follows: seizure (2.5%, 1.6%), rash (2.2%, 1.9%), and hypersensitivity reactions (9.4%, 8.3%).

Parathyroid carcinoma and primary HPT for whom parathyroidectomy is not a treatment option.

Overall, the safety profile in patients with parathyroid carcinoma or intractable (failed or contraindicated to surgery) primary HPT was similar to that seen in patients with CKD and secondary HPT; the most frequent adverse events in this patient group were nausea and vomiting.

Summary of the safety of cinacalcet in subjects with primary HPT.

The safety profile of cinacalcet was similar across the 5 studies in primary HPT. Overall, common adverse events observed in these studies included gastrointestinal events (nausea, vomiting, abdominal pain), headache, paresthesia, anxiety, asthenia, dizziness, and arthralgia. Most adverse events were mild to moderate in severity. The most common event considered related to cinacalcet was nausea, which was also the most common adverse event leading to withdrawal. The safety profile of cinacalcet in this subject population was generally consistent with that in subjects with CKD and no unique safety concern was identified for cinacalcet in the treatment of primary HPT.
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.

Post marketing data.

Spontaneous post marketing reports have been received describing diarrhoea, myalgia, rash, seizures, gastrointestinal bleeding, chondrocalcinosis pyrophosphate and hypersensitivity reactions, including angioedema and urticaria, in association with cinacalcet HCl administration.
Isolated idiosyncratic cases of hypotension and/or worsening of heart failure have been reported in cinacalcet-treated patients with impaired cardiac function in post marketing safety surveillance.
Common: between 1% and 10%; uncommon: between 0.1% and 1%; rare: between 0.01% and 0.1%; very rare: between 0.001% and 0.01%.

Immune system disorders.

Uncommon: hypersensitivity reactions.

Skin and subcutaneous tissue disorders.

Common: rash. Very rare: angioedema and urticaria.

Gastrointestinal disorders.

Rare: diarrhoea.

Musculoskeletal and connective tissue disorders.

Rare: myalgia. Common: back pain.

Laboratory values.

Low laboratory serum calcium levels were very common in clinical studies. Serum calcium levels should be monitored in patients receiving cinacalcet (see Section 4.4 Special Warnings and Precautions for Use; Section 4.2 Dose and Method of Administration).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Doses titrated up to 300 mg once daily have been safely administered to patients receiving dialysis. Overdosage of cinacalcet may lead to hypocalcaemia. In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcaemia and appropriate measures taken to correct serum calcium levels (see Section 4.4 Special Warnings and Precautions for Use).
Since cinacalcet is highly protein bound, haemodialysis is not an effective treatment for overdosage of cinacalcet.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Cinacalcet reduces PTH while simultaneously lowering Ca x P, calcium and phosphorus levels in chronic kidney disease in patients receiving dialysis.
Secondary hyperparathyroidism (HPT) is a progressive disease, which occurs in patients with chronic kidney disease (CKD) and manifests as increases in parathyroid hormone (PTH) levels and derangements in calcium and phosphorus metabolism. Increased PTH stimulates osteoclastic activity resulting in cortical bone resorption and marrow fibrosis. The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion. Cinacalcet directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
In CKD patients with uncontrolled secondary HPT, reductions in PTH were associated with a favourable impact on bone specific alkaline phosphatase (BALP), N-telopeptide (N-Tx), bone turnover, bone fibrosis, and incidence of bone fracture.
Studies in a rat model of chronic renal insufficiency (CRI) (5/6 nephrectomy) assessed the effects of cinacalcet treatment on parathyroid gland hyperplasia. Cinacalcet treatment reduced PTH and parathyroid cell proliferation to levels comparable to vehicle-treated, non-nephrectomised animals, demonstrating that cinacalcet prevented the development of secondary HPT.

Pharmacodynamics.

Reductions in PTH levels correlate with cinacalcet concentrations. Nadir PTH occurs approximately 2 to 6 hours post dose, corresponding with cinacalcet Cmax. After steady state is reached, serum calcium concentrations remain constant over the dosing interval.

Clinical trials.

Secondary hyperparathyroidism in patients with chronic kidney disease.

