西那卡塞片剂药品说明书(英文)-日本
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Kyowa Hakko Kirin Co., Ltd.
1
Revised: January 2010 (version 5)
Standard Commodity Classification No. of Japan
873999 - DRUG FOR TREATMENT OF SECONDARY HYPERPARATHYROIDISM (CALCIUM RECEPTOR AGONIST)
Approval No. Date of listing in the NHI reimbursement price
December 2007 January 2008
March 2004
Expiration date Specified on the outer package.
Date of initial marketing in Japan International birth date
1. Composition Brand name Active ingredients (per tablet) Regpara Tablets Regpara Tablets 25 mg 75 mg Cinacalcet Cinacalcet hydrochloride hydrochloride 27.55 mg (including 82.65 mg (including 75 mg of cinacalcet) 25 mg of cinacalcet) Pregelatinized starch, Pregelatinized starch, Crystalline cellulose, Crystalline cellulose, Povidone, Povidone, Crospovidone, Crospovidone, Magnesium stearate, Light anhydrous Lactose hydrate, silicic acid, Hypromellose, Talc, Titanium oxide, Magnesium stearate, Triacetin, Lactose hydrate, Macrogol 400, Hypromellose, Yellow ferric oxide Titanium oxide, Triacetin, Macrogol 400, Yellow ferric oxide, Blue No.2 aluminum lake Light-yellow, Light-green to lightfilm-coated tablets yellowish green, film-coated tablets
CONTRAINDICATIONS (Regpara is contraindicated in the following patients.) Patients with a history of hypersensitivity to any of the ingredienh gastrointestinal hemorrhage and/or gastrointestinal ulcer or a history of gastrointestinal hemorrhage and/or gastrointestinal ulcer [The symptoms may worsen or recur.] 2. Important Precautions (1) During treatment with Regpara, sufficient caution should be exercised to avoid hypocalcaemia by periodical measurement of the serum calcium level. If hypocalcaemia occurs or may occur, it should be taken into account to use calcium or vitamin D preparations, as well as to reduce the dose of Regpara. (See <Precautions related to dosage and administration>.) If administration of calcium or vitamin D preparations is discontinued during treatment with Regpara, caution should be exercised for possible occurrence of hypocalcaemia. Symptoms likely to be associated with hypocalcaemia such as prolonged QT interval, paresthesia, cramping, feeling unwell, arrhythmia, decreased blood pressure, and seizure, etc. have been reported in clinical studies on the drug. (2) At the start of administration and during the dose adjustment period, the patient’s symptoms should be frequently monitored and caution should be exercised for possible occurrence of adverse reactions. 3. Drug Interactions Precautions for coadministration (Regpara should be administered with care when coadministered with the following drugs.)
Inactive ingredients
Color and dosage form
2
Measures to be taken Serum calcium level 8.4 mg/dL or less Actions Administration of Regpara In principle, the dose should not be increased (should be decreased as needed.) Administration of calcium or vitamin D preparations should be considered.
INDICATIONS
Secondary hyperparathyroidism in patients undergoing maintenance dialysis
DOSAGE AND ADMINISTRATION
The starting dosage for adults is 25 mg of cinacalcet once daily, to be orally administered. With careful management of the patient’s serum parathyroid hormone (PTH) and calcium levels, the dose may then be adjusted within a range of 25-75 mg once daily. If no improvement is found in PTH, the dose may be increased up to 100 mg once daily. If dose increase is required, dose should be increased by 25 mg at a time, at intervals of at least 3 weeks. <Precautions related to Dosage and Administration> 1. Regpara has an effect of decreasing calcium in blood. Therefore, it should be confirmed that the patient’s serum calcium level is not low (9.0 mg/dL or more) prior to administration. 2. The serum calcium level should be determined once a week at the start of administration and during the dose adjustment period, and at least once every two weeks during the maintenance period. If serum calcium level decreases to 8.4 mg/dL or less, the following measures should be taken.
Drugs Azole antifungals Itraconazole, etc. Macrolide antibiotics Erythromycin, Clarithromycin, etc. Amiodarone hydrochloride Grapefruit juice Signs, Symptoms and Treatment The plasma concentration of cinacalcet may increase and the effect of the drug may enhance. The AUC of cinacalcet increased about two-fold, when cinacalcet was coadministered with ketoconazole1) . Mechanism and Risk Factors Cinacalcet is metabolized in part by CYP3A4. Therefore, the coadministration of CYP3A4 inhibitors, listed in the left column, with cinacalcet have a potency to inhibit the cinacalcet metabolism and lead to an increase of plasma cinacalcet concentration. Cinacalcet is a inhibitor of CYP2D6. Therefore, the coadministration of cinacalcet with CYP2D6 substrates listed in the left column have a potency to inhibit the metabolism of those CYP2D6 substrates and lead to an increase of their blood concentrations. The blood calciumdecreasing effect of cinacalcet may be strengthened.
Kyowa Hakko Kirin Co. , Ltd.
Dose Examinaincrease/Retions start of treatment The serum If the dose is calcium increased, the should be serum calcium determined level should at least be confirmed once a to have week. recovered to 8.4 mg/dL or It is more prior to recomdose increase. mended to If the treatperform ment is reelectrocar- started, the diography. serum calcium level should be confirmed to have recovered to 8.4 mg/dL or more prior to restart, and then the initial dose should be set at the pre-withdrawal level or less.
REGPARA Tablets 25 mg REGPARA Tablets 75 mg
< Cinacalcet Hydrochloride >
Prescription drug: Caution - Use only as directed by a physician. Storage Store at room temperature. 25 mg 21900AMX01750 75 mg 21900AMX01751
Face
Reverse
Lateral
Face
Reverse
Lateral
Appearance Diameter Thickness Weight Identification code 8 mm 4 mm ca. 207 mg KR02 8 mm 4 mm ca. 207 mg KR03
DESCRIPTION
1
Revised: January 2010 (version 5)
Standard Commodity Classification No. of Japan
873999 - DRUG FOR TREATMENT OF SECONDARY HYPERPARATHYROIDISM (CALCIUM RECEPTOR AGONIST)
Approval No. Date of listing in the NHI reimbursement price
December 2007 January 2008
March 2004
Expiration date Specified on the outer package.
Date of initial marketing in Japan International birth date
1. Composition Brand name Active ingredients (per tablet) Regpara Tablets Regpara Tablets 25 mg 75 mg Cinacalcet Cinacalcet hydrochloride hydrochloride 27.55 mg (including 82.65 mg (including 75 mg of cinacalcet) 25 mg of cinacalcet) Pregelatinized starch, Pregelatinized starch, Crystalline cellulose, Crystalline cellulose, Povidone, Povidone, Crospovidone, Crospovidone, Magnesium stearate, Light anhydrous Lactose hydrate, silicic acid, Hypromellose, Talc, Titanium oxide, Magnesium stearate, Triacetin, Lactose hydrate, Macrogol 400, Hypromellose, Yellow ferric oxide Titanium oxide, Triacetin, Macrogol 400, Yellow ferric oxide, Blue No.2 aluminum lake Light-yellow, Light-green to lightfilm-coated tablets yellowish green, film-coated tablets
CONTRAINDICATIONS (Regpara is contraindicated in the following patients.) Patients with a history of hypersensitivity to any of the ingredienh gastrointestinal hemorrhage and/or gastrointestinal ulcer or a history of gastrointestinal hemorrhage and/or gastrointestinal ulcer [The symptoms may worsen or recur.] 2. Important Precautions (1) During treatment with Regpara, sufficient caution should be exercised to avoid hypocalcaemia by periodical measurement of the serum calcium level. If hypocalcaemia occurs or may occur, it should be taken into account to use calcium or vitamin D preparations, as well as to reduce the dose of Regpara. (See <Precautions related to dosage and administration>.) If administration of calcium or vitamin D preparations is discontinued during treatment with Regpara, caution should be exercised for possible occurrence of hypocalcaemia. Symptoms likely to be associated with hypocalcaemia such as prolonged QT interval, paresthesia, cramping, feeling unwell, arrhythmia, decreased blood pressure, and seizure, etc. have been reported in clinical studies on the drug. (2) At the start of administration and during the dose adjustment period, the patient’s symptoms should be frequently monitored and caution should be exercised for possible occurrence of adverse reactions. 3. Drug Interactions Precautions for coadministration (Regpara should be administered with care when coadministered with the following drugs.)
Inactive ingredients
Color and dosage form
2
Measures to be taken Serum calcium level 8.4 mg/dL or less Actions Administration of Regpara In principle, the dose should not be increased (should be decreased as needed.) Administration of calcium or vitamin D preparations should be considered.
INDICATIONS
Secondary hyperparathyroidism in patients undergoing maintenance dialysis
DOSAGE AND ADMINISTRATION
The starting dosage for adults is 25 mg of cinacalcet once daily, to be orally administered. With careful management of the patient’s serum parathyroid hormone (PTH) and calcium levels, the dose may then be adjusted within a range of 25-75 mg once daily. If no improvement is found in PTH, the dose may be increased up to 100 mg once daily. If dose increase is required, dose should be increased by 25 mg at a time, at intervals of at least 3 weeks. <Precautions related to Dosage and Administration> 1. Regpara has an effect of decreasing calcium in blood. Therefore, it should be confirmed that the patient’s serum calcium level is not low (9.0 mg/dL or more) prior to administration. 2. The serum calcium level should be determined once a week at the start of administration and during the dose adjustment period, and at least once every two weeks during the maintenance period. If serum calcium level decreases to 8.4 mg/dL or less, the following measures should be taken.
Drugs Azole antifungals Itraconazole, etc. Macrolide antibiotics Erythromycin, Clarithromycin, etc. Amiodarone hydrochloride Grapefruit juice Signs, Symptoms and Treatment The plasma concentration of cinacalcet may increase and the effect of the drug may enhance. The AUC of cinacalcet increased about two-fold, when cinacalcet was coadministered with ketoconazole1) . Mechanism and Risk Factors Cinacalcet is metabolized in part by CYP3A4. Therefore, the coadministration of CYP3A4 inhibitors, listed in the left column, with cinacalcet have a potency to inhibit the cinacalcet metabolism and lead to an increase of plasma cinacalcet concentration. Cinacalcet is a inhibitor of CYP2D6. Therefore, the coadministration of cinacalcet with CYP2D6 substrates listed in the left column have a potency to inhibit the metabolism of those CYP2D6 substrates and lead to an increase of their blood concentrations. The blood calciumdecreasing effect of cinacalcet may be strengthened.
Kyowa Hakko Kirin Co. , Ltd.
Dose Examinaincrease/Retions start of treatment The serum If the dose is calcium increased, the should be serum calcium determined level should at least be confirmed once a to have week. recovered to 8.4 mg/dL or It is more prior to recomdose increase. mended to If the treatperform ment is reelectrocar- started, the diography. serum calcium level should be confirmed to have recovered to 8.4 mg/dL or more prior to restart, and then the initial dose should be set at the pre-withdrawal level or less.
REGPARA Tablets 25 mg REGPARA Tablets 75 mg
< Cinacalcet Hydrochloride >
Prescription drug: Caution - Use only as directed by a physician. Storage Store at room temperature. 25 mg 21900AMX01750 75 mg 21900AMX01751
Face
Reverse
Lateral
Face
Reverse
Lateral
Appearance Diameter Thickness Weight Identification code 8 mm 4 mm ca. 207 mg KR02 8 mm 4 mm ca. 207 mg KR03
DESCRIPTION