Zemplar 2 ug/mL
Paricalcitol · INJECTION, SOLUTION · AbbVie Inc.
Zemplar is a injection, solution containing paricalcitol at 2 ug/mL, taken intravenous. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Zemplar
- Generic Name
- Paricalcitol
- NDC Code (Product)
0074-4637- Manufacturer
- AbbVie Inc.
- Strength
- 2 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA020819
- Drug Class
- Vitamin D2 Analog [EPC]; Vitamin D Analog [EPC]
- Marketing Start
- 04/17/1998
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1 ). CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2 ). 1.1 Chronic Kidney Disease Stages 3 and 4 ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. 1.2 Chronic Kidney Disease Stage 5 ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initial Dosage: CKD Stages 3 and 4 ( 2.1 , 2.3 ) Adult: Baseline iPTH ≤ 500 pg/mL 1 mcg orally daily or 2 mcg three times a week* Adult: Baseline iPTH > 500 pg/mL 2 mcg orally daily or 4 mcg three times a week* Pediatric: Ages 10 to 16 years 1 mcg orally three times a week* Dose Titration: CKD Stages 3 and 4 ( 2.1 , 2.3 ) Adult: iPTH same, increased or decreased by < 30% relative to baseline Increase dose by 1 mcg daily or 2 mcg three times a week* Adult: iPTH decreased by ≥ 30% and ≤ 60% relative to baseline Maintain dose Adult: iPTH decreased by > 60% or iPTH < 60 pg/mL relative to baseline Decrease dose by 1 mcg daily or 2 mcg three times a week* Pediatric: Ages 10 to 16 years Increase each dose by 1 mcg three times a week every 4 weeks or decrease each dose by 1 mcg three times a week at any time based on iPTH, serum calcium and phosphorus levels.* * Not more frequently than every other day when dosing three times a week. Initial Dosage: CKD Stage 5 ( 2.2 , 2.3 ) Adult Dose (micrograms) = baseline iPTH (pg/mL) divided by 80. Administer dose orally three times a week.* Pediatric: Ages 10 to 16 years Dose (micrograms) = baseline iPTH (pg/mL) divided by…
Contraindications
4 CONTRAINDICATIONS ZEMPLAR capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity [see Warnings and Precautions ( 5.1 )] . Evidence of hypercalcemia ( 4 ). Evidence of vitamin D toxicity ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Table 6 shows the clinically significant drug interactions with ZEMPLAR capsules. Table 6: Clinically Significant Drug Interactions with Paricalcitol CYP3A Inhibitors Clinical Impact Paricalcitol is partially metabolized by CYP3A. Hence, exposure of paricalcitol will increase upon coadministration with strong CYP3A inhibitors such as but not limited to: boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Intervention Dose adjustment of ZEMPLAR capsules may be necessary. Monitor closely for iPTH and serum calcium concentrations, if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor. Cholestyramine Clinical Impact Drugs that impair intestinal absorption of fat-soluble vitamins, such as cholestyramine, may interfere with the absorption of paricalcitol. Intervention Recommend to take ZEMPLAR capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine (or at as great an interval as possible) to avoid impeding absorption of paricalcitol. Mineral Oil Cl…
Adverse Reactions
6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reactions (> 5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults The safety of ZEMPLAR capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of ZEMPLAR capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the ZEMPLAR capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3: Table 3. Adverse Reactions by Body Sy…
Frequently Asked Questions
What is Zemplar used for?
Zemplar contains Paricalcitol. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Zemplar a controlled substance?
Zemplar is not classified as a controlled substance by the DEA.
What is the generic name for Zemplar?
The generic name for Zemplar is Paricalcitol. There are 10 other brand versions of Paricalcitol.
What is the NDC code for Zemplar 2 ug/mL?
The NDC (National Drug Code) for Zemplar 2 ug/mL is 0074-4637, listed by AbbVie Inc..