Three, 6-month, multicentre, randomised, double-blind, placebo-controlled clinical studies were conducted in CKD patients receiving dialysis with uncontrolled secondary HPT (n = 665 on cinacalcet, 471 on placebo). The patient population consisted of both recently established and long-standing dialysis patients, with a range of 1 to 359 months. Cinacalcet was administered either alone or in combination with vitamin D sterols; 34% of patients were not receiving vitamin D sterols at study entry. The majority (more than 90%) of patients were receiving phosphate binders. Dose adjustments in phosphate binder therapy were permitted throughout the study. Vitamin D doses remained constant unless the patient developed hypercalcaemia, hypocalcaemia, or hyperphosphataemia. Patients continued on their previously prescribed drugs including: calcium channel blockers, ACE inhibitors, beta-blockers, hypoglycaemics, and lipid lowering agents.
Cinacalcet (or placebo) was initiated at a dose of 30 mg and titrated every 3 or 4 weeks to a maximum dose of 180 mg once daily to achieve an iPTH of 10.6 to 26.5 picomol/L (1.5 to 4 times the upper limit of normal). The severity of secondary HPT ranged from mild to severe (iPTH values of 28.8 to 969.5 picomol/L), with mean (SE) baseline iPTH concentrations across the 3 studies of 77.8 (2.2) and 72.5 (2.0) picomol/L for the cinacalcet and placebo groups, respectively. Significant reductions in iPTH, serum calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet-treated patients compared with placebo-treated patients receiving standard of care, and the results were consistent across the 3 studies (Table 2).
Mean iPTH and Ca x P by treatment group for the overall study population during the 6-month treatment period are presented in Figure 1 and Figure 2.
In patients receiving cinacalcet, reductions in iPTH and Ca x P occurred within 2 weeks and were maintained for at least 12 months of treatment (n = 99 on cinacalcet, 111 on placebo).
Cinacalcet decreased iPTH and Ca x P levels regardless of disease severity (i.e. baseline iPTH value), dialysis modality (PD versus HD), duration of dialysis, and whether or not vitamin D sterols were administered. Approximately 60% of patients with mild (iPTH from 31.8 to 53.0 picomol/L), moderate (iPTH between 53.0 and 84.8 picomol/L), or severe (iPTH above 84.8 picomol/L) secondary HPT achieved at least a 30% reduction in iPTH levels. Cinacalcet treatment also reduced iPTH and Ca x P in patients with elevated Ca x P levels.
The impact of cinacalcet on bone disease, including the risk of adynamic bone disease, has not been conclusively evaluated.
The pivotal clinical studies were designed to evaluate the effect of cinacalcet on biochemical parameters, including PTH, serum calcium and phosphorus. Clinical outcomes such as quality of life, rate of parathyroidectomy, symptomatic bone disease, hospitalisation, or mortality were not pre-specified endpoints and were not evaluated within individual studies. The pivotal efficacy and safety studies in patients with secondary hyperparathyroidism of chronic kidney disease, requiring dialysis, did not examine quality of life benefits. There were no differences between cinacalcet and placebo treated patients in terms of statistically significant differences in self-reported cognitive functioning scale scores during the efficacy assessment phase.
EVOLVE (evaluation of cinacalcet HCl therapy to lower cardiovascular events) was a randomised, double-blind clinical study evaluating cinacalcet HCl vs. placebo for the reduction of the risk of all-cause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving dialysis. The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112). Because the primary composite endpoint did not reach statistical significance, secondary endpoints were not tested for statistical significance. Primary and secondary endpoints are shown in Table 3.

Parathyroid carcinoma.

Twenty-nine patients with parathyroid carcinoma were enrolled in an open-label study. Parathyroid carcinoma and severe hypercalcaemia in these patients were persistent despite previous parathyroidectomy and bisphosphonate therapy. The study consisted of two phases, a dose-titration phase and a maintenance phase. Cinacalcet was administered at doses ranging from 30 mg twice daily to 90 mg four times daily, and mean serum calcium declined from 3.53 to 3.10 mmol/L across the titration phase (up to 16 weeks). Sixty-two percent of patients (18 of 29) achieved a reduction in serum calcium of at least 0.25 mmol/L.

Primary HPT for whom parathyroidectomy is not a treatment option.

Seventeen patients with primary HPT for whom parathyroidectomy was not a treatment option were enrolled in an open-label study. The study consisted of two phases, a dose-titration phase and a maintenance phase. Cinacalcet was administered at doses ranging from 30 mg twice daily to 90 mg four times daily, and mean serum calcium declined from 3.18 to 2.60 mmol/L across the titration phase (up to 16 weeks). Eighty-eight percent of patients (15 of 17) achieved a reduction in serum calcium of at least 0.25 mmol/L.
An additional 114 patients with primary HPT and hypercalcaemia, including 25 patients with recurrent primary HPT after parathyroidectomy, were enrolled in 3 controlled studies and one open label study. In one study of 45 patients with primary HPT, including 12 patients with recurrent primary HPT after parathyroidectomy, cinacalcet normalised serum calcium in approximately 80% of patients, and this was sustained for up to 3 years.

