doxercalciferol

ROUTE	ONSET	PEAK	DURATION
PO	unknown	8 wk	1 wk
IV	unknown	8 wk	1 wk

Seen primarily as manifestations of toxicity (hypercalcemia)

CV: edema, arrhythmias, bradycardia, hypertension

EENT: conjunctivitis, photophobia, rhinorrhea

F and E: hypercalcemia

GI: nausea, vomiting, ↑liver enzymes, anorexia, constipation, dry mouth, metallic taste, PANCREATITIS, polydipsia, weight loss

GU: ↓libido, albuminuria, azotemia, nocturia, polyuria

Metab: hyperthermia

MS: arthralgia, bone pain, metastatic calcification, muscle pain

Neuro: dizziness, headache, malaise, somnolence, weakness

Resp: dyspnea

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, HYPOTENSION, DYSPNEA, AND CARDIAC ARREST)

Interactions ⬆ ⬇

Drug-drug:

Cholestyramine, colestipol, or mineral oil↓ absorption of vitamin D analogues.
Use with thiazide diuretics may result in hypercalcemia.
Corticosteroids↓ effectiveness of vitamin D analogues.
Use with digoxin↑ risk of arrhythmias.
Concurrent use of magnesium-containing drugs may lead to hypermagnesemia.
Calcium-containing drugs may ↑ risk of hypercalcemia.
Concurrent use of other Vitamin D supplements (↑ risk of hypercalcemia).
Agents that induce liver enzymes (phenobarbital, rifampin) and agents that inhibit liver enzymes (atazanavir, clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, verapamil, voriconazole) may alter requirements for doxercalciferol (monitoring of calcium and phosphorus recommended).

Drug-Food:

Ingestion of foods high in calcium content (see Food Sources for Specific Nutrients) may lead to hypercalcemia.

Route/Dosage ⬆ ⬇

PO (Adults ): Dialysis patients: 10 mcg 3 times weekly (at dialysis); dose may be adjusted by 2.5 mcg at 8-wk intervals based on intact PTH concentrations (maximum dose = 20 mcg 3 times weekly). Non-dialysis patients: 1 mcg/day; dose may be adjusted by 0.5 mcg at 2–wk intervals based on intact PTH concentrations (maximum dose = 3.5 mcg/day).
IV (Adults ): 4 mcg 3 times weekly at the end of dialysis; dose may be adjusted by 1–2 mcg at 8-wk intervals based on intact PTH concentrations (maximum dose = 6 mcg 3 times weekly).

Availability ⬆ ⬇

(Generic available)

Capsules: 0.5 mcg; 1 mcg; 2.5 mcg
Solution for injection: 2 mcg/mL

Assessment ⬆ ⬇

Assess for symptoms of vitamin deficiency prior to and periodically during therapy.
Assess patient for bone pain and weakness prior to and during therapy.
Observe patient carefully for evidence of hypocalcemia (paresthesia, muscle twitching, laryngospasm, colic, cardiac arrhythmias, and Chvostek’s or Trousseau’s sign). Protect symptomatic patient by raising and padding side rails; keep bed in low position.

Lab Test Considerations:

Monitor serum ionized calcium, phosphorus, and intact PTH concentrations prior to starting therapy, then weekly during the first 12 wk of therapy then periodically during therapy. Maintain serum calcium times phosphorus product (Ca X P) at <55 mg²/dL².
- Monitor alkaline phosphatase concentration periodically.

Toxicity and Overdose:

Toxicity is manifested as hypercalcemia, hypercalciuria, and hyperphosphatemia. Assess patient for appearance of nausea, vomiting, anorexia, weakness, constipation, headache, bone pain, and metallic taste. Later symptoms include polyuria, polydipsia, photophobia, rhinorrhea, pruritus, and cardiac arrhythmias. Notify health care professional immediately if these signs of hypervitaminosis D occur. Treatment usually consists of discontinuation of doxercalciferol, a low-calcium diet, use of low-calcium dialysate in peritoneal dialysis patients, or administration of a laxative. IV hydration and loop diuretics may be ordered to increase urinary excretion of calcium. Hemodialysis may also be used.

Implementation ⬆ ⬇

PO: Doses usually given during dialysis sessions.
IV Push: Administer by rapid injection through the catheter at the end of a hemodialysis period.

Patient/Family Teaching ⬆ ⬇

Advise patient that medication may be given during their dialysis session.
Review diet modifications with patient. See Food Sources for Specific Nutrients for foods high in calcium and vitamin D. Renal patients must still consider renal failure diet in food selection. Health care professional may order concurrent calcium supplement.
Encourage patient to comply with dietary recommendations of health care professional. Explain that the best source of vitamins is a well-balanced diet with foods from the 4 basic food groups and the importance of sunlight exposure. See Food Sources for Specific Nutrients for foods high in vitamin D.
Patients self-medicating with vitamin supplements should be cautioned not to exceed RDA. The effectiveness of megadoses for treatment of various medical conditions is unproved and may cause side effects.
Advise patient to avoid concurrent use of antacids containing magnesium.
Review symptoms of overdose and instruct patient to report these promptly to health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor infants exposed to doxercalciferol through breast milk for signs and symptoms of hypercalcemia.
Emphasize the importance of follow-up exams to evaluate progress.

Evaluation/Desired Outcomes ⬆ ⬇

Normalization of serum calcium and parathyroid hormone levels.

