ibandronate

ROUTE	ONSET	PEAK	DURATION
PO	unknown	0.5–2 hr	up to 1 mo
IV	unknown	3 hr	up to 3 mo

Contraindicated in:

Hypersensitivity;
Abnormalities of the esophagus that delay esophageal emptying (e.g., strictures, achalasia);
Uncorrected hypocalcemia;
Inability to stand/sit upright for at least 60 min;
Severe renal impairment (CCr <30 mL/min);
OB: Pregnancy.

Use Cautiously in:

History of upper GI disorders;
Concurrent use of NSAIDs or aspirin;
Invasive dental procedures, cancer, receiving chemotherapy, corticosteroids, or angiogenesis inhibitors, poor oral hygiene, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly fitting dentures (may ↑ risk of jaw osteonecrosis);
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: Consider age-related in body mass, renal and hepatic function, concurrent disease states, and drug therapy in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: ERYTHEMA MULTIFORME, STEVENS-JOHNSON SYNDROME

GI: diarrhea, dyspepsia, dysphagia, ESOPHAGEAL CANCER, esophageal/gastric ulcer, esophagitis

Local: injection site reactions

MS: musculoskeletal pain, pain in arms/legs, femur fractures, osteonecrosis (primarily of jaw)

Resp: asthma exacerbation

Misc: ANAPHYLAXIS

Interactions ⬆ ⬇

Drug-drug:

Calcium-, aluminum-, magnesium-, and iron- containing products, including antacids↓ absorption (ibandronate should be taken 60 min before).
Concurrent use of NSAIDs, including aspirin, may ↑ risk of gastric irritation.

Milk and other foods ↓ absorption.

Route/Dosage ⬆ ⬇

PO (Adults ): 150 mg once monthly.
IV (Adults ): 3 mg every 3 mo.

Availability ⬆ ⬇

(Generic available)

Tablets: 150 mg
Injection (prefilled syringes): 1 mg/mL

Assessment ⬆ ⬇

Osteoporosis: Assess patients for low bone mass before and periodically during therapy.
IV: Monitor for signs and symptoms of anaphylactic reactions (swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; skin rash, redness, or swelling; dizziness or fainting; fast heartbeat or pounding in chest; sweating) during therapy. Discontinue injection immediately and begin supportive treatment if symptoms occur.
Perform a routine oral exam prior to initiation of therapy. Dental exam with appropriate preventative dentistry should be considered prior to therapy. Patients with history of tooth extraction, poor oral hygiene, gingival infections, diabetes, or use of a dental appliance or those taking immunosuppressive therapy, angiogenesis inhibitors, or systemic corticosteroids are at greater risk for osteonecrosis of the jaw.

Lab Test Considerations:

Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating ibandronate therapy.
- May cause ↓ total alkaline phosphatase levels.
- May cause hypercholesterolemia.

Implementation ⬆ ⬇

PO: Administer first thing in the morning with 6–8 oz plain water 30 min before other medications, beverages, or food. DNC: Tablet should be swallowed whole; do not break, crush, or chew.
- Once-monthly tablet should be administered on the same date each mo.

IV Administration:

IV: Administer using prefilled syringe. Do not administer solution that is discolored or contains particulate matter. Administer IV only; other routes may cause tissue damage.
Rate: Administer as a 15–30 sec bolus.
Y-Site Incompatibility: Do not administer with calcium-containing solutions or other IV drugs.