5.2 Pharmacokinetic Properties

Absorption.

After oral administration of cinacalcet, maximum plasma concentration is achieved in approximately 2 to 6 hours. The absolute bioavailability of cinacalcet is approximately 25%. Administration of cinacalcet with food results in an approximate 50 to 80% increase in bioavailability. Increases in plasma concentrations are similar, regardless of the fat content of the meal.
After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of approximately 6 hours and a terminal half-life of 30 to 40 hours. Steady state drug levels are achieved within 7 days with minimal accumulation. The AUC and Cmax of cinacalcet increase linearly over the once daily dose range of 30 to 180 mg. The pharmacokinetics of cinacalcet do not change over time.

Distribution.

The volume of distribution is high (approximately 1000 L), indicating extensive distribution. Cinacalcet in plasma is approximately 97% bound to plasma proteins and in whole blood, cinacalcet distributes minimally into red blood cells.

Metabolism.

Cinacalcet is metabolised by multiple enzymes, primarily CYP3A4, CYP1A2 and CYP2D6. The major circulating metabolites are inactive. After administration of a 75 mg radio-labelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.

Excretion.

Renal excretion of metabolites was the prevalent route of elimination of radioactivity. Approximately 80% of the dose was recovered in the urine and 15% in the faeces.

Special populations.

Hepatic impairment.

Mild hepatic impairment did not alter the pharmacokinetics of cinacalcet. Compared to subjects with normal liver function, average AUC of cinacalcet was approximately 2 times higher in subjects with moderate impairment and approximately 4 times higher in subjects with severe impairment (see Section 4.4 Special Warnings and Precautions for Use). Because doses are titrated for each subject based on safety and efficacy parameters, no additional dose adjustment is necessary for subjects with hepatic impairment.

Renal impairment.

The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy volunteers. No dosage adjustment based on the degree of renal function is necessary.

Geriatric patients.

There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet. No dosage adjustment based on age is necessary.

Paediatric patients.

The safety and efficacy of cinacalcet has not been studied in children and are not established. A single dose pharmacokinetic study has been completed in paediatric patients 6-17 years of age (N = 12). The pharmacokinetic parameters following a 15 mg dose are summarized in Table 4.
Whilst a 15 mg dose of cinacalcet was used in the paediatric PK study, this dose strength is not registered.
Six of the twelve subjects experienced decreases in serum calcium below the lower limit of normal (2.23 mmol/L). In these six subjects, baseline values were in the range of 2.20 to 2.52 mmol/L and the decreased values were in the range of 2.00 to 2.22 mmol/L. In the same study, QT interval prolongation, assessed as unrelated to cinacalcet, was reported in one of the twelve subjects.
The use of multiple doses in paediatric subjects has not been studied. On the basis of these limited data, there is a potential for higher exposures and greater pharmacodynamic effects in the lighter/younger relative to the heavier/old paediatric subjects when treated with identical doses of cinacalcet (see Section 4.4 Special Warnings and Precautions for Use, Serum calcium).

5.3 Preclinical Safety Data

Genotoxicity.

Cinacalcet was negative in the Ames assay, Chinese Hamster Ovary HGPT forward mutation assay, in vitro chromosome aberration assay and the mouse micronucleus assay. These tests indicate that cinacalcet is unlikely to pose a genotoxic risk to humans.

Carcinogenicity.

Cinacalcet, administered orally at dietary doses up to 200 mg/kg to mice and 35 mg/kg/day to rats for 104 weeks, showed no evidence of carcinogenic potential. These doses resulted in total systemic exposure (AUCs) approximately equivalent to the exposures observed in humans given the maximum dose of 360 mg/day. A decreased incidence of thyroid C-cell adenomas was observed in rats treated with cinacalcet.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, colloidal anhydrous silica, crospovidone, povidone, magnesium stearate, Opadry complete film coating system 03K51674 green (ARTG PI No: 109807).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

All strengths of Cinacalcet Viatris are available in PVC/PVDC/Al blister packs of 28 tablets.

Australian register of therapeutic goods (ARTG).

AUST R 289379.

Cinacalcet Viatris cinacalcet 30 mg tablet blister pack.

AUST R 289380.

Cinacalcet Viatris cinacalcet 60 mg tablet blister pack.

AUST R 289381.

Cinacalcet Viatris cinacalcet 90 mg tablet blister pack.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: N-[1-(R)-(1-naphthyl) ethyl]-3-[3-(trifluoromethyl) phenyl]-1-aminopropane hydrochloride.
Molecular formula: C22H22F3N.HCl.
Molecular weight: 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base).

CAS number.

364782-34-3.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes