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Drug details for : ZEMPLAR Soft Capsules
| Drug class description : | Vitamin D analog |
| Generic Name : | Paricalcitol |
| Drug description : | Capsule, soft 1 microgram capsule: oval, gray soft capsule imprinted with and ZA 2 micrograms capsule: oval, orange-brown soft capsule imprinted with and ZF 4 micrograms capsule: oval, gold soft capsule imprinted with and ZK |
| Presentation : | Zemplar 1 microgram capsules, soft - Paricalcitol: 1 microgram, Excipients (Ethanol): 0.71 mg. Zemplar 2 micrograms capsules, soft - Paricalcitol: 2 micrograms, Excipients (Ethanol): 1.42 mg. Zemplar 4 micrograms capsules, soft - Paricalcitol: 4 micrograms, Excipients (Ethanol): 1.42 mg |
| Indications : | Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease Stages 3 and 4) patients and chronic renal failure (chronic kidney disease Stage 5) patients on haemodialysis or peritoneal dialysis. |
| Adult Dosage : | Zemplar can be taken with or without food. Chronic Kidney Disease (CKD) Stages 3 and 4 Zemplar should be administered once a day, either daily or three times a week taken every other day. Initial Dose The initial dose is based on baseline intact parathyroid hormone (iPTH) levels. Baseline iPTH Level - Daily Dose - Three Times a Week Dose* 500 pg/mL (56 pmol/L) - 1 microgram - 2 micrograms > 500 pg/mL (56 pmol/L) - 2 micrograms - 4 micrograms * To be administered no more frequently than every other day Dose Titration Dosing must be individualised based on serum or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus. Serum calcium levels should be closely monitored after initiation of the treatment and during dose titration periods. If hypercalcemia or a persistently elevated calcium-phosphorus product greater than 55 mg2/dL2 (4.4 mmol2 /L2) is observed, the dose of calcium based phosphate binders should be reduced or withheld. Alternatively, the dose of Zemplar may be reduced or temporarily interrupted. If interrupted, the drug should be restarted at a lower dose, when serum calcium and calcium-phosphorus product are in the target range. Chronic Kidney Disease (CKD), Stage 5 Zemplar should be administered three times a week every other day. Initial Dose The initial dose of Zemplar in micrograms is based on a baseline iPTH level (pg/mL)/60 [(pmol/L)/7], up to an initial maximum dose of 32 micrograms. Dose Titration Subsequent dosing should be individualised and based on iPTH, serum calcium and phosphorus levels. A suggested dose titration of paricalcitol capsules is based on the following formula: OR Serum calcium and phosphorus levels should be closely monitored after initiation, during dose titration periods, and with co-administration of strong P450 3A inhibitors. If an elevated serum calcium or elevated Ca x P is observed and the patient is on a calcium-based phosphate binder, the binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If serum calcium > 11.0 mg/dL (2.8 mmol/L) or Ca x P > 70 mg2/dL2 (5.6 mmol2/L2) or iPTH 150 pg/mL, the dose should be decreased by 2 to 4 micrograms with respect to that calculated by the most recent iPTH/60 (pg/mL) [iPTH/7 (pmol/L)]. If further adjustment is required, the dose of paricalcitol capsules should be reduced or interrupted until these parameters are normalised. As iPTH approaches the target range (150-300 pg/mL), small, individualised dose adjustments may be necessary in order to achieve a stable iPTH. In situations where monitoring of iPTH, Ca or P occurs less frequently than once per week, a more modest initial and dose titration ratio may be warranted. Special Populations Hepatic Impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment. There is no experience in patients with severe hepatic impairment. |
| Child Dosage : | Safety and efficacy of Zemplar Capsules in paediatric patients have not been established. |
| Elderly Dosage : | No overall differences in safety and effectiveness were observed between elderly patients (65 – 75 years) with regard to younger patients, but greater sensitivity of some older individuals cannot be ruled out. |
| Contra Indications : | Paricalcitol should not be given to patients with evidence of vitamin D toxicity, hypercalcaemia, or hypersensitivity to paricalcitol or any of the excipients in this medicinal product. |
| Special Precautions : | Over suppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to low-turnover bone disease. Patient monitoring and individualised dose titration is required to reach appropriate physiological endpoints. If clinically significant hypercalcaemia develops and the patient is receiving a calcium-based phosphate binder, the dose of the calcium-based phosphate binder should be reduced or interrupted. Digitalis toxicity is potentiated by hypercalcemia of any cause, so caution should be applied when digitalis is prescribed concomitantly with paricalcitol (See Interactions). Caution should be exercised if co-administering paricalcitol with ketoconazole (See Interactions). Warning for excipients: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 1 mcg, 2 mcg and 4 mcg capsule which may be harmful to those suffering from alcoholism (See Adult Dosage). To be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy. |
| Interactions : | Ketoconazole: Ketoconazole is known to be a nonspecific inhibitor of several cytochrome P450 enzymes. The available in vivo and in vitro data suggest that ketoconazole may interact with enzymes that are responsible for the metabolism of paricalcitol and other vitamin D analogs. Caution should be taken while dosing paricalcitol with ketoconazole.The effect of multiple doses of ketaconazole administered as 200 mg, twice daily (BID) for 5 days on the pharmacokinetics of paricalcitol capsule has been studied in healthy subjects. The Cmax of paricalcitol was minimally affected, but AUC0- approximately doubled in the presence of ketoconazole. The mean half-life of paricalcitol was 17.0 hours in the presence of ketoconazole as compared to 9.8 hours, when paricalcitol was administered alone (See Special Precautions). The results of this study indicate that following either oral or intravenous administration of paricalcitol the maximum amplification of the paricalcitol AUCINF from a drug interaction with ketoconazole is not likely to be greater than about two-fold. Specific interaction studies were not performed. Digitalis toxicity is potentiated by hypercalcaemia of any cause, so caution should be applied when digitalis is prescribed concomitantly with paricalcitol. Prescription-based phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation. High doses of calcium-containing preparation or thiazide diuretics may increase the risk of hypercalcaemia. Magnesium-containing preparations (e.g. antacids) should not be taken concomitantly with vitamin D preparations, because hypermagnesemia may occur. Aluminium-containing preparations (e.g. antacids, phosphate-binders) should not be administered chronically with Vitamin D medicinal products, as increased blood levels of aluminium and aluminium bone toxicity may occur. There is no adequate data on the use of paricalcitol in pregnant women. Animal studies have shown reproductive toxicity. Potential risk in human use is not known, therefore paricalcitol should be not be used unless clearly necessary. Lactation: It is not known whether paricalcitol is excreted in human milk. Animal studies have shown excretion of paricalcitol or its metabolites in breast milk, in small amounts. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Zemplar should be made taking into account the benefit of breast-feeding to the child and the benefit of Zemplar therapy to the woman. |
| Adverse Reactions : | Chronic Kidney Disease, Stages 3 and 4 The safety of paricalcitol capsules has been evaluated in three 24-week, double-blind, placebo-controlled, multi-centre clinical trials involving 220 CKD Stage 3 and 4 patients. There were no statistically significant differences between the paricalcitol-treated patients and placebo-treated patients in the incidence of hypercalcaemia Zemplar (2/106, 2 %) vs placebo (0/111, 0 %) or elevated calcium phosphorus product Zemplar (13/106, 12%) vs placebo (7/111, 6%). The most commonly reported adverse reaction for paricalcitol treated patients was rash, occurring in 2% of patients. All adverse events at least possibly related to paricalcitol, both clinical and laboratory, are displayed below by MedDRA System Organ Class, Preferred Term and frequency. The following frequency groupings are used: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Investigations Hepatic Enzyme Abnormal Uncommon Nervous system disorders Dizziness Dysgeusia Uncommon Uncommon Gastrointestinal disorders Stomach discomfort Constipation Dry mouth Common Uncommon Uncommon Skin and subcutaneous tissue disorders Rash Pruritus Urticaria Common Uncommon Uncommon Musculoskeletal and connective tissue disorders Muscle spasms Uncommon Immune system disorders Hypersensitivity Uncommon Chronic Kidney Disease, Stage 5 The safety of paricalcitol capsules has been evaluated in one 12-week, double-blind, placebo-controlled, multi-centre clinical trial involving 88 CKD Stage 5 patients. There were no statistically significant differences between the paricalcitol-treated patients and placebo-treated patients in the incidence of hypercalcaemia Zemplar (1/61, 2%) vs placebo (0/26, 0.0%), or elevated calcium phosphorus product Zemplar (6/61, 10%) vs placebo (1/26, 4%). All adverse events at least possibly related to paricalcitol, both clinical and laboratory, are displayed below by MedDRA System Organ Class, Preferred Term and frequency. The following frequency groupings are used: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Adverse Reactions Reported in Stage 5 CKD pivotal phase III Study System Organ Class Preferred Term Frequency Nervous system disorders Dizziness Common Gastrointestinal disorders DiarrhoeaGastroesophageal reflux disease Common Common Skin and subcutaneous tissue disorders: Acne - Common. Metabolism and nutrition disorders: Hypercalcaemia - Common, Hypocalcaemia - Common. Reproductive system and breast disorders: Breast tenderness - Common The following additional adverse reactions have been seen in clinical trials with Zemplar injection. Common Nervous system disorders: headache, dysgeusia Skin and subcutaneous tissue disorders: pruritis Endocrine disorders: hypoparathyroidism Metabolism and nutrition disorders: hyperphosphataemia, hypercalcaemia Uncommon Investigations: heart rate irregular, bleeding time prolonged, aspartate aminotransferase increased, weight decreased Cardiac disorders: cardiac arrest, atrial flutter, arrhythmia Blood and lymphatic system disorders: neutropenia, leukopenia, anaemia, lymphadenopathy Nervous system disorders: cerebrovascular accident, transient ischemic attack, coma, syncope, dizziness, myoclonus, paraesthesia, hypoesthesia Eye disorders: glaucoma, conjunctivitis, ocular hyperaemia Ear and labyrinth disorders: ear discomfort Respiratory, thoracic and mediastinal disorders: pulmonary oedema, epistaxis, dyspnoea, orthopnoea, wheezing, cough Gastrointestinal disorders: intestinal ischaemia, rectal haemmorrhage, gastritis, dysphagia, irritable bowel syndrome, diarrhoea, constipation, dyspepsia, vomiting, nausea, dry mouth, stomach discomfort Skin and subcutaneous tissue disorders: rash pruritic, rash, blister, alopecia, hirsutism, night sweats, injection site pain, skin burning sensation, Musculoskeletal and connective tissue disorders: arthralgia, myalgia, back pain, joint stiffness, muscle twitching Endocrine disorders: hyperparathyroidism Metabolism and nutrition disorders: anorexia, decreased appetite Infections and infestations: sepsis, pneumonia, influenza, upper respiratory tract infection, nasopharyngitis, vaginal infection Neoplasms benign, malignant, unspecified (including cysts and polyps): breast cancer Vascular disorders: hypotension, hypertension General disorders and administration site conditions: chest pain, gait disturbance, oedema, peripheral, oedema, swelling, chest discomfort, pyrexia, asthenia, pain, fatigue, malaise, thirst, feeling abnormal, Immune system disorders: hypersensitivity Reproductive system and breast disorders: breast pain, erectile dysfunction Psychiatric disorders: delirium, confusional state, agitation, sleep disorder, insomnia, nervousness, restlessness. Post-marketing adverse reactions reported with Zemplar injection: Immune system disorders: hypersensitivity Skin and subcutaneous tissue disorders: angioedema, laryngeal oedema, urticaria. |
| Manufacturer : | Abbott |
| Drug Availability : | (POM) |
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