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Mimpara 30 mg film-coated tablets Cinacalcet,Hydrochloride
2014-06-14 18:58:47 来源: 作者: 【 】 浏览:341次 评论:0

For doctors

 

What is it and how is it used?

Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).

Mimpara is used:

In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroids glands. “Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” means that the hyperparathyroidism is caused by another condition, e.g., kidney disease. Both primary and secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.

What do you have to consider before using it?

Do not take Mimpara:

Take special care with Mimpara:

Children under the age of 18 must not take Mimpara.

Before you start taking Mimpara, tell your doctor if you have or have ever had:

For additional information see section 4.

During treatment with Mimpara, tell your doctor:

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Please tell your doctor if you are taking the following medicines.

These can affect how Mimpara works:

Mimpara may affect how the following work:

Taking Mimpara with food and drink

Mimpara should be taken with or shortly after food.

Pregnancy and breast-feeding

Always tell your doctor if you are pregnant or planning to become pregnant. Mimpara has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.

It is not known whether Mimpara is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Mimpara.

If you are pregnant or planning to become pregnant ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness and seizures have been reported by patients taking Mimpara. If you experience these, your ability to drive or operate machinery may be affected.

If you have an intolerance to some sugars

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Always take Mimpara exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how much Mimpara you must take.

Mimpara must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be divided.

Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.

If you are being treated for secondary hyperparathyroidism

The usual starting dose for Mimpara is 30 mg (one tablet) once per day.

If you are being treated for parathyroid cancer or primary hyperparathyroidism

The usual starting dose for Mimpara is 30 mg (one tablet) twice per day.

If you take more Mimpara than you should

If you take more Mimpara than you should you must contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.

If you forget to take Mimpara

Do not take a double dose to make up for forgotten doses.

If you have forgotten a dose of Mimpara, you should take your next dose as normal.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Mimpara can have side effects, although not everybody gets them.

If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures you should tell you doctor immediately.These may be signs that your calcium levels are too low (hypocalcaemia).

Very common side effects (seen in more than 1 in 10 people taking Mimpara):

Common side effects (seen in more than 1 in 100 people taking Mimpara):

Uncommon side effects (seen in more than 1 in 1000 people taking Mimpara):

Frequency not known

After taking Mimpara a very small number of patients with heart failure had worsening of their condition. Low blood pressure (hypotension) has also been seen in a very small number of these patients. As so few cases have been seen it is not known whether they are due to Mimpara, or not.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Mimpara after the expiry date which is stated on the outer carton and on the blister. The expiry date refers to the last day of that month.

(or) Do not use Mimpara after the expiry date which is stated on the outer carton and on the bottle.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Mimpara is a medicine that contains the active substance cinacalcet. It is available as light green, oval tablets (30, 60 and 90 mg).

What is it used for?

Mimpara is used in adults and elderly patients in the following ways:
- to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products. Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to bone and joint pain and deformities of the arms and legs. ‘Secondary’ means that it is caused by another condition. Mimpara can be used as part of treatment including phosphate binders or vitamin D sterols;
- to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate. ‘Primary’ means that the hyperparathyroidism is not caused by any other condition.
The medicine can only be obtained with a prescription.

How is it used?

In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day. The dose is adjusted every two to four weeks, according to the patient’s PTH levels, up to a maximum of 180 mg once a day. PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Mimpara. Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Mimpara. Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day. The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Mimpara is taken with food or shortly after a meal.

How does it work?

The active substance in Mimpara, cinacalcet, is a calcimimetic agent. This means that it mimics the action of calcium in the body. Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also leads to a decrease in blood calcium levels.

How has it been studied?

Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 dialysis patients with serious kidney disease. The studies lasted for six months. The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.
Mimpara has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective. The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study). The study continued for over three years. A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year. Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.

What benefits has it shown during the studies?

In dialysis patients with serious kidney disease, about 40% of the patients taking Mimpara had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo. Mimpara brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17). The results of the additional studies supported the use of Mimpara for hypercalcaemia in patients with primary hyperparathyroidism.

What is the risk associated?

The most common side effects with Mimpara in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting. In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting. For the full list of all side effects reported with Mimpara, see the Package Leaflet.
Mimpara should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Mimpara’s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated. The Committee recommended that Mimpara be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara to Amgen Europe B.V. on 22 October 2004. The marketing authorisation was renewed on 22 October 2009.

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Name

 

Mimpara 30 mg film-coated tablets

 

Composition

 

Each tablet contains 30 mg cinacalcet (as hydrochloride).

Excipients:

Each 30 mg tablet contains 2.74 mg of lactose.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet (tablet).

Light green, oval, film-coated tablet marked “AMG” on one side and “30” on the other.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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