Patient/Family Teaching ⬆ ⬇

Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D. Wait at least 60 min after administration before taking supplemental calcium and vitamin D.
- Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
- Inform patient that severe musculoskeletal pain may occur within days, mo, or yr after starting ibandronate. Symptoms may resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
- Advise patient to notify health care professional if rash or signs and symptoms of osteonecrosis of the jaw (pain, numbness, swelling of or drainage from the jaw, mouth, or teeth) occur.
- Instruct patient to notify health care professional if swallowing difficulties, chest pain, new or worsening heartburn, or trouble or pain when swallowing occurs; may be signs of problems of the esophagus.
- Advise patient to inform health care professional of ibandronate therapy prior to dental surgery.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
PO: Instruct patient on the importance of taking as directed, first thing in the morning, 60 min before other medications, beverages, or food. Ibandronate should be taken with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease absorption). Do not chew or suck on tablet. If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. If a once-monthly dose is missed and the next scheduled dose is >7 days away, take in the morning following the date it is remembered. Resume original schedule the following mo. If the next dose is <7 days away, omit dose and take next scheduled dose. Do not discontinue without consulting health care professional.
- Caution patient to remain upright for 60 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation. Advise patient to stop taking ibandronate and contact health care professional if symptoms of esophageal irritation (new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn) occur.
IV: Advise patient that IV doses should not be administered sooner than every 3 mo. If a dose is missed, have health care professional administer as soon as possible; next injection should be scheduled 3 mo from last injection.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention of or decrease in the progression of osteoporosis in postmenopausal women. Discontinuation after 3–5 yr should be considered for women with low risk for fractures.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0004- Genentech, Inc.
- 0004-0186- Boniva
  - 0004-0186-83- 1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK

0004- Genentech, Inc.
- 0004-0191- Boniva
  - 0004-0191-09- 1 SYRINGE, GLASS in 1 CARTON (0004-0191-09) > 3 mL in 1 SYRINGE, GLASS

23155- Heritage Pharmaceuticals Inc.
- 23155-162- Ibandronate sodium
  - 23155-162-31- 3 mL in 1 VIAL, GLASS (23155-162-31)

25021- Sagent Pharmaceuticals
- 25021-827- ibandronate sodium
  - 25021-827-61- 1 SYRINGE in 1 CARTON (25021-827-61) > 3 mL in 1 SYRINGE

33342- Macleods Pharmaceuticals Limited
- 33342-150- IBANDRONATE SODIUM
  - 33342-150-53- 3 CARTON in 1 BOX (33342-150-53) > 1 BLISTER PACK in 1 CARTON (33342-150-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK

47781- Alvogen Inc.
- 47781-103- IBANDRONATE SODIUM
  - 47781-103-21- 1 BLISTER PACK in 1 CARTON (47781-103-21) > 3 TABLET in 1 BLISTER PACK

47781- Alvogen Inc.
- 47781-103- IBANDRONATE SODIUM
  - 47781-103-33- 3 BLISTER PACK in 1 BOX (47781-103-33) > 1 TABLET in 1 BLISTER PACK (47781-103-07)

55111- Dr. Reddy's Laboratories Limited
- 55111-575- Ibandronate sodium
  - 55111-575-03- 3 BLISTER PACK in 1 CARTON (55111-575-03) > 1 TABLET in 1 BLISTER PACK (55111-575-11)

55111- Dr. Reddy's Laboratories Limited
- 55111-575- Ibandronate sodium
  - 55111-575-43- 1 BLISTER PACK in 1 CARTON (55111-575-43) > 3 TABLET in 1 BLISTER PACK (55111-575-13)

55150- AuroMedics Pharma LLC
- 55150-191- Ibandronate Sodium
  - 55150-191-83- 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) > 3 mL in 1 SYRINGE, GLASS

60429- Golden State Medical Supply, Inc.
- 60429-643- IBANDRONATE SODIUM
  - 60429-643-73- 3 BLISTER PACK in 1 PACKAGE (60429-643-73) > 1 TABLET, FILM COATED in 1 BLISTER PACK

60505- Apotex Corp
- 60505-2795- IBANDRONATE SODIUM
  - 60505-2795-0- 3 BLISTER PACK in 1 PACKAGE (60505-2795-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

60505- Apotex Corp.
- 60505-6097- Ibandronate Sodium
  - 60505-6097-0- 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) > 3 mL in 1 SYRINGE, GLASS

62756- Sun Pharmaceutical Industries, Inc.
- 62756-218- IBANDRONATE SODIUM
  - 62756-218-40- 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) > 3 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-237- Ibandronate Sodium
  - 65862-237-03- 1 BLISTER PACK in 1 CARTON (65862-237-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK

67457- Mylan Institutional LLC
- 67457-524- ibandronate sodium
  - 67457-524-33- 1 SYRINGE, GLASS in 1 CARTON (67457-524-33) > 3 mL in 1 SYRINGE, GLASS

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