Doxercalciferol
Generic Name: doxercalciferol
Brand Names:
Doxercalciferol
11 DESCRIPTION Doxercalciferol injection contains doxercalciferol, which is a synthetic vitamin D 2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D 2 (1α,25-(OH) 2 D 2 ), a naturally occurring, biologically active form of vitamin D 2 . Doxercalciferol, USP is a white to off-white crystallized powder with a calculated molecular weight of 412.66 and a molecular formula of C 28 H 44 O 2 .
Overview
11 DESCRIPTION Doxercalciferol injection contains doxercalciferol, which is a synthetic vitamin D 2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D 2 (1α,25-(OH) 2 D 2 ), a naturally occurring, biologically active form of vitamin D 2 . Doxercalciferol, USP is a white to off-white crystallized powder with a calculated molecular weight of 412.66 and a molecular formula of C 28 H 44 O 2 .
Uses
1 INDICATIONS AND USAGE Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog: Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Before initiating treatment, ensure serum calcium is not above the upper limit of normal. ( 2.1 ) Dosage for doxercalciferol injection in patients with CKD on dialysis : Initiate dosing at 4 mcg by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day). Maximum dose is 18 mcg weekly. ( 2.4 ) Target the maintenance dose of doxercalciferol injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. ( 2 ) See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia [see Warnings and Precautions (5.1) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Adynamic Bone Disease [see Warnings and Precautions (5.4) ] The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with doxercalciferol. Table 3: Clinically Significant Drug Interactions with Doxercalciferol Injection Drugs that May Increase the Risk of Hypercalcemia Clinical Impact Concomitant administration of high doses of calcium-containing preparations or other vitamin D compounds may increase the risk of hypercalcemia. Thiazide diuretics are known to induce hypercalcemia by reducing excretion of calcium in the urine. Examples Calcium-containing products, other vitamin D compounds or thiazide diuretics Intervention Monitor serum calcium concentrations more frequently and adjust doxercalciferol dose as needed [see Warnings and Precautions (5.1) ].
Warnings
5 WARNINGS AND PRECAUTIONS Hypercalcemia : Can occur during treatment with doxercalciferol and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly. ( 2 , 5.1 ) Digitalis Toxicity : Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of doxercalciferol. 4 CONTRAINDICATIONS Doxercalciferol is contraindicated in patients with: Hypercalcemia [see Warnings and Precautions (5.1) ] Vitamin D toxicity [see Warnings and Precautions (5.1) ] Known hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol injection; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see Warnings and Pr...
Pregnancy
8.1 Pregnancy Risk Summary The limited available data with doxercalciferol in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations ] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxercalciferol injection is a clear, colorless aqueous solution supplied in 2 mL amber glass vials as follows. Total Strength per Total Volume Strength per mL Flip-off Cap Color Vial Count per Carton × Total Vial Volume and vial Type Carton NDC Vial NDC 2 mcg per mL 2 mcg/mL Yellow 1 × 1 mL single-dose vial 55150-357-01 55150-357-01 50 × 1 mL sing...
Frequently Asked Questions
What is Doxercalciferol used for?▼
1 INDICATIONS AND USAGE Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog: Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. ( 1 )
What are the side effects of Doxercalciferol?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia [see Warnings and Precautions (5.1) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Adynamic Bone Disease [see Warnings and Precautions (5.4) ] The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Doxercalciferol during pregnancy?▼
8.1 Pregnancy Risk Summary The limited available data with doxercalciferol in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations ] .
What are the important warnings for Doxercalciferol?▼
5 WARNINGS AND PRECAUTIONS Hypercalcemia : Can occur during treatment with doxercalciferol and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly. ( 2 , 5.1 ) Digitalis Toxicity : Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of doxercalciferol. 4 CONTRAINDICATIONS Doxercalciferol is contraindicated in patients with: Hypercalcemia [see Warnings and Precautions (5.1) ] Vitamin D toxicity [see Warnings and Precautions (5.1) ] Known hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol injection; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see Warnings and Pr...
Related Medications
Anaplasma Phagocytophilum, Babesia Microti, Bartonella Henselae, Borrelia Burgdorferi Nosode, Ehrlichia Nosode (canine), Mycoplasma Pneumoniae, Morbillinum, Meningococcus Nosode, Hepatitis B Nosode
anaplasma phagocytophilum, babesia microti, bartonella henselae, borrelia burgdorferi nosode, ehrlichia nosode (canine), mycoplasma pneumoniae, morbillinum, meningococcus nosode, hepatitis b nosode
PURPOSE: Anaplasma Phagocytophilum – Joint Pain, Babesia Microti - Headache, Bartonella Henselae - Fever, Borrelia Burgdorferi Nosode – Stiff Neck, Change in Smell and Taste, Ehrlichia Nosode – Flu Symptoms, Hepatitis B Nosode – Muscle Aches, Meningococcus Nosode – Fever, Morbillinum – Difficulty Chewing, Mycoplasma Pneumoniae - Headache
Amprolium
amprolium
Dosage form: POWDER. Active ingredients: AMPROLIUM (1 kg/kg). Category: BULK INGREDIENT.
Broad Spectrum
broad spectrum
Purpose Sunscreen
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.