US Brand Names ⬆ ⬇

Hectorol, vitamin D₂

Code ⬆

NDC Code

0054- West-Ward Pharmaceuticals Corp.
- 0054-0338- Doxercalciferol
  - 0054-0338-19- 50 CAPSULE in 1 BOTTLE (0054-0338-19)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0339- Doxercalciferol
  - 0054-0339-19- 50 CAPSULE in 1 BOTTLE (0054-0339-19)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0388- Doxercalciferol
  - 0054-0388-19- 50 CAPSULE in 1 BOTTLE (0054-0388-19)

0409- Hospira, Inc.
- 0409-1330- DOXERCALCIFEROL
  - 0409-1330-01- 50 VIAL, MULTI-DOSE in 1 CARTON (0409-1330-01) > 2 mL in 1 VIAL, MULTI-DOSE (0409-1330-11)

0641- West-Ward Pharmaceutical Corp.
- 0641-6154- Doxercalciferol
  - 0641-6154-25- 25 AMPULE in 1 BOX (0641-6154-25) > 2 mL in 1 AMPULE (0641-6154-01)

0955- Winthrop U.S.
- 0955-17,20- Doxercalciferol
  - 0955-17,20-50- 1 BOTTLE in 1 CARTON (0955-17,20-50) > 50 CAPSULE in 1 BOTTLE

0955- Winthrop U.S.
- 0955-1721- Doxercalciferol
  - 0955-1721-50- 1 BOTTLE in 1 CARTON (0955-1721-50) > 50 CAPSULE in 1 BOTTLE

0955- Winthrop U.S.
- 0955-1722- Doxercalciferol
  - 0955-1722-50- 1 BOTTLE in 1 CARTON (0955-1722-50) > 50 CAPSULE in 1 BOTTLE

17478- Akorn, Inc.
- 17478-987- Doxercalciferol
  - 17478-987-11- 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-987-11) > 1 mL in 1 VIAL, SINGLE-DOSE (17478-987-01)

17478- Akorn, Inc.
- 17478-987- Doxercalciferol
  - 17478-987-21- 25 VIAL, SINGLE-DOSE in 1 CARTON (17478-987-21) > 1 mL in 1 VIAL, SINGLE-DOSE (17478-987-01)

17478- Akorn, Inc.
- 17478-988- Doxercalciferol
  - 17478-988-12- 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-988-12) > 2 mL in 1 VIAL, SINGLE-DOSE (17478-988-02)

17478- Akorn, Inc.
- 17478-988- Doxercalciferol
  - 17478-988-22- 25 VIAL, SINGLE-DOSE in 1 CARTON (17478-988-22) > 2 mL in 1 VIAL, SINGLE-DOSE (17478-988-02)

43598- Dr.Reddy's Laboratories Inc
- 43598-850- DOXERCALCIFEROL
  - 43598-850-50- 50 VIAL, MULTI-DOSE in 1 CARTON (43598-850-50) > 2 mL in 1 VIAL, MULTI-DOSE (43598-850-11)

58468- Genzyme Corporation
- 58468-0123- Hectorol
  - 58468-0123-1- 50 VIAL, SINGLE-USE in 1 BOX (58468-0123-1) > 2 mL in 1 VIAL, SINGLE-USE

58468- Genzyme Corporation
- 58468-0126- Hectorol
  - 58468-0126-1- 50 VIAL, SINGLE-USE in 1 BOX (58468-0126-1) > 1 mL in 1 VIAL, SINGLE-USE

58468- Genzyme Corporation
- 58468-0127- Hectorol
  - 58468-0127-1- 50 VIAL, MULTI-DOSE in 1 BOX (58468-0127-1) > 2 mL in 1 VIAL, MULTI-DOSE

64980- Rising Pharmaceuticals, Inc.
- 64980-228- Doxercalciferol
  - 64980-228-50- 1 BOTTLE in 1 CARTON (64980-228-50) > 50 CAPSULE in 1 BOTTLE

64980- Rising Pharmaceuticals, Inc.
- 64980-229- Doxercalciferol
  - 64980-229-50- 1 BOTTLE in 1 CARTON (64980-229-50) > 50 CAPSULE in 1 BOTTLE

64980- Rising Pharmaceuticals, Inc.
- 64980-230- Doxercalciferol
  - 64980-230-50- 1 BOTTLE in 1 CARTON (64980-230-50) > 50 CAPSULE in 1 BOTTLE

68084- American Health Packaging
- 68084-872- Doxercalciferol
  - 68084-872-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-872-25) > 1 CAPSULE in 1 BLISTER PACK (68084-872-95)

68180- Lupin Pharmaceuticals, Inc.
- 68180-718- Doxercalciferol
  - 68180-718-12- 10 VIAL, MULTI-DOSE in 1 CARTON (68180-718-12) > 2 mL in 1 VIAL, MULTI-DOSE (68180-718-01)

68180- Lupin Pharmaceuticals, Inc.
- 68180-718- Doxercalciferol
  - 68180-718-52- 50 VIAL, MULTI-DOSE in 1 CARTON (68180-718-52) > 2 mL in 1 VIAL, MULTI-DOSE (68180-718-01)

70121- Amneal Pharmaceuticals LLC
- 70121-1392- Doxercalciferol
  - 70121-1392-5- 50 VIAL, SINGLE-DOSE in 1 CARTON (70121-1392-5) > 2 mL in 1 VIAL, SINGLE-DOSE (70121-1392-1)

70121- Amneal Pharmaceuticals LLC
- 70121-1393- Doxercalciferol
  - 70121-1393-5- 50 VIAL, SINGLE-DOSE in 1 CARTON (70121-1393-5) > 1 mL in 1 VIAL, SINGLE-DOSE (70121-1393-1)

70121- Amneal Pharmaceuticals LLC
- 70121-1408- Doxercalciferol
  - 70121-1408-5- 50 VIAL, MULTI-DOSE in 1 CARTON (70121-1408-5) > 2 mL in 1 VIAL, MULTI-DOSE (70121-1408-1)